BMJ Open · For peer review only 1 A multi-centre individual-randomized controlled trial of...

For peer review only

A multi-centre individual-randomized controlled trial of screening and brief alcohol intervention to prevent risky

drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): Study protocol

Journal: BMJ Open

Manuscript ID bmjopen-2016-012474

Article Type: Protocol

Date Submitted by the Author: 29-Apr-2016

Complete List of Authors: Giles, Emma ; Teesside University, Health and Social Care Institute Coulton, Simon; University of Kent, Centre for Health Services Research Deluca, Paolo; King\'s College London, Addictions Department, Institute of Psychiatry Drummond, Colin; Kings College London, Addictions Department, Institute of Psychiatry Howel, Denise; Newcastle University, Institute of Health and Society Kaner, Eileen; Newcastle University, Institute of Health and Society McColl, Elaine; Newcastle University, Newcastle Clinical Trials Unit, 1-4 Claremont Terrace

McGovern, Ruth; Newcastle University, Institute of Health and Society Scott, Stephanie; Newcastle University, Institute of Health and Society Stamp, Elaine; Newcastle University, Institute of Health and Society Sumnall, Harry; Liverpool John Moores University, Centre for Public Health Tate, Les; North Tyneside Council, Young People's Drug and Alcohol Department Todd, Liz; Newcastle University, School of Education, Communication and Language Sciences Vale, Luke; Newcastle University, UK, Health Economics Group, Institute of Health and Society Birch, Jennifer; Teesside University, Health and Social Care Institute Boniface, Sadie; King\'s College London, Addictions Department, Institute

of Psychiatry Frankham, Jo; Liverpool John Moores University, Faculty of Education, Health and Community Gilvarry, Eilish; Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital Howe, Nicola; Newcastle University, Newcastle Clinical Trials Unit, 1-4 Claremont Road McGeechan, Grant; Teesside University, Health and Social Care Institute McGowan, Victoria; Durham University, Department of Geography Ogilvie, Jayne; University of Kent, Centre for Health Services Research Stanley, Grant; Liverpool John Moores University, Faculty of Education,

Health and Community Newbury-Birch, Dorothy; Teesside University, Health and Social Care Institute

<b>Primary Subject Heading</b>:

Public health

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

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Secondary Subject Heading: Addiction, Health policy

Keywords: Alcohol, Brief Intervention, Randomised Controlled Trial, School Setting

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A multi-centre individual-randomized controlled trial of screening and brief

alcohol intervention to prevent risky drinking in young people aged 14-15 in a

high school setting (SIPS JR-HIGH): Study protocol

Emma L Giles1, Simon Coulton

2, Paolo Deluca

3, Colin Drummond

3, Denise Howel

4, Eileen

Kaner4, Elaine McColl

4,5, Ruth McGovern

4, Stephanie Scott

4, Elaine Stamp

4, Harry Sumnall

6,

Les Tate7, Liz Todd

8, Luke Vale

9, Jennifer Birch

1, Sadie Boniface

3, Jo Frankham

10, Eilish

Gilvarry11

, Nicola Howe5, Grant J McGeechan

1, Victoria McGowan

12, Jayne Ogilvie

2, Grant

Stanley10

, Dorothy Newbury-Birch1

Corresponding author: Dr Emma L Giles; Health and Social Care Institute, Alcohol and Public

Health Team, Teesside University, Middlesbrough, TS1 3BA, UK; [email protected], 01642

384916.

Trial Sponsor: Mrs Lois Neal, Faculty of Medical Sciences, Newcastle University, Framlington

Place, Newcastle upon Tyne, Tyne and Wear, NE2 4HH, UK; [email protected].

1Health and Social Care Institute, Alcohol and Public Health Team, Teesside University,

Middlesbrough, TS1 3BA, UK. 2Centre for Health Services Research, George Allen Wing, University of Kent, Canterbury,

Kent, CT2 7NZ, UK. 3Addictions Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College

London, PO48, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, UK. 4Institute of Health and Society, Baddiley-Clark Building, Newcastle University, Richardson

Road, Newcastle upon Tyne, NE2 4AX, UK. 5Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle

upon Tyne, NE2 4AE, UK. 6Centre for Public Health, Liverpool John Moores University, Henry Cotton Campus, Level 2,

15-21 Webster Street, Liverpool, L3 2ET, UK. 7Young People’s Drug and Alcohol Department, North Tyneside Council, Hudson Street,

North Shields, Tyne and Wear, NE30 1DL, UK. 8 School of Education, Communication and Language Sciences, King George VI Building,

Newcastle University, Newcastle upon Tyne, NE1 7RU, UK. 9

Health Economics Group, Institute of Health and Society, Baddiley-Clark Building,

Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. 10

Faculty of Education, Health and Community, Liverpool John Moores University, IM

Marsh, Barkhill Road, Aigburth, Liverpool, L17 6BD, UK. 11

Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital, Gosforth,

Newcastle upon Tyne, NE3 3XT, UK. 12

Durham University, Department of Geography, Durham City, DH1 3LE, UK.

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Keywords: alcohol, young people, randomized controlled trial, high school, brief

intervention. Word count: 5076 (excl. references)

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ABSTRACT

Introduction: Drinking can have adverse impacts on health, wellbeing, education and social

outcomes for adolescents. Adolescents in England are amongst the heaviest drinkers in

Europe. In recent years the proportion of adolescents who drink alcohol has fallen, although

consumption among those who do drink has actually increased.

Methods and analysis: This is an individually randomized two armed trial that incorporates

a control arm of usual school-based practice plus a leaflet on alcohol issues, and an

intervention arm which combines usual practice with the addition of a 30 minute brief

intervention delivered by school learning mentors/trained staff. At least thirty schools will

be recruited from four regions in England (the North East, the North West, London, Kent

and Medway) to achieve the target of obtaining data on 235 per arm at follow-up. The

primary outcome is total alcohol consumed in the last 28 days, using the 28 day Timeline

Follow Back questionnaire measured at 12-month follow-up. The analysis of the

intervention will consider effectiveness and cost-effectiveness. An embedded qualitative

study will explore, via 1:1 in-depth interviews with (n=80) parents, young people and school

staff, intervention experience, the fidelity of the intervention and acceptability issues.

Thematic narrative synthesis will be used to report qualitative data.

Ethics and dissemination: Ethical approval was granted by Teesside University.

Dissemination plans include: writing papers for publication, conference presentations,

disseminating to local and national education departments, and the wider public health

community including via Fuse, and engaging with school staff and young people at the study

outset to comment on whether and how the project can be improved.

Registration details

ISRCTN Number: ISRCTN45691494; Ethical approval: 164/15

Funded by NIHR PHR 13/117/02; Sponsored by: Newcastle University. Protocol version 1.4.

Project timeline

The project began on 01/09/2015; the end of the study is anticipated as 31/03/2017.

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STRENGTHS AND LIMITATIONS OF STUDY

- A robust randomised-controlled study design.

- Validated screening tools used to measure attitudes and behaviours.

- Limited prior research has explored the use of alcohol brief interventions in UK

school settings.

- This definitive trial follows on from a successful pilot feasibility trial.

- The study relies on recruitment of sufficient school sites and willingness of learning

mentors to engage with the trial.

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BACKGROUND

Adolescents in England are amongst the heaviest drinkers in Europe 1. The percentage of

young people who have ever had an alcoholic drink in England increases with age from 10%

of 11-12 year olds to 34% of 13-15 year olds, and the prevalence of drinking in the last week

rises from 1% of 11 year olds to 18% of 15 year olds 2. In recent years the proportion of

adolescents who drink alcohol has fallen, although consumption among those who do drink

has actually increased 2. Alcohol can have adverse impacts on health, wellbeing, education

and social (including learning) outcomes for the many young people who are drinking

alcohol. The impact of alcohol on the development and behaviour of young people has been

well researched in early 3, middle

4 and late adolescence

5. It is now well known that young

people are much more vulnerable than adults to the adverse effects of alcohol, due to a

range of physical and psycho-social factors which often interact 6.

There is no standardized definition of risky drinking in young people and so our definition

encompasses commonly understood concepts of hazardous drinking (at a level or pattern

that increases the risk of physical or psychological problems), harmful drinking (defined by

the presence of these problems) and binge drinking (risky single occasion, high intensity

drinking which can be episodic) as well as the Department of Health concepts of increasing

and high risk drinking 7. The Chief Medical Officer for England has provided

recommendations on alcohol consumption in young people 8 based on an evidence review

of the risks and harms of alcohol to young people 6. The recommendations state that

children should abstain from alcohol before the age of 15 and those aged 15-17 are advised

not to drink, but if they do drink it should be no more than what equates to adult daily

benchmarks 9.

Primary and secondary preventative interventions for risky drinking

There is a large volume of research on universal prevention to reduce risky drinking in the

school setting 10 11

. Such prevention is directed at all young people, whether they drink

alcohol or not, and aims to delay the age that drinking begins, often via general health

education. This body of work has shown mixed results with only a small number of

programmes reporting that interventions delivered in a school setting were more effective

in reducing alcohol use than control conditions 11

. Secondary prevention, i.e. targeting

interventions at young people who are already drinking alcohol, may be a more effective

and efficient strategy since the intervention is likely to have more salience for the

individuals receiving it.

This secondary prevention generally consists of screening (to identify relevant potential

recipients) followed by structured advice or counselling of short duration which is aimed at

reducing alcohol consumption or decreasing problems associated with drinking 12

. The

interventions are based on social cognitive theory which is derived from social learning

theory 13

.

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This current research aims to develop the evidence base by focusing on screening and brief

intervention to reduce risky drinking in younger adolescents (aged 14-15) in a school

context. The study follows on from the SIPS JR-HIGH pilot feasibility study which was funded

by the National Institute of Health Research Public Health Programme (NIHR PHR)

(ISRCTN07073105).

� Main Trial

AIMS, OBJECTIVES AND METHODS

Research aim

The aim of the study is to evaluate the effectiveness and cost-effectiveness of alcohol

screening and brief intervention to reduce risky drinking in young people aged 14-15 in the

English school setting.

Primary outcome

• Total alcohol consumed in standard units in the last 28 days, using the 28 day Timeline

Follow Back questionnaire 14

at 12-month follow-up.

Baseline measurements

• Student Alcohol Questionnaire (A-SAQ) 15

to measure risky drinking (scoring ‘4 or more

times but not every month’, ‘at least once a month but not every week’, ‘every week but

not every day’, or ‘every day’);

• Alcohol use frequency, quantity (on a typical occasion) and binge drinking (six or more

drinks in one session for men and women) assessed using the modified 10 question

Alcohol Use Disorders Identification Test (AUDIT) 16

which has been shown to be a highly

sensitive tool for college students 17

;

• Alcohol related problems assessed using the validated Rutgers Alcohol Problems

Inventory (RAPI) which includes measures on aggression 3;

• Drunkenness during the last 30 days, dichotomised as ‘never’ and ‘once or more’ 4;

• Drinking motives assessed using the 20-item Drinking Motives Questionnaire (DMQ).

This tool uses a six-point Likert scale, which measures motives to drinking across four

domains (social, coping, enhancement and conformity). Higher scores within each

domain indicate stronger endorsement of positive reinforcement received through

consumption of alcohol 5;

• General psychological health using the 14 item Warwick Edinburgh Mental Well-Being

Scale (WEMWBS) 18

. This tool uses a five-point Likert scale which gives a score of one to

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five per question giving a minimum score of 14 and maximum score of 70. A higher

WEMWBS score indicates a higher level of mental well-being 19

. The WEMWBS has been

previously validated in UK adolescents20

;

• Two questions relating to sexual risk taking are included. These are the same questions

as in the pilot study 21

. These questions are: ‘After drinking alcohol, have you engaged in

sexual intercourse that you regretted the next day?’ and ‘After drinking alcohol, have

you ever engaged in sexual intercourse without a condom?’ Both questions can be

answered with one of the three following options: ‘I have never engaged in sexual

intercourse’, ‘Yes’, or ‘No’;

• Energy drink consumption will be assessed by asking young people how many times a

week they consume energy drinks. Young people can answer: ‘never’, ‘less than once a

week’, ‘2-4 days a week’, ‘5-6 days a week’, ‘every day once a day’, and ‘every day more

than once a day’;

• Age of first smoking and how many cigarettes were smoked in the past 30 days 1;

• Demographic information collected will include gender and ethnicity. The first part of

the postcode will be collected for trial participants;

• Quality of life measured using the EQ-5D 5L, which is a valid measure for those aged 12

or older, and will be used to measure health related quality of life 22

. Responses to the

five items will be converted into utility scores using the UK population algorithm. This

will be administered at baseline and 12 months post intervention 22

;

• Quality Adjusted Life Years (QALY) estimated using general population tariffs from

responses to EQ-5D 5L administered and scored at baseline and 12 months.

12-month follow-up measurements

• All tools assessed at baseline;

• Percent days abstinence over last 28 days, drinks per drinking day and days>2 units from

28 day TLFB;

• Incremental cost per QALY gained at 12 months;

• Depending on findings, modelled estimates of incremental cost per QALY and cost-

consequences in the longer term;

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• National Health Service (NHS), educational, social, and criminal services data estimated

using a modified S-SUQ 23

and a learning mentor case diary developed in the pilot study,

measured at 12 months post intervention;

• Cost-consequences presented in the form of a balance sheet for outcomes at 12

months.

TRIAL PARTICIPANTS

Young people aged 14-15 in Year 10 in at least 30 Secondary/High schools/Academies in

four sites: the North East of England, North West of England, Kent and Medway, and

London. Schools will be included if they have learning mentors (or equivalent members of

pastoral staff, including teachers fulfilling this role) employed by the school. Screening will

take place in the personal, social and health education (PSHE) or equivalent lesson,

registration class, on a classroom basis, or in assembly. Interventions will take place in the

learning mentor’s classroom or office space. Pupils receive no recompense for taking part in

the trial, although each participating school will receive £1000 to assist with administration

and other costs of research participation.

Inclusion criteria

Young people aged 14-15 years inclusive, whose parents do not opt them out of the study,

scoring positively on the A-SAQ, leaving their name, and are willing and able to provide

informed written assent for intervention and follow-up.

Exclusion criteria

Young people already seeking or receiving help for an alcohol use disorder, with a

recognised diagnosis of a mental health disorder, or exhibit challenging behaviour.

TRIAL PROCEDURES

Learning mentors (or equivalent members of pastoral/trained staff; hereafter referred to as

‘learning mentors’) employed by schools will deliver the intervention. All learning mentors

will receive school-based training in the study procedures and intervention. Training for

learning mentors will be carried out by the trained Research Co-Ordinators. Simulated

scenarios between learning mentors will be audio recorded and learning mentors will be

assessed by an interventionist prior to embarking on the study with more training support

offered if needed. Learning mentors will be provided with materials and on-going guidance

and supervision will be provided by research staff. Support on implementing screening and

paperwork relevant to the research will be provided by the research team, with a Research

Co-ordinator in each geographical site. Research staff and trainers will maintain regular

contact with schools throughout the study period, including site visits and telephone and

email support.

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Control arm

Usual practice on alcohol health education as delivered normally to all students, including in

Personal Social and Health Education (PSHE) lessons and curriculum delivered by class

teachers, and usual individualised support for young people with an identified alcohol

concern. Young people in the control arm will also be given a healthy lifestyle information

leaflet (not containing advice about alcohol) with local sources of help, by the trained staff.

Usual practice may vary from school to school and information related to this will be

captured by researchers at both time points of the study.

Intervention

In addition to input equivalent to the control arm, young people who are eligible and assent

to participate will take part in a single 30-minute personalised interactive worksheet-based

session which was developed during the pilot feasibility trial. This will be delivered by the

trained staff (at school) and will contain personalised feedback about the individual

student’s drinking behaviour, and behaviour change counselling which encompasses the

elements of the FRAMES approach [20]. The intervention also includes advice about the

health and social consequences of continued risky alcohol consumption.

Randomization

Neither the learning mentor nor the young person will know which arm they are

randomized to until after they assent to take part in the trial. Young people will be

randomized in a 1:1 ratio to the intervention and control arms, with individual

randomization stratified by school. A statistician not otherwise involved with the study will

produce a computer-generated allocation list to ensure allocation concealment.

[Insert Figure 1 Here]

RECRUITMENT, ASSENT AND SCREENING

Recruitment

In each of the four geographical sites, initially school performance league tables 24

will be

reviewed and schools from the top, middle and bottom of the league table will be

contacted. Snowball sampling will allow contact with potential schools via relationships with

recruited schools. Gatekeepers and key personnel (e.g. School Board of Governors; County

Council contacts) will be approached to suggest – and create an initial contact – with

potential schools.

Option to opt-out of screening (assent)

In advance of screening, all parents/caregivers (hereafter referred to as ‘parents’) will be

informed by letter, sent by the school, that young people will be screened as part of the

study within their child’s school. Parents will have the choice to opt their child out of the

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study by completing an opt-out form and sending this (in the freepost envelope provided) to

the co-ordinating research centre at Teesside University. Those young people whose

parents have opted them out of the study will not complete the questionnaire. If the opt-

out is received after the questionnaire is completed, the questionnaire will be removed

from the trial. Additionally, where possible, young people who have been opted-out will not

be in the classroom at the time the questionnaire takes place. Obtaining assent to take part

in this manner is a method widely used in various national youth questionnaires of alcohol

consumption and other health behaviours 25

.

Screening for the trial

A video-clip will be played to the young people opted into the study, in each school, to give

instructions on completing the questionnaires (see:

https://www.youtube.com/watch?v=2ZBm3VZVtx0&feature=em-upload_owner). This

video-clip will only provide guidance on the process of questionnaire completion and not on

the content. Young people will be asked to voluntarily leave their name and class on the

questionnaire. Young people will have the option to: a) not complete the questionnaire

(indicative of lack of assent to screening from the young person); b) complete the

questionnaire anonymously; or c) complete the questionnaire adding their name and class.

Each young person will place their completed questionnaire in an envelope and then return

it to the teacher. Teachers will not open these envelopes. Individual responses will not be

shared with the class teacher or learning mentor. The Research Co-Ordinator will collect the

sealed envelopes from the school. Those young people who have screened positively on the

A-SAQ (see below) and have left their name will be eligible for the trial. Completed baseline

questionnaires by trial participants will be used for the baseline measurements.

DATA COLLECTION

Baseline data collection

The study envelope will contain a series of questionnaires including the study screening

questionnaire (part of the A-SAQ): ‘In the last 12 months how often have you drunk more

than 3 units of alcohol?’ with the response options of ‘Never’; ‘less than 4 times’; ‘4 or more

times but not every month’; ‘at least once a month but not every week’; ‘every week but

not every day’; ‘every day’. Scoring ‘4 or more times’, or more frequently, indicates a

positive screen and eligibility for the trial. This score was shown in our pilot feasibility trial to

be a methodologically robust approach to identifying the adolescent population who may

benefit from an intervention 21

. The A-SAQ will be embedded within a larger questionnaire

with items addressing a number of health and lifestyle topics (described above).

Invitation to meet with learning mentors

Completed baseline questionnaires will be enclosed in a sealed envelope and returned to

the individual universities coordinating each study site. The A-SAQ will be scored and a list

of ID numbers and names of those that score positive will be sent to a researcher at

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Teesside University. After learning mentor training (convened by study site coordinators),

learning mentors will be given case packs for each eligible young person. Learning mentors

will invite young people who scored positive on A-SAQ on the baseline questionnaire to a

meeting with them in their office, where they will open the case pack. In the case pack there

will be an information leaflet, a case diary, assent forms, and a sealed envelope which

contains the randomized condition (intervention or control). Young people will be informed

that participation is voluntary and will be given the information leaflet to read before

signing the assent form. The assent form also asks for the first part of the young person’s

postcode. The postcode information will be used to enable a stratified sample of young

people to be invited to take part in the qualitative study. Once a young person has assented

the second envelope will be opened which will state whether the participant has been

randomized to intervention or control. The learning mentor will then deliver the brief

intervention or give the participant the control leaflet (in the same meeting). The completed

case packs will be sealed and returned to coordinating sites, then couriered to Teesside

University. At all times, only the randomization statistician (AB), one researcher (JB), and

individual learning mentors who meet with the young people will know of the

randomization allocations before the trial ends.

12-month follow-up

Follow-up will occur 12 months post intervention. All young people who are randomized

into the trial will be invited to meet with the Research Co-ordinator (in school) where they

will be asked to complete the same questionnaires used at baseline. The researcher will be

blinded to the condition the young person was allocated to. The TLFB (including the primary

outcome measure of total alcohol consumption) will also be completed face-to-face in

schools with the researcher in order to limit bias in the results. All trial participants will be

given an admit-one cinema voucher, to compensate them for their time involved in the

study 26

. Trial participants’ baseline and follow-up questionnaires will be linked with a

unique ID (the screening number). All participants will be asked by the researcher at follow-

up whether they are willing to be contacted for an in-depth interview by a researcher who

may be the same individual or another researcher.

Intervention fidelity

It is important to ensure learning mentors deliver the intervention in accordance with the

intervention manual. To establish intervention fidelity, we will complete competency and

fidelity checks at two time points: 1) competency checks of learning mentor training, and 2)

fidelity checks of cases delivered during the intervention phase. For the competency checks,

each learning mentor will have one simulated intervention with another learning mentor or

the research co-ordinator. Of these sessions, at least 80% will be recorded and ‘signed off’

by an independent expert rater from the research team using the BECCI rating scale 27

.

Additionally, 20% of live cases will be assessed for fidelity (using a pragmatic sampling

approach). The BECCI scale is a tool that measures the skills involved in behaviour change

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counselling. It is scored 0-4 with a score of two or more (skills used to ‘some extent’) being

acceptable as used in previous studies21 28-30

. The young people will provide assent for the

live case recording to take place. As the recording and analysis of the delivery of the

intervention sessions forms part of the employment contract of the learning mentors,

formal consent is not required.

Sample size calculation

Using estimates from the pilot trial (mean year group size = 210, 87% completing baseline

questionnaire, 20% being positive on A-SAQ and leaving contact details, 80% recruited to

trial and 88% providing data at 12 months follow-up), the sample size has been calculated to

have a 90% power to detect a standardized difference of 0.3 (which equates to a ratio of 1.5

in geometric means in total alcohol units in 28 days) using a significance level of 5%. Follow-

up data will be required on 235 young people per arm (Figure 1).

ANALYSIS

Baseline data

Descriptive statistics (comparisons of percentages, means or medians as appropriate) will be

used to report the pupil-level baseline data, and completeness of intervention received

between those allocated to the two trial arms.

Primary outcome

The primary effectiveness analysis will be by intention-to-treat. Multiple linear regression

will be used to compare the primary outcomes between the two randomization groups at

12 months, adjusting for any imbalance in key covariates.

Secondary outcomes

The secondary outcomes will be analysed in a similar manner. Comparisons of means will be

presented as mean differences or ratios of geometric means (if a logarithmic transform is

necessary for skewed data) with 95% Confidence Intervals (CI) odds ratios and 95% CIs will

be presented for binary outcomes. Exploratory analyses will also be undertaken, for

example, to examine differences in outcome by gender, deprivation and extent of

intervention received, though there is limited power to investigate these comparisons. We

will consider any difference in attrition rates, and any non-randomness of the attrition,

when comparing outcomes between the two groups.

Health economics

The economic component will include both a within trial cost-utility and cost-consequence

analysis and, as described below, a model based analysis taking the perspective of the UK

public sector (NHS, educational, social, and criminal services). The cost-utility analysis will

use measures of effectiveness limited to health related quality of life as measured by EQ-5D

5L. The cost-consequence analysis will take the same perspective for costs but will present

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these alongside all of the primary and secondary measures of effectiveness outlined above.

The follow-up for the within trial analyses will be 12 months so discounting will not be

conducted. For the model based analysis the time horizon will be longer (potentially up to

the participant’s life time) and costs and effects will be discounted at 1.5%, the UK

recommended rate for public health interventions 31

, with a sensitivity analysis used to

explore the impact of higher (and lower) discount rates.

Within trial analysis cost-utility and cost-consequence analyses

For each trial participant the use of health, educational, criminal, and social care services

will be elicited using the S-SUQ administered at baseline (with a recall period of three

months) and 12 months. Further cost data will come from the learning mentor time case

diaries completed by the learning mentors for each contact. Costs for healthcare and social

services will be obtained from standard sources such as NHS reference (www.gov.uk), the

British National Formulary 32

for medications, Unit costs of Health and Social Care 33

for

contacts with primary care. Further data will come from the study centres themselves. Data

on the use of educational services will be elicited via the questionnaire. As part of the pilot

trial we confirmed with the expert group the type of services relevant to collect, and have

also added further questions related to days missed from school and truancy.

Learning mentor training costs will be included and will need to be apportioned according to

scaled up practice. This will be informed by data from the training conducted as part of the

trial and through expert opinion. The time of educational staff will be sought through a

parallel costing exercise in which these staff will be asked to provide information on the

impact of the intervention on their workload. With respect to learning mentors, a detailed

proforma (case diary) was developed and tested in the pilot to capture resource use and this

new tool will be used in this study. With respect to school building and other large capital

items, the opportunity cost will be considered. Some resources (e.g. buildings) will exist with

or without the intervention and the intervention may not displace any other activity. In this

circumstance the opportunity cost of the building would be zero. However, costs might be

incurred in terms of heat, power and light and these data will be captured using standard

costing methods 34

. For each participant, measures of use of resources will be combined

with unit costs to provide a cost for that participant. We anticipate that the price year

adopted for the base case analysis will be 2017 when the final analysis is conducted.

The EQ-5D 5L will be administered at baseline and 12 months with UK population tariffs 35

used. Health state utilities from the EQ-5D 5L will then be used to estimate QALYs using the

area under the curve approach 22

.

� Qualitative Study

Aims

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In addition to the main trial, an embedded qualitative study will be conducted. The

qualitative study will:

• Explore the delivery and efficacy of screening and brief intervention approaches in the

school setting, and to elicit participants’ experiences of the study;

• In interviews with school staff: explore the mechanisms and processes of implementing

the SIPS JR-HIGH intervention to understand how this brief intervention could become

embedded in the work role of school staff, the prioritisation of educational or well-being

work, the scope for team or individual professional input, staff skill mix and turnover,

resources, role development and training needs, and participants’ assent;

• In interviews with young people: explore their experiences of taking part in the study

and their views on any derived benefits, adverse events, or improvements;

• In interviews with parents: explore their views on school-led interventions for

adolescent alcohol use, issues relating to parental consent to take part in such

interventions, and the appropriateness of school-led health promotion work across the

school-home interface.

Sample

At each of the four research sites, we will seek to interview a minimum of: two teachers and

four learning mentors from different schools (24 interviews in total); and participating

young people from a random selection of included schools, with an even representation of

males and females across both trial arms (40 interviews). We will also interview parents of

young people in attendance at schools in each of the four sites (16 interviews in total). We

will endeavour to include mothers and fathers (both co-habiting and lone parents) in the

sample as well as parents of both boys and girls covering different cultural groups. Variation

will also be sought in terms of drinking risk status of the young people (based on A-SAQ

screening data) and socioeconomic status of young people and parents (as measured by

index of multiple deprivation rank of school and the first part of the pupil’s postcode at

baseline and A-SAQ score at follow-up). Teachers and learning mentors will be sampled

according to variation of socioeconomic status of the school where they are employed. Data

saturation for either dataset (school staff or young people) will be defined as no

substantively new themes having emerged from the analysis of three consecutive interviews 36

.

RECRUITMENT, CONSENT AND ASSENT

Research Co-Ordinators from each of the four sites will disseminate an invitation letter and

information leaflets to all participating teachers and learning mentors. In addition, school

staff from each of the four sites will disseminate the letter and information leaflet to all

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young people. Schools will text parents and direct them to an online platform containing the

invitation letter and information leaflet.

The online facility will offer the ability to opt-in to the study, which parents, young people

and school staff can complete if they wish to participate in the qualitative interviews.

Alternatively, they can contact the research co-ordinator to arrange a suitable interview

date by email or telephone.

Consent and assent

All participants will be given a copy of a relevant information sheet and school staff and

parents will be asked to complete a consent form and young people an assent/consent form

before taking part in the qualitative component of the study.

STUDY DESIGN

Semi-structured face-to-face interviews will be conducted with all participants. All

interviews will be audio recorded and transcribed verbatim.

ANALYSIS

Data from all interviews will be subjected to thematic analysis, which is appropriate for

qualitative health research which seeks to explore key concepts pertinent to the research

aims, but without presupposing a rigid framework and a priori selection of key themes 37

.

This analytic strategy is characterised by an inductive approach, in which analysis is open

and flexible, allowing themes to be generated from the research, in order that findings have

relevance to applied research questions, but are not led by the researchers, as would a

deductive approach dictate 38 39

. Data will be coded by a qualitative researcher following

standard thematic analysis procedures. That said, our development of the discussion guide

for the interviews will be informed by theory on the likelihood of embedding study

interventions in clinical practice, namely Normalization Process Theory 40

. It is expected that

the discussion guide will include questions linked to intervention implementation, such as

role legitimacy (appropriateness of role/parental views, any role conflicts), adequacy

(training, how the children are identified, how the intervention is conducted) and support

(time available, support from school, parents). This theory considers factors that affect

implementation in four key areas: how people make sense of a new practice (coherence);

the willingness of people to sign-up and commit to the new practice (cognitive

participation); their ability to take on the work required of the practice (collective action);

and activity undertaken to monitor and review the practice (reflexive monitoring). The

approach is increasingly used in studies of the implementation of interventions in health

care (www.normalizationprocess.org). Data from interviews with young people and parents

will also be analysed inductively first through open coding and thematic analysis, and will

follow the principles of constant comparison thereafter 41

. In this way, a qualitative

researcher will read the interview transcripts and identify important or recurrent themes

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emerging from the transcripts. These emergent themes will be utilised to code the

remaining transcripts, with open coding of any new themes that may emerge to expand on

the emerging theory/results. In addition to NPT, we will also develop the discussion guide

accounting for Bourdieu’s concept of habitus 42 43

; an approach used successfully by this

team in qualitative work with young people within the age range of this study 44

and their

parents 45

. Habitus represents a set of tastes and dispositions shared with others in social

space 45

, providing cultural norms and historic precedents continually reproduced through

practice 46

. Use of this theoretical framework offers a mechanism in which to explore young

people’s socially constructed responses to brief intervention. Furthermore, the reciprocal

idea of an individual and their interaction with society accords with the social learning

underpinning of brief intervention.

At least one other qualitative expert will read and second-code a proportion of interviews

with both young people and staff; any divergence between coders will be discussed on an

on-going basis to inform the analysis, resolve divergent interpretations and enrich the

analysis 37

. Coded data will be reviewed to produce a detailed description of key results. We

will use NVivo software to aid indexing and charting. Analysis will be ongoing throughout

the process of data collection, and will be discussed at regular meetings within the research

team in order to identify areas for closer consideration (including negative case analysis)

and to enhance credibility of the analytical process and data interpretation 47

. Qualitative

analysis will take place prior to outcomes analysis, in keeping with published

recommendations 48

.

