INT J LANG COMMUN DISORD, MAY–JUNE 2012,VOL. 47, NO. 3, 233–244

Research Report

The Social Communication Intervention Project: a randomized controlledtrial of the effectiveness of speech and language therapy for school-agechildren who have pragmatic and social communication problems withor without autism spectrum disorder

Catherine Adams†, Elaine Lockton†, Jenny Freed†, Jacqueline Gaile†, Gillian Earl‡, Kirsty McBean†,Marysia Nash§, Jonathan Green¶, Andy Vail¶ and James Law∗†Human Communication and Deafness Division, University of Manchester, Manchester, UK‡NHS Lothian, Edinburgh, UK§Speech and Language Therapy Department, Royal Hospital for Sick Children, Edinburgh, UK¶Child and Adolescent Psychiatry, University of Manchester, Manchester, UK∗School of Education, Communication and Language Sciences, University of Newcastle, Newcastle, UK

(Received August