TRIANGULATION

Once the qualitative interviews from this study have been carried out and analysed

separately, they will be combined with the quantitative data from the main trial at the

‘analysis/interpretation’ phase, which is a process often described as 'triangulation' 49

. In

our study, data will be reconciled by adopting a model which relies on the principle of

complementarity 50

. Within this approach it is explicitly recognised that qualitative and

quantitative methods may be used to examine different aspects of an overall research

question 49

.

STUDY REPORTING AND PUBLICATIONS

If the intervention is shown to be effective and efficient we will develop a manualised

alcohol screening and brief intervention protocol to facilitate uptake/adoption in routine

practice in secondary schools in England.

It is planned to publish this study in peer reviewed articles and to present data at national

and international meetings. Results of the study will also be reported to the Sponsor and

Funder, and will be available on their website. All manuscripts, abstracts or other modes of

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presentation will be reviewed by the Trial Steering Group and funder prior to submission.

Individuals will not be identifiable in any study report.

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Figure Legend

Figure 1: Study flowchart

Authors’ contributions

All of the authors contributed to the design and development of this trial protocol. DNB is

the chief investigator and ELG is the project manager of the SIPS JR-HIGH trial. The

disciplines represented in the team include: public health research (EK, DNB, SO’N, RM; ELG;

GM); alcohol and policy expertise (EK, DNB, SO’N, RM); conducting research with children

and young people (SO’N, RM); child and adolescent psychiatry (PM); health psychology (PD);

addiction psychiatry (CD, EG); criminology (DNB); medical statistics (DH, SC, ES) and trial

methodology (EM, SC, EK, CD, DH, CS, CH), health economics (MD, EG), and trial

management (CS, CH). LT has experience of education and learning mentors. The Newcastle

Clinical Trials Unit is a UK CRC-registered Clinical Trials Unit, with a strong track record in the

design, conduct, and analysis of NIHR-funded trials, including those of complex

interventions and feasibility/pilot trials. VM, ELG and DNB wrote the first draft of the paper

and all authors contributed to successive drafts. All authors read and approved the final

manuscript.

Funding statement

This work is supported by the National Institute for Health Research Public Health Research

(NIHR) Programme Grant Number 13/117/02. The views and opinions expressed herein are

those of the authors and do not necessarily reflect those of the PHR Programme, NIHR, NHS,

or the Department of Health.

Colin Drummond is partly funded by the NIHR Biomedical Research Centre for Mental

Health at South London and Maudsley NHS Foundation Trust and King’s College London, and

is partly funded by the NIHR Collaborations for Leadership in Applied Health Research and

Care South London at King’s College Hospital NHS Foundation Trust.

Eileen Kaner is funded by the NIHR School of Primary Care Research and the NIHR School of

Public Health as a member of Fuse, a UKCRC Centre of Excellence in Public Health.

Ruth McGovern is funded through an NIHR Post Doctorate Fellowship.

Stephanie Scott is funded by the NIHR School of Public Health.

Competing Interest’s Statement

Eilish Gilvarry is a reviewer for NIHR.

Denise Howel was a member of the NIHR Health Services and Delivery Research

Commissioning Board until December 2015, and is a sub-panel member for NIHR

Programme Grants for Applied Research from February 2016.

Eileen Kaner is a funding board member of the NIHR Public Health Research funding board

and the NIHR Senior Fellowships panel.

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Elaine McColl is a sub-panel member for NIHR Programme Grants for Applied Research.

Luke Vale is a member of the NIHR Health Technology Assessment Clinical Evaluation and

Trials Panel, NIHR Programme Grants for Applied Research Panel and Director of NIHR

Research Design Service for the North East.

Remaining authors have no competing interests to declare.

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REFERENCES

1. Hibbell B, Guttormsson U, Ahlström S, et al. The 2011 ESPAD Report: Substance Use

Among Students in 36 European Countries. 2012.

2. Hawkins V. Smoking, drinking and drug use among young people in England in 2014.

London: Health and Social Care Information Centre, 2015.

3. White H, Labouvie H. Towards the assessment of adolescent problem drinking. J Stud

Alcohol 1989;50(30):7.

4. Segrott J, Gillespie D, Holliday J, et al. Preventing substance misuse: study protocol for a

randomised controlled trial of the Strengthening Families Programme 10–14 UK (SFP

10–14 UK). BMC Public Health 2014;14(49):1-21.

5. Cooper M. Motivations for alcohol use among adolescents: Development and validation

of a four-factor model. Psychol Assess 1994;6:117-28.

6. Newbury-Birch D, Gilvarry E, McArdle P, et al. The impact of alcohol consumption on

young people: A review of reviews: Department of Children Schools and Families,

2009.

7. NHS Choices. The risks of drinking too much. Secondary The risks of drinking too much.

www.nhs.uk/Livewell/alcohol/Pages/Effectsofalcohol.aspx.

8. Department of Health. Guidance on the consumption of alcohol by children and young

people from Sir Liam Donaldson Chief Medical Officer for England: Crown Copyright,

2009.

9. Department of Health. Alcohol Guidelines Review –Report from the Guidelines

development group to the UK Chief Medical Officers. In: Department of Health, ed.

London, 2016.

10. National Institute for Clinical Excellence. Interventions in schools to prevent and reduce

alcohol use among children and young people. London: NICE, 2007.

11. Foxcroft D, Tsertsvadze A. Universal school-based prevention programs for alcohol

misuse in young people: Cochrane Database of Systematic Reviews, 2011.

12. Kaner E, Dickinson H, Beyer F, et al. The effectiveness of brief alcohol interventions in

primary care settings: a comprehensive review. Drug Alcohol Rev 2009;28:301-23.

13. Bandura A. Social learning theory. Englewood Cliffs, NJ: Prentice-Hall, 1997.

14. Sobell L, Sobell M. Alcohol Timeline Followback Users' Manual. Toronto, Canada:

Addiction Research Foundation, 1995.

15. Engs RC, D.J. H. The Student Alcohol Questionnaire: an updated reliability of the drinking

patterns, problems, knowledge, and attitude subscales. Psychol Rep 1994;74(1):12-

14.

16. Babor T, De La Fuente J, Saunders J, et al. AUDIT, The Alcohol Use Disorders

Identification Test, guidelines for use in primary health care. Geneva: World Health

Organisation, 1989.

17. Reinert DF, Allen JP. The Alcohol Use Disorders Identification Test: An Update of

Research Findings. Alcohol Clin Exp Res 2007;Vol. 31(No. 2):pp. 185-99.

18. NHS Health Scotland, University of Warwick. Warwick-Edinburgh Mental Well-Being

Scale (WEMWBS). Scotland, 2006.

19. Tennant R, Hiller L, Fishwick R, et al. The Warwick-Edinburgh Mental Well-being Scale

(WEMWBS): development and UK validation. Health Qual Life Outcomes 2007;5:63.

Page 21 of 65


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2016. Dow

nloaded from



21

20. Clarke A, Friede T, Putz R, et al. Warwick-Edinburgh Mental Well-Being Scale

(WEMWBS): Validated for teenage school students in England and Scotland. A mixed

methods assessment. BMC Public Health 2011;11:487.

21. Newbury-Birch D, Scott S, O'Donnell A, et al. A pilot feasibility cluster randomised

controlled trial of screening and brief alcohol intervention to prevent hazardous

drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH). In: NIHR

Public Health Research Program Report, ed., 2014.

22. Euroquol. EuroQuol-a new facility for the measurement of health-related quality of life.

Health Policy 1990;16:199 - 208.

23. Team UR. Cost effectiveness of treatment for alcohol problems: findings of the

randomised UK alcohol treatment trial (UKATT). BMJ 2005;331(7516):544.

24. Performance Tables - The Department for Education - School and College. Secondary

Performance Tables - The Department for Education - School and College 2016.

http://www.education.gov.uk/schools/performance/.

25. Fuller E. Smoking, drinking and drug use among young people in England in 2013.

London: NatCen Social Research, 2014.

26. Systematic Review of Strategies to Reduce Attrition in Randomised Trials. The Society for

Clinical Trials Annual Meeting; 2013; Boston. Clinical Trials.

27. Lane C, Huws-Thomas M, Hood K, et al. Measuring adaptations of motivational

interviewing: the development and validation of the behavior change counseling

index (BECCI). Patient Educ Couns 2005;56(2):166-73.

28. Kaner E, Bland M, Cassidy P, et al. Effectiveness of screening and brief alcohol

intervention in primary care (SIPS trial): pragmatic cluster randomised controlled

trial. BMJ 2013;346.

29. Drummond C, Deluca P, Coulton S, et al. The effectiveness of alcohol screening and brief

intervention in emergency departments: a multicentre pragmatic cluster randomized

controlled trial. PLOS ONE 2014;9(6):e99463.

30. Newbury-Birch D, Coulton S, Bland M, et al. Alcohol screening and brief interventions for

offenders in the probation setting (SIPS Trial): a pragmatic multicentre cluster

randomised controlled trial. Alcohol Alcoholism 2014;49(5):540-48.

31. National Institute for Clinical Excellence. Guide to the methods of technology appraisal.

London, 2013.

32. British Medical Association, Royal Pharmaceutical Society. British National Formulary

Edition 65, 2013.

33. Curtis L. Unit Costs of Health and Social Care 2012. In: Personal Social Services Research

Unit, ed. Canterbury: University of Kent, 2013.

34. Drummond M, Stoddart G, Torrance G. Methods for the Economic Evaluation of Health

Care Programmes. Oxford: Oxford University Press, 2005.

35. Kind P, Hardman G, Macran S. UK population norms for EQ-5D. University of York:

Centre for Health Economics, 1999.

36. Francis J, Johnston M, Robertson C, et al. What is an adequate sample size?

Operationalising data saturation for theory-based interview studies. Psychol Health

2009;25(10):1229-45.

37. Pope C, Ziebland S, Mays N. Analysing qualitative data. BMJ 2000;320(7227):114-16.

38. Ritchie J, Lewis J. Qualitative Research Practice: A Guide for Social Science Students and

Researchers: Sage, 2003.

Page 22 of 65


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123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2016. Dow

nloaded from



22

39. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A,

Burgess R, eds. Analysing qualitative data London: Routledge, 1993:17394. London:

Routledge, 1993.

40. May C, Finch T, Ballini L, et al. Evaluating complex interventions and health technologies

using normalization process theory: development of a simplified approach and web-

enabled toolkit. BMC Health Serv Res 2011;11(1):245.

41. Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and

techniques. Newbury Park CA: Sage, 1990.

42. Bordiue P. The Logic of Practice. Cambridge: Polity Press, 1990.

43. Bordiue P. Distinction. Cambridge, 1984.

44. Scott S, Baker R, Shucksmith J, et al. Autonomy, special offers and routines: a Q

methodological study of industry-driven marketing influences on young people's

drinking behaviour. Addict 2014:n/a-n/a.

45. Brierley-Jones L, Ling J, McCabe K, et al. Habitus of ‘home’ and ‘traditional’ drinking: a

qualitative analysis of reported middle class alcohol use. Sociol Health Illn

2014;36(7):1054-76.

46. Crawshaw P, Bunton R. Logics of practice in the risk environment. Health Risk Soc

2008;11(3):269-82.

47. Barbour R. The Newfound Credibility of Qualitative Research? Tales of Technical

Essentialism and Co-Option. Qual Health Res 2003;13(7):1019-27.

48. O'Cathain A, Thomas KJ, Drabble SJ, et al. What can qualitative research do for

randomised controlled trials? A systematic mapping review. BMJ Open 2013;3(6).

49. O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed

methods studies. BMJ 2010;341(c4587).

50. Moffatt S, White M, Mackintosh J, et al. Using quantitative and qualitative data in health

services research – what happens when mixed method findings conflict? BMC Health

Serv Res 2006;6(28):1-10.

Page 23 of 65


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Flowchart of Study

338x190mm (96 x 96 DPI)

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APPENDIX 1

A multi-centre individual-randomised

controlled trial of screening and brief

alcohol intervention to prevent risky

drinking in young people aged 14-15 in

a high school setting (SIPS JR-HIGH):

Study protocol

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V1.4 26.04.2016

Full Title: A multi-centre individual-randomised controlled trial of

screening and brief alcohol intervention to prevent risky drinking in

young people aged 14-15 in a high school setting (SIPS JR-HIGH)

Short title: SIPS JR-HIGH

Chief Investigator: Professor Dorothy Newbury-Birch1

Co-applicants: Professor Eileen Kaner2, Professor Elaine McColl

2,7, Denise Howel

2, Elaine

Stamp2, Dr Ruth McGovern

2, Dr Stephanie Scott

2, Professor Luke Vale

2, Professor Liz Todd

2,

Professor Simon Coulton3, Professor Colin Drummond

4, Dr Paolo Deluca

4, Professor Harry

Sumnall5, Les Tate

6

Principal Investigators (sites): Professor Dorothy Newbury-Birch (North East), Professor Harry

Sumnall (North West), Professor Simon Coulton (Kent), Professor Colin Drummond/Dr Paolo

Deluca (London).

Project Manager: Dr Emma Giles1

Senior Trial Manager (NCTU): Claire Macdonald7

Research Co-ordinators: Dr Grant McGeechan1, Jayne Ogilvie

3, Dr Sadie Boniface

4, Jo

Frankham5, Grant Stanley

5

Qualitative Researcher: Dr Victoria McGowan1

Database Manager: Nicola Howe2

Administrative Assistant: Robert Sayer1

1Health and Social Care Institute, Teesside University,

2Institute of Health and Society,

Newcastle University, 3University of Kent,

4Kings College London,

5Liverpool John Moores

University, 6North Tyneside Council,

7Newcastle Clinical Trials Unit, Newcastle University

• ISRCTN Number: ISRCTN45691494

• Ethics approval number: No 164/15

• Protocol Version and Date: Version 1.4. 26.04.2015

• Funded by / Grant reference: NIHR PHR 13/117/02

• Sponsored by: Newcastle University

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V1.4 26.04.2016

1. Protocol contacts

Chief Investigator: Professor Dorothy Newbury-Birch, Professor of Alcohol and Public Health

Research, Health and Social Care Institute, Teesside University, Middlesbrough. TS1 3BA.

[email protected]

Project Manager: Dr Emma Giles, Senior Research Lecturer in Public Health, Health and Social

Care Institute, Teesside University, Middlesbrough. TS1 3BA. [email protected]

Newcastle Lead: Professor Eileen Kaner, Institute Director, Newcastle University, Institute of

Health and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX.

[email protected]

Sponsor: Mrs Lois Neal, Faculty of Medical Sciences, Newcastle University, Framlington Place,

Newcastle upon Tyne, Tyne and Wear, NE2 4HH. [email protected]

Senior Research Interventionist: Dr Ruth McGovern, Newcastle University, Institute of Health

and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX. [email protected]

Statistics: Denise Howel, Senior Lecturer in Epidemiological Statistics, Newcastle University,

Institute of Health and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX.

[email protected]

QOL/Health Economics: Professor Luke Vale, Newcastle University, Health Foundation Chair

in Health Economics. Newcastle University, Institute of Health and Society, Newcastle upon

Tyne, Tyne and Wear, NE2 4AX. [email protected]

Senior Trial Manager (NCTU): Claire Macdonald, Newcastle University, Newcastle Clinical

Trials Unit, 1-4 Claremont Terrace, Newcastle upon Tyne, Tyne and Wear, NE2 4AE.

[email protected]

Database Manager: Nicola Howe, Newcastle University, Newcastle Clinical Trials Unit, 1-4

Claremont Terrace, Newcastle upon Tyne, Tyne and Wear, NE2 4AE.

[email protected]

Administrative Assistant: Robert Sayer, Health and Social Care Institute, Teesside University,

Middlesbrough. TS1 3BA. [email protected]

Emergency contact (e.g. out of office hours): Professor Dorothy Newbury-Birch 07980629456

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V1.4 26.04.2016

2. Protocol signature page

REPRESENTATIVE OF THE RESEARCH SPONSOR

Name: Lois Neal Position: Assistant Registrar

Signature: Date:

CHIEF INVESTIGATOR

Name: Professor Dorothy Newbury-Birch Position: Professor of Alcohol and Public

Health Research

Signature: Date:

PROJECT MANAGER

Name: Dr Emma L Giles Position: Senior Research Lecturer in Public

Health

Signature: Date:

STATISTICIAN

Name: Ms Denise Howel Position: Senior Lecturer in Epidemiological

Statistics

Signature: Date:

HEALTH ECONOMIST

Name: Professor Luke Vale Position: Health Foundation Chair in Health

Economics

Signature: Date:

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V1.4 26.04.2016

2.1 Principal Investigator signature

I confirm that I have read and understood protocol 1.4 dated 26.04.2015. I agree to comply

with the study protocol, the principles of Good Clinical Practice (GCP), research governance,

clinical trial regulations and appropriate reporting requirements.

Print Name

Site Name/I.D.

Signature ……………………………… Date …………

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Contents 1. Protocol contacts ................................................................................................................................ 2

2. Protocol signature page ...................................................................................................................... 3

2.1 Principal Investigator signature ................................................................................................. 4

3. Glossary of abbreviations.................................................................................................................... 7

4. Responsibilities ................................................................................................................................... 8

4.1 Trial management ..................................................................................................................... 8

4.2 Trial conduct at sites ................................................................................................................. 8

4.3 The Caldicott principles ............................................................................................................. 9

5. Protocol summary .............................................................................................................................11

6. Background .......................................................................................................................................12

6.1 Consequences of drinking in early life..................................................................................... 12

6.2 Primary and secondary preventative interventions for risky drinking .................................... 12

6.3 Brief intervention .................................................................................................................... 13

6.4 Rationale for current study ..................................................................................................... 13

7. Research aim and objectives ............................................................................................................14

7.1 Primary objective..................................................................................................................... 14

7.2 Secondary objectives ............................................................................................................... 14

8. Study design ......................................................................................................................................15

9. Outcome trial assessments ...............................................................................................................15

9.1 Baseline assessments .............................................................................................................. 15

9.2 12 month assessments ............................................................................................................ 15

9.3 Primary outcome measure: ..................................................................................................... 16

9.3.1 Secondary (effectiveness) outcomes measures: .................................................................... 16

9.3.2 Secondary (health economic) outcome measures: ................................................................ 16

9.4 Definition of end of study:....................................................................................................... 16

10. Participants .......................................................................................................................................16

10.1 Socioeconomic context and inequalities ................................................................................. 16

10.2 Inclusion criteria ...................................................................................................................... 17

10.3 Exclusion criteria ..................................................................................................................... 17

11. Trial procedures ................................................................................................................................17

11.1 Training .................................................................................................................................... 17

11.2 Control arm ............................................................................................................................. 18

11.3 Intervention ............................................................................................................................. 18

12. Randomisation ..................................................................................................................................18

12.1 Questionnaire and intervention process ................................................................................. 19

12.2 Flowchart of study ................................................................................................................... 21

13. Screening, recruitment and assent ...................................................................................................21

13.1 Screening and eligibility criteria .............................................................................................. 21

13.2 Option to opt-out of screening ............................................................................................... 21

13.3 Screening for the trial .............................................................................................................. 22

13.4 Data collection ......................................................................................................................... 22

13.4.1 Baseline data collection ........................................................................................................ 22

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13.4.2 Invitation to meet with learning mentors ............................................................................ 22

13.5 Assent procedures ................................................................................................................... 23

13.4.3 12-month follow-up ............................................................................................................. 23

13.4.4 Intervention fidelity .............................................................................................................. 24

14. Project timetables and milestones ...................................................................................................24

15. Statistical considerations ..................................................................................................................24

15.1 Sample size calculation ............................................................................................................ 24

15.2 Analysis .................................................................................................................................... 25

15.2.1 Baseline data ........................................................................................................................ 25

15.2.2 Primary outcome .................................................................................................................. 25

15.2.3 Secondary outcomes ............................................................................................................ 25

15.2.4 Interim analyses ................................................................................................................... 25

15.2.5 Missing data ......................................................................................................................... 25

16. Health economics ..............................................................................................................................25

16.1 Within trial analysis cost-utility and cost-consequence analyses ........................................... 26

16.2 Model based analysis .............................................................................................................. 27

17. Qualitative work ................................................................................................................................27

18. Triangulation .....................................................................................................................................27

19. Compliance and withdrawal .............................................................................................................28

19.1 Assessment of compliance ...................................................................................................... 28

19.2 Withdrawal of participants ...................................................................................................... 28

20. Data monitoring, quality control and quality assurance ..................................................................28

21. Adverse event monitoring and reporting .........................................................................................29

22. Ethics and regulatory issues ..............................................................................................................29

23. Research governance ........................................................................................................................29

24. Confidentiality ...................................................................................................................................30

25. Insurance and finance .......................................................................................................................30

26. Study report/publications .................................................................................................................31

27. References ........................................................................................................................................31

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3. Glossary of abbreviations

AUDIT Alcohol Use Disorders Identification Test

A-SAQ Student Alcohol Questionnaire

BECCI Behaviour Change Counselling Index

C.I. Confidence Intervals

C-RCT Cluster Randomised Control Trial

DMES Data Monitoring and Ethics Committee

DMQ Drinking Motives Questionnaire

EQ-5D 5L European Quality of Life Five Dimension

EQ-5D-Y European Quality of Life Five Dimension – Youth

FRAMES Feedback, Responsibility, Advice, Menu, Empathy and Self-efficacy

GCP Good Clinical Practice

MRC Medical Research Council

NHS National Health Service

NHS EED National Health Service Economic Evaluation Database

NICE The National Institute for Health and Care Excellence

NIHR PHR National Institute of Health Research, Public Health Research

PI Principal Investigator

PSHE Personal Social and Health Education Lessons

QALYS Quality Adjusted Life Years

RAPI Rutgers Alcohol Problems Inventory

RCT Randomised Control Trial

S-SUQ Short Service Use Questionnaire

TLFB Time Line Follow Back

TOC Trial Oversite Committee

WEMWBS Warwick Edinburgh Mental Well-Being Scale

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4. Responsibilities

Sponsor: Newcastle University are the award holders and will act as the sponsor for this

study.

Funder: NIHR PHR is funding this study.

Trial management: A Trial Management Group (TMG) will be appointed and will be

responsible for overseeing the progress of the trial. The day-to-day management of the trial

will be co-ordinated by the Project Manager. A Trial Steering Group (TSC) and a separate Data

Management and Ethics Committee (DMEC) will also be appointed to monitor trial data.

Chief Investigator: The Chief Investigator will have overall responsibility for the trial.

Principal Investigators: The Principal Investigators (PIs) will have overall responsibility for the

conduct of the study at a particular trial site.

4.1 Trial management

The following functions falling under the responsibility of the sponsor will be delegated to

Professor Dorothy Newbury-Birch [Chief Investigator]:

• Ethics Committee Opinion (including application for research ethics committee

favourable opinion, notification of protocol amendments and end of trial, site specific

assessment and local approval).

• Good Clinical Practice and Trial Conduct (including GCP arrangements, data monitoring,

emergency and safety procedures).

Administration of funding for the study will be carried out by Newcastle University who hold

the award. Professor Eileen Kaner is the lead for Newcastle University.

4.2 Trial conduct at sites

Site PI responsibilities

• Study conduct and the welfare of study subjects.

• Familiarity with the study conditions.

• Compliance with the protocol, documentation of any protocol deviations and reporting

of all serious adverse events.

• Screening and recruitment of subjects.

• Compliance with the Principles of GCP, the Research Governance Framework for Health

and Social Care, the Data Protection Act and any other relevant legislation and

regulatory guidance.

• Ensuring that no participant is recruited into the study until all relevant regulatory

permissions and approvals have been obtained.

• Obtaining written informed assent from participants prior to any study specific

procedures.

• The PIs shall be qualified by education, training and experience to assume responsibility

for the proper conduct of the trial. S/he shall provide a current signed and dated

curriculum vitae as evidence for the Trial Master File.

• Ensuring Study Site team members are appropriately qualified by education, training

and experience to undertake the conduct of the study.

• Availability for TSCs, DMECs, monitoring visits and in the case of an audit.

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• Maintaining study documentation and compliance with reporting requests.

• Maintaining a site file, including copies of study approval, list of subjects and their

signed informed assent forms.

• Documenting appropriate delegation of tasks to other study personnel e.g. Research

Co-ordinators.

• Ensuring data collected is accurate, timely and complete.

• Providing updates on the progress of the trial.

• Ensuring subject confidentiality is maintained during the project and archival period.

• Ensuring archival of study documentation for a minimum of ten years following the end

of the study, unless local arrangements require a longer period.

4.3 The Caldicott principles

Principle 1. Justify the purpose(s) for using confidential information: Every proposed use or

transfer of personal confidential data within or from an organisation should be clearly

defined, scrutinised and documented, with continuing uses regularly reviewed, by an

appropriate guardian.

How we will abide by Principle 1: Should we need to transfer personal data between

Newcastle and Teesside Universities we will keep a log of the transfer, who requested and

who executed the transfer, together with the reason for the transfer. This log will be kept on

a password protected Excel file.

Principle 2. Don't use personal confidential data unless it is absolutely necessary: Personal

confidential data items should not be included unless it is essential for the specified

purpose(s) of that flow. The need for patients to be identified should be considered at each

stage of satisfying the purpose(s).

How we will abide by Principle 2: We will gather limited personal data, including name and

first part of postcode for trial participants. This is to allow us to map behaviours to socio

demographic characteristics.

Principle 3. Use the minimum necessary personal confidential data: Where use of personal

confidential data is considered to be essential, the inclusion of each individual item of data

should be considered and justified so that the minimum amount of personal confidential data

is transferred or accessible as is necessary for a given function to be carried out.

How we will abide by Principle 3: We will ask for name and class only to minimise the

amount of personal we collect from the young people. For trial participants we will ask for the

first part of their postcode.

Principle 4. Access to personal confidential data should be on a strict need-to-know basis:

Only those individuals who need access to personal confidential data should have access to it,

and they should only have access to the data items that they need to see. This may mean

introducing access controls or splitting data flows where one data flow is used for several

purposes.

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How we will abide by Principle 4: Only the Study Research Administrator at Teesside

University will have access to all of the information to ensure allocation concealment in the

trial. The data will be accessed on a need-to-know basis only.

Principle 5. Everyone with access to personal confidential data should be aware of their

responsibilities: Action should be taken to ensure that those handling personal confidential

data - both clinical and non-clinical staff - are made fully aware of their responsibilities and

obligations to respect patient confidentiality.

How we will abide by Principle 5: We will be providing training to all active researchers in the

trial to ensure they understand confidentiality principles.

Principle 6. Comply with the law: Every use of personal confidential data must be lawful.

Someone in each organisation handling personal confidential data should be responsible for

ensuring that the organisation complies with legal requirements.

How we will abide by Principle 6: The research sponsor will ensure that all use of personal

data will be lawful.

Principle 7. The duty to share information can be as important as the duty to protect

patient confidentiality: Health and social care professionals should have the confidence to

share information in the best interests of their patients within the framework set out by these

principles. They should be supported by the policies of their employers, regulators and

professional bodies.

How we will abide by Principle 7: We will abide by the policies of participating organisations.

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5. Protocol summary

Trial Title A multi-centre individual-randomised controlled trial of

screening and brief alcohol intervention to prevent risky drinking

in young people aged 14-15 in a high school setting (SIPS JR-

HIGH)

Acronym (short title)

SIPS JR-HIGH

Protocol version and

date

Summary of Trial

Design

1.4 26.04.2016

A four-centre, individually randomised two armed Randomised

Controlled Trial (RCT) incorporating a control arm of usual

practice on alcohol issues and a 30 minute brief intervention

arm.

Summary of

Participant Population

Young people aged 14-15 years inclusive, whose parents do not

opt them out of the study, scoring positively on the A-SAQ, leave

their name and willing and able to provide informed assent for

intervention and follow-up.

Planned Sample Size

4,200 pupils in year 10; with 257 in each arm at the 12-month

follow-up.

Planned Number of

Sites

At least five schools in each of the four geographical sites: North

East, North West, London and Kent.

Study Intervention

30 minute brief alcohol intervention.

Follow Up Duration

At 12-months post intervention; completion of a questionnaire.

Planned Trial Period

01 September 2015 - 31 December 2017.

Primary objective: Total alcohol consumed in the last 28 days.

Outcome measure: Time Line Follow-Back (TLFB) questionnaire at 12-month follow-up.

Secondary (effectiveness) objective: To measure % days abstinence over last 28 days; risky

drinking; smoking behaviour; alcohol-related problems; drunkenness during the last 30 days;

and emotional wellbeing.

Outcome measures: Drinks per day and days>2 units from 28 day TLFB; risky drinking using

the Student Alcohol Questionnaire (A-SAQ), Alcohol Use Disorders Identification Test (AUDIT)

and TLFB; smoking behaviour and alcohol related problems using the Rutgers Alcohol

Problems Inventory (RAPI); drunkenness dichotomised as ‘never’ or ‘once or more’; emotional

wellbeing using the Warwick Edinburgh Mental Health Well-being Scale (WEMWBS) and

Drinking Motives Questionnaire (DMQ).

Secondary (health economics) objectives: To measure Quality of Life Years (QALY) and health

state utility and cost-consequences at 12 months.

Outcome measures: Quality of life and health state utility measured using the European

Quality of Life Five Dimension (EQ-5D 5L) [1]; QALYs estimated using general population

tariffs from responses to EQ-5D 5L administered and scored at baseline and 12 months;

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National Health Service (NHS), educational, social, and criminal services data estimated using

a modified Short Service Use Questionnaire (S-SUQ) and a learning mentor diary sheet

developed in the pilot study; Incremental cost per QALY gained at 12 months; Cost-

consequences presented in the form of a balance sheet for outcomes at 12 months;

depending on findings, modelled estimates of incremental cost per QALY and cost-

consequences in the longer term.

6. Background

Adolescents in England are amongst the heaviest drinkers in Europe [1]. The percentage of

young people who have ever had an alcoholic drink in England increases with age from 6% of

11 year olds to 72% of 15 year olds, and the prevalence of drinking in the last month rises

from 2% of 11 year olds to 43% of 15 year olds [2]. Whilst drinking typically increases over

adolescence, there has been a reduction over time across all ages of adolescents, although

amongst those who drink they typically consume a higher volume. Nevertheless, drinking can

have adverse impacts on health and social (including learning) outcomes for the many young

people who are drinking alcohol.

6.1 Consequences of drinking in early life

The impact of alcohol on the development and behaviour of young people has been well

researched in early [3], middle [4] and late adolescence [5]. It is now well known that young

people are much more vulnerable than adults to the adverse effects of alcohol, due to a range

of physical and psycho-social factors which often interact [6]. These adverse effects include:

physiological factors [4]; neurological factors due to changes that occur in the developing

adolescent brain after alcohol exposure [7]; cognitive factors due to psychoactive effects of

alcohol which impair judgement and increase the likelihood of accidents and trauma [8]; and

social factors which arise from a typically high-intensity drinking pattern (often called ‘binge

drinking’) which leads to intoxication and risk-taking behaviour [9].

Our definition of risky drinking encompasses commonly understood concepts of hazardous

drinking (at a level or pattern that increases the risk of physical or psychological problems),

harmful drinking (defined by the presence of these problems) and binge drinking (risky single

occasion high intensity drinking which can be episodic) as well as the Department of Health

concepts of increasing and high risk drinking [10]. Evidence suggests that risky drinking among

young people occurs commonly in the context of other forms of challenging behaviour such

as aggression and risk-taking [11]. The Chief Medical Officer for England has provided

recommendations on alcohol consumption in young people [12] based on an evidence review

of the risks and harms of alcohol to young people [6]. The recommendations state that

children should abstain from alcohol before the age of 15 and those aged 15-17 are advised

not to drink, but if they do drink it should be no more 3-4 units and 2-3 units per week in

males and females respectively, on no more than one day per week [12] which equates to

adult daily drinking recommendations.

6.2 Primary and secondary preventative interventions for risky drinking

There is a large volume of evidence on primary prevention to reduce risky drinking in the

school setting [13, 14]. Such prevention is directed at all young people, whether they drink

alcohol or not, and aims to delay the age that drinking begins, often via general health

education. This body of work has shown mixed results with only a small number of

programmes reporting positive outcomes [14] and this body of work has been reported to be

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methodologically weak [15]. Secondary prevention, i.e. targeting interventions at young

people who are already drinking alcohol, may be a more effective and efficient strategy since

the intervention will have more salience for the individuals receiving it.

This secondary prevention generally consists of screening (to identify relevant recipients)

followed by structured advice or counselling of short duration which is aimed at reducing

alcohol consumption or decreasing problems associated with drinking [16]. The interventions

are based on social cognitive theory (from health psychology) which is drawn from social

learning theory [17]; these theories regard behaviour to be the result of an interaction

between individual, behavioural and environmental factors. It is assumed that each individual

has cognitive (thinking) and affective (feeling) attributes that affect not only how they behave

but also how their behaviour is influenced and/or reinforced by aspects of the external world.

Thus, brief interventions generally focus on individuals’ beliefs and attitudes about behaviour,

their sense of personal confidence (self-efficacy) about changing beliefs and attitudes and a

focus on how an individual’s behaviour sits in relation to other people’s actions (normative

comparison).

6.3 Brief intervention

A key feature of brief intervention is that it is designed to be delivered by generalist

practitioners (not addiction specialists) and is targeted at individuals who may not be aware

they are experiencing alcohol-related risk or harm. The goal is usually reduced alcohol

consumption or a decrease in alcohol-related problems [18]. There is variation in the duration

and frequency of brief intervention [19] but there are two broad types: simple structured

advice - based on the FRAMES model (feedback, responsibility, advice, menu, empathy and

self-efficacy) and motivational interviewing [20]. Since the time available for delivering brief

intervention may not allow for motivational interviewing in its full form [19], its ethos and

techniques have been distilled into a more directive format called Behaviour Change

Counselling [21] which has been successfully used in a number of UK trials [22-25]. Existing

evidence described above demonstrates that alcohol screening and brief intervention for

young people have been successful for selected individuals, in certain settings.

6.4 Rationale for current study

The Chief Medical Officer for England has stated that school is seen as a key resource in the

prevention, detection and treatment for risky drinking [26]. However, the current evidence is

limited as it relates primarily to white, USA-based study participants and provides insufficient

evidence to be confident about the use of alcohol screening and brief intervention to reduce

excessive drinking and/or alcohol-related harm in younger adolescents aged under 16 and in a

school setting in the UK [27-29]. Nevertheless, there is evidence that the most practical and

effective forms of brief intervention in this setting are those based upon the FRAMES model.

Specifically approaches containing personalised feedback about a young person’s drinking

behaviour with motivational interviewing approaches, such as behaviour change counselling,

can help to reduce levels of alcohol-related risk [23].

This current work builds on the evidence base by focusing on screening and brief intervention

to reduce risky drinking in younger adolescents (aged 14-15). The proposed study follows on

from the SIPS JR-HIGH pilot feasibility study which was funded under the National Institute of

Health Research Public Health Programme (NIHR PHR) commissioned call 10/3002 Alcohol

and Young People: Interventions to prevent risky drinking of alcohol by school aged children

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and young people [30]. The trial was registered on the ISRCTN register as ISRCTN07073105.

The pilot feasibility trial was a three-arm cluster-randomised control trial (c-RCT) (with

randomisation at the school level) with an integrated qualitative component to assess the

feasibility and acceptability of a future definitive trial of brief alcohol intervention in a school

setting. The trial measured recruitment and retention to the study, and explored facilitators

and barriers to the use of these interventions with year 10 pupils (aged 14-15) in seven

schools in the North East of England [23].

In our pilot feasibility study, young people who screened positively on a single alcohol

screening question (collected in the context of a baseline classroom survey of drinking and

other health behaviours) and assented to take part in our trial were randomised to either:

provision of an advice leaflet (control arm, n=two schools); a 30-minute brief interactive

session which combined structured advice and behaviour change counselling techniques

delivered by the school learning mentor, and an advice leaflet (Intervention 1, n=two

schools); or the 30-minute brief interactive session and an advice leaflet with the addition of a

60-minute session involving family members delivered by the school learning mentor

(Intervention 2, n=three schools). Trial participants were followed-up at 12 months (88%

retention). The results showed that it was not possible to carry out the second arm of the trial

with parents, therefore the definitive study will only include two arms. As there are only two

arms to the trial it is feasible to change to an individually randomised trial.

7. Research aim and objectives

The aim of the study is to evaluate the effectiveness and cost-effectiveness of alcohol

screening and brief intervention to reduce risky drinking in young people aged 14-15 in the

English high school setting.

7.1 Primary objective

To conduct an individually randomised controlled trial to evaluate the effectiveness and cost-

effectiveness of alcohol screening and brief intervention for risky drinkers compared to

standard usual practice on alcohol issues conducted by learning mentors with young people

aged 14-15 in the school setting in the North East, North West, South East and London,

England. Effectiveness is measured by total alcohol consumed in the last 28 days as measured

by the 28 day TLFB.

7.2 Secondary objectives

• To measure effectiveness in terms of % days abstinence over last 28 days; risky drinking;

smoking behaviour; alcohol-related problems; drunkenness during the last 30 days; and

emotional wellbeing.

• To measure the cost-effectiveness of the intervention in terms of quality of life and health

state utility; QALYs; Service use costs and cost-consequences at 12 months post

intervention.

• To monitor the fidelity of alcohol screening and brief intervention delivered by learning

mentors in the school setting.

• To explore barriers and facilitators of implementation with staff.

• To explore young people’s experiences of the intervention and its impact upon their

alcohol use.

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• If the intervention is shown to be effective and efficient to: develop a manualised

screening and brief intervention protocol to facilitate uptake/adoption in routine practice

in secondary schools in England.

8. Study design

This is a multicentre individually randomised controlled trial comparing effectiveness and

cost-effectiveness of alcohol brief intervention with treatment as usual in young people aged

14-15 in the school setting who screen positive for risky drinking using the A-SAQ.

9. Outcome trial assessments

9.1 Baseline assessments

Baseline data will be collected though self-completion questionnaires.

• Age of first smoking and how many cigarettes were smoked in the past 30 days [1].

• Alcohol use frequency, quantity (on a typical occasion) and binge drinking assessed using

the modified 10 question AUDIT [31] which has been shown to be a highly sensitive tool

for college students [32].

• Alcohol related problems assessed using the validated RAPI which includes measures on

aggression [33].

• Drinking motives assessed using the 20-item DMQ. This tool uses a six-point Likert scale,

which measures motives to drinking across four domains (social, coping, enhancement

and conformity). Higher scores within each domain indicate stronger endorsement of

positive reinforcement received through consumption of alcohol [34].

• Use of NHS, educational, social, and criminal services data elicited using a modified S-SUQ

to capture health and social service use costs [35].

• The 14 item WEMWBS to assess general psychological health [36].This tool uses a five-

point Likert scale which gives a score of one to five per question giving a minimum score

of 14 and maximum score of 70. A higher WEMWBS score indicates a higher level of

mental well-being [37]. The EQ-5D 5L, a valid measure for those aged 12 or older, will be

used to measure health related quality of life [38]. Response will be converted into utility

scores using the UK population algorithm.

• Two questions relating to sexual risk taking are included in the questionnaire. These are

the same questions as in the pilot study [23]. These questions are: “After drinking alcohol,

have you engaged in sexual intercourse that you regretted the next day?” and “After

drinking alcohol, have you ever engaged in sexual intercourse without a condom?” Both

questions can be answered with one of the three following options: I have never engaged

in sexual intercourse, Yes, or No.

• Energy drink consumption will be assessed by asking young people how many times a

week they drink energy drinks. Young people can answer never, less than once a week, 2-

4 days a week, 5-6 days a week, every day once a day, and every data more than once a

day.

• Demographic information will be collected: gender, ethnicity. The first part of the

postcode will be collected for trial participants.

9.2 12 month assessments

All tools used at baseline (self-completion questionnaires) as well as the 28 day TLFB

questionnaire (administered by a Research Co-ordinator).

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9.3 Primary outcome measure:

Total alcohol consumed in the last 28 days, using the 28 day TLFB questionnaire [39] at 12-

month follow-up.

9.3.1 Secondary (effectiveness) outcomes measures:

• % days abstinence over last 28 days, drinks per drinking day and days>2 units from 28

day TLFB;

• Risky drinking using the A-SAQ, AUDIT [31] and 28 day TLFB [39];

• Use of energy drinks;

• Smoking behaviour;

• Alcohol related problems using the RAPI [33] and sexual risk taking;

• Drunkenness during the last 30 days, dichotomised as ‘never’ and once or more [40];

• Emotional wellbeing using the WEMWBS [36] and drinking motives using the DMQ

[34].

9.3.2 Secondary (health economic) outcome measures:

• Quality of life and health state utility measured using the EQ-5D 5L [38];

• QALYs estimated using general population tariffs from responses to EQ-5D 5L

administered and scored at baseline and 12 months;

• NHS, educational, social, and criminal services data estimated using a modified S-SUQ

and a learning mentor case diary developed in the pilot study;

• Incremental cost per QALY gained at 12 months;

• Cost-consequences presented in the form of a balance sheet for outcomes at 12

months;

• Depending on findings, modelled estimates of incremental cost per QALY and cost-

consequences in the longer term.

9.4 Definition of end of study:

The end of study will be the last participant’s final study contact, at 12 months follow up

(anticipated as 31/03/2017).

10. Participants

Young people aged 14-15 in Year 10 in at least 30 Secondary/High schools/Academies in four

centres: the North East of England, North West of England, Kent and London. Schools will be

included if they have learning mentors (or equivalent members of pastoral staff including

teachers fulfilling this role) employed by the school. Screening will take place in the personal,

social and health education (PSHE) or equivalent lesson or registration class on a classroom by

classroom basis. Interventions will take place in the learning mentor’s classroom or office

space.

10.1 Socioeconomic context and inequalities

In 2008, a survey of 1,250 young people living in deprived communities in Britain found that

over a third did not know what a unit of alcohol was and did not understand the term binge

drinking [41]. Of these young people, 39% drank up to 20 units per week and 15% drank over

20 units per week [41]. Thus the adverse effects of social deprivation on young people may be

compounded by possible health and social problems related to heavy drinking. Usually, the

alcohol harm paradox is primarily known within an adult context and this may be due to the

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fact that generally average consumption is reported. It seems reasonable to extrapolate the

phenomenon to young people and they may also experience adverse consequences due to

parental effects. The proposed project will be working with schools in four geographical sites,

which will provide a range of social strata. Individuals with lower socio-economic status

generally experience disproportionately more alcohol-related problems than higher socio-

economic status people (an outcome that is not always linked to drinking level) and so any

reduction in consumption or concomitant problems that occurs as a result of our intervention

is likely to benefit the lower socio-economic status group most. Recent data shows that

uptake of free school meals (rather than rates of eligibility) is highest in inner London (69%)

compared to the North East (57%), the North West (53%) and the South East (36%) [42]. We

are also collecting individual postcode data (first part of postcode) for trial participants which

will enable us to calculate Indices of Multiple Deprivation. Fourteen percent of the population

in England and Wales are from a minority ethnic group. There are differences in ethnicity in

our four proposed geographical sites. The non-white British population in the areas is: North

East (5%); North West (10%); South East (9%) and London (40%) [43].

Inclusion and exclusion criteria have been chosen to maintain a balance between ensuring the

sample is representative of the wider population whilst ensuring that the trial population are

able to engage both with the intervention and follow-up.

10.2 Inclusion criteria

Young people aged 14-15 years inclusive, whose parents do not opt them out of the study,

scoring positively on the A-SAQ, leave their name, and are willing and able to provide

informed written assent for intervention and follow-up.

10.3 Exclusion criteria

• Already seeking or receiving help for an alcohol use disorder.

• Those with a recognised mental health or challenging behaviour.

11. Trial procedures

This study has been designed in line with the Medical Research Council (MRC)

recommendations for evaluation of complex interventions and the pilot feasibility study has

informed the development of this proposed study [23]. This proposal represents stage five of

the MRC framework ‘evaluating a complex intervention’ and comprises a RCT with

effectiveness, cost-effectiveness and qualitative elements [44]. The trial will incorporate

individual randomisation of pupils within schools. The pilot feasibility study found the data

collection tools easy to use for the young people involved with very low levels of non-

completion. The primary outcome of alcohol consumption using the TLFB will only be

measured at 12 months post intervention so as not to bias the control group’s responses.

Learning mentors (or equivalent members of pastoral staff employed by schools) will deliver

the intervention. Local areas vary in their essential qualifications for appointment for learning

mentors; however, as a minimum they need to have a good standard of general education,

especially literacy and numeracy, as well as experience of working with young people.

11.1 Training

All learning mentors will receive school-based training in the study procedures and

intervention. Some schools will have one learning mentor whilst other schools will have more.

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Research Co-ordinators will work with the individual schools to reach a pragmatic solution to

how many are trained for the trial. Learning mentors will be brought together at one of the

schools in each geographical site for this training or carried out in individual schools. Such

outreach training was found to be the most cost-effective implementation strategy for

alcohol screening and brief intervention delivery in the pilot [23] and other settings [45].

Training for learning mentors will be carried out by the trained Research Co-ordinators using a

simulated scenario within a training package developed and employed in the pilot. Simulated

scenarios will be videotaped and learning mentors will be assessed by the trainer prior to

embarking on the study with more support if needed. Learning mentors will be provided with

support materials and on-going support and supervision will be provided by research staff

working on, and in collaboration with, the project. Support on implementing screening and

paperwork relevant to the research will be provided by the research team, with a Research

Co-ordinator in each geographical site. Research staff and trainers will maintain regular

contact with schools throughout the study period, including site visits and telephone and

email support.

11.2 Control arm

Usual practice on alcohol issues as delivered normally to all students in PSHE lessons and

curriculum delivered by class teachers. Young people will also be given a healthy lifestyle

information leaflet with local sources of help with healthy lifestyle issues, by the learning

mentor, to those that assent to the trial. Usual practice may vary from school to school and

information related to this will be captured by researchers at both time points of the study.

11.3 Intervention

In addition to input equivalent to the control arm, the young people who are eligible and

assent to participate will take part in a single 30-minute personalised interactive worksheet-

based session which was developed during the pilot feasibility trial. This will be delivered by

the learning mentor and will contain structured feedback about the individual student’s

drinking behaviour, and advice about the health and social consequences of continued risky

alcohol consumption. The intervention encompasses the elements of the FRAMES approach

for eliciting behaviour change [20].

12. Randomisation

Young people will not know which arm they are randomised to when they agree to take part

in the study, and nor will the learning mentor until they open the envelope. Pupils will be

randomised in a 1:1 ratio to the intervention and control arms, with individual randomisation

stratified by school.

A statistician not otherwise involved with the study will produce a computer-generated

allocation list using random permuted blocks to ensure allocation concealment. The

statistician will be provided with a list of screening identification numbers (identifying the

site, school and young person) for eligible participants, in the form of an Excel spreadsheet.

Randomisation will be undertaken by this statistician and an updated spreadsheet, including

allocation of the study arm, will be returned to the administrative assistant at Teesside

University.

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12.1 Questionnaire and intervention process

• Questionnaires are printed (n=4200). Then a screening number is attached to each

questionnaire using a sticky label or automated printing.

• The screening number will identify the geographical site, the school, and the

participant number. For example: NEF0001 [eg North East, FerryMoor School, participant

number 0001/4200].

• Labelled questionnaires are inserted into envelopes at Teesside University by the

allocated Research Associate (Jennifer Birch: JB) and the Alcohol and Public Health team at

Teesside University.

• Questionnaires are batched by school by JB at Teesside University and couriered to

geographical research sites.

• Research Co-ordinators take their 1,050 questionnaires to relevant individual schools.

• Year 10 pupils confidentially complete their questionnaires in school time1. They put

the questionnaires into the spare blank envelope and seal.

• Research Co-ordinators collect the sealed envelopes from each school.

• Research Co-ordinators take the sealed envelopes back to respective Universities.

They open the envelopes and create a pile of questionnaires which score positive on ASAQ

and where young people have left their name (i.e. the young person is eligible). These are

double checked.

• Research Co-ordinators create an excel spreadsheet of all those scoring positively who

have left their name. They have one column for the screening number and one column for the

name. They send this encrypted excel spreadsheet to JB at Teesside ([email protected]).

• Over the next few months Research Co-ordinators then input questionnaire data into

a secure validated clinical data management system (Elsevier’s MACRO). Recording of A-SAQ

and screening number of the potentially eligible takes priority and should be completed

within a week of getting them from the schools. Inputting of all questionnaires (positive and

negative) can occur within the year, with priority given to positive (with no name)

questionnaires.

• The page from the questionnaire that has the young person’s name and screening

code on will be removed and will be couriered separately from the completed questionnaires

back to Teesside University once entered into the MACRO system.

• JB at Teesside University receives the excel spreadsheets from the Research Co-

ordinators, creates a Master file, and saves a copy. She then removes the names from the

excel spreadsheet, so that only screening numbers remain. She then sends this encrypted

excel file (without names) to an independent statistician at Newcastle University (to be

identified). The statistician will send JB a file showing the random allocations of these

screening numbers to intervention or control. This is only seen by JB.

• JB will remerge the screening numbers and arm allocation that she receives from the

statistician to the names and keep a record of which young person was allocated to

intervention and control.

• In the meantime JB and the Alcohol and Public Health Team at Teesside University will

be making up the intervention and control packs.

• Once JB has received the allocated list only JB will print intervention and control

sheets, sticker all packs with relevant screening numbers and place them inside relevant

1 Opt-out consent will already have been attained, prior to step 5.

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packs depending on the allocation of participants. This will be double checked for accuracy by

GW. Only JB and GW will know to which arm young people were allocated. Young peoples’

names and school will be put on a sticker on the front of the envelope.

• An envelope will be made for each young person. Inside the envelope will be the

information sheet and assent forms and a sealed envelope. The sealed envelope will only be

opened if the young person assents and this envelope will reveal the condition the young

person has been allocated to.

• An assent log for each school will be made with the screening identification numbers,

space to record the date and time of their appointment with the learning mentor and

whether or not the young person agreed to take part.

• JB seals these envelopes and couriers them to sites outside Teesside University.

• Research Co-ordinators receive these sealed envelopes and do not open them.

• Research Co-ordinators take the sealed envelopes to the schools and give them to the

learning mentors.

• Learning mentors see young people individually. The learning mentor asks the young

person if they wish to take part. A note is made of this on the enclosed cover sheet and assent

forms signed.

• Only then will the learning mentor open the second envelope and know which arm

each young person has been allocated to. This information will be shared with the young

person.

• The intervention or control condition is carried out by the learning mentors as

relevant.

• At the end of the session, all relevant materials (e.g. control: assent update;

intervention: assent update, case diary, worksheet) are placed back in the same envelope and

sealed.

• The learning mentors give these sealed envelopes to the Research Co-ordinators.

• Research Co-ordinators do not open these envelopes and courier them back to


• At Teesside University, only JB will open these envelopes, and will make an electronic

note on the database of whether each young person assented, and if yes took part. If any

young people have not completed either an intervention or control (for e.g. due to absence

from school), then JB will need to liaise with Research Co-ordinators to let them know that

they need to alert the learning mentors to ensure that when the young person is next present

in school that they need to deliver either the intervention or control.

• It is important that only JB knows the allocations, so only JB should open these

envelopes.

• Over the next 11 months, JB will finalise inputting a record of the intervention and

control groups, and will make up packs for the 12-month follow up questionnaire.

• For those that assented to the trial, at the 12-month follow-up point, a repeat of the

baseline questionnaire packs will be made. These will be couriered to sites.

• Research Co-ordinators will then take these envelopes into the schools. The young

person will complete the 12-month questionnaire on their own, as at baseline. Once this is

finished and in the envelope the Research Co-ordinator will go through the TLFB with the

young person. The researcher will complete the TLFB. The TLFB will then be placed into the

envelope and sealed in front of the young person. Researcher Co-ordinators will then take the

envelopes back to the research site. At no point do the research Co-ordinators ask which

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arm the young person was allocated to 12 months previously; young people should be

discouraged from volunteering this information.

• Research Co-ordinators will then input the data from these questionnaires to MACRO.

• Research Co-ordinators will courier the completed follow up questionnaires back to


12.2 Flowchart of study

Pupils in year 10 in at least 30 schools (five per geographical site)

n=4,200

Complete baseline survey1

n=3,654

Eligible and Screen positive

2

n=730

Assent to study

3

n=584

CONTROL INTERVENTION

n=292 n=292

Follow up at 12 months

4

Follow up at 12 months

4

n=257 n=257

1. Complete baseline survey (87%); 2. Screen positive and leave name on questionnaire (20%);

3. Assent to study (80%); 4. 88% of those that assent to study. (%s assumed from pilot RCT

(23)).

13. Screening, recruitment and assent

13.1 Screening and eligibility criteria

Screening will take place in the PSHE or registration class on a classroom by classroom basis.

13.2 Option to opt-out of screening

In advance of screening, all parents/caregivers will be informed by letter, sent by the school,

that screening and the study will be taking place in their child’s school. Parents will have the

option to indicate that they do not wish for their child to be screened or considered for

participation in the study at this stage by completing an opt-out form and returning to the co-

ordinating research centre at Teesside University. Those young people whose parents have

opted them out of the study will not complete the questionnaires and where possible will not

be in the classroom at the time the survey takes place. We will work with the individual

schools to ensure these children are given different tasks to do when the survey is taking

place. Obtaining assent to take part in this manner is a method widely used in various

national youth surveys of alcohol consumption and other health behaviours [2].

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13.3 Screening for the trial

The teacher will introduce the questionnaires during a PSHE or registration class, making it

clear to young people that completion of any identifiable information is not compulsory. A

video-clip will be played to the entire class, in each school, to give instructions on completing

the questionnaires. This video-clip will only concentrate on the questionnaire completion and

not on the topic of the questionnaires. Young people will be asked to voluntarily leave their

name and class. Young people will have the option to not complete the questionnaire

(indicative of lack of assent to screening from the young person), to complete the

questionnaire anonymously, or to complete the questionnaire with their name and class. Each

young person will place their completed questionnaires in a sealed envelope and return to

the teacher. Teachers will be told not to open these envelopes. Individual responses will not

be shared with the class teacher or learning mentor. The researcher will collect the sealed

envelopes from the school. Those young people who have screened positively (Scoring 4

times or more frequently on the A-SAQ – see below) and have left their name will be eligible

for the trial. Leaving a contact name did not create any issues in the pilot trial. Completed

baseline questionnaires by trial participants will be used for the baseline measurements. Data

from the whole year group (which includes everyone who has completed a questionnaire) will

be written up as a journal article.

13.4 Data collection

13.4.1 Baseline data collection

The study envelope will contain a series of questionnaires (see section 9.1) including the study

screening questionnaire: the A-SAQ ‘In the last 12 months how often have you drunk more

than 3 units of alcohol?’ with the response options of ‘Never; less than 4 times; 4 or more

times but not every month; at least once a month but not every week; every week but not

every day; every day’. Scoring 4 times or more frequently indicates a positive screen and

eligibility for the trial. This score was shown in our pilot feasibility trial to be a

methodologically robust approach to identifying the adolescent population who may benefit

from an intervention [23]. The A-SAQ will be embedded within a larger questionnaire with

items addressing a number of health and lifestyle topics.

13.4.2 Invitation to meet with learning mentors

• Returned survey questionnaires will be enclosed in a sealed envelope and taken back

to the individual universities. The A-SAQ will be scored and a list of screening numbers and

names of those that score positive and leave their name will be sent to the study

administrator at Teesside University (see section 12.1 re randomisation procedure). The

learning mentor will be given packs with names of potentially eligible young people. They will

be given an assent log to complete of progress with potentially eligible young people.

Learning mentors will invite young people for who they have an envelope for to a meeting

with them in their office where they will open the relevant envelope for the young person. In

the envelope will be an information leaflet and assent forms and a sealed envelope. Potential

young people will be informed that participation is not compulsory and will be given the

information leaflet to read. The assent form will ask for the first part of the young person’s

postcode as well as assent. The postcode information will be used to enable a stratified

sample of young people who are asked to take part in the qualitative work. Once a young

person has assented the second envelope will be opened which will state whether it is a

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control or intervention case. Until this point the learning mentor will not know which

condition the young person has been allocated to.

13.5 Assent procedures

Nb: Ethical approval for qualitative work will be sought separately.

13.4.3 12-month follow-up

Follow-up will occur 12 months post intervention. All young people who come into the trial

will be invited to meet with the project researcher (in the school setting) where they will be

asked to complete the same battery of questionnaires used at baseline. If a young person

involved in the study has moved to another school attempts will be made to contact them

there to complete the questionnaires. The researcher will be blinded to the condition the

young person was allocated to. The TLFB (including the primary outcome measure of total

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alcohol consumption consumed) will also be completed face-to-face in schools with the

researcher in order to limit bias in the results. All trial participants will be given a cinema

voucher to compensate them for the time involved in the study [46]. Trial participants’

baseline and follow-up questionnaires will be linked with a unique ID (the screening number).

All participants will be asked by the researcher at follow-up whether they are willing to be

contacted by a researcher who may be the same individual or another researcher for an in-

depth interview.

13.4.4 Intervention fidelity

An important measure of process relates to how the intervention is conducted which will also

help to understand barriers and facilitators to rolling out the intervention. Each learning

mentor will have one simulated intervention with another learning mentor or the research

co-ordinator, recorded post training (competency check). Learning mentors will only be

allowed to go ‘live’ if the research co-ordinator believes they are competent. Of these

sessions, at least 80% will be recorded and further checked by an expert rater (RM).

Furthermore twenty per cent of randomly selected cases in the trial will be audio taped and

transcribed and assessed for treatment fidelity by one independent expert rater from the

research team (RM), with any discrepancies discussed with a second expert rater (EG); using

the BECCI rating scale [47]. The BECCI scale is scored 0-4 with a score of two or more being

accepted as acceptable as used in previous studies [22-25]. The young people will provide

assent for this recording to take place. As the recording and analysis of the delivery of the

intervention sessions forms part of the employment contract of the learning mentors, formal

consent is not required.

14. Project timetables and milestones

Months

-6-0 03/15-08/15 Protocol development, ethics application, recruitment of staff

1-3 09/15-11/15 Study set up and training of Research Co-ordinators

4 12/15 Training of learning mentors, and provision of opt-out letters to

parents

4 12/15 Baseline survey and screening

5-7 01/16-03/16 Case recruitment (control/intervention)

7-9 03/16-05/16 Staff interviews

17-19 01/17-03/17 12 month follow-ups with trial participants

19-20 03/17-04/17 Young people interviews

7-26 04/16-10/17 Qualitative analysis

6-26 05/16-10/17 Data inputting and analysis of RCT

24-28 08/17-12/17 Writing of final report

27-28 11/17-12/17 Dissemination

15. Statistical considerations

15.1 Sample size calculation

Using estimates from the pilot trial (mean year group size = 210, 87% completing baseline

survey, 20% being positive on A-SAQ and leaving contact details, 80% recruited to trial and

88% providing data at 12 months follow-up), the sample size has been calculated to have a

90% power to detect a standardized difference of 0.3 (which equates to a ratio of 1.5 in

geometric means in total alcohol units in 28 days) using a significance level of 5%. Follow-up

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data will be required on 235 children per arm. The number of young people in 20 schools (5

per region) however means that this number will be increased to 257 in each arm at follow-

up. Anticipated numbers at each point of the study are illustrated in the flowchart in section

12.2.

15.2 Analysis

15.2.1 Baseline data

Descriptive statistics (comparisons of percentages, means or medians as appropriate) will be

used to report the pupil-level baseline data, and extent of intervention received between

those allocated to the two trial arms.

15.2.2 Primary outcome

The researchers will be blind to the randomisation condition. The primary outcome is derived

from the 28-day TLFB (units of alcohol consumed in period). The primary effectiveness

analysis will be by intention-to-treat. Multiple linear regression will be used to compare the

primary outcomes between the two randomisation groups at 12 months, adjusting for any

imbalance in key covariates.

15.2.3 Secondary outcomes

The secondary outcomes will be analysed in a similar manner. Comparisons of means will be

presented as mean differences or ratios of geometric means (if a logarithmic transform is

necessary for skewed data) with 95% C.I. Odds ratios and 95% C.I.’s will be presented for

binary outcomes. Exploratory analyses will also be undertaken, for example, to examine

differences in outcome by gender, deprivation and extent of intervention received, though

there is limited power to investigate these comparisons. We will consider any difference in

attrition rates, and any non-randomness of the attrition, when comparing outcomes between

the two groups.

15.2.4 Interim analyses

There are no planned interim analyses, other than descriptive analysis to report on

recruitment.

15.2.5 Missing data

The pattern and extent of missing observations because of loss to follow-up will be examined

to investigate both the extent of missingness, and whether it is missing at random or is

informative. Unless specified by the scale developers, where no more than 20% of questions

are missing or uninterpretable on specific scales, the score will be calculated by using the

mean value of the respondent specific completed responses on the rest of the scale to

replace the missing items. The use of appropriate multiple imputation techniques will be

considered.

16. Health economics

The economic component will include both a within trial cost-utility and cost-consequence

analysis and, as described below, a model based analysis taking the perspective of the UK

public sector (NHS, educational, social, and criminal services). The cost-utility analysis will use

measures of effectiveness limited to health related quality of life as measured by EQ-5D 5L.

The cost-consequence analysis will take the same perspective for costs but will present these

alongside all of the primary and secondary measures of effectiveness outlined in section 9.3.

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The follow-up for the within trial analyses will be 12 months so discounting will not be

conducted. For the model based analysis the time horizon will be longer (potentially up to the

participant’s life time) and costs and effects will be discounted at 1.5%, the UK recommended

rate for public health interventions [48] with, a sensitivity analysis used to explore the impact

of higher (and lower) discount rates.

16.1 Within trial analysis cost-utility and cost-consequence analyses

For each trial participant the use of health, educational, criminal, and social care services will

be elicited using the S-SUQ administered at baseline (with a recall period of 3 months) and 12

months. Further cost data will come from the learning mentor time case diaries completed by

the learning mentors for each contact. Costs for healthcare and social services will be

obtained from standard sources such as NHS reference (www.gov.uk), the British National

Formulary [49] for medications, Unit costs of Health and Social Care [50] for contacts with

primary care. Further data will come from the study centres themselves. Data on the use of

educational services will be elicited via the questionnaire. As part of the pilot trial we

confirmed with the expert group the type of services relevant to collect. However based on

lessons learned from the pilot additional questions related to days missed from school/

truancy have been added to the questionnaire.

Learning mentor training costs will be included and will need to be apportioned according to

scaled up practice. This will be informed by data from the training conducted as part of the

trial and through expert opinion. The time of educational staff will be sought through a

parallel costing exercise in which these staff will be asked to provide information on the

impact of the intervention on their workload. With respect to learning mentors, a detailed

proforma was developed and tested in the pilot to capture resource use and this new tool will

be used in this study. With respect to school building and other large capital items, the

opportunity cost will be considered. Some resources (e.g. buildings) will exist with or without

the intervention and the intervention may not displace any other activity. In this circumstance

the opportunity cost of the building would be zero. However, costs might be incurred in terms

of heat, power and light and these data will be captured using standard costing methods [51].

For each participant, measures of use of resources will be combined with unit costs to provide

a cost for that participant. We anticipate that the price year adopted for the base case

analysis will be 2017 when the final analysis is conducted.

In the pilot trial the European Quality of Life Five Dimension – Youth (EQ-5D-Y) was used. In

the definitive trial we will use the EQ-5D 5L as it may be more sensitive to changes as each

question on the EQ-5D 5L has five levels compared with the three levels on the EQ-5D-Y.

Furthermore, the EQ-5D 5L is valid for use in participants aged 12 years or older. The EQ-5D

5L is also in line with The National Institute for Health and Care Excellence (NICE) Public

Health Methods Guidance. In the pilot, considerable variation in responses to the EQ-5D-Y

was observed and it is therefore plausible that it will capture important differences. The EQ-

5D 5L will be administered at baseline and 12 months with UK population tariffs [52] used.

Health state utilities from the EQ-5D 5L will then be used to estimate QALYs using the area

under the curve approach [38].

Data on costs and QALYs will be used to estimate mean cost and QALYs for the intervention

and control groups. The cost and QALY data will then be used to estimate incremental costs

and QALYs and incremental costs per QALY gained. These data will be presented as point

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estimates and bootstrapping techniques will be used to estimate the statistical imprecision

surrounding them. The results of this stochastic analysis will be presented as cost and QALY

plots and as cost-effectiveness acceptability curves. Linear interpolation between time points

will be used, assuming the change happens at the end of the time point.

The cost-consequence analysis will present the cost data and effects data in the form of

balance sheets. In the balance sheets the interventions will be presented in a series of

pairwise comparisons with data on costs and effects presented as pros and cons for an

experimental intervention compared with a control. Thus, the approach can capture wider

effects than those captured by measures of cost or quality of life. The principle underpinning

a balance sheet is that the analyst should seek to capture all costs and benefits no matter on

whom they may fall; the same principles underpinning a cost-benefit analysis [53]. This

approach has been used in prior evaluations as a way of integrating both quantitative and

qualitative findings into a single assessment [54, 55].

16.2 Model based analysis

In an economic evaluation the time horizon should be sufficiently long enough to capture all

costs and benefits of relevance. Ideally, within a trial setting the data collection period would

be sufficiently long enough to capture all relevant costs and benefits. Such a proposal would

significantly increase costs, increase burden on participants, and costs and benefits in the

longer term may be subject to a host of exogenous factors. Hence, the longer term collection

of data within a trial setting may not produce reliable data on longer term outcomes. In the

absence of longer term trial data, longer term data from the literature will be considered.

The economic model based analysis, most likely taking the form of a state transition model,

will be conducted if it is plausible that extrapolation over a longer time horizon could change

the within trial based analyses. For example, if at the end of the 12 month follow-up, the

QALY gain is not of sufficient magnitude to justify the cost to society, modelling can illustrate

whether the eventual long-term gain becomes more worthwhile. The model will be

constructed following guidelines for best practice in economics modelling [56, 57]. The use of

services will be modelled and the costs of these events will be based on data from the trial

and, where necessary, supplemented by focused searches of the literature and health

economic databases, (National Health Service Economic Evaluations Database (NHS EED) and

the CEA Registry. As already noted both costs and outcomes will be discounted at 1.5% in the

base case analyses. The model will be used to produce estimates of costs, QALYs, incremental

cost per QALY gained, and cost-consequences. The model will be probabilistic and

distributions will be attached to all parameters, the shape and type of distribution will depend

upon the data available and recommendations for good practice in modelling [56]. The results

will also be presented as point estimates, and for the cost-consequence analysis 95%

confidence intervals. For the cost-utility analysis, data will be presented as plots of costs and

QALYs derived from the probabilistic analysis and cost-effectiveness acceptability curves.

Deterministic sensitivity analyses to explore other uncertainties will also be conducted.

17. Qualitative work

Separate ethical approval will be sought for the qualitative work.

18. Triangulation

Once the quantitative and qualitative elements of the study have been carried out and

analysed separately they will be brought together at the ‘analysis/interpretation’ phase which

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is a process often described as 'triangulation' [58]. In our study, data will be reconciled by

adopting a model which relies on the principle of complementarity [59]. Within this approach

it is explicitly recognised that qualitative and quantitative methods may be used to examine

different aspects of an overall research question [58].

19. Compliance and withdrawal

19.1 Assessment of compliance

Where feasible, visits to the individual school in the geographical sites will happen at least

once every two weeks with telephone calls if necessary in between. These study visits will be

conducted by site Research Co-ordinators.

19.2 Withdrawal of participants

Young people who do not leave their name on the questionnaire will not be able to be

identified post completion and therefore their data cannot be withdrawn if requested. For the

trial, participants have the right to withdraw from the trial at any time for any reason, and

without giving a reason. The investigators also have the right to withdraw participants from

the study intervention if s/he judges this to be in the participant’s best interests. It is

understood by all concerned that an excessive rate of withdrawals can render the study

uninterpretable; therefore, unnecessary withdrawal of participants should be avoided. Should

a participant decide to withdraw from the study, all efforts will be made to report the reason

for withdrawal as thoroughly as possible.

There are two withdrawal options:

1. Withdrawing completely (i.e. withdrawal from both the study intervention and

provision of follow-up data)

2. Withdrawing partially (i.e. withdrawal from study intervention but continuing to provide

follow-up data by completing 12-month follow-up questionnaires).

Assent will be sought from participants choosing option 1 to retain data collected up to the

point of withdrawal. Participants will be asked if they would be happy for the reason for the

decision to withdraw to be recorded.

20. Data monitoring, quality control and quality assurance

This is a low risk trial and major safety data are not anticipated. As agreed by Newcastle

University/NIHR PHR a TSC will be set up as well as a separate Data Monitoring and Ethics

Committee (DMEC). Both will occur with independent members meeting in closed session.

The groups will also take responsibility for monitoring study conduct and data collected will

be performed by central review to ensure the study is conducted in accordance with GCP. The

main areas of focus will include assent/consent, data quality and essential documents in the

study. The TSC will consist of Professor Matthew Hickman as Chair, an independent school

representative, independent statistician, the CI of the study (DNB); the Project Manager (EG);

the study statistician (DH) and other members of the TSG as appropriate. Following the initial

pre-study meeting, the TSG will meet annually. Their role is to monitor progress and supervise

the trial to ensure it is conducted to high standards in accordance with the protocol, the

principles of GCP, relevant regulations and guidelines and with regard to participant safety.

The purpose of this committee will be to monitor efficacy and safety endpoints, although only

independent members may have access to unblinded study data. A written charter will be

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agreed and used by the TSC. All monitoring findings will be reported and followed up with the

appropriate persons in a timely manner. The DMEC will take responsibility for the ethical

compliance of the trial and will meet once yearly prior to the TSG meetings.

The study may be subject to inspection and audit by Newcastle University under their remit as

sponsor, and other regulatory bodies to ensure adherence to GCP. The investigators/

institutions will permit trial-related monitoring, audits, ethical committee review and

regulatory inspection(s), providing direct access to source data/documents.

Table of events

Time

Visit 1 Initial

Screening

Visit 2

Baseline visit

Confirmation of eligibility

and Randomisation

12 month follow-up

12 months post baseline (+/- 10

weeks)

Study

questionnaire

completion

X X

Study discussion

/ Informed

assent

X

Informed of

randomisation

allocation

X

28 day TLFB

questionnaire X

The quality and retention of study data will be the responsibility of Professor Dorothy

Newbury-Birch, who will act as data custodian for the study. All study data will be retained in

accordance with the Data Protection Act (1998), the Directive on GCP (2005/28/EC), sponsor

and local policy.

21. Adverse event monitoring and reporting

Due to the nature of the study it is not expected that participants will experience any adverse

events/serious adverse events during the study. In the event that the participant reports an

event related to the study during a study visit this will be reported on the adverse event/

harms case report form and entered into MACRO.

22. Ethics and regulatory issues

As participants are not being recruited from the NHS, the proposed research will not require

NHS ethical approval but we will seek multi-site ethical approval from Teesside University

ethics committee, which covers all non-NHS studies carried out at the University. Information

sheets will be provided to all eligible subjects and written informed assent/consent obtained

prior to any study procedures.

23. Research governance

Newcastle University will be the nominated sponsor of the research and will hold the award.

Professor Newbury-Birch will be the Chief Investigator based at Teesside University together

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with the Project Manager and North East staff relating to the study. The Research Co-

ordinators and Project Manager will meet weekly (by Skype) to progress the study (Working

Group). Other investigators will be invited to attend meetings when necessary. The study will

have a TMG, which will consist of the Chief Investigator, co-applicants, Project Manager,

Research Co-ordinators, researchers and CTU staff involved in the study as well as two lay

members (to be identified). Professor Eilish Gilvarry who chaired the pilot study TMG will

chair this group. Further to this we will set up an independent TOC (see section 18) with

membership in accordance with NIHR guidelines. The project will be subject to the

requirements of the Data Protection Act 1998 and the Freedom of Information Act 2000 and

other relevant UK and European legislation relevant to the conduct of clinical research. The

project will be managed and conducted in accordance with the MRCs Guidelines on Good

Clinical Practice in Clinical Trials (www.mrc.ac.uk), which will include compliance with national

and international regulations on the ethical involvement of participants in clinical research

(including the Declaration of Helsinki). Newcastle Clinical Trials Unit Standard Operating

Procedures will be followed.

All data for the study will be held in a secure environment identified by a screening ID. Master

registers containing participant identifiable information and participant identification

numbers will be stored in a secure area separate from the majority of data. Remote electronic

data capture and data management will be conducted by Newcastle Clinical Trials Unit using

Elsevier’s MACRO. All staff employed on the project will be employed by academic

organisations and subject to the Terms and Conditions of Service and contracts of

employment of the employing organisations. The project will use standardised research and

clinical protocols and adherence to the protocols will be monitored by the Trial Steering

Committee.

All trial data will be identified using a unique trial identification number (the screening

number). No personally identifiable information will be held beyond the final 12-month

follow-up. Analytical datasets will not contain any participant identifiable information.

Anonymised hard-copy data will be retained for a period of five years following the end of the

trial. Electronic data will be kept for 10 years following the end of the trial.

24. Confidentiality

Personal data will be regarded as strictly confidential. To preserve anonymity, any data

relating to the questionnaire leaving the sites will be anonymised and will identify participants

with their screening number. The study will comply with the Data Protection Act, 1998. All

study records and Investigator Site Files will be kept at site in a locked filing cabinet with

restricted access. All data will be sent to the co-ordinating centre (Teesside University) by

secure courier where it will be kept in a locked filing cabinet with restricted access. Names of

those in the trial will be sent off site by secure email /courier by site study Research Co-

ordinators to the administrative assistant at the co-ordination centre (Teesside University)

and will be couriered separately from the questionnaire responses.

25. Insurance and finance

Indemnity in respect of potential liability arising from negligent harm relating to design and

conduct of the research is provided by Teesside University for those protocol authors who

have their substantive contracts of employment with Teesside University. Indemnity in

respect of potential liability arising from negligent harm relating to design and conduct of the

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research is provided by Newcastle University for those protocol authors who have their

substantive contracts of employment with Newcastle University.

Indemnity in respect of potential liability arising from negligent harm relating to management

of the research is provided by the Sponsor.

This is a non-commercial study and there are no arrangements for non-negligent

compensation. NIHR Public Health Research Programme is funding the study.

26. Study report/publications

The data will be the property of the Chief Investigator and Co-applicants. Publication will be

the responsibility of the Chief Investigator. It is planned to publish this study in peer review

articles and to present data at national and international meetings. Results of the study will

also be reported to the Sponsor and Funder, and will be available on their web site. All

manuscripts, abstracts or other modes of presentation will be reviewed by the TOC and

funder prior to submission. Individuals will not be identified from any study report.

Participants will be informed about the results at the end of the study, including a lay

summary of the results if requested.

27. References

1. Hibbell, B., et al., The 2011 ESPAD Report: Substance Use Among Students in 36

European Countries. 2012.

2. Fuller, E. and Et al, Smoking, drinking and drug use among young people in England in

2013. 2014, NatCen Social Research: London.

3. Zucker, R., et al., Developmental perspective on underage alcohol use. Developmental

processes and mechanisms 0-10. Alcohol Research and Health, 2009. 32(1): p. 16-29.

4. Windle, M., et al., Transitions Into Underage and Problem Drinking Summary of

Developmental Processes and Mechanisms: Ages 10–15. Alcohol Research and Health,

2009. 32(1): p. 30-40.

5. Brown, S., et al., Underage Alcohol Use Summary of Developmental Processes and

Mechanisms: Ages 16–20. Alcohol Research and Health, 2009. 32(1): p. 41-52.

6. Newbury-Birch, D., et al., The impact of alcohol consumption on young people: A

review of reviews. 2009, Department of Children Schools and Families.

7. Squeglia, L.M., et al., Brain response to working memory over three years of

adolescence: Influence of initiating heavy drinking. Journal of Studies on Alcohol and

Drugs, 2012. 73(5): p. 749.

8. Rodham, K., et al., Adolescents’ perception of risk and challenge: A qualitative study.

Journal of Adolescence, 2006. 29: p. 261-72.

9. MacArthur, G., et al., Patterns of alcohol use and multiple risk behaviour by gender

during early and late adolescence: the ALSPAC cohort. Journal of Public Health, 2012.

34(Suppl 1): p. i20-i30.

10. NHS Choices. The risks of drinking too much. 05/08/2014]; Available from:

www.nhs.uk/Livewell/alcohol/Pages/Effectsofalcohol.aspx.

11. McGue, M., et al., Origins and Consequences of Age at First Drink. Associations with

Substance-use Disorders, Dishinbitory Behavior and Psychopathology, and P3

Amplitude. Alcoholism, Clinical and Experimental Research, 2001. 25(8): p. 1156-1165.

12. Donaldson, L., Guidance on the consumption of alcohol by children and young people.

2009, Department of Health: London.

Page 56 of 65


BMJ Open

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BM



ber 2016. Dow

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32

V1.4 26.04.2016

13. National Institute for Clinical Excellence, Interventions in schools to prevent and reduce

alcohol use among children and young people. 2007, NICE: London.

14. Foxcroft, D. and A. Tsertsvadze, Universal shool-based prevention programs for alcohol

misuse in young people, in Cochrane Database of Systematic Reviews. 2011.

15. World Health Organization, Alcohol in the European Union. consumption, harm and

policy approaches, ed. P. Anderson, L. Moller, and G. Galea. 2012: WHO Regional

Office for Europe.

16. Kaner, E., et al., The effectiveness of brief alcohol interventions in primary care

settings: a comprehensive review. Drug and Alcohol Review, 2009. 28: p. 301-323.

17. Bandura, A., Social learning theory. 1997, Englewood Cliffs, NJ: Prentice-Hall.

18. Bien, T.H., W.R. Miller, and J.S. Tonigan, Brief interventions for alcohol problems: a

review. Addiction, 1993. 88(3): p. 315-335.

19. Kaner, E., et al., Effectiveness of brief alcohol interventions in primary care populations.

Cochrane Database of Systematic Reviews, 2007. Issue 2.

20. Miller, W. and V. Sanchez, Motivating Young Adults for Treatment and Lifestyle

Change. 1993, Notre Eame: University of Notre Dame Press.

21. Rollnick, S., P. Mason, and C. Butler, Health Behaviour Change: A guide for

practitioners. 1999, Edinburgh: Churchill Livingstone.

22. Kaner, E., et al., Effectiveness of screening and brief alcohol intervention in primary

care (SIPS trial): pragmatic cluster randomised controlled trial. BMJ, 2013. 346: p. 1-14.

23. Newbury-Birch, D., et al., A pilot feasibility cluster randomised controlled trial of

screening and brief alcohol intervention to prevent hazardous drinking in young people

aged 14-15 in a high school setting (SIPS JR-HIGH), N.P.H.R.P. Report, Editor. 2014.

24. Drummond, C., et al., The effectiveness of alcohol screening and brief intervention in

emergency departments: a multicentre pragmatic cluster randomized controlled trial.

PLOS ONE, 2014. 9(6): p. e99463.

25. Newbury-Birch, D., et al., Alcohol screening and brief interventions for offenders in the

probation setting (SIPS Trial): a pragmatic multicentre cluster randomised controlled

trial. Alcohol & Alcoholism, 2014. In Press.

26. Department of Health, The Annual Report of the Chief Medical Officer 2012: Our

Children Deserve Better: Prevention Pays. 2013, Department of Health: London.

27. Yuma-Guerrero, P., et al., Screening, Brief Intervention, and Referral for alcohol Use in

Adolescents: A Systematic Review. Pediatrics, 2012. 130: p. 115-122.

28. Tripodi, S.J., et al., Interventions for reducing adolescent alcohol abuse: A meta-

analytic review. Archives of Pediatrics and Adolescent Medicine, 2010. 164 (1): p. 85-

91.

29. Carney, T. and B. Myers, Effectiveness of early interventions for substance-using

adolescents: findings from a systematic review and meta-analysis. Substance Abuse

Treatment, Prevention, and Policy, 2012. 7(1): p. 25.

30. O'Neil, S., et al., Brief intervention to prevent hazardous drinking in young people aged

14-15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized

controlled trial. Trials, 2012. 13(166).

31. Babor, T., et al., AUDIT, The Alcohol Use Disorders Identification Test, guidelines for use

in primary health care. 1989, World Health Organisation: Geneva.

32. Reinert, D.F. and J.P. Allen, The Alcohol Use Disorders Identification Test: An Update of

Research Findings. Alcoholism: Clinical & Experimental Research, 2007. Vol. 31(No. 2):

p. pp. 185-199.

Page 57 of 65


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2016. Dow

nloaded from



33

V1.4 26.04.2016

33. White, H. and H. Labouvie, Towards the assessment of adolescent problem drinking.

Journal of studies of Alcohol, 1989. 50(30): p. 7.

34. Cooper, M., Motivations for alcohol use among adolescents: Development and

validation of a four-factor model. Psychological Assessment, 1994. 6: p. 117-128.

35. UKATT Research Team, Cost effectiveness of treatment for alcohol problems: findings

of the randomised UK alcohol treatment trial (UKATT). British Medical Journal, 2005.

331(7516): p. 544.

36. NHS Health Scotland and University of Warwick, Warwick-Edinburgh Mental Well-

Being Scale (WEMWBS). 2006: Scotland.

37. Tennant, R., et al., The Warwick-Edinburgh Mental Well-being Scale (WEMWBS):

development and UK validation. Health and Quality of Life Outcomes, 2007. 5: p. 63.

38. Euroquol, EuroQuol-a new facility for the measurement of health-related quality of life.

Health Policy, 1990. 16: p. 199 - 208.

39. Sobell, L. and M. Sobell, Alcohol Timeline Followback Users' Manual. 1995, Toronto,

Canada: Addiction Research Foundation.

40. Segrott, J., et al., Preventing substance misuse: study protocol for a randomised

controlled trial of the Strengthening Families Programme 10–14 UK (SFP 10–14 UK).

BMC Public Health, 2014. 14(49): p. 1-21.

41. Talbot, S. and T. Crabbe, Binge drinking: young people's attitude and behaviour, P.

Futures, Editor. 2008, Crime Concern: London.

42. Nelson, M., et al., Seventh annual survey of take up of school lunches in England 2012,

Children's Food Trust.

43. Office for National Statistics, Ethnicity and National Identity in England and Wales

2011. 2012.

44. Medical Research Council, Developing and evaluating complex interventions: new

guidance. 2008: London.

45. Kaner, E.F.S., et al., A RCT of three training and support strategies to encourage

implementation of screening and brief alcohol intervention by general practitioners.

British Journal of General Practice, 1999. 49: p. 699-703.

46. Brueton, V., et al. Systematic Review of Strategies to Reduce Attrition in Randomised

Trials. in The Society for Clinical Trials Annual Meeting. 2013. Boston: Clinical Trials.

47. Lane, C., et al., Measuring adaptations of motivational interviewing: The development

and validation of the Behaviour Change Counselling Index (BECCI),. Patient Education

and Counselling 2005. 56: p. 166-173.

48. National Institute for Clinical Excellence, Guide to the methods of technology

appraisal. 2013: London.

49. British Medical Association and Royal Pharmaceutical Society, British National

Formulary Edition 65. 2013.

50. Curtis, L., Unit Costs of Health and Social Care 2012, PSSRU, Editor. 2013, University of

Kent: Canterbury.

51. Drummond, M., G. Stoddart, and G. Torrance, Methods for the Economic Evaluation of

Health Care Programmes. 2005, Oxford: Oxford University Press.

52. Kind, P., G. Hardman, and S. Macran, UK population norms for EQ-5D. 1999, Centre for

Health Economics: University of York.

53. McIntosh, E., Economic evaluation of guideline implementation strategies, in Changing

professional practice: Theory and practice of clinical guidelines implementation, T.

Thorson and M. Makela, Editors. 1999, Danish Institute for Health Services:

Copenhagen.

Page 58 of 65


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V1.4 26.04.2016

54. Hoddinott, P., et al., Process evaluation for the FEeding Support Team (FEST)

randomised controlled feasibility trial of proactive and reactive telephone support for

breastfeeding women living in disadvantaged areas. BMJ Open, 2012. 2(2): p.

e001039.

55. Hoddinott, P., et al., The FEeding Support Team (FEST) randomised, controlled

feasibility trial for proactive and reactive telephone support for breastfeeding women

living in disadvantaged areas. BMJ Open, 2012. 2(2): p. e000652.

56. Kaltenthaler et al. NICE DSU Technical Support Document 13 Available from:

http://www.nicedsu.org.uk.

57. Caro, J., et al., Modeling good research practices—overview: a report of the ISPOR-

SMDM modeling good research practices task force-1. Value Health, 2012. 15(796-

803).

58. O'Cathain, A., E. Murphy, and J. Nicholl, Three techniques for integrating data in mixed

methods studies British Medical Journal, 2010. 341: p. 1147-1150.

59. Moffatt, S., et al., Using quantitative and qualitative data in health services research –

what happens when mixed method findings conflict? BMC Health Services Research,

2006. 6(28): p. 1-10.

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APPENDIX 2

A multi-centre individual randomised





Pupil assent form

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Pupil Assent Form V2.0 17.08.2015

This project was funded by the National Institute for Health Research PHR (project number 13/177/002

A multi-centre individual randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school

setting (SIPS JR-HIGH): Pupil Assent Form Please read each of the following statements and place your initials in the box if you agree with the statement. If you have initialled every statement please write your name and the date below. 1. I have had a chance to read the participant information leaflet dated 17.07.2015 (version

2.0) for the above study. 2. Someone else has explained this project to me. 3. I have had the opportunity to ask all of the questions I want about this study and they have

been answered to my satisfaction. 4. I understand that taking part is voluntary and that I am free to change my mind at any time

without giving a reason and without my education, services from school and legal rights being affected.

5. I understand that data from my school records may be looked at by members of the

research team if it is relevant to my taking part in this research. 6. I understand that any data created from this study will be held in a locked filing cabinet for

five years after the trial, when the paper copies of the data will be destroyed. Electronic data will be stored on password protected computers for ten years. All data collected will be anonymised and kept confidential.

7. I understand I will be contacted for follow up in 12 months and my data will be kept until this point.

8. I agree to my session being recorded if asked.

9. I understand that I may be asked to take part in an interview on my experience of taking part in this study.

10. I agree to take part in this study. I am aware that a copy of this consent form will be

provided to me for my records.

Name of Participant Signature Date

Name of Witness Signature Date

The participant, school and research co-ordinating centre at Teesside University will have a copy of this form.

Participant Postcode

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SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Section/item Item No

Description Addressed on page number

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym ___1__________

Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry ___2__________

2b All items from the World Health Organization Trial Registration Data Set ___n/a________

Protocol version 3 Date and version identifier ____2_________

Funding 4 Sources and types of financial, material, and other support ___18________

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors ___1 & 18______

5b Name and contact information for the trial sponsor ___1__________

5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and

interpretation of data; writing of the report; and the decision to submit the report for publication, including

whether they will have ultimate authority over any of these activities

___16__________

5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint

adjudication committee, data management team, and other individuals or groups overseeing the trial, if

applicable (see Item 21a for data monitoring committee)

___1__________

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2

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the trial, including summary of relevant

studies (published and unpublished) examining benefits and harms for each intervention

__3-4_________

6b Explanation for choice of comparators __3-4_________

Objectives 7 Specific objectives or hypotheses __4___________

Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group),

allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)

___6-7_______

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will

be collected. Reference to where list of study sites can be obtained

__6___________

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and

individuals who will perform the interventions (eg, surgeons, psychotherapists)

__6-9__________

Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be

administered

__6-9_________

11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose

change in response to harms, participant request, or improving/worsening disease)

__6___________

11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence

(eg, drug tablet return, laboratory tests)

__9-10_________

11d Relevant concomitant care and interventions that are permitted or prohibited during the trial __6-9_________

Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood

pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg,

median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen

efficacy and harm outcomes is strongly recommended

__4-6_________

Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for

participants. A schematic diagram is highly recommended (see Figure)

__Appendix 1____

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Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including

clinical and statistical assumptions supporting any sample size calculations

__10___________

Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size __7-9________

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any

factors for stratification. To reduce predictability of a random sequence, details of any planned restriction

(eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants

or assign interventions

__7___________

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered,

opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned

__7___________

Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to

interventions

__7___________

Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome

assessors, data analysts), and how

__9___________

17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s

allocated intervention during the trial

__9___________

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related

processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known.

Reference to where data collection forms can be found, if not in the protocol

__8-10________

18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be

collected for participants who discontinue or deviate from intervention protocols

__9___________

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Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data quality

(eg, double data entry; range checks for data values). Reference to where details of data management

procedures can be found, if not in the protocol

__Appendix 1____

Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the

statistical analysis plan can be found, if not in the protocol

__10-11________

20b Methods for any additional analyses (eg, subgroup and adjusted analyses) __10-11_______

20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any

statistical methods to handle missing data (eg, multiple imputation)

_Appendix 1_____

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of

whether it is independent from the sponsor and competing interests; and reference to where further details

about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not

needed

_Appendix 1_____

21b Description of any interim analyses and stopping guidelines, including who will have access to these interim

results and make the final decision to terminate the trial

_Appendix 1____

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse

events and other unintended effects of trial interventions or trial conduct

__Appendix 1____

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent

from investigators and the sponsor

__Appendix 1____

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval __2___________

Protocol

amendments

25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes,

analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

_Appendix 1_____

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Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and

how (see Item 32)

__7-8________

26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary

studies, if applicable

__n/a________

Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared, and maintained

in order to protect confidentiality before, during, and after the trial

__Appendix 1____

Declaration of

interests

28 Financial and other competing interests for principal investigators for the overall trial and each study site _16-17_________

Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that

limit such access for investigators

_Appendix 1____

Ancillary and post-

trial care

30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial

participation

_Appendix 1_____

Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals,

the public, and other relevant groups (eg, via publication, reporting in results databases, or other data

sharing arrangements), including any publication restrictions

_2____________

31b Authorship eligibility guidelines and any intended use of professional writers _16____________

31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code _Appendix 1_____

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to participants and authorised surrogates _Appendix 2_____

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular

analysis in the current trial and for future use in ancillary studies, if applicable

__n/a________

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.

Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons

“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.

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A multi-centre individual-randomized controlled trial of screening and brief alcohol intervention to prevent risky

drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): Study protocol

Journal: BMJ Open

Manuscript ID bmjopen-2016-012474.R1

Article Type: Protocol

Date Submitted by the Author: 23-Aug-2016

Complete List of Authors: Giles, Emma ; Teesside University, Health and Social Care Institute Coulton, Simon; University of Kent, Centre for Health Services Research Deluca, Paolo; King\'s College London, Addictions Department, Institute of Psychiatry Drummond, Colin; Kings College London, Addictions Department, Institute of Psychiatry Howel, Denise; Newcastle University, Institute of Health and Society Kaner, Eileen; Newcastle University, Institute of Health and Society McColl, Elaine; Newcastle University, Newcastle Clinical Trials Unit, 1-4 Claremont Terrace

McGovern, Ruth; Newcastle University, Institute of Health and Society Scott, Stephanie; Newcastle University, Institute of Health and Society Stamp, Elaine; Newcastle University, Institute of Health and Society Sumnall, Harry; Liverpool John Moores University, Centre for Public Health Tate, Les; North Tyneside Council, Young People's Drug and Alcohol Department Todd, Liz; Newcastle University, School of Education, Communication and Language Sciences Vale, Luke; Newcastle University, UK, Health Economics Group, Institute of Health and Society Boniface, Sadie; King\'s College London, Addictions Department, Institute of Psychiatry

Ferguson, Jennifer; Teesside University Frankham, Jo; Liverpool John Moores University, Faculty of Education, Health and Community Gilvarry, Eilish; Northumberland Tyne and Wear NHS Foundation Trust, St Nicholas Hospital Howe, Nicola; Newcastle University, Newcastle Clinical Trials Unit, 1-4 Claremont Road McGeechan, Grant; Teesside University, Health and Social Care Institute Stanley, Grant; Liverpool John Moores University, Faculty of Education, Health and Community Newbury-Birch, Dorothy; Teesside University, Health and Social Care

Institute

<b>Primary Subject Heading</b>:

Public health

Secondary Subject Heading: Addiction, Health policy


BMJ Open on July 2, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2016-012474 on 23 D

ecember 2016. D

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Keywords: Alcohol, Brief Intervention, Randomised Controlled Trial, School Setting

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A multi-centre individual-randomized controlled trial of screening and brief 1

alcohol intervention to prevent risky drinking in young people aged 14-15 in a 2

high school setting (SIPS JR-HIGH): Study protocol 3

4

Emma L Giles1, Simon Coulton

2, Paolo Deluca

3, Colin Drummond

3, Denise Howel

4, Eileen 5

Kaner4, Elaine McColl

4,5, Ruth McGovern

4, Stephanie Scott

4, Elaine Stamp

4, Harry Sumnall

6, 6

Les Tate7, Liz Todd

8, Luke Vale

9, Sadie Boniface

3, Jennifer Ferguson

1, Jo Frankham

10, Eilish 7

Gilvarry11

, Nicola Howe5, Grant J McGeechan

1, Grant Stanley

10, Dorothy Newbury-Birch

1 8

9

Corresponding author: Dr Stephanie Scott, Human Nutrition Research Centre and Institute 10

of Health and Society, William Leech Building, Medical School, Newcastle University, 11

Newcastle upon Tyne, Tyne and Wear, NE2 4HH, [email protected], 0191 2087734. 12

Trial Sponsor: Mrs Lois Neal, Faculty of Medical Sciences, Newcastle University, Framlington 13

Place, Newcastle upon Tyne, Tyne and Wear, NE2 4HH, UK; [email protected]. 14

15 1Health and Social Care Institute, Alcohol and Public Health Team, Teesside University, 16

Middlesbrough, TS1 3BA, UK. 17 2Centre for Health Services Research, George Allen Wing, University of Kent, Canterbury, 18

Kent, CT2 7NZ, UK. 19 3Addictions Department, Institute of Psychiatry, Psychology & Neuroscience, King’s College 20

London, PO48, 4 Windsor Walk, Denmark Hill, London, SE5 8BB, UK. 21 4Institute of Health and Society, Baddiley-Clark Building, Newcastle University, Richardson 22

Road, Newcastle upon Tyne, NE2 4AX, UK. 23 5Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle 24

upon Tyne, NE2 4AE, UK. 25 6Centre for Public Health, Liverpool John Moores University, Henry Cotton Campus, Level 2, 26

15-21 Webster Street, Liverpool, L3 2ET, UK. 27 7Young People’s Drug and Alcohol Department, North Tyneside Council, Hudson Street, 28

North Shields, Tyne and Wear, NE30 1DL, UK. 29 8 School of Education, Communication and Language Sciences, King George VI Building, 30

Newcastle University, Newcastle upon Tyne, NE1 7RU, UK. 31 9

Health Economics Group, Institute of Health and Society, Baddiley-Clark Building, 32

Newcastle University, Richardson Road, Newcastle upon Tyne, NE2 4AX, UK. 33 10

Faculty of Education, Health and Community, Liverpool John Moores University, IM 34

Marsh, Barkhill Road, Aigburth, Liverpool, L17 6BD, UK. 35 11

Northumberland, Tyne and Wear NHS Foundation Trust, St. Nicholas Hospital, Gosforth, 36

Newcastle upon Tyne, NE3 3XT, UK. 37

38

39

Keywords: alcohol, young people, randomized controlled trial, high school, brief 40

intervention. Word count: 5500 (excl. references) 41

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ABSTRACT 42

Introduction: Drinking has adverse impacts on health, wellbeing, education and social 43

outcomes for adolescents. Adolescents in England are amongst the heaviest drinkers in 44

Europe. Recently, the proportion of adolescents who drink alcohol has fallen, although 45

consumption among those who do drink has actually increased. This trial seeks to 46

investigate how effective and efficient an alcohol brief intervention is with 11-15 years olds 47

to encourage lower alcohol consumption. 48

49

Methods and analysis: This is an individually randomized two armed trial incorporating a 50

control arm of usual school-based practice and a leaflet on a healthy lifestyle (excl. alcohol), 51

and an intervention arm which combines usual practice with a 30 minute brief intervention 52

delivered by school learning mentors and a leaflet on alcohol. At least thirty schools will be 53

recruited from four regions in England (North East, North West, London, Kent and Medway) 54

to follow-up 235 per arm. The primary outcome is total alcohol consumed in the last 28 55

days, using the 28 day Timeline Follow Back questionnaire measured at 12-month follow-up. 56

The analysis of the intervention will consider effectiveness and cost-effectiveness. A 57

qualitative study will explore, via 1:1 in-depth interviews with (n=80) parents, young people 58

and school staff, intervention experience, intervention fidelity and acceptability issues, using 59

thematic narrative synthesis to report qualitative data. 60

61

Ethics and dissemination: Ethical approval was granted by Teesside University. 62

Dissemination plans include: academic publications, conference presentations, 63

disseminating to local and national education departments, and the wider public health 64

community including via Fuse, and engaging with school staff and young people to comment 65

on whether and how the project can be improved. 66

67

Registration details 68

ISRCTN Number: ISRCTN45691494; Ethical approval: 164/15. 69

Funded by NIHR PHR 13/117/02; Sponsored by: Newcastle University. Protocol version 1.4. 70

71

Project timeline 72

The project began on 01/09/2015; the end of the study is anticipated as 31/12/2017. 73

74

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STRENGTHS AND LIMITATIONS OF STUDY 75

- A robust randomised-controlled study design. 76

- Validated screening tools used to measure attitudes and behaviours. 77

- Limited prior research has explored the use of alcohol brief interventions in UK 78

school settings. 79

- This definitive trial follows on from a successful pilot feasibility trial. 80

- The study relies on recruitment of sufficient school sites and willingness of learning 81

mentors to engage with the trial. 82

83

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BACKGROUND 84

Adolescents in England are amongst the heaviest drinkers in Europe 1. The percentage of 85

young people who have ever had an alcoholic drink in England increases with age from 10% 86

of 11-12 year olds to 34% of 13-15 year olds, and the prevalence of drinking in the last week 87

rises from 1% of 11 year olds to 18% of 15 year olds making them an important age group to 88

target 2. In recent years the proportion of adolescents who drink alcohol has fallen, although 89

consumption among those who do drink has actually increased 2. Alcohol can have adverse 90

impacts on health, wellbeing, education and social (including learning) outcomes for the 91

many young people who are drinking alcohol. The impact of alcohol on the development 92

and behaviour of young people has been well researched in early3, middle

4 and late 93

adolescence 5. It is now well known that young people are much more vulnerable than 94

adults to the adverse effects of alcohol, due to a range of physical and psycho-social factors 95

which often interact 6. 96

97

There is no standardized definition of risky drinking in young people and so our definition 98

encompasses commonly understood concepts of hazardous drinking (at a level or pattern 99

that increases the risk of physical or psychological problems), harmful drinking (defined by 100

the presence of these problems) and binge drinking (risky single occasion, high intensity 101

drinking which can be episodic) as well as the Department of Health concepts of increasing 102

and high risk drinking 7. The Chief Medical Officer for England has provided 103

recommendations on alcohol consumption in young people 8 based on an evidence review 104

of the risks and harms of alcohol to young people 6. The recommendations state that 105

children should abstain from alcohol before the age of 15 and those aged 15-17 are advised 106

not to drink, but if they do drink it should be no more than what equates to adult daily 107

benchmarks 9. 108

109

Primary and secondary preventative interventions for risky drinking 110

There is a large volume of research on universal prevention to reduce risky drinking in the 111

school setting 10 11

. Such prevention is directed at all young people, whether they drink 112

alcohol or not, and aims to delay the age that drinking begins, often via general health 113

education. This body of work has shown mixed results with only a small number of 114

programmes reporting that interventions delivered in a school setting were more effective 115

in reducing alcohol use than control conditions 12

. Secondary prevention, i.e. targeting 116

interventions at young people who are already drinking alcohol, may be a more effective 117

and efficient strategy since the intervention is likely to have more salience for the 118

individuals receiving it 13 14

. 119

120

This secondary prevention generally consists of alcohol brief interventions and screening (to 121

identify relevant potential recipients) followed by structured advice or counselling of short 122

duration which is aimed at reducing alcohol consumption or decreasing problems associated 123

with drinking 15

. The interventions are often based on social cognitive theory which is 124

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derived from social learning theory 16

. These types of intervention have been found to be 125

particularly effective with this age group13

. 126

127

This current research aims to develop the evidence base by focusing on a secondary 128

prevention intervention of screening and brief intervention to reduce risky drinking in 129

younger adolescents (aged 14-15) in a school context. The study follows on from the SIPS JR-130

HIGH pilot feasibility study which was funded by the National Institute of Health Research 131

Public Health Programme (NIHR PHR) (ISRCTN07073105) 14

. 132

133

� Main Trial 134

AIMS, OBJECTIVES AND METHODS 135

Research aim 136

The aim of the study is to evaluate the effectiveness and cost-effectiveness1 of alcohol 137

screening and brief intervention to reduce risky drinking in young people aged 14-15 in the 138

English school setting. Validated tools will be used in the study for primary and secondary 139

outcomes measures. 140

141

Primary outcome 142

• Total alcohol consumed in standard units in the last 28 days, using the 28 day Timeline 143

Follow Back questionnaire 17

at 12-month follow-up. 144

145

Baseline secondary outcome measurements 146

• Student Alcohol Questionnaire (A-SAQ) 18

to measure risky drinking (scoring ‘4 or more 147

times but not every month’, ‘at least once a month but not every week’, ‘every week but 148

not every day’, or ‘every day’); 149

150

• Alcohol use frequency, quantity (on a typical occasion) and binge drinking (six or more 151

drinks in one session for men and women) 19

assessed using the modified 10 question 152

Alcohol Use Disorders Identification Test (AUDIT) 20

,21

; 153

154

• Alcohol related problems assessed using the validated Rutgers Alcohol Problems 155

Inventory (RAPI) which includes measures on aggression 22

; 156

157

• Drunkenness during the last 30 days, dichotomised as ‘never’ and ‘once or more’ 4; 158

159

• Drinking motives assessed using the 20-item Drinking Motives Questionnaire (DMQ). 160

This tool uses a six-point Likert scale, which measures motives to drinking across four 161

domains (social, coping, enhancement and conformity). Higher scores within each 162

1 Cost-effectiveness will be established to determine whether it is worthwhile to roll-out the ABI across schools

in England, should it be found to be effective.

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domain indicate stronger endorsement of positive reinforcement received through 163

consumption of alcohol 5; 164

165

• General psychological health using the 14 item Warwick Edinburgh Mental Well-Being 166

Scale (WEMWBS) 23

. This tool uses a five-point Likert scale which gives a score of one to 167

five per question giving a minimum score of 14 and maximum score of 70. A higher 168

WEMWBS score indicates a higher level of mental well-being 24

.25

; 169

170

• Two questions relating to sexual risk taking are included. These are the same questions 171

as in the pilot study 14

. These questions are: ‘After drinking alcohol, have you engaged in 172

sexual intercourse that you regretted the next day?’ and ‘After drinking alcohol, have 173

you ever engaged in sexual intercourse without a condom?’ Both questions can be 174

answered with one of the three following options: ‘I have never engaged in sexual 175

intercourse’, ‘Yes’, or ‘No’; 176

177

• Energy drink consumption will be assessed by asking young people how many times a 178

week they consume energy drinks. Young people can answer: ‘never’, ‘less than once a 179

week’, ‘2-4 days a week’, ‘5-6 days a week’, ‘every day once a day’, and ‘every day more 180

than once a day’; 181

182

• Age of first smoking and how many cigarettes were smoked in the past 30 days 1; 183

184

• Demographic information collected will include gender and ethnicity. The first part of 185

the postcode will be collected for trial participants; 186

187

• Quality of life measured using the EQ-5D Y, which is a valid measure for those aged 12 or 188

older, and will be used to measure health related quality of life 26

. Responses to the five 189

items will be converted into utility scores using the UK population algorithm. This will be 190

administered at baseline and 12 months post intervention 26

; 191

192

• Quality Adjusted Life Years (QALY) estimated using general population tariffs from 193

responses to EQ-5D Y administered and scored at baseline and 12 months. 194

195

12-month follow-up measurements 196

• All tools assessed at baseline; 197

198

• Percent days abstinence over last 28 days, drinks per drinking day and days>2 units from 199

28 day TLFB; 200

201

• Incremental cost per QALY gained at 12 months; 202

203

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• Depending on findings, modelled estimates of incremental cost per QALY and cost-204

consequences in the longer term; 205

206

• National Health Service (NHS), educational, social, and criminal services data estimated 207

using a modified S-SUQ 27

and a learning mentor case diary developed in the pilot study, 208

measured at 12 months post intervention; 209

210

• Cost-consequences presented in the form of a balance sheet for outcomes at 12 months 211

(For further details see Appendix 1). 212

213

TRIAL PARTICIPANTS 214

Young people aged 14-15 in Year 10 in at least 30 Secondary/High schools/Academies in 215

four sites: the North East of England, North West of England, Kent and Medway, and 216

London. Schools will be included if they have learning mentors (or equivalent members of 217

pastoral staff, including teachers fulfilling this role) employed by the school (most schools 218

have these pastoral/learning mentor staff roles). Screening will take place in the personal, 219

social and health education (PSHE) or equivalent lesson, registration class, on a classroom 220

basis, or in assembly. Interventions will take place in the learning mentor’s classroom or 221

office space. Pupils receive minimal recompense for taking part in the trial (an ‘admit one’ 222

cinema voucher), and each participating school will receive £1000 to assist with 223

administration and other costs of full research participation. 224

225

Inclusion criteria 226

Young people aged 14-15 years inclusive, whose parents do not opt them out of the study, 227

scoring positively on the A-SAQ, leaving their name, and are willing and able to provide 228

informed written assent (see appendix 2) for intervention and follow-up. 229

230

Exclusion criteria 231

Young people already seeking or receiving help for an alcohol use disorder, with a 232

recognised diagnosis of a mental health disorder, or exhibit challenging behaviour. 233

234

TRIAL PROCEDURES 235

Learning mentors (or equivalent members of pastoral/trained staff; hereafter referred to as 236

‘learning mentors’) employed by schools will deliver the intervention. All learning mentors 237

will receive school-based training in the study procedures and intervention. Training for 238

learning mentors will be carried out by the trained Research Co-Ordinators. Simulated 239

scenarios between learning mentors will be audio recorded and learning mentors will be 240

assessed by an interventionist prior to embarking on the study with more training support 241

offered if needed. Learning mentors will be provided with materials and on-going guidance 242

and supervision will be provided by research staff. Support on implementing screening and 243

paperwork relevant to the research will be provided by the research team, with a Research 244

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Co-ordinator in each geographical site. Research staff and trainers will maintain regular 245

contact with schools throughout the study period, including site visits and telephone and 246

email support. 247

248

Control arm 249

Usual practice on alcohol health education as delivered normally to all students, including in 250

Personal Social and Health Education (PSHE) lessons and curriculum delivered by class 251

teachers, and usual individualised support for young people with an identified alcohol 252

concern. Young people in the control arm will also be given a healthy lifestyle information 253

leaflet (not containing advice about alcohol) with local sources of help, by the trained staff. 254

Usual practice may vary from school to school and information related to this will be 255

captured by researchers at both time points of the study. 256

257

Intervention 258

In addition to input equivalent to the control arm, young people who are eligible and assent 259

to participate will take part in a single 30-minute personalised interactive worksheet-based 260

session which was developed during the pilot feasibility trial. This brief intervention is 261

grounded in psychological theory and broadly based upon social learning theory which 262

views behaviour as a dynamic interaction between the individual, behaviour and 263

environment. As such, the intervention focuses on both personal and contextual factors 264

related to drinking behavior16

. This will be delivered by the trained staff (at school) and will 265

contain personalised feedback about the individual student’s drinking behaviour, and 266

behaviour change counselling which encompasses the elements of the FRAMES approach 267

and helps the young person to talk through: how much they drink; how many units are in 268

their drinks; who with, where and why they drink; when they might feel at risk from 269

drinking; what they think are the positive and negatives to drinking; what they perceive 270

others to think about their drinking; whether they would reduce their drinking, why and 271

why not; and what they could do about their drinking [20]. The intervention also includes 272

advice about the health and social consequences of continued risky alcohol consumption 273

and a leaflet on alcohol. 274

275

Randomization 276

Neither the learning mentor nor the young person will know which arm they are 277

randomized to until after they assent to take part in the trial. Young people will be 278

individually randomized in a 1:1 ratio to the intervention and control arms. A statistician not 279

otherwise involved with the study will produce a computer-generated allocation list to 280

ensure allocation concealment. All efforts will be made to conceal allocation to young 281

people, school staff (except LM delivering the sessions) and research staff, but we are 282

unable to guarantee that young adults will not discuss their allocation with each other. 283

284

[Insert Figure 1 Here] 285

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Safeguarding 286

Should issues arise that concern learning mentors or research staff (e.g. alcohol and mental 287

health issues), confidentiality will be broken and the necessary support provided to the 288

young person. Safeguarding issues will be recorded in the trial database. Confidentiality will 289

not be broken otherwise, and school staff will be informed through training that they must 290

work to the same rules as doctors and nurses, meaning that confidentiality can only be 291

broken without consent in exceptional (safeguarding) circumstances. Research/trial staff 292

will provide assistance and support on this issue throughout the trial. 293

294

RECRUITMENT, ASSENT AND SCREENING 295

Recruitment 296

In each of the four geographical sites, initially school performance league tables 28

will be 297

reviewed and schools from the top, middle and bottom of the league table will be 298

contacted. Snowball sampling will allow contact with potential schools via relationships with 299

recruited schools, although may bias the sample and reduce generalisability of results. That 300

said, efforts will be made to recruit a cross-section of schools including academy schools, 301

schools in deprived areas and religious schools. Gatekeepers and key personnel (e.g. School 302

Board of Governors; County Council contacts) will be approached to suggest – and create an 303

initial contact – with potential schools. 304

305

Option to opt-out of screening (assent) 306

In advance of screening, all parents/caregivers (hereafter referred to as ‘parents’) will be 307

informed by letter, sent by the school, that young people will be screened as part of the 308

study within their child’s school. Parents will have the choice to opt their child out of the 309

study by completing an opt-out form and sending this (in the freepost envelope provided) to 310

the co-ordinating research centre at Teesside University. Those young people whose 311

parents have opted them out of the study will not complete the questionnaire. If the opt-312

out is received after the questionnaire is completed, the questionnaire will be removed 313

from the trial. Additionally, where possible, young people who have been opted-out will not 314

be in the classroom at the time the questionnaire takes place. Obtaining assent to take part 315

in this manner is a method widely used in various national youth questionnaires of alcohol 316

consumption and other health behaviours 29

. 317

318

Screening for the trial 319

A video-clip will be played to the young people opted into the study, in each school, to give 320

instructions on completing the questionnaires (see: 321

https://www.youtube.com/watch?v=2ZBm3VZVtx0&feature=em-upload_owner). This 322

video-clip will only provide guidance on the process of questionnaire completion and not on 323

the content. Young people will be asked to voluntarily leave their name and class on the 324

questionnaire. Young people will have the option to: a) not complete the questionnaire 325

(indicative of lack of assent to screening from the young person); b) complete the 326

questionnaire anonymously; or c) complete the questionnaire adding their name and class. 327

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Each young person will place their completed questionnaire in an envelope and then return 328

it to the teacher. Teachers will not open these envelopes. Individual responses will not be 329

shared with the class teacher or learning mentor. The Research Co-Ordinator will collect the 330

sealed envelopes from the school. Those young people who have screened positively on the 331

A-SAQ (see below) and have left their name will be eligible for the trial. Completed baseline 332

questionnaires by trial participants will be used for the baseline measurements. 333

334

DATA COLLECTION 335

Baseline data collection 336

The study envelope will contain a series of questionnaires including the study screening 337

questionnaire (part of the A-SAQ): ‘In the last 12 months how often have you drunk more 338

than 3 units of alcohol?’ with the response options of ‘Never’; ‘less than 4 times’; ‘4 or more 339

times but not every month’; ‘at least once a month but not every week’; ‘every week but 340

not every day’; ‘every day’. Scoring ‘4 or more times’, or more frequently, indicates a 341

positive screen and eligibility for the trial. This score was shown in our pilot feasibility trial to 342

be a methodologically robust approach to identifying the adolescent population who may 343

benefit from an intervention 14

. The A-SAQ will be embedded within a larger questionnaire 344

with items addressing a number of health and lifestyle topics (described above). 345

346

Invitation to meet with learning mentors 347

Completed baseline questionnaires will be enclosed in a sealed envelope and returned to 348

the individual universities coordinating each study site. The A-SAQ will be scored and a list 349

of ID numbers and names of those that score positive will be sent to a researcher at 350

Teesside University. After learning mentor training (convened by study site coordinators), 351

learning mentors will be given case packs for each eligible young person. Learning mentors 352

will invite young people who scored positive on A-SAQ on the baseline questionnaire to a 353

meeting with them in their office, where they will open the case pack. In the case pack there 354

will be an information leaflet, a case diary, assent forms, and a sealed envelope which 355

contains the randomized condition (intervention or control). Young people will be informed 356

that participation is voluntary and will be given the information leaflet to read before 357

signing the assent form. The assent form also asks for the first part of the young person’s 358

postcode. The postcode information will be used to enable a stratified sample of young 359

people to be invited to take part in the qualitative study. Once a young person has assented 360

the second envelope will be opened which will state whether the participant has been 361

randomized to intervention or control. The learning mentor will then deliver the brief 362

intervention or give the participant the control leaflet (in the same meeting). The completed 363

case packs will be sealed and returned to coordinating sites, then couriered to Teesside 364

University. At all times, only the randomization statistician (AB), two researchers (JB, LA), 365

and individual learning mentors who meet with the young people will know of the 366

randomization allocations before the trial ends. 367

368

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12-month follow-up 369

Follow-up will occur 12 months post intervention. All young people who are randomized 370

into the trial will be invited to meet with the Research Co-ordinator (in school) where they 371

will be asked to complete the same questionnaires used at baseline. The researcher will be 372

blinded to the condition the young person was allocated to. The TLFB (including the primary 373

outcome measure of total alcohol consumption) will also be completed face-to-face in 374

schools with the researcher in order to limit bias in the results. All trial participants will be 375

given an admit-one cinema voucher, to compensate them for their time involved in the 376

study 30

. Trial participants’ baseline and follow-up questionnaires will be linked with a 377

unique ID (the screening number). All participants will be asked by the researcher at follow-378

up whether they are willing to be contacted for an in-depth interview by a researcher who 379

may be the same individual or another researcher. 380

381

Intervention fidelity 382

It is important to ensure learning mentors deliver the intervention in accordance with the 383

intervention manual. To establish intervention fidelity, we will complete competency and 384

fidelity checks at two time points: 1) competency checks of learning mentor training, and 2) 385

fidelity checks of cases delivered during the intervention phase. For the competency checks, 386

each learning mentor will have one simulated intervention with another learning mentor or 387

the research co-ordinator. Of these sessions, at least 80% will be recorded and ‘signed off’ 388

by an independent expert rater from the research team using the BECCI rating scale 31

. 389

Additionally, we will attempt to assess 20% of live cases for fidelity (using a pragmatic 390

sampling approach). The BECCI scale is a tool that measures the skills involved in behaviour 391

change counselling. It is scored 0-4 with a score of two or more (skills used to ‘some extent’) 392

being acceptable as used in previous studies14 32-34

. The young people will provide assent for 393

the live case recording to take place. As the recording and analysis of the delivery of the 394

intervention sessions forms part of the employment contract of the learning mentors, 395

formal consent is not required. 396

397

Sample size calculation 398

Using estimates from the pilot trial (mean year group size = 210, 87% completing baseline 399

questionnaire, 20% being positive on A-SAQ and leaving contact details, 80% recruited to 400

trial and 88% providing data at 12 months follow-up), achieving follow-up data on 235 401

young people per arm the sample size has been calculated to have a 90% power to detect a 402

standardized difference of 0.3 (which equates to a ratio of 1.5 in geometric means in total 403

alcohol units in 28 days) using a significance level of 5% (Figure 1). 404

405

ANALYSIS 406

Baseline data 407

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Descriptive statistics (comparisons of percentages, means or medians as appropriate) will be 408

used to report the pupil-level baseline data, and completeness of intervention received 409

between those allocated to the two trial arms. 410

411

Primary outcome 412

The primary effectiveness analysis will be by intention-to-treat. Multiple linear regression 413

will be used to compare the primary outcomes between the two randomization groups at 414

12 months, adjusting for any imbalance in key covariates including school. 415

416

Secondary outcomes 417

The secondary outcomes will be analysed in a similar manner. Comparisons of means will be 418

presented as mean differences or ratios of geometric means (if a logarithmic transform is 419

necessary for skewed data) with 95% Confidence Intervals (CI) odds ratios and 95% CIs will 420

be presented for binary outcomes. Exploratory analyses will also be undertaken, for 421

example, to examine differences in outcome by gender, deprivation and extent of 422

intervention received, though there is limited power to investigate these comparisons. 423

These moderators have been included so as to consider whether the ABI may need to be 424

targeted when delivered, should it be shown to be effective. We will consider any difference 425

in attrition rates, and any non-randomness of the attrition, when comparing outcomes 426

between the two groups. The pattern of missing observations because of loss to follow-up 427

will be examined to determine both the extent of missingness, and whether it is missing at 428

random or is informative. If data are missing to a sufficient extent, the use of appropriate 429

multiple imputation techniques will be considered. 430

431

Health economics 432

The economic component will include both a within trial cost-utility and cost-consequence 433

analysis and, as described below, a model based analysis taking the perspective of the UK 434

public sector (NHS, educational, social, and criminal services). The cost-utility analysis will 435

use measures of effectiveness limited to health related quality of life as measured by EQ-5D 436

Y. The cost-consequence analysis will take the same perspective for costs but will present 437

these alongside all of the primary and secondary measures of effectiveness outlined above. 438

The follow-up for the within trial analyses will be 12 months so discounting will not be 439

conducted. For the model based analysis the time horizon will be longer (potentially up to 440

the participant’s life time) and costs and effects will be discounted at 1.5%, the UK 441

recommended rate for public health interventions 35

, with a sensitivity analysis used to 442

explore the impact of higher (and lower) discount rates. 443

444

Within trial analysis cost-utility and cost-consequence analyses 445

For each trial participant the use of health, educational, criminal, and social care services 446

will be elicited using the S-SUQ administered at baseline (with a recall period of three 447

months) and 12 months. Further cost data will come from the learning mentor time case 448

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diaries completed by the learning mentors for each contact. Costs for healthcare and social 449

services will be obtained from standard sources such as NHS reference (www.gov.uk), the 450

British National Formulary 36

for medications, Unit costs of Health and Social Care 37

for 451

contacts with primary care. Further data will come from the study centres themselves. Data 452

on the use of educational services will be elicited via the questionnaire. As part of the pilot 453

trial we confirmed with the expert group the type of services relevant to collect, and have 454

also added further questions related to days missed from school and truancy. 455

456

Learning mentor training costs will be included and will need to be apportioned according to 457

scaled up practice. This will be informed by data from the training conducted as part of the 458

trial and through expert opinion. The time of educational staff will be sought through a 459

parallel costing exercise in which these staff will be asked to provide information on the 460

impact of the intervention on their workload. With respect to learning mentors, a detailed 461

proforma (case diary) was developed and tested in the pilot to capture resource use for 462

cost-effectiveness analyses, and this new tool will be used in this study. With respect to 463

school building and other large capital items, the opportunity cost will be considered. Some 464

resources (e.g. buildings) will exist with or without the intervention and the intervention 465

may not displace any other activity. In this circumstance the opportunity cost of the building 466

would be zero. However, costs might be incurred in terms of heat, power and light and 467

these data will be captured using standard costing methods 38

. For each participant, 468

measures of use of resources will be combined with unit costs to provide a cost for that 469

participant. We anticipate that the price year adopted for the base case analysis will be 470

2017 when the final analysis is conducted. 471

472

The EQ-5D Y will be administered at baseline and 12 months with UK population tariffs 39

473

used. Health state utilities from the EQ-5D Y will then be used to estimate QALYs using the 474

area under the curve approach 26

. 475

476

� Qualitative Study 477

Aims 478

In addition to the main trial, an embedded qualitative study will be conducted. The 479

qualitative study will: 480

• Explore the delivery and efficacy of screening and brief intervention approaches in the 481

school setting, and to elicit participants’ experiences of the study; 482

483

• In interviews with school staff: explore the mechanisms and processes of implementing 484

the SIPS JR-HIGH intervention to understand how this brief intervention could become 485

embedded in the work role of school staff, the prioritisation of educational or well-being 486

work, the scope for team or individual professional input, staff skill mix and turnover, 487

resources, role development and training needs, and participants’ assent; 488

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• In interviews with young people: explore their experiences of taking part in the study 489

and their views on any derived benefits, adverse events, or improvements; 490

491

• In interviews with parents: explore their views on school-led interventions for 492

adolescent alcohol use, issues relating to parental consent to take part in such 493

interventions, and the appropriateness of school-led health promotion work across the 494

school-home interface. 495

496

Sample 497

At each of the four research sites, we will seek to interview a minimum of: two teachers and 498

four learning mentors from different schools (24 interviews in total); and participating 499

young people from a random selection of included schools, with an even representation of 500

males and females across both trial arms (40 interviews). We will also interview parents of 501

young people in attendance at schools in each of the four sites (16 interviews in total). We 502

will endeavour to include mothers and fathers (both co-habiting and lone parents) in the 503

sample as well as parents of both boys and girls covering different cultural groups. Variation 504

will also be sought in terms of drinking risk status of the young people (based on A-SAQ 505

screening data) and socioeconomic status of young people and parents (as measured by 506

index of multiple deprivation rank of school and the first part of the pupil’s postcode at 507

baseline and A-SAQ score at follow-up). Teachers and learning mentors will be sampled 508

according to variation of socioeconomic status of the school where they are employed. Data 509

saturation for either dataset (school staff or young people) will be defined as no 510

substantively new themes having emerged from the analysis of three consecutive interviews 511 40

. 512

513

RECRUITMENT, CONSENT AND ASSENT 514

Research Co-Ordinators from each of the four sites will disseminate an invitation letter and 515

information leaflets to all participating teachers and learning mentors. In addition, school 516

staff from each of the four sites will disseminate the letter and information leaflet to all 517

young people. Schools will text parents and direct them to an online platform containing the 518

invitation letter and information leaflet. 519

520

The online facility will offer the ability to opt-in to the study, which parents, young people 521

and school staff can complete if they wish to participate in the qualitative interviews. 522

Alternatively, they can contact the research co-ordinator to arrange a suitable interview 523

date by email or telephone. 524

Consent and assent 525

All participants will be given a copy of a relevant information sheet and school staff and 526

parents will be asked to complete a consent form and young people an assent/consent form 527

before taking part in the qualitative component of the study. 528

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STUDY DESIGN 529

Semi-structured face-to-face interviews will be conducted with all participants. All 530

interviews will be audio recorded and transcribed verbatim. 531

532

ANALYSIS 533

Data from all interviews will be subjected to thematic analysis, which is appropriate for 534

qualitative health research which seeks to explore key concepts pertinent to the research 535

aims, but without presupposing a rigid framework and a priori selection of key themes 41

. 536

This analytic strategy is characterised by an inductive approach, in which analysis is open 537

and flexible, allowing themes to be generated from the research, in order that findings have 538

relevance to applied research questions, but are not led by the researchers, as would a 539

deductive approach dictate 42 43

. Data will be coded by a qualitative researcher following 540

standard thematic analysis procedures. That said, our development of the discussion guide 541

for the interviews will be informed by theory on the likelihood of embedding study 542

interventions in clinical practice, namely Normalization Process Theory 44

. It is expected that 543

the discussion guide will include questions linked to intervention implementation, such as 544

role legitimacy (appropriateness of role/parental views, any role conflicts), adequacy 545

(training, how the children are identified, how the intervention is conducted) and support 546

(time available, support from school, parents). This theory considers factors that affect 547

implementation in four key areas: how people make sense of a new practice (coherence); 548

the willingness of people to sign-up and commit to the new practice (cognitive 549

participation); their ability to take on the work required of the practice (collective action); 550

and activity undertaken to monitor and review the practice (reflexive monitoring). The 551

approach is increasingly used in studies of the implementation of interventions in health 552

care (www.normalizationprocess.org). Data from interviews with young people and parents 553

will also be analysed inductively first through open coding and thematic analysis, and will 554

follow the principles of constant comparison thereafter 45

. In this way, a qualitative 555

researcher will read the interview transcripts and identify important or recurrent themes 556

emerging from the transcripts. These emergent themes will be utilised to code the 557

remaining transcripts, with open coding of any new themes that may emerge to expand on 558

the emerging theory/results. In addition to NPT, we will also develop the discussion guide 559

accounting for Bourdieu’s concept of habitus 46 47

; an approach used successfully by this 560

team in qualitative work with young people within the age range of this study 48

and their 561

parents 49

. Habitus represents a set of tastes and dispositions shared with others in social 562

space 49

, providing cultural norms and historic precedents continually reproduced through 563

practice 50

. Use of this theoretical framework offers a mechanism in which to explore young 564

people’s socially constructed responses to brief intervention. Furthermore, the reciprocal 565

idea of an individual and their interaction with society accords with the social learning 566

underpinning of brief intervention. 567

568

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At least one other qualitative expert will read and second-code a proportion of interviews 569

with both young people and staff; any divergence between coders will be discussed on an 570

on-going basis to inform the analysis, resolve divergent interpretations and enrich the 571

analysis 41

. Coded data will be reviewed to produce a detailed description of key results. We 572

will use NVivo software to aid indexing and charting. Analysis will be ongoing throughout 573

the process of data collection, and will be discussed at regular meetings within the research 574

team in order to identify areas for closer consideration (including negative case analysis) 575

and to enhance credibility of the analytical process and data interpretation 51

. Qualitative 576

analysis will take place prior to outcomes analysis, in keeping with published 577

recommendations 52

. 578

579

TRIANGULATION 580

Once the qualitative interviews from this study have been carried out and analysed 581

separately, they will be combined with the quantitative data from the main trial at the 582

‘analysis/interpretation’ phase, which is a process often described as 'triangulation' 53

. In 583

our study, data will be reconciled by adopting a model which relies on the principle of 584

complementarity 54

. Within this approach it is explicitly recognised that qualitative and 585

quantitative methods may be used to examine different aspects of an overall research 586

question 53

. 587

588

STUDY REPORTING AND PUBLICATIONS 589

If the intervention is shown to be effective and efficient we will develop a manualised 590

alcohol screening and brief intervention protocol to facilitate uptake/adoption in routine 591

practice in secondary schools in England. 592

593

It is planned to publish this study in peer reviewed articles and to present data at national 594

and international meetings. Results of the study will also be reported to the Sponsor and 595

Funder, and will be available on their website. All manuscripts, abstracts or other modes of 596

presentation will be reviewed by the Trial Steering Group and funder prior to submission. 597

Individuals will not be identifiable in any study report. 598

599

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Figure Legend 600

Figure 1: Study flowchart 601

602

Authors’ contributions 603

All of the authors contributed to the design and development of this trial protocol. DNB is 604

the chief investigator and ELG is the project manager of the SIPS JR-HIGH trial. The 605

disciplines represented in the team include: public health research (EK, DNB, SO’N, RM; ELG; 606

GM); alcohol and policy expertise (EK, DNB, SO’N, RM); conducting research with children 607

and young people (SO’N, RM); child and adolescent psychiatry (PM); health psychology (PD); 608

addiction psychiatry (CD, EG); criminology (DNB); medical statistics (DH, SC, ES) and trial 609

methodology (EM, SC, EK, CD, DH, CS, CH), health economics (MD, EG), and trial 610

management (CS, CH). LT has experience of education and learning mentors. The Newcastle 611

Clinical Trials Unit is a UK CRC-registered Clinical Trials Unit, with a strong track record in the 612

design, conduct, and analysis of NIHR-funded trials, including those of complex 613

interventions and feasibility/pilot trials. ELG and DNB wrote the first draft of the paper and 614

all authors contributed to successive drafts. All authors read and approved the final 615

manuscript. 616

617

Funding statement 618

This work is supported by the National Institute for Health Research Public Health Research 619

(NIHR) Programme Grant Number 13/117/02. The views and opinions expressed herein are 620

those of the authors and do not necessarily reflect those of the PHR Programme, NIHR, NHS, 621

or the Department of Health. 622

623

Colin Drummond is partly funded by the NIHR Biomedical Research Centre for Mental 624

Health at South London and Maudsley NHS Foundation Trust and King’s College London, and 625

is partly funded by the NIHR Collaborations for Leadership in Applied Health Research and 626

Care South London at King’s College Hospital NHS Foundation Trust. 627

628

Eileen Kaner is funded by the NIHR School of Primary Care Research and the NIHR School of 629

Public Health as a member of Fuse, a UKCRC Centre of Excellence in Public Health. 630

631

Ruth McGovern is funded through an NIHR Post Doctorate Fellowship. 632

633

Stephanie Scott is funded by the NIHR School of Public Health. 634

635

Competing Interest’s Statement 636

Eilish Gilvarry is a reviewer for NIHR. 637

638

Denise Howel was a member of the NIHR Health Services and Delivery Research 639

Commissioning Board until December 2015, and is a sub-panel member for NIHR 640

Programme Grants for Applied Research from February 2016. 641

642

Eileen Kaner is a funding board member of the NIHR Public Health Research funding board 643

and the NIHR Senior Fellowships panel. 644

645

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Elaine McColl is a sub-panel member for NIHR Programme Grants for Applied Research. 646

647

Luke Vale is a member of the NIHR Health Technology Assessment Clinical Evaluation and 648

Trials Panel, NIHR Programme Grants for Applied Research Panel and Director of NIHR 649

Research Design Service for the North East. 650

651

Remaining authors have no competing interests to declare. 652

653

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REFERENCES 654

655

1. Hibbell B, Guttormsson U, Ahlström S, et al. The 2011 ESPAD Report: Substance Use 656

Among Students in 36 European Countries. 2012. 657

2. Hawkins V. Smoking, drinking and drug use among young people in England in 2014. 658

London: Health and Social Care Information Centre, 2015. 659

3. Patton R, Deluca P, Kaner E, et al. Alcohol screening and brief intervention for 660

adolescents: The how, what and where of reducing alcohol consumption and related 661

harm among young people. Alcohol and Alcoholism 2013;49(2):207-12. 662

4. Segrott J, Gillespie D, Holliday J, et al. Preventing substance misuse: study protocol for a 663

randomised controlled trial of the Strengthening Families Programme 10–14 UK (SFP 664

10–14 UK). BMC Public Health 2014;14(49):1-21. 665

5. Cooper M. Motivations for alcohol use among adolescents: Development and validation 666

of a four-factor model. Psychological Assessment 1994;6:117-28. 667

6. Newbury-Birch D, Gilvarry E, McArdle P, et al. The impact of alcohol consumption on 668

young people: A review of reviews: Department of Children Schools and Families, 669

2009. 670

7. NHS Choices. The risks of drinking too much [Available from: 671

http://www.nhs.uk/Livewell/alcohol/Pages/Effectsofalcohol.aspx. 672

8. Department of Health. Guidance on the consumption of alcohol by children and young 673

people from Sir Liam Donaldson Chief Medical Officer for England: Crown Copyright, 674

2009. 675

9. Department of Health. Alcohol Guidelines Review –Report from the Guidelines 676

development group to the UK Chief Medical Officers. In: Health Do, ed. London, 677

2016. 678

10. Hale D, Fitzgerald-Yau N, Viner R. A Systematic Review of Effective Interventions for 679

Reducing Multiple Health Risk Behaviors in Adolescence. American Journal of Public 680

Health 2014;104(5):e19-e41. 681

11. National Institute for Health and Clinical Excellence. Interventions in schools to prevent 682

and reduce alcohol use among children and young people, 2007. 683

12. Foxcroft D, Tsertsvadze A. Universal school-based prevention programs for alcohol 684

misuse in young people: Cochrane Database of Systematic Reviews, 2011. 685

13. Griffin KW, Botvin GJ. Evidence-Based Interventions for Preventing Substance Use 686

Disorders in Adolescents. Child and Adolescent Psychiatric Clinics of North America 687

2010;19 (3):505-26. 688

14. Newbury-Birch D, Scott S, O'Donnell A, et al. A pilot feasibility cluster randomised 689

controlled trial of screening and brief alcohol intervention to prevent hazardous 690

drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH). London: 691

NIHR Public Health Research Program Report, 2014. 692

15. Kaner E, Dickinson H, Beyer F, et al. The effectiveness of brief alcohol interventions in 693

primary care settings: a comprehensive review. Drug and Alcohol Review 694

2009;28:301-23. 695

16. Bandura A. Social learning theory. Englewood Cliffs, NJ: Prentice-Hall, 1997. 696

17. Sobell L, Sobell M. Alcohol Timeline Followback Users' Manual. Toronto, Canada: 697

Addiction Research Foundation, 1995. 698

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18. Engs RC, D.J. H. The Student Alcohol Questionnaire: an updated reliability of the drinking 699

patterns, problems, knowledge, and attitude subscales. Psychological Reports 700

1994;74(1):12-14. 701

19. NHS Direct. Binge Drinking 2014 [Available from: 702

http://www.nhs.uk/Livewell/alcohol/Pages/Bingedrinking.aspx. 703

20. Babor T, De La Fuente J, Saunders J, et al. AUDIT, The Alcohol Use Disorders 704

Identification Test, guidelines for use in primary health care. Geneva: World Health 705

Organisation, 1989. 706

21. Reinert DF, Allen JP. The Alcohol Use Disorders Identification Test: An Update of 707

Research Findings. Alcoholism: Clinical & Experimental Research 2007;Vol. 31(No. 708

2):pp. 185-99. 709

22. White H, Labouvie H. Towards the assessment of adolescent problem drinking. Journal 710

of studies of Alcohol 1989;50(30):7. 711

23. NHS Health Scotland, University of Warwick. Warwick-Edinburgh Mental Well-Being 712

Scale (WEMWBS). Scotland, 2006. 713

24. Tennant R, Hiller L, Fishwick R, et al. The Warwick-Edinburgh Mental Well-being Scale 714

(WEMWBS): development and UK validation. Health and Quality of Life Outcomes 715

2007;5:63. 716

25. Clarke A, Friede T, Putz R, et al. Warwick-Edinburgh Mental Well-Being Scale 717

(WEMWBS): Validated for teenage school students in England and Scotland. A mixed 718

methods assessment. BMC Public Health 2011;11:487. 719

26. Euroquol. EuroQuol-a new facility for the measurement of health-related quality of life. 720

Health Policy 1990;16:199 - 208. 721

27. Team UR. Cost effectiveness of treatment for alcohol problems: findings of the 722

randomised UK alcohol treatment trial (UKATT). British Medical Journal 723

2005;331(7516):544. 724

28. Performance Tables - The Department for Education - School and College 2016 725

[Available from: http://www.education.gov.uk/schools/performance/. 726

29. Fuller E. Smoking, drinking and drug use among young people in England in 2013. 727

London: NatCen Social Research, 2014. 728

30. Systematic Review of Strategies to Reduce Attrition in Randomised Trials. The Society for 729

Clinical Trials Annual Meeting; 2013; Boston. Clinical Trials. 730

31. Lane C, Huws-Thomas M, Hood K, et al. Measuring adaptations of motivational 731

interviewing: the development and validation of the behavior change counseling 732

index (BECCI). Patient Educ Couns 2005;56(2):166-73. 733

32. Kaner E, Bland M, Cassidy P, et al. Effectiveness of screening and brief alcohol 734

intervention in primary care (SIPS trial): pragmatic cluster randomised controlled 735

trial. BMJ 2013;346. 736

33. Drummond C, Deluca P, Coulton S, et al. The effectiveness of alcohol screening and brief 737

intervention in emergency departments: a multicentre pragmatic cluster randomized 738

controlled trial. PLOS ONE 2014;9(6):e99463. 739

34. Newbury-Birch D, Coulton S, Bland M, et al. Alcohol screening and brief interventions for 740

offenders in the probation setting (SIPS Trial): a pragmatic multicentre cluster 741

randomised controlled trial. Alcohol & Alcoholism 2014;49(5):540-48. 742

35. National Institute for Clinical Excellence. Guide to the methods of technology appraisal. 743

London, 2013. 744

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ber 2016. Dow

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21

36. British Medical Association, Royal Pharmaceutical Society. British National Formulary 745

Edition 65, 2013. 746

37. Curtis L. Unit Costs of Health and Social Care 2012. In: PSSRU, ed. Canterbury: University 747

of Kent, 2013. 748

38. Drummond M, Stoddart G, Torrance G. Methods for the Economic Evaluation of Health 749

Care Programmes. Oxford: Oxford University Press, 2005. 750

39. Kind P, Hardman G, Macran S. UK population norms for EQ-5D. University of York: 751

Centre for Health Economics, 1999. 752

40. Francis J, Johnston M, Robertson C, et al. What is an adequate sample size? 753

Operationalising data saturation for theory-based interview studies. Psychology & 754

Health 2009;25(10):1229-45. 755

41. Pope C, Ziebland S, Mays N. Analysing qualitative data. BMJ 2000;320(7227):114-16. 756

42. Ritchie J, Lewis J. Qualitative Research Practice: A Guide for Social Science Students and 757

Researchers: Sage, 2003. 758

43. Ritchie J, Spencer L. Qualitative data analysis for applied policy research. In: Bryman A, 759

Burgess R, eds. Analysing qualitative data London: Routledge, 1993:17394. London: 760

Routledge, 1993. 761

44. May C, Finch T, Ballini L, et al. Evaluating complex interventions and health technologies 762

using normalization process theory: development of a simplified approach and web-763

enabled toolkit. BMC Health Services Research 2011;11(1):245. 764

45. Strauss A, Corbin J. Basics of qualitative research: grounded theory procedures and 765

techniques. Newbury Park CA: Sage, 1990. 766

46. Bordiue P. The Logic of Practice. Cambridge: Polity Press, 1990. 767

47. Bordiue P. Distinction. Cambridge, 1984. 768

48. Scott S, Baker R, Shucksmith J, et al. Autonomy, special offers and routines: a Q 769

methodological study of industry-driven marketing influences on young people's 770

drinking behaviour. Addiction 2014:n/a-n/a. 771

49. Brierley-Jones L, Ling J, McCabe K, et al. Habitus of ‘home’ and ‘traditional’ drinking: a 772

qualitative analysis of reported middle class alcohol use. Sociology of Health and 773

Illnewss 2014;36(7):1054-76. 774

50. Crawshaw P, Bunton R. Logics of practice in the risk environment. Health, Risk and 775

Society 2008;11(3):269-82. 776

51. Barbour RS. The Newfound Credibility of Qualitative Research? Tales of Technical 777

Essentialism and Co-Option. Qualitative Health Research 2003;13(7):1019-27. 778

52. O'Cathain A, Thomas KJ, Drabble SJ, et al. What can qualitative research do for 779

randomised controlled trials? A systematic mapping review. BMJ Open 2013;3(6). 780

53. O'Cathain A, Murphy E, Nicholl J. Three techniques for integrating data in mixed 781

methods studies. British Medical Journal 2010;341(c4587). 782

54. Moffatt S, White M, Mackintosh J, et al. Using quantitative and qualitative data in health 783

services research – what happens when mixed method findings conflict? BMC Health 784

Services Research 2006;6(28):1-10. 785

786

787

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108x60mm (300 x 300 DPI)

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APPENDIX 1

A multi-centre individual-randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): Study protocol

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Full Title: A multi-centre individual-randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH) Short title: SIPS JR-HIGH Chief Investigator: Professor Dorothy Newbury-Birch1 Co-applicants: Professor Eileen Kaner2, Professor Elaine McColl2,7, Denise Howel2, Elaine Stamp2, Dr Ruth McGovern2, Dr Stephanie Scott2, Professor Luke Vale2, Professor Liz Todd2, Professor Simon Coulton3, Professor Colin Drummond4, Dr Paolo Deluca4, Professor Harry Sumnall5, Les Tate6 Principal Investigators (sites): Professor Dorothy Newbury-Birch (North East), Professor Harry Sumnall (North West), Professor Simon Coulton (Kent), Professor Colin Drummond/Dr Paolo Deluca (London). Project Manager: Dr Emma Giles1 Senior Trial Manager (NCTU): Claire Macdonald7 Research Co-ordinators: Dr Grant McGeechan1, Jayne Ogilvie3, Dr Sadie Boniface4, Jo Frankham5, Grant Stanley5 Qualitative Researcher: Dr Grant McGeechan1

Database Manager: Nicola Howe2

Administrative Assistant: Robert Sayer1

1Health and Social Care Institute, Teesside University, 2Institute of Health and Society, Newcastle University, 3University of Kent, 4Kings College London, 5Liverpool John Moores University, 6North Tyneside Council, 7Newcastle Clinical Trials Unit, Newcastle University

ISRCTN Number: ISRCTN45691494

Ethics approval number: No 164/15

Protocol Version and Date: Version 1.4. 26.04.2015

Funded by / Grant reference: NIHR PHR 13/117/02

Sponsored by: Newcastle University

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1. Protocol contacts Chief Investigator: Professor Dorothy Newbury-Birch, Professor of Alcohol and Public Health Research, Health and Social Care Institute, Teesside University, Middlesbrough. TS1 3BA. [email protected] Project Manager: Dr Emma Giles, Senior Research Lecturer in Public Health, Health and Social Care Institute, Teesside University, Middlesbrough. TS1 3BA. [email protected] Newcastle Lead: Professor Eileen Kaner, Institute Director, Newcastle University, Institute of Health and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX. [email protected] Sponsor: Mrs Lois Neal, Faculty of Medical Sciences, Newcastle University, Framlington Place, Newcastle upon Tyne, Tyne and Wear, NE2 4HH. [email protected] Senior Research Interventionist: Dr Ruth McGovern, Newcastle University, Institute of Health and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX. [email protected] Statistics: Denise Howel, Senior Lecturer in Epidemiological Statistics, Newcastle University, Institute of Health and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX. [email protected] QOL/Health Economics: Professor Luke Vale, Newcastle University, Health Foundation Chair in Health Economics. Newcastle University, Institute of Health and Society, Newcastle upon Tyne, Tyne and Wear, NE2 4AX. [email protected] Senior Trial Manager (NCTU): Claire Macdonald, Newcastle University, Newcastle Clinical Trials Unit, 1-4 Claremont Terrace, Newcastle upon Tyne, Tyne and Wear, NE2 4AE. [email protected] Database Manager: Nicola Howe, Newcastle University, Newcastle Clinical Trials Unit, 1-4 Claremont Terrace, Newcastle upon Tyne, Tyne and Wear, NE2 4AE. [email protected] Administrative Assistant: Robert Sayer, Health and Social Care Institute, Teesside University, Middlesbrough. TS1 3BA. [email protected] Emergency contact (e.g. out of office hours): Professor Dorothy Newbury-Birch 07980629456

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2. Protocol signature page

REPRESENTATIVE OF THE RESEARCH SPONSOR

Name: Lois Neal Position: Assistant Registrar Signature: Date:

CHIEF INVESTIGATOR

Name: Professor Dorothy Newbury-Birch Position: Professor of Alcohol and Public Health Research

Signature: Date:

PROJECT MANAGER

Name: Dr Emma L Giles Position: Senior Research Lecturer in Public Health

Signature: Date:

STATISTICIAN

Name: Ms Denise Howel Position: Senior Lecturer in Epidemiological Statistics

Signature: Date:

HEALTH ECONOMIST

Name: Professor Luke Vale Position: Health Foundation Chair in Health Economics

Signature: Date:

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2.1 Principal Investigator signature I confirm that I have read and understood protocol 1.4 dated 26.04.2015. I agree to comply with the study protocol, the principles of Good Clinical Practice (GCP), research governance, clinical trial regulations and appropriate reporting requirements. Print Name Site Name/I.D. Signature ……………………………… Date …………

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Contents 1. Protocol contacts ................................................................................................................................ 2

2. Protocol signature page ...................................................................................................................... 3

2.1 Principal Investigator signature ................................................................................................. 4

3. Glossary of abbreviations.................................................................................................................... 7

4. Responsibilities ................................................................................................................................... 8

4.1 Trial management ..................................................................................................................... 8

4.2 Trial conduct at sites ................................................................................................................. 8

4.3 The Caldicott principles ............................................................................................................. 9

5. Protocol summary .............................................................................................................................11

6. Background .......................................................................................................................................12

6.1 Consequences of drinking in early life..................................................................................... 12

6.2 Primary and secondary preventative interventions for risky drinking .................................... 12

6.3 Brief intervention .................................................................................................................... 13

6.4 Rationale for current study ..................................................................................................... 13

7. Research aim and objectives ............................................................................................................14

7.1 Primary objective..................................................................................................................... 14

7.2 Secondary objectives ............................................................................................................... 14

8. Study design ......................................................................................................................................15

9. Outcome trial assessments ...............................................................................................................15

9.1 Baseline assessments .............................................................................................................. 15

9.2 12 month assessments ............................................................................................................ 15

9.3 Primary outcome measure: ..................................................................................................... 16

9.3.1 Secondary (effectiveness) outcomes measures: .................................................................... 16

9.3.2 Secondary (health economic) outcome measures: ................................................................ 16

9.4 Definition of end of study:....................................................................................................... 16

10. Participants .......................................................................................................................................16

10.1 Socioeconomic context and inequalities ................................................................................. 16

10.2 Inclusion criteria ...................................................................................................................... 17

10.3 Exclusion criteria ..................................................................................................................... 17

11. Trial procedures ................................................................................................................................17

11.1 Training .................................................................................................................................... 17

11.2 Control arm ............................................................................................................................. 18

11.3 Intervention ............................................................................................................................. 18

12. Randomisation ..................................................................................................................................18

12.1 Questionnaire and intervention process ................................................................................. 18

12.2 Flowchart of study ................................................................................................................... 21

13. Screening, recruitment and assent ...................................................................................................21

13.1 Screening and eligibility criteria .............................................................................................. 21

13.2 Option to opt-out of screening ............................................................................................... 21

13.3 Screening for the trial .............................................................................................................. 21

13.4 Data collection ......................................................................................................................... 22

13.4.1 Baseline data collection ........................................................................................................ 22

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13.4.2 Invitation to meet with learning mentors ............................................................................ 22

13.5 Assent procedures ................................................................................................................... 23

13.4.3 12-month follow-up ............................................................................................................. 23

13.4.4 Intervention fidelity .............................................................................................................. 24

14. Project timetables and milestones ...................................................................................................24

15. Statistical considerations ..................................................................................................................24

15.1 Sample size calculation ............................................................................................................ 24

15.2 Analysis .................................................................................................................................... 25

15.2.1 Baseline data ........................................................................................................................ 25

15.2.2 Primary outcome .................................................................................................................. 25

15.2.3 Secondary outcomes ............................................................................................................ 25

15.2.4 Interim analyses ................................................................................................................... 25

15.2.5 Missing data ......................................................................................................................... 25

16. Health economics ..............................................................................................................................25

16.1 Within trial analysis cost-utility and cost-consequence analyses ........................................... 26

16.2 Model based analysis .............................................................................................................. 27

17. Qualitative work ................................................................................................................................27

18. Triangulation .....................................................................................................................................27

19. Compliance and withdrawal .............................................................................................................28

19.1 Assessment of compliance ...................................................................................................... 28

19.2 Withdrawal of participants ...................................................................................................... 28

20. Data monitoring, quality control and quality assurance ..................................................................28

21. Adverse event monitoring and reporting .........................................................................................29

22. Ethics and regulatory issues ..............................................................................................................29

23. Research governance ........................................................................................................................29

24. Confidentiality ...................................................................................................................................30

25. Insurance and finance .......................................................................................................................30

26. Study report/publications .................................................................................................................31

27. References ........................................................................................................................................31

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3. Glossary of abbreviations AUDIT Alcohol Use Disorders Identification Test A-SAQ Student Alcohol Questionnaire BECCI Behaviour Change Counselling Index C.I. Confidence Intervals C-RCT Cluster Randomised Control Trial DMES Data Monitoring and Ethics Committee DMQ Drinking Motives Questionnaire EQ-5D-Y European Quality of Life Five Dimension – Youth FRAMES Feedback, Responsibility, Advice, Menu, Empathy and Self-efficacy GCP Good Clinical Practice MRC Medical Research Council NHS National Health Service NHS EED National Health Service Economic Evaluation Database NICE The National Institute for Health and Care Excellence NIHR PHR National Institute of Health Research, Public Health Research PI Principal Investigator PSHE Personal Social and Health Education Lessons QALYS Quality Adjusted Life Years RAPI Rutgers Alcohol Problems Inventory RCT Randomised Control Trial S-SUQ Short Service Use Questionnaire TLFB Time Line Follow Back TOC Trial Oversite Committee WEMWBS Warwick Edinburgh Mental Well-Being Scale

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4. Responsibilities Sponsor: Newcastle University are the award holders and will act as the sponsor for this study. Funder: NIHR PHR is funding this study. Trial management: A Trial Management Group (TMG) will be appointed and will be responsible for overseeing the progress of the trial. The day-to-day management of the trial will be co-ordinated by the Project Manager. A Trial Steering Group (TSC) and a separate Data Management and Ethics Committee (DMEC) will also be appointed to monitor trial data. Chief Investigator: The Chief Investigator will have overall responsibility for the trial. Principal Investigators: The Principal Investigators (PIs) will have overall responsibility for the conduct of the study at a particular trial site. 4.1 Trial management The following functions falling under the responsibility of the sponsor will be delegated to Professor Dorothy Newbury-Birch [Chief Investigator]:

Ethics Committee Opinion (including application for research ethics committee favourable opinion, notification of protocol amendments and end of trial, site specific assessment and local approval).

Good Clinical Practice and Trial Conduct (including GCP arrangements, data monitoring, emergency and safety procedures).

Administration of funding for the study will be carried out by Newcastle University who hold the award. Professor Eileen Kaner is the lead for Newcastle University.

4.2 Trial conduct at sites Site PI responsibilities

Study conduct and the welfare of study subjects.

Familiarity with the study conditions.

Compliance with the protocol, documentation of any protocol deviations and reporting of all serious adverse events.

Screening and recruitment of subjects.

Compliance with the Principles of GCP, the Research Governance Framework for Health and Social Care, the Data Protection Act and any other relevant legislation and regulatory guidance.

Ensuring that no participant is recruited into the study until all relevant regulatory permissions and approvals have been obtained.

Obtaining written informed assent from participants prior to any study specific procedures.

The PIs shall be qualified by education, training and experience to assume responsibility for the proper conduct of the trial. S/he shall provide a current signed and dated curriculum vitae as evidence for the Trial Master File.

Ensuring Study Site team members are appropriately qualified by education, training and experience to undertake the conduct of the study.

Availability for TSCs, DMECs, monitoring visits and in the case of an audit.

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Maintaining study documentation and compliance with reporting requests.

Maintaining a site file, including copies of study approval, list of subjects and their signed informed assent forms.

Documenting appropriate delegation of tasks to other study personnel e.g. Research Co-ordinators.

Ensuring data collected is accurate, timely and complete.

Providing updates on the progress of the trial.

Ensuring subject confidentiality is maintained during the project and archival period.

Ensuring archival of study documentation for a minimum of ten years following the end of the study, unless local arrangements require a longer period.

4.3 The Caldicott principles

Principle 1. Justify the purpose(s) for using confidential information: Every proposed use or transfer of personal confidential data within or from an organisation should be clearly defined, scrutinised and documented, with continuing uses regularly reviewed, by an appropriate guardian. How we will abide by Principle 1: Should we need to transfer personal data between Newcastle and Teesside Universities we will keep a log of the transfer, who requested and who executed the transfer, together with the reason for the transfer. This log will be kept on a password protected Excel file. Principle 2. Don't use personal confidential data unless it is absolutely necessary: Personal confidential data items should not be included unless it is essential for the specified purpose(s) of that flow. The need for patients to be identified should be considered at each stage of satisfying the purpose(s). How we will abide by Principle 2: We will gather limited personal data, including name and first part of postcode for trial participants. This is to allow us to map behaviours to socio demographic characteristics. Principle 3. Use the minimum necessary personal confidential data: Where use of personal confidential data is considered to be essential, the inclusion of each individual item of data should be considered and justified so that the minimum amount of personal confidential data is transferred or accessible as is necessary for a given function to be carried out. How we will abide by Principle 3: We will ask for name and class only to minimise the amount of personal we collect from the young people. For trial participants we will ask for the first part of their postcode. Principle 4. Access to personal confidential data should be on a strict need-to-know basis: Only those individuals who need access to personal confidential data should have access to it, and they should only have access to the data items that they need to see. This may mean introducing access controls or splitting data flows where one data flow is used for several purposes.

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How we will abide by Principle 4: Only the Study Research Administrator at Teesside University will have access to all of the information to ensure allocation concealment in the trial. The data will be accessed on a need-to-know basis only. Principle 5. Everyone with access to personal confidential data should be aware of their responsibilities: Action should be taken to ensure that those handling personal confidential data - both clinical and non-clinical staff - are made fully aware of their responsibilities and obligations to respect patient confidentiality. How we will abide by Principle 5: We will be providing training to all active researchers in the trial to ensure they understand confidentiality principles. Principle 6. Comply with the law: Every use of personal confidential data must be lawful. Someone in each organisation handling personal confidential data should be responsible for ensuring that the organisation complies with legal requirements. How we will abide by Principle 6: The research sponsor will ensure that all use of personal data will be lawful. Principle 7. The duty to share information can be as important as the duty to protect patient confidentiality: Health and social care professionals should have the confidence to share information in the best interests of their patients within the framework set out by these principles. They should be supported by the policies of their employers, regulators and professional bodies. How we will abide by Principle 7: We will abide by the policies of participating organisations.

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5. Protocol summary

Trial Title A multi-centre individual-randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH)

Acronym (short title)

SIPS JR-HIGH Protocol version and date

Summary of Trial Design

1.4 26.04.2016

A four-centre, individually randomised two armed Randomised Controlled Trial (RCT) incorporating a control arm of usual practice on alcohol issues and a 30 minute brief intervention arm.

Summary of Participant Population

Young people aged 14-15 years inclusive, whose parents do not opt them out of the study, scoring positively on the A-SAQ, leave their name and willing and able to provide informed assent for intervention and follow-up.

Planned Sample Size

4,200 pupils in year 10; with 235 in each arm at the 12-month follow-up.

Planned Number of Sites

At least five schools in each of the four geographical sites: North East, North West, London and Kent.

Study Intervention

30 minute brief alcohol intervention.

Follow Up Duration

At 12-months post intervention; completion of a questionnaire.

Planned Trial Period

01 September 2015 - 31 December 2017.

Primary objective: Total alcohol consumed in the last 28 days. Outcome measure: Time Line Follow-Back (TLFB) questionnaire at 12-month follow-up. Secondary (effectiveness) objective: To measure % days abstinence over last 28 days; risky drinking; smoking behaviour; alcohol-related problems; drunkenness during the last 30 days; and emotional wellbeing. Outcome measures: Drinks per day and days>2 units from 28 day TLFB; risky drinking using the Student Alcohol Questionnaire (A-SAQ), Alcohol Use Disorders Identification Test (AUDIT) and TLFB; smoking behaviour and alcohol related problems using the Rutgers Alcohol Problems Inventory (RAPI); drunkenness dichotomised as ‘never’ or ‘once or more’; emotional wellbeing using the Warwick Edinburgh Mental Health Well-being Scale (WEMWBS) and Drinking Motives Questionnaire (DMQ). Secondary (health economics) objectives: To measure Quality of Life Years (QALY) and health state utility and cost-consequences at 12 months. Outcome measures: Quality of life and health state utility measured using the European Quality of Life Five Dimension (EQ-5D Y) [1]; QALYs estimated using general population tariffs from responses to EQ-5D Y administered and scored at baseline and 12 months; National

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Health Service (NHS), educational, social, and criminal services data estimated using a modified Short Service Use Questionnaire (S-SUQ) and a learning mentor diary sheet developed in the pilot study; Incremental cost per QALY gained at 12 months; Cost-consequences presented in the form of a balance sheet for outcomes at 12 months; depending on findings, modelled estimates of incremental cost per QALY and cost-consequences in the longer term. 6. Background Adolescents in England are amongst the heaviest drinkers in Europe [1]. The percentage of young people who have ever had an alcoholic drink in England increases with age from 6% of 11 year olds to 72% of 15 year olds, and the prevalence of drinking in the last month rises from 2% of 11 year olds to 43% of 15 year olds [2]. Whilst drinking typically increases over adolescence, there has been a reduction over time across all ages of adolescents, although amongst those who drink they typically consume a higher volume. Nevertheless, drinking can have adverse impacts on health and social (including learning) outcomes for the many young people who are drinking alcohol. 6.1 Consequences of drinking in early life The impact of alcohol on the development and behaviour of young people has been well researched in early [3], middle [4] and late adolescence [5]. It is now well known that young people are much more vulnerable than adults to the adverse effects of alcohol, due to a range of physical and psycho-social factors which often interact [6]. These adverse effects include: physiological factors [4]; neurological factors due to changes that occur in the developing adolescent brain after alcohol exposure [7]; cognitive factors due to psychoactive effects of alcohol which impair judgement and increase the likelihood of accidents and trauma [8]; and social factors which arise from a typically high-intensity drinking pattern (often called ‘binge drinking’) which leads to intoxication and risk-taking behaviour [9]. Our definition of risky drinking encompasses commonly understood concepts of hazardous drinking (at a level or pattern that increases the risk of physical or psychological problems), harmful drinking (defined by the presence of these problems) and binge drinking (risky single occasion high intensity drinking which can be episodic) as well as the Department of Health concepts of increasing and high risk drinking [10]. Evidence suggests that risky drinking among young people occurs commonly in the context of other forms of challenging behaviour such as aggression and risk-taking [11]. The Chief Medical Officer for England has provided recommendations on alcohol consumption in young people [12] based on an evidence review of the risks and harms of alcohol to young people [6]. The recommendations state that children should abstain from alcohol before the age of 15 and those aged 15-17 are advised not to drink, but if they do drink it should be no more 3-4 units and 2-3 units per week in males and females respectively, on no more than one day per week [12] which equates to adult daily drinking recommendations. 6.2 Primary and secondary preventative interventions for risky drinking There is a large volume of evidence on primary prevention to reduce risky drinking in the school setting [13, 14]. Such prevention is directed at all young people, whether they drink alcohol or not, and aims to delay the age that drinking begins, often via general health education. This body of work has shown mixed results with only a small number of programmes reporting positive outcomes [14] and this body of work has been reported to be

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methodologically weak [15]. Secondary prevention, i.e. targeting interventions at young people who are already drinking alcohol, may be a more effective and efficient strategy since the intervention will have more salience for the individuals receiving it. This secondary prevention generally consists of screening (to identify relevant recipients) followed by structured advice or counselling of short duration which is aimed at reducing alcohol consumption or decreasing problems associated with drinking [16]. The interventions are based on social cognitive theory (from health psychology) which is drawn from social learning theory [17]; these theories regard behaviour to be the result of an interaction between individual, behavioural and environmental factors. It is assumed that each individual has cognitive (thinking) and affective (feeling) attributes that affect not only how they behave but also how their behaviour is influenced and/or reinforced by aspects of the external world. Thus, brief interventions generally focus on individuals’ beliefs and attitudes about behaviour, their sense of personal confidence (self-efficacy) about changing beliefs and attitudes and a focus on how an individual’s behaviour sits in relation to other people’s actions (normative comparison). 6.3 Brief intervention A key feature of brief intervention is that it is designed to be delivered by generalist practitioners (not addiction specialists) and is targeted at individuals who may not be aware they are experiencing alcohol-related risk or harm. The goal is usually reduced alcohol consumption or a decrease in alcohol-related problems [18]. There is variation in the duration and frequency of brief intervention [19] but there are two broad types: simple structured advice - based on the FRAMES model (feedback, responsibility, advice, menu, empathy and self-efficacy) and motivational interviewing [20]. Since the time available for delivering brief intervention may not allow for motivational interviewing in its full form [19], its ethos and techniques have been distilled into a more directive format called Behaviour Change Counselling [21] which has been successfully used in a number of UK trials [22-25]. Existing evidence described above demonstrates that alcohol screening and brief intervention for young people have been successful for selected individuals, in certain settings. 6.4 Rationale for current study The Chief Medical Officer for England has stated that school is seen as a key resource in the prevention, detection and treatment for risky drinking [26]. However, the current evidence is limited as it relates primarily to white, USA-based study participants and provides insufficient evidence to be confident about the use of alcohol screening and brief intervention to reduce excessive drinking and/or alcohol-related harm in younger adolescents aged under 16 and in a school setting in the UK [27-29]. Nevertheless, there is evidence that the most practical and effective forms of brief intervention in this setting are those based upon the FRAMES model. Specifically approaches containing personalised feedback about a young person’s drinking behaviour with motivational interviewing approaches, such as behaviour change counselling, can help to reduce levels of alcohol-related risk [23]. This current work builds on the evidence base by focusing on screening and brief intervention to reduce risky drinking in younger adolescents (aged 14-15). The proposed study follows on from the SIPS JR-HIGH pilot feasibility study which was funded under the National Institute of Health Research Public Health Programme (NIHR PHR) commissioned call 10/3002 Alcohol and Young People: Interventions to prevent risky drinking of alcohol by school aged children

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and young people [30]. The trial was registered on the ISRCTN register as ISRCTN07073105. The pilot feasibility trial was a three-arm cluster-randomised control trial (c-RCT) (with randomisation at the school level) with an integrated qualitative component to assess the feasibility and acceptability of a future definitive trial of brief alcohol intervention in a school setting. The trial measured recruitment and retention to the study, and explored facilitators and barriers to the use of these interventions with year 10 pupils (aged 14-15) in seven schools in the North East of England [23]. In our pilot feasibility study, young people who screened positively on a single alcohol screening question (collected in the context of a baseline classroom survey of drinking and other health behaviours) and assented to take part in our trial were randomised to either: provision of an advice leaflet (control arm, n=two schools); a 30-minute brief interactive session which combined structured advice and behaviour change counselling techniques delivered by the school learning mentor, and an advice leaflet (Intervention 1, n=two schools); or the 30-minute brief interactive session and an advice leaflet with the addition of a 60-minute session involving family members delivered by the school learning mentor (Intervention 2, n=three schools). Trial participants were followed-up at 12 months (88% retention). The results showed that it was not possible to carry out the second arm of the trial with parents, therefore the definitive study will only include two arms. As there are only two arms to the trial it is feasible to change to an individually randomised trial. 7. Research aim and objectives The aim of the study is to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14-15 in the English high school setting. 7.1 Primary objective To conduct an individually randomised controlled trial to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention for risky drinkers compared to standard usual practice on alcohol issues conducted by learning mentors with young people aged 14-15 in the school setting in the North East, North West, South East and London, England. Effectiveness is measured by total alcohol consumed in the last 28 days as measured by the 28 day TLFB.

7.2 Secondary objectives

To measure effectiveness in terms of % days abstinence over last 28 days; risky drinking; smoking behaviour; alcohol-related problems; drunkenness during the last 30 days; and emotional wellbeing.

To measure the cost-effectiveness of the intervention in terms of quality of life and health state utility; QALYs; Service use costs and cost-consequences at 12 months post intervention.

To monitor the fidelity of alcohol screening and brief intervention delivered by learning mentors in the school setting.

To explore barriers and facilitators of implementation with staff.

To explore young people’s experiences of the intervention and its impact upon their alcohol use.

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If the intervention is shown to be effective and efficient to: develop a manualised screening and brief intervention protocol to facilitate uptake/adoption in routine practice in secondary schools in England.

8. Study design This is a multicentre individually randomised controlled trial comparing effectiveness and cost-effectiveness of alcohol brief intervention with treatment as usual in young people aged 14-15 in the school setting who screen positive for risky drinking using the A-SAQ. 9. Outcome trial assessments 9.1 Baseline assessments Baseline data will be collected though self-completion questionnaires.

Age of first smoking and how many cigarettes were smoked in the past 30 days [1].

Alcohol use frequency, quantity (on a typical occasion) and binge drinking assessed using the modified 10 question AUDIT [31] which has been shown to be a highly sensitive tool for college students [32].

Alcohol related problems assessed using the validated RAPI which includes measures on aggression [33].

Drinking motives assessed using the 20-item DMQ. This tool uses a six-point Likert scale, which measures motives to drinking across four domains (social, coping, enhancement and conformity). Higher scores within each domain indicate stronger endorsement of positive reinforcement received through consumption of alcohol [34].

Use of NHS, educational, social, and criminal services data elicited using a modified S-SUQ to capture health and social service use costs [35].

The 14 item WEMWBS to assess general psychological health [36].This tool uses a five-point Likert scale which gives a score of one to five per question giving a minimum score of 14 and maximum score of 70. A higher WEMWBS score indicates a higher level of mental well-being [37]. The EQ-5D Y, a valid measure for those aged 12 or older, will be used to measure health related quality of life [38]. Response will be converted into utility scores using the UK population algorithm.

Two questions relating to sexual risk taking are included in the questionnaire. These are the same questions as in the pilot study [23]. These questions are: “After drinking alcohol, have you engaged in sexual intercourse that you regretted the next day?” and “After drinking alcohol, have you ever engaged in sexual intercourse without a condom?” Both questions can be answered with one of the three following options: I have never engaged in sexual intercourse, Yes, or No.

Energy drink consumption will be assessed by asking young people how many times a week they drink energy drinks. Young people can answer never, less than once a week, 2-4 days a week, 5-6 days a week, every day once a day, and every data more than once a day.

Demographic information will be collected: gender, ethnicity. The first part of the postcode will be collected for trial participants.

9.2 12 month assessments All tools used at baseline (self-completion questionnaires) as well as the 28 day TLFB questionnaire (administered by a Research Co-ordinator).

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9.3 Primary outcome measure: Total alcohol consumed in the last 28 days, using the 28 day TLFB questionnaire [39] at 12-month follow-up. 9.3.1 Secondary (effectiveness) outcomes measures:

% days abstinence over last 28 days, drinks per drinking day and days>2 units from 28 day TLFB;

Risky drinking using the A-SAQ, AUDIT [31] and 28 day TLFB [39];

Use of energy drinks;

Smoking behaviour;

Alcohol related problems using the RAPI [33] and sexual risk taking;

Drunkenness during the last 30 days, dichotomised as ‘never’ and once or more [40];

Emotional wellbeing using the WEMWBS [36] and drinking motives using the DMQ [34].

9.3.2 Secondary (health economic) outcome measures:

Quality of life and health state utility measured using the EQ-5D Y [38];

QALYs estimated using general population tariffs from responses to EQ-5D Y administered and scored at baseline and 12 months;

NHS, educational, social, and criminal services data estimated using a modified S-SUQ and a learning mentor case diary developed in the pilot study;

Incremental cost per QALY gained at 12 months;

Cost-consequences presented in the form of a balance sheet for outcomes at 12 months;

Depending on findings, modelled estimates of incremental cost per QALY and cost-consequences in the longer term.

9.4 Definition of end of study: The end of study will be the last participant’s final study contact, at 12 months follow up (trial end date of 31/12/2017). 10. Participants Young people aged 14-15 in Year 10 in at least 30 Secondary/High schools/Academies in four centres: the North East of England, North West of England, Kent and London. Schools will be included if they have learning mentors (or equivalent members of pastoral staff including teachers fulfilling this role) employed by the school. Screening will take place in the personal, social and health education (PSHE) or equivalent lesson or registration class on a classroom by classroom basis. Interventions will take place in the learning mentor’s classroom or office space. 10.1 Socioeconomic context and inequalities In 2008, a survey of 1,250 young people living in deprived communities in Britain found that over a third did not know what a unit of alcohol was and did not understand the term binge drinking [41]. Of these young people, 39% drank up to 20 units per week and 15% drank over 20 units per week [41]. Thus the adverse effects of social deprivation on young people may be compounded by possible health and social problems related to heavy drinking. Usually, the alcohol harm paradox is primarily known within an adult context and this may be due to the

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fact that generally average consumption is reported. It seems reasonable to extrapolate the phenomenon to young people and they may also experience adverse consequences due to parental effects. The proposed project will be working with schools in four geographical sites, which will provide a range of social strata. Individuals with lower socio-economic status generally experience disproportionately more alcohol-related problems than higher socio-economic status people (an outcome that is not always linked to drinking level) and so any reduction in consumption or concomitant problems that occurs as a result of our intervention is likely to benefit the lower socio-economic status group most. Recent data shows that uptake of free school meals (rather than rates of eligibility) is highest in inner London (69%) compared to the North East (57%), the North West (53%) and the South East (36%) [42]. We are also collecting individual postcode data (first part of postcode) for trial participants which will enable us to calculate Indices of Multiple Deprivation. Fourteen percent of the population in England and Wales are from a minority ethnic group. There are differences in ethnicity in our four proposed geographical sites. The non-white British population in the areas is: North East (5%); North West (10%); South East (9%) and London (40%) [43]. Inclusion and exclusion criteria have been chosen to maintain a balance between ensuring the sample is representative of the wider population whilst ensuring that the trial population are able to engage both with the intervention and follow-up. 10.2 Inclusion criteria Young people aged 14-15 years inclusive, whose parents do not opt them out of the study, scoring positively on the A-SAQ, leave their name, and are willing and able to provide informed written assent for intervention and follow-up. 10.3 Exclusion criteria

Already seeking or receiving help for an alcohol use disorder. Those with a recognised mental health or challenging behaviour.

11. Trial procedures This study has been designed in line with the Medical Research Council (MRC) recommendations for evaluation of complex interventions and the pilot feasibility study has informed the development of this proposed study [23]. This proposal represents stage five of the MRC framework ‘evaluating a complex intervention’ and comprises a RCT with effectiveness, cost-effectiveness and qualitative elements [44]. The trial will incorporate individual randomisation of pupils within schools. The pilot feasibility study found the data collection tools easy to use for the young people involved with very low levels of non-completion. The primary outcome of alcohol consumption using the TLFB will only be measured at 12 months post intervention so as not to bias the control group’s responses. Learning mentors (or equivalent members of pastoral staff employed by schools) will deliver the intervention. Local areas vary in their essential qualifications for appointment for learning mentors; however, as a minimum they need to have a good standard of general education, especially literacy and numeracy, as well as experience of working with young people. 11.1 Training All learning mentors will receive school-based training in the study procedures and intervention. Some schools will have one learning mentor whilst other schools will have more.

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Research Co-ordinators will work with the individual schools to reach a pragmatic solution to how many are trained for the trial. Learning mentors will be brought together at one of the schools in each geographical site for this training or carried out in individual schools. Such outreach training was found to be the most cost-effective implementation strategy for alcohol screening and brief intervention delivery in the pilot [23] and other settings [45]. Training for learning mentors will be carried out by the trained Research Co-ordinators using a simulated scenario within a training package developed and employed in the pilot. Simulated scenarios will be videotaped and learning mentors will be assessed by the trainer prior to embarking on the study with more support if needed. Learning mentors will be provided with support materials and on-going support and supervision will be provided by research staff working on, and in collaboration with, the project. Support on implementing screening and paperwork relevant to the research will be provided by the research team, with a Research Co-ordinator in each geographical site. Research staff and trainers will maintain regular contact with schools throughout the study period, including site visits and telephone and email support. 11.2 Control arm Usual practice on alcohol issues as delivered normally to all students in PSHE lessons and curriculum delivered by class teachers. Young people will also be given a healthy lifestyle information leaflet with local sources of help with healthy lifestyle issues, by the learning mentor, to those that assent to the trial. Usual practice may vary from school to school and information related to this will be captured by researchers at both time points of the study. 11.3 Intervention In addition to input equivalent to the control arm, the young people who are eligible and assent to participate will take part in a single 30-minute personalised interactive worksheet-based session which was developed during the pilot feasibility trial. This will be delivered by the learning mentor and will contain structured feedback about the individual student’s drinking behaviour, and advice about the health and social consequences of continued risky alcohol consumption. The intervention encompasses the elements of the FRAMES approach for eliciting behaviour change [20]. 12. Randomisation Young people will not know which arm they are randomised to when they agree to take part in the study, and nor will the learning mentor until they open the envelope. Pupils will be randomised in a 1:1 ratio to the intervention and control arms, with individual randomisation. A statistician not otherwise involved with the study will produce a computer-generated allocation list using random permuted blocks to ensure allocation concealment. The statistician will be provided with a list of screening identification numbers (identifying the site, school and young person) for eligible participants, in the form of an Excel spreadsheet. Randomisation will be undertaken by this statistician and an updated spreadsheet, including allocation of the study arm, will be returned to the administrative assistant at Teesside University. 12.1 Questionnaire and intervention process

Questionnaires are printed (n=4200). Then a screening number is attached to each

questionnaire using a sticky label or automated printing.

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The screening number will identify the geographical site, the school, and the

participant number. For example: NEF0001 [eg North East, FerryMoor School, participant

number 0001/4200].

Labelled questionnaires are inserted into envelopes at Teesside University by the

allocated Research Associate (Jennifer Birch: JB) and the Alcohol and Public Health team at


Questionnaires are batched by school by JB at Teesside University and couriered to

geographical research sites.

Research Co-ordinators take their 1,050 questionnaires to relevant individual schools.

Year 10 pupils confidentially complete their questionnaires in school time1. They put the questionnaires into the spare blank envelope and seal.

Research Co-ordinators collect the sealed envelopes from each school.

Research Co-ordinators take the sealed envelopes back to respective Universities. They open the envelopes and create a pile of questionnaires which score positive on ASAQ and where young people have left their name (i.e. the young person is eligible). These are double checked.

Research Co-ordinators create an excel spreadsheet of all those scoring positively who have left their name. They have one column for the screening number and one column for the name. They send this encrypted excel spreadsheet to JB at Teesside ([email protected]).

Over the next few months Research Co-ordinators then input questionnaire data into a secure validated clinical data management system (Elsevier’s MACRO). Recording of A-SAQ and screening number of the potentially eligible takes priority and should be completed within a week of getting them from the schools. Inputting of all questionnaires (positive and negative) can occur within the year, with priority given to positive (with no name) questionnaires.

The page from the questionnaire that has the young person’s name and screening code on will be removed and will be couriered separately from the completed questionnaires back to Teesside University once entered into the MACRO system.

JB at Teesside University receives the excel spreadsheets from the Research Co-ordinators, creates a Master file, and saves a copy. She then removes the names from the excel spreadsheet, so that only screening numbers remain. She then sends this encrypted excel file (without names) to an independent statistician at Newcastle University (to be identified). The statistician will send JB a file showing the random allocations of these screening numbers to intervention or control. This is only seen by JB.

JB will remerge the screening numbers and arm allocation that she receives from the statistician to the names and keep a record of which young person was allocated to intervention and control.

In the meantime JB and the Alcohol and Public Health Team at Teesside University will be making up the intervention and control packs.

Once JB has received the allocated list only JB will print intervention and control sheets, sticker all packs with relevant screening numbers and place them inside relevant packs depending on the allocation of participants. This will be double checked for accuracy by GW. Only JB and GW will know to which arm young people were allocated. Young peoples’ names and school will be put on a sticker on the front of the envelope.

1 Opt-out consent will already have been attained, prior to step 5.

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An envelope will be made for each young person. Inside the envelope will be the information sheet and assent forms and a sealed envelope. The sealed envelope will only be opened if the young person assents and this envelope will reveal the condition the young person has been allocated to.

An assent log for each school will be made with the screening identification numbers, space to record the date and time of their appointment with the learning mentor and whether or not the young person agreed to take part.

JB seals these envelopes and couriers them to sites outside Teesside University.

Research Co-ordinators receive these sealed envelopes and do not open them.

Research Co-ordinators take the sealed envelopes to the schools and give them to the learning mentors.

Learning mentors see young people individually. The learning mentor asks the young person if they wish to take part. A note is made of this on the enclosed cover sheet and assent forms signed.

Only then will the learning mentor open the second envelope and know which arm each young person has been allocated to. This information will be shared with the young person.

The intervention or control condition is carried out by the learning mentors as relevant.

At the end of the session, all relevant materials (e.g. control: assent update; intervention: assent update, case diary, worksheet) are placed back in the same envelope and sealed.

The learning mentors give these sealed envelopes to the Research Co-ordinators.

Research Co-ordinators do not open these envelopes and courier them back to Teesside University.

At Teesside University, only JB and LA will open these envelopes, and both will make an electronic note on the database of whether each young person assented, and if yes took part. If any young people have not completed either an intervention or control (for e.g. due to absence from school), then JB and LA will need to liaise with Research Co-ordinators to let them know that they need to alert the learning mentors to ensure that when the young person is next present in school that they need to deliver either the intervention or control.

Only JB and LA (Lisa Anderson) will open these envelopes.

Over the next 11 months, JB and LA will finalise inputting a record of the intervention and control groups, and will make up packs for the 12-month follow up questionnaire.

For those that assented to the trial, at the 12-month follow-up point, a repeat of the baseline questionnaire packs will be made. These will be couriered to sites.

Research Co-ordinators will then take these envelopes into the schools. The young person will complete the 12-month questionnaire on their own, as at baseline. Once this is finished and in the envelope the Research Co-ordinator will go through the TLFB with the young person. The researcher will complete the TLFB. The TLFB will then be placed into the envelope and sealed in front of the young person. Researcher Co-ordinators will then take the envelopes back to the research site. At no point do the research Co-ordinators ask which arm the young person was allocated to 12 months previously; young people should be discouraged from volunteering this information.

Research Co-ordinators will then input the data from these questionnaires to MACRO.

Research Co-ordinators will courier the completed follow up questionnaires back to Teesside University.

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12.2 Flowchart of study

Pupils in year 10 in at least 30 schools (five per geographical site) n=4,200

Complete baseline survey1

n=3,654

Eligible and Screen positive2

n=730

Assent to study3

n=534

CONTROL

INTERVENTION

n=267

n=267

Follow up at 12 months4

Follow up at 12 months4

n=235

n=235

1. Complete baseline survey (87%); 2. Screen positive and leave name on questionnaire (20%); 3. Assent to study (80%); 4. 88% of those that assent to study. (%s assumed from pilot RCT (23)). 13. Screening, recruitment and assent 13.1 Screening and eligibility criteria Screening will take place in the PSHE or registration class on a classroom by classroom basis. 13.2 Option to opt-out of screening In advance of screening, all parents/caregivers will be informed by letter, sent by the school, that screening and the study will be taking place in their child’s school. Parents will have the option to indicate that they do not wish for their child to be screened or considered for participation in the study at this stage by completing an opt-out form and returning to the co-ordinating research centre at Teesside University. Those young people whose parents have opted them out of the study will not complete the questionnaires and where possible will not be in the classroom at the time the survey takes place. We will work with the individual schools to ensure these children are given different tasks to do when the survey is taking place. Obtaining assent to take part in this manner is a method widely used in various national youth surveys of alcohol consumption and other health behaviours [2]. 13.3 Screening for the trial The teacher will introduce the questionnaires during a PSHE or registration class, making it clear to young people that completion of any identifiable information is not compulsory. A video-clip will be played to the entire class, in each school, to give instructions on completing

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the questionnaires. This video-clip will only concentrate on the questionnaire completion and not on the topic of the questionnaires. Young people will be asked to voluntarily leave their name and class. Young people will have the option to not complete the questionnaire (indicative of lack of assent to screening from the young person), to complete the questionnaire anonymously, or to complete the questionnaire with their name and class. Each young person will place their completed questionnaires in a sealed envelope and return to the teacher. Teachers will be told not to open these envelopes. Individual responses will not be shared with the class teacher or learning mentor. The researcher will collect the sealed envelopes from the school. Those young people who have screened positively (Scoring 4 times or more frequently on the A-SAQ – see below) and have left their name will be eligible for the trial. Leaving a contact name did not create any issues in the pilot trial. Completed baseline questionnaires by trial participants will be used for the baseline measurements. Data from the whole year group (which includes everyone who has completed a questionnaire) will be written up as a journal article. 13.4 Data collection 13.4.1 Baseline data collection The study envelope will contain a series of questionnaires (see section 9.1) including the study screening questionnaire: the A-SAQ ‘In the last 12 months how often have you drunk more than 3 units of alcohol?’ with the response options of ‘Never; less than 4 times; 4 or more times but not every month; at least once a month but not every week; every week but not every day; every day’. Scoring 4 times or more frequently indicates a positive screen and eligibility for the trial. This score was shown in our pilot feasibility trial to be a methodologically robust approach to identifying the adolescent population who may benefit from an intervention [23]. The A-SAQ will be embedded within a larger questionnaire with items addressing a number of health and lifestyle topics. 13.4.2 Invitation to meet with learning mentors

Returned survey questionnaires will be enclosed in a sealed envelope and taken back to the individual universities. The A-SAQ will be scored and a list of screening numbers and names of those that score positive and leave their name will be sent to the study administrator at Teesside University (see section 12.1 re randomisation procedure). The learning mentor will be given packs with names of potentially eligible young people. They will be given an assent log to complete of progress with potentially eligible young people. Learning mentors will invite young people for who they have an envelope for to a meeting with them in their office where they will open the relevant envelope for the young person. In the envelope will be an information leaflet and assent forms and a sealed envelope. Potential young people will be informed that participation is not compulsory and will be given the information leaflet to read. The assent form will ask for the first part of the young person’s postcode as well as assent. The postcode information will be used to enable a stratified sample of young people who are asked to take part in the qualitative work. Once a young person has assented the second envelope will be opened which will state whether it is a control or intervention case. Until this point the learning mentor will not know which condition the young person has been allocated to.

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13.5 Assent procedures

Nb: Ethical approval for qualitative work will be sought separately.

13.4.3 12-month follow-up Follow-up will occur 12 months post intervention. All young people who come into the trial will be invited to meet with the project researcher (in the school setting) where they will be asked to complete the same battery of questionnaires used at baseline. If a young person involved in the study has moved to another school attempts will be made to contact them there to complete the questionnaires. The researcher will be blinded to the condition the young person was allocated to. The TLFB (including the primary outcome measure of total alcohol consumption consumed) will also be completed face-to-face in schools with the researcher in order to limit bias in the results. All trial participants will be given a cinema

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voucher to compensate them for the time involved in the study [46]. Trial participants’ baseline and follow-up questionnaires will be linked with a unique ID (the screening number). All participants will be asked by the researcher at follow-up whether they are willing to be contacted by a researcher who may be the same individual or another researcher for an in-depth interview. 13.4.4 Intervention fidelity An important measure of process relates to how the intervention is conducted which will also help to understand barriers and facilitators to rolling out the intervention. Each learning mentor will have one simulated intervention with another learning mentor or the research co-ordinator, recorded post training (competency check). Learning mentors will only be allowed to go ‘live’ if the research co-ordinator believes they are competent. Of these sessions, at least 80% will be recorded and further checked by an expert rater (RM). Furthermore twenty per cent of randomly selected cases in the trial will be audio taped and transcribed and assessed for treatment fidelity by one independent expert rater from the research team (RM), with any discrepancies discussed with a second expert rater (EG); using the BECCI rating scale [47]. The BECCI scale is scored 0-4 with a score of two or more being accepted as acceptable as used in previous studies [22-25]. The young people will provide assent for this recording to take place. As the recording and analysis of the delivery of the intervention sessions forms part of the employment contract of the learning mentors, formal consent is not required. 14. Project timetables and milestones

Months

-6-0 03/15-08/15 Protocol development, ethics application, recruitment of staff

1-3 09/15-11/15 Study set up and training of Research Co-ordinators

4 12/15 Training of learning mentors, and provision of opt-out letters to parents

4 12/15 Baseline survey and screening

5-7 01/16-03/16 Case recruitment (control/intervention)

7-9 03/16-05/16 Staff interviews

17-19 01/17-03/17 12 month follow-ups with trial participants

19-20 03/17-04/17 Young people interviews

7-26 04/16-10/17 Qualitative analysis

6-26 05/16-10/17 Data inputting and analysis of RCT

24-28 08/17-12/17 Writing of final report

27-28 11/17-12/17 Dissemination

15. Statistical considerations 15.1 Sample size calculation Using estimates from the pilot trial (mean year group size = 210, 87% completing baseline survey, 20% being positive on A-SAQ and leaving contact details, 80% recruited to trial and 88% providing data at 12 months follow-up), the sample size has been calculated to have a 90% power to detect a standardized difference of 0.3 (which equates to a ratio of 1.5 in geometric means in total alcohol units in 28 days) using a significance level of 5%. Follow-up data will be required on 235 children per arm. The number of young people in 20 schools (5 per region) however means that this number will be increased to 235 in each arm at follow-

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up. Anticipated numbers at each point of the study are illustrated in the flowchart in section 12.2. 15.2 Analysis 15.2.1 Baseline data Descriptive statistics (comparisons of percentages, means or medians as appropriate) will be used to report the pupil-level baseline data, and extent of intervention received between those allocated to the two trial arms. 15.2.2 Primary outcome The researchers will be blind to the randomisation condition. The primary outcome is derived from the 28-day TLFB (units of alcohol consumed in period). The primary effectiveness analysis will be by intention-to-treat. Multiple linear regression will be used to compare the primary outcomes between the two randomisation groups at 12 months, adjusting for any imbalance in key covariates. 15.2.3 Secondary outcomes The secondary outcomes will be analysed in a similar manner. Comparisons of means will be presented as mean differences or ratios of geometric means (if a logarithmic transform is necessary for skewed data) with 95% C.I. Odds ratios and 95% C.I.’s will be presented for binary outcomes. Exploratory analyses will also be undertaken, for example, to examine differences in outcome by gender, deprivation and extent of intervention received, though there is limited power to investigate these comparisons. We will consider any difference in attrition rates, and any non-randomness of the attrition, when comparing outcomes between the two groups. 15.2.4 Interim analyses There are no planned interim analyses, other than descriptive analysis to report on recruitment. 15.2.5 Missing data The pattern and extent of missing observations because of loss to follow-up will be examined to investigate both the extent of missingness, and whether it is missing at random or is informative. Unless specified by the scale developers, where no more than 20% of questions are missing or uninterpretable on specific scales, the score will be calculated by using the mean value of the respondent specific completed responses on the rest of the scale to replace the missing items. The use of appropriate multiple imputation techniques will be considered. 16. Health economics The economic component will include both a within trial cost-utility and cost-consequence analysis and, as described below, a model based analysis taking the perspective of the UK public sector (NHS, educational, social, and criminal services). The cost-utility analysis will use measures of effectiveness limited to health related quality of life as measured by EQ-5D Y. The cost-consequence analysis will take the same perspective for costs but will present these alongside all of the primary and secondary measures of effectiveness outlined in section 9.3. The follow-up for the within trial analyses will be 12 months so discounting will not be conducted. For the model based analysis the time horizon will be longer (potentially up to the

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participant’s life time) and costs and effects will be discounted at 1.5%, the UK recommended rate for public health interventions [48] with, a sensitivity analysis used to explore the impact of higher (and lower) discount rates. 16.1 Within trial analysis cost-utility and cost-consequence analyses For each trial participant the use of health, educational, criminal, and social care services will be elicited using the S-SUQ administered at baseline (with a recall period of 3 months) and 12 months. Further cost data will come from the learning mentor time case diaries completed by the learning mentors for each contact. Costs for healthcare and social services will be obtained from standard sources such as NHS reference (www.gov.uk), the British National Formulary [49] for medications, Unit costs of Health and Social Care [50] for contacts with primary care. Further data will come from the study centres themselves. Data on the use of educational services will be elicited via the questionnaire. As part of the pilot trial we confirmed with the expert group the type of services relevant to collect. However based on lessons learned from the pilot additional questions related to days missed from school/ truancy have been added to the questionnaire. Learning mentor training costs will be included and will need to be apportioned according to scaled up practice. This will be informed by data from the training conducted as part of the trial and through expert opinion. The time of educational staff will be sought through a parallel costing exercise in which these staff will be asked to provide information on the impact of the intervention on their workload. With respect to learning mentors, a detailed proforma was developed and tested in the pilot to capture resource use and this new tool will be used in this study. With respect to school building and other large capital items, the opportunity cost will be considered. Some resources (e.g. buildings) will exist with or without the intervention and the intervention may not displace any other activity. In this circumstance the opportunity cost of the building would be zero. However, costs might be incurred in terms of heat, power and light and these data will be captured using standard costing methods [51]. For each participant, measures of use of resources will be combined with unit costs to provide a cost for that participant. We anticipate that the price year adopted for the base case analysis will be 2017 when the final analysis is conducted. Like in the pilot trial we will use the European Quality of Life Five Dimension – Youth (EQ-5D-Y) was used. The EQ-5D Y will be administered at baseline and 12 months with UK population tariffs [52] used. Health state utilities from the EQ-5D Y will then be used to estimate QALYs using the area under the curve approach [38]. Data on costs and QALYs will be used to estimate mean cost and QALYs for the intervention and control groups. The cost and QALY data will then be used to estimate incremental costs and QALYs and incremental costs per QALY gained. These data will be presented as point estimates and bootstrapping techniques will be used to estimate the statistical imprecision surrounding them. The results of this stochastic analysis will be presented as cost and QALY plots and as cost-effectiveness acceptability curves. Linear interpolation between time points will be used, assuming the change happens at the end of the time point. The cost-consequence analysis will present the cost data and effects data in the form of balance sheets. In the balance sheets the interventions will be presented in a series of pairwise comparisons with data on costs and effects presented as pros and cons for an

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experimental intervention compared with a control. Thus, the approach can capture wider effects than those captured by measures of cost or quality of life. The principle underpinning a balance sheet is that the analyst should seek to capture all costs and benefits no matter on whom they may fall; the same principles underpinning a cost-benefit analysis [53]. This approach has been used in prior evaluations as a way of integrating both quantitative and qualitative findings into a single assessment [54, 55]. 16.2 Model based analysis In an economic evaluation the time horizon should be sufficiently long enough to capture all costs and benefits of relevance. Ideally, within a trial setting the data collection period would be sufficiently long enough to capture all relevant costs and benefits. Such a proposal would significantly increase costs, increase burden on participants, and costs and benefits in the longer term may be subject to a host of exogenous factors. Hence, the longer term collection of data within a trial setting may not produce reliable data on longer term outcomes. In the absence of longer term trial data, longer term data from the literature will be considered. The economic model based analysis, most likely taking the form of a state transition model, will be conducted if it is plausible that extrapolation over a longer time horizon could change the within trial based analyses. For example, if at the end of the 12 month follow-up, the QALY gain is not of sufficient magnitude to justify the cost to society, modelling can illustrate whether the eventual long-term gain becomes more worthwhile. The model will be constructed following guidelines for best practice in economics modelling [56, 57]. The use of services will be modelled and the costs of these events will be based on data from the trial and, where necessary, supplemented by focused searches of the literature and health economic databases, (National Health Service Economic Evaluations Database (NHS EED) and the CEA Registry. As already noted both costs and outcomes will be discounted at 1.5% in the base case analyses. The model will be used to produce estimates of costs, QALYs, incremental cost per QALY gained, and cost-consequences. The model will be probabilistic and distributions will be attached to all parameters, the shape and type of distribution will depend upon the data available and recommendations for good practice in modelling [56]. The results will also be presented as point estimates, and for the cost-consequence analysis 95% confidence intervals. For the cost-utility analysis, data will be presented as plots of costs and QALYs derived from the probabilistic analysis and cost-effectiveness acceptability curves. Deterministic sensitivity analyses to explore other uncertainties will also be conducted. 17. Qualitative work Separate ethical approval will be sought for the qualitative work. 18. Triangulation Once the quantitative and qualitative elements of the study have been carried out and analysed separately they will be brought together at the ‘analysis/interpretation’ phase which is a process often described as 'triangulation' [58]. In our study, data will be reconciled by adopting a model which relies on the principle of complementarity [59]. Within this approach it is explicitly recognised that qualitative and quantitative methods may be used to examine different aspects of an overall research question [58].

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19. Compliance and withdrawal

19.1 Assessment of compliance Where feasible, visits to the individual school in the geographical sites will happen at least once every two weeks with telephone calls if necessary in between. These study visits will be conducted by site Research Co-ordinators. 19.2 Withdrawal of participants Young people who do not leave their name on the questionnaire will not be able to be identified post completion and therefore their data cannot be withdrawn if requested. For the trial, participants have the right to withdraw from the trial at any time for any reason, and without giving a reason. The investigators also have the right to withdraw participants from the study intervention if s/he judges this to be in the participant’s best interests. It is understood by all concerned that an excessive rate of withdrawals can render the study uninterpretable; therefore, unnecessary withdrawal of participants should be avoided. Should a participant decide to withdraw from the study, all efforts will be made to report the reason for withdrawal as thoroughly as possible. There are two withdrawal options: 1. Withdrawing completely (i.e. withdrawal from both the study intervention and

provision of follow-up data) 2. Withdrawing partially (i.e. withdrawal from study intervention but continuing to provide

follow-up data by completing 12-month follow-up questionnaires). Assent will be sought from participants choosing option 1 to retain data collected up to the point of withdrawal. Participants will be asked if they would be happy for the reason for the decision to withdraw to be recorded. 20. Data monitoring, quality control and quality assurance This is a low risk trial and major safety data are not anticipated. As agreed by Newcastle University/NIHR PHR a TSC will be set up as well as a separate Data Monitoring and Ethics Committee (DMEC). Both will occur with independent members meeting in closed session. The groups will also take responsibility for monitoring study conduct and data collected will be performed by central review to ensure the study is conducted in accordance with GCP. The main areas of focus will include assent/consent, data quality and essential documents in the study. The TSC will consist of Professor Matthew Hickman as Chair, an independent school representative, independent statistician, the CI of the study (DNB); the Project Manager (EG); the study statistician (DH) and other members of the TSG as appropriate. Following the initial pre-study meeting, the TSG will meet annually. Their role is to monitor progress and supervise the trial to ensure it is conducted to high standards in accordance with the protocol, the principles of GCP, relevant regulations and guidelines and with regard to participant safety. The purpose of this committee will be to monitor efficacy and safety endpoints, although only independent members may have access to unblinded study data. A written charter will be agreed and used by the TSC. All monitoring findings will be reported and followed up with the appropriate persons in a timely manner. The DMEC will take responsibility for the ethical compliance of the trial and will meet once yearly prior to the TSG meetings.

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The study may be subject to inspection and audit by Newcastle University under their remit as sponsor, and other regulatory bodies to ensure adherence to GCP. The investigators/ institutions will permit trial-related monitoring, audits, ethical committee review and regulatory inspection(s), providing direct access to source data/documents. Table of events

Time

Visit 1 Initial Screening

Visit 2 Baseline visit

Confirmation of eligibility and Randomisation

12 month follow-up 12 months post baseline (+/- 10

weeks)

Study questionnaire completion

X X

Study discussion / Informed assent

X

Informed of randomisation allocation

X

28 day TLFB questionnaire

X

The quality and retention of study data will be the responsibility of Professor Dorothy Newbury-Birch, who will act as data custodian for the study. All study data will be retained in accordance with the Data Protection Act (1998), the Directive on GCP (2005/28/EC), sponsor and local policy. 21. Adverse event monitoring and reporting Due to the nature of the study it is not expected that participants will experience any adverse events/serious adverse events during the study. In the event that the participant reports an event related to the study during a study visit this will be reported on the adverse event/ harms case report form and entered into MACRO.

22. Ethics and regulatory issues As participants are not being recruited from the NHS, the proposed research will not require NHS ethical approval but we will seek multi-site ethical approval from Teesside University ethics committee, which covers all non-NHS studies carried out at the University. Information sheets will be provided to all eligible subjects and written informed assent/consent obtained prior to any study procedures. 23. Research governance Newcastle University will be the nominated sponsor of the research and will hold the award. Professor Newbury-Birch will be the Chief Investigator based at Teesside University together with the Project Manager and North East staff relating to the study. The Research Co-ordinators and Project Manager will meet weekly (by Skype) to progress the study (Working Group). Other investigators will be invited to attend meetings when necessary. The study will have a TMG, which will consist of the Chief Investigator, co-applicants, Project Manager,

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Research Co-ordinators, researchers and CTU staff involved in the study as well as two lay members (to be identified). Professor Eilish Gilvarry who chaired the pilot study TMG will chair this group. Further to this we will set up an independent TOC (see section 18) with membership in accordance with NIHR guidelines. The project will be subject to the requirements of the Data Protection Act 1998 and the Freedom of Information Act 2000 and other relevant UK and European legislation relevant to the conduct of clinical research. The project will be managed and conducted in accordance with the MRCs Guidelines on Good Clinical Practice in Clinical Trials (www.mrc.ac.uk), which will include compliance with national and international regulations on the ethical involvement of participants in clinical research (including the Declaration of Helsinki). Newcastle Clinical Trials Unit Standard Operating Procedures will be followed.

All data for the study will be held in a secure environment identified by a screening ID. Master registers containing participant identifiable information and participant identification numbers will be stored in a secure area separate from the majority of data. Remote electronic data capture and data management will be conducted by Newcastle Clinical Trials Unit using Elsevier’s MACRO. All staff employed on the project will be employed by academic organisations and subject to the Terms and Conditions of Service and contracts of employment of the employing organisations. The project will use standardised research and clinical protocols and adherence to the protocols will be monitored by the Trial Steering Committee.

All trial data will be identified using a unique trial identification number (the screening number). No personally identifiable information will be held beyond the final 12-month follow-up. Analytical datasets will not contain any participant identifiable information. Anonymised hard-copy data will be retained for a period of five years following the end of the trial. Electronic data will be kept for 10 years following the end of the trial. 24. Confidentiality Personal data will be regarded as strictly confidential. To preserve anonymity, any data relating to the questionnaire leaving the sites will be anonymised and will identify participants with their screening number. The study will comply with the Data Protection Act, 1998. All study records and Investigator Site Files will be kept at site in a locked filing cabinet with restricted access. All data will be sent to the co-ordinating centre (Teesside University) by secure courier where it will be kept in a locked filing cabinet with restricted access. Names of those in the trial will be sent off site by secure email /courier by site study Research Co-ordinators to the administrative assistant at the co-ordination centre (Teesside University) and will be couriered separately from the questionnaire responses. 25. Insurance and finance Indemnity in respect of potential liability arising from negligent harm relating to design and conduct of the research is provided by Teesside University for those protocol authors who have their substantive contracts of employment with Teesside University. Indemnity in respect of potential liability arising from negligent harm relating to design and conduct of the research is provided by Newcastle University for those protocol authors who have their substantive contracts of employment with Newcastle University.

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Indemnity in respect of potential liability arising from negligent harm relating to management of the research is provided by the Sponsor.

This is a non-commercial study and there are no arrangements for non-negligent compensation. NIHR Public Health Research Programme is funding the study. 26. Study report/publications The data will be the property of the Chief Investigator and Co-applicants. Publication will be the responsibility of the Chief Investigator. It is planned to publish this study in peer review articles and to present data at national and international meetings. Results of the study will also be reported to the Sponsor and Funder, and will be available on their web site. All manuscripts, abstracts or other modes of presentation will be reviewed by the TOC and funder prior to submission. Individuals will not be identified from any study report. Participants will be informed about the results at the end of the study, including a lay summary of the results if requested. 27. References 1. Hibbell, B., et al., The 2011 ESPAD Report: Substance Use Among Students in 36

European Countries. 2012. 2. Fuller, E. and Et al, Smoking, drinking and drug use among young people in England in

2013. 2014, NatCen Social Research: London. 3. Zucker, R., et al., Developmental perspective on underage alcohol use. Developmental

processes and mechanisms 0-10. Alcohol Research and Health, 2009. 32(1): p. 16-29. 4. Windle, M., et al., Transitions Into Underage and Problem Drinking Summary of

Developmental Processes and Mechanisms: Ages 10–15. Alcohol Research and Health, 2009. 32(1): p. 30-40.

5. Brown, S., et al., Underage Alcohol Use Summary of Developmental Processes and Mechanisms: Ages 16–20. Alcohol Research and Health, 2009. 32(1): p. 41-52.

6. Newbury-Birch, D., et al., The impact of alcohol consumption on young people: A review of reviews. 2009, Department of Children Schools and Families.

7. Squeglia, L.M., et al., Brain response to working memory over three years of adolescence: Influence of initiating heavy drinking. Journal of Studies on Alcohol and Drugs, 2012. 73(5): p. 749.

8. Rodham, K., et al., Adolescents’ perception of risk and challenge: A qualitative study. Journal of Adolescence, 2006. 29: p. 261-72.

9. MacArthur, G., et al., Patterns of alcohol use and multiple risk behaviour by gender during early and late adolescence: the ALSPAC cohort. Journal of Public Health, 2012. 34(Suppl 1): p. i20-i30.

10. NHS Choices. The risks of drinking too much. 05/08/2014]; Available from: www.nhs.uk/Livewell/alcohol/Pages/Effectsofalcohol.aspx.

11. McGue, M., et al., Origins and Consequences of Age at First Drink. Associations with Substance-use Disorders, Dishinbitory Behavior and Psychopathology, and P3 Amplitude. Alcoholism, Clinical and Experimental Research, 2001. 25(8): p. 1156-1165.

12. Donaldson, L., Guidance on the consumption of alcohol by children and young people. 2009, Department of Health: London.

13. National Institute for Clinical Excellence, Interventions in schools to prevent and reduce alcohol use among children and young people. 2007, NICE: London.

Page 55 of 64


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BM



ber 2016. Dow

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32 V1.4 26.04.2016

14. Foxcroft, D. and A. Tsertsvadze, Universal shool-based prevention programs for alcohol misuse in young people, in Cochrane Database of Systematic Reviews. 2011.

15. World Health Organization, Alcohol in the European Union. consumption, harm and policy approaches, ed. P. Anderson, L. Moller, and G. Galea. 2012: WHO Regional Office for Europe.

16. Kaner, E., et al., The effectiveness of brief alcohol interventions in primary care settings: a comprehensive review. Drug and Alcohol Review, 2009. 28: p. 301-323.

17. Bandura, A., Social learning theory. 1997, Englewood Cliffs, NJ: Prentice-Hall. 18. Bien, T.H., W.R. Miller, and J.S. Tonigan, Brief interventions for alcohol problems: a

review. Addiction, 1993. 88(3): p. 315-335. 19. Kaner, E., et al., Effectiveness of brief alcohol interventions in primary care populations.

Cochrane Database of Systematic Reviews, 2007. Issue 2. 20. Miller, W. and V. Sanchez, Motivating Young Adults for Treatment and Lifestyle

Change. 1993, Notre Eame: University of Notre Dame Press. 21. Rollnick, S., P. Mason, and C. Butler, Health Behaviour Change: A guide for

practitioners. 1999, Edinburgh: Churchill Livingstone. 22. Kaner, E., et al., Effectiveness of screening and brief alcohol intervention in primary

care (SIPS trial): pragmatic cluster randomised controlled trial. BMJ, 2013. 346: p. 1-14. 23. Newbury-Birch, D., et al., A pilot feasibility cluster randomised controlled trial of

screening and brief alcohol intervention to prevent hazardous drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH), N.P.H.R.P. Report, Editor. 2014.

24. Drummond, C., et al., The effectiveness of alcohol screening and brief intervention in emergency departments: a multicentre pragmatic cluster randomized controlled trial. PLOS ONE, 2014. 9(6): p. e99463.

25. Newbury-Birch, D., et al., Alcohol screening and brief interventions for offenders in the probation setting (SIPS Trial): a pragmatic multicentre cluster randomised controlled trial. Alcohol & Alcoholism, 2014. In Press.

26. Department of Health, The Annual Report of the Chief Medical Officer 2012: Our Children Deserve Better: Prevention Pays. 2013, Department of Health: London.

27. Yuma-Guerrero, P., et al., Screening, Brief Intervention, and Referral for alcohol Use in Adolescents: A Systematic Review. Pediatrics, 2012. 130: p. 115-122.

28. Tripodi, S.J., et al., Interventions for reducing adolescent alcohol abuse: A meta-analytic review. Archives of Pediatrics and Adolescent Medicine, 2010. 164 (1): p. 85-91.

29. Carney, T. and B. Myers, Effectiveness of early interventions for substance-using adolescents: findings from a systematic review and meta-analysis. Substance Abuse Treatment, Prevention, and Policy, 2012. 7(1): p. 25.

30. O'Neil, S., et al., Brief intervention to prevent hazardous drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial. Trials, 2012. 13(166).

31. Babor, T., et al., AUDIT, The Alcohol Use Disorders Identification Test, guidelines for use in primary health care. 1989, World Health Organisation: Geneva.

32. Reinert, D.F. and J.P. Allen, The Alcohol Use Disorders Identification Test: An Update of Research Findings. Alcoholism: Clinical & Experimental Research, 2007. Vol. 31(No. 2): p. pp. 185-199.

33. White, H. and H. Labouvie, Towards the assessment of adolescent problem drinking. Journal of studies of Alcohol, 1989. 50(30): p. 7.

Page 56 of 64


BMJ Open

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http://bmjopen.bm

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BM



ber 2016. Dow

nloaded from



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34. Cooper, M., Motivations for alcohol use among adolescents: Development and validation of a four-factor model. Psychological Assessment, 1994. 6: p. 117-128.

35. UKATT Research Team, Cost effectiveness of treatment for alcohol problems: findings of the randomised UK alcohol treatment trial (UKATT). British Medical Journal, 2005. 331(7516): p. 544.

36. NHS Health Scotland and University of Warwick, Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). 2006: Scotland.

37. Tennant, R., et al., The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health and Quality of Life Outcomes, 2007. 5: p. 63.

38. Euroquol, EuroQuol-a new facility for the measurement of health-related quality of life. Health Policy, 1990. 16: p. 199 - 208.

39. Sobell, L. and M. Sobell, Alcohol Timeline Followback Users' Manual. 1995, Toronto, Canada: Addiction Research Foundation.

40. Segrott, J., et al., Preventing substance misuse: study protocol for a randomised controlled trial of the Strengthening Families Programme 10–14 UK (SFP 10–14 UK). BMC Public Health, 2014. 14(49): p. 1-21.

41. Talbot, S. and T. Crabbe, Binge drinking: young people's attitude and behaviour, P. Futures, Editor. 2008, Crime Concern: London.

42. Nelson, M., et al., Seventh annual survey of take up of school lunches in England 2012, Children's Food Trust.

43. Office for National Statistics, Ethnicity and National Identity in England and Wales 2011. 2012.

44. Medical Research Council, Developing and evaluating complex interventions: new guidance. 2008: London.

45. Kaner, E.F.S., et al., A RCT of three training and support strategies to encourage implementation of screening and brief alcohol intervention by general practitioners. British Journal of General Practice, 1999. 49: p. 699-703.

46. Brueton, V., et al. Systematic Review of Strategies to Reduce Attrition in Randomised Trials. in The Society for Clinical Trials Annual Meeting. 2013. Boston: Clinical Trials.

47. Lane, C., et al., Measuring adaptations of motivational interviewing: The development and validation of the Behaviour Change Counselling Index (BECCI),. Patient Education and Counselling 2005. 56: p. 166-173.

48. National Institute for Clinical Excellence, Guide to the methods of technology appraisal. 2013: London.

49. British Medical Association and Royal Pharmaceutical Society, British National Formulary Edition 65. 2013.

50. Curtis, L., Unit Costs of Health and Social Care 2012, PSSRU, Editor. 2013, University of Kent: Canterbury.

51. Drummond, M., G. Stoddart, and G. Torrance, Methods for the Economic Evaluation of Health Care Programmes. 2005, Oxford: Oxford University Press.

52. Kind, P., G. Hardman, and S. Macran, UK population norms for EQ-5D. 1999, Centre for Health Economics: University of York.

53. McIntosh, E., Economic evaluation of guideline implementation strategies, in Changing professional practice: Theory and practice of clinical guidelines implementation, T. Thorson and M. Makela, Editors. 1999, Danish Institute for Health Services: Copenhagen.

54. Hoddinott, P., et al., Process evaluation for the FEeding Support Team (FEST) randomised controlled feasibility trial of proactive and reactive telephone support for

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breastfeeding women living in disadvantaged areas. BMJ Open, 2012. 2(2): p. e001039.

55. Hoddinott, P., et al., The FEeding Support Team (FEST) randomised, controlled feasibility trial for proactive and reactive telephone support for breastfeeding women living in disadvantaged areas. BMJ Open, 2012. 2(2): p. e000652.

56. Kaltenthaler et al. NICE DSU Technical Support Document 13 Available from: http://www.nicedsu.org.uk.

57. Caro, J., et al., Modeling good research practices—overview: a report of the ISPOR-SMDM modeling good research practices task force-1. Value Health, 2012. 15(796-803).

58. O'Cathain, A., E. Murphy, and J. Nicholl, Three techniques for integrating data in mixed methods studies British Medical Journal, 2010. 341: p. 1147-1150.

59. Moffatt, S., et al., Using quantitative and qualitative data in health services research – what happens when mixed method findings conflict? BMC Health Services Research, 2006. 6(28): p. 1-10.

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APPENDIX 2

A multi-centre individual randomised





Pupil assent form

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Pupil Assent Form V2.0 17.08.2015

This project was funded by the National Institute for Health Research PHR (project number 13/177/002

A multi-centre individual randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school

setting (SIPS JR-HIGH): Pupil Assent Form Please read each of the following statements and place your initials in the box if you agree with the statement. If you have initialled every statement please write your name and the date below. 1. I have had a chance to read the participant information leaflet dated 17.07.2015 (version

2.0) for the above study. 2. Someone else has explained this project to me. 3. I have had the opportunity to ask all of the questions I want about this study and they have

been answered to my satisfaction. 4. I understand that taking part is voluntary and that I am free to change my mind at any time

without giving a reason and without my education, services from school and legal rights being affected.

5. I understand that data from my school records may be looked at by members of the

research team if it is relevant to my taking part in this research. 6. I understand that any data created from this study will be held in a locked filing cabinet for

five years after the trial, when the paper copies of the data will be destroyed. Electronic data will be stored on password protected computers for ten years. All data collected will be anonymised and kept confidential.

7. I understand I will be contacted for follow up in 12 months and my data will be

kept until this point.

8. I agree to my session being recorded if asked.

9. I understand that I may be asked to take part in an interview on my experience of taking part in this study.

10. I agree to take part in this study. I am aware that a copy of this consent form will be

provided to me for my records.

Name of Participant Signature Date

Name of Witness Signature Date

The participant, school and research co-ordinating centre at Teesside University will have a copy of this form.

Participant Postcode

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1

SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*

Section/item Item No

Description Addressed on page number

Administrative information

Title 1 Descriptive title identifying the study design, population, interventions, and, if applicable, trial acronym ___1__________

Trial registration 2a Trial identifier and registry name. If not yet registered, name of intended registry ___3__________

2b All items from the World Health Organization Trial Registration Data Set ___n/a________

Protocol version 3 Date and version identifier ____3_________

Funding 4 Sources and types of financial, material, and other support ___18________

Roles and

responsibilities

5a Names, affiliations, and roles of protocol contributors ___1 & 18______

5b Name and contact information for the trial sponsor ___1__________

5c Role of study sponsor and funders, if any, in study design; collection, management, analysis, and

interpretation of data; writing of the report; and the decision to submit the report for publication, including

whether they will have ultimate authority over any of these activities

___18__________

5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint

adjudication committee, data management team, and other individuals or groups overseeing the trial, if

applicable (see Item 21a for data monitoring committee)

___1__________

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2

Introduction

Background and

rationale

6a Description of research question and justification for undertaking the trial, including summary of relevant

studies (published and unpublished) examining benefits and harms for each intervention

__5-6_________

6b Explanation for choice of comparators __5-6_________

Objectives 7 Specific objectives or hypotheses __6___________

Trial design 8 Description of trial design including type of trial (eg, parallel group, crossover, factorial, single group),

allocation ratio, and framework (eg, superiority, equivalence, noninferiority, exploratory)

___8-9_______

Methods: Participants, interventions, and outcomes

Study setting 9 Description of study settings (eg, community clinic, academic hospital) and list of countries where data will

be collected. Reference to where list of study sites can be obtained

__8___________

Eligibility criteria 10 Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and

individuals who will perform the interventions (eg, surgeons, psychotherapists)

__8__________

Interventions 11a Interventions for each group with sufficient detail to allow replication, including how and when they will be

administered

__9_________

11b Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose

change in response to harms, participant request, or improving/worsening disease)

__10___________

11c Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence

(eg, drug tablet return, laboratory tests)

__11-12_______

11d Relevant concomitant care and interventions that are permitted or prohibited during the trial __8-9_________

Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood

pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg,

median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen

efficacy and harm outcomes is strongly recommended

__6-8_________

Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for

participants. A schematic diagram is highly recommended (see Figure)

__Appendix 1____

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Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including

clinical and statistical assumptions supporting any sample size calculations

__12-13_______

Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size __10________

Methods: Assignment of interventions (for controlled trials)

Allocation:

Sequence

generation

16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any

factors for stratification. To reduce predictability of a random sequence, details of any planned restriction

(eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants

or assign interventions

__9-10_________

Allocation

concealment

mechanism

16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered,

opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned

__9-10________

Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to

interventions

__9-10________

Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome

assessors, data analysts), and how

__9-10________

17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s

allocated intervention during the trial

__9-10_________

Methods: Data collection, management, and analysis

Data collection

methods

18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related

processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of

study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known.

Reference to where data collection forms can be found, if not in the protocol

__6-7________

18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be

collected for participants who discontinue or deviate from intervention protocols

__12___________

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Data management 19 Plans for data entry, coding, security, and storage, including any related processes to promote data quality

(eg, double data entry; range checks for data values). Reference to where details of data management

procedures can be found, if not in the protocol

__Appendix 1____

Statistical methods 20a Statistical methods for analysing primary and secondary outcomes. Reference to where other details of the

statistical analysis plan can be found, if not in the protocol

__13-14________

20b Methods for any additional analyses (eg, subgroup and adjusted analyses) __13-14_______

20c Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any

statistical methods to handle missing data (eg, multiple imputation)

_Appendix 1_____

Methods: Monitoring

Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of

whether it is independent from the sponsor and competing interests; and reference to where further details

about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not

needed

_Appendix 1_____

21b Description of any interim analyses and stopping guidelines, including who will have access to these interim

results and make the final decision to terminate the trial

_Appendix 1____

Harms 22 Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse

events and other unintended effects of trial interventions or trial conduct

__Appendix 1____

Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent

from investigators and the sponsor

__Appendix 1____

Ethics and dissemination

Research ethics

approval

24 Plans for seeking research ethics committee/institutional review board (REC/IRB) approval __3___________

Protocol

amendments

25 Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes,

analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals,

regulators)

_Appendix 1_____

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Consent or assent 26a Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and

how (see Item 32)

__10________

26b Additional consent provisions for collection and use of participant data and biological specimens in ancillary

studies, if applicable

__n/a________

Confidentiality 27 How personal information about potential and enrolled participants will be collected, shared, and maintained

in order to protect confidentiality before, during, and after the trial

__Appendix 1____

Declaration of

interests

28 Financial and other competing interests for principal investigators for the overall trial and each study site _18-19_________

Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that

limit such access for investigators

_Appendix 1____

Ancillary and post-

trial care

30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial

participation

_Appendix 1_____

Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals,

the public, and other relevant groups (eg, via publication, reporting in results databases, or other data

sharing arrangements), including any publication restrictions

_3____________

31b Authorship eligibility guidelines and any intended use of professional writers _18____________

31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code _Appendix 1_____

Appendices

Informed consent

materials

32 Model consent form and other related documentation given to participants and authorised surrogates _Appendix 2_____

Biological

specimens

33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular

analysis in the current trial and for future use in ancillary studies, if applicable

__n/a________

*It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items.

Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons

“Attribution-NonCommercial-NoDerivs 3.0 Unported” license.

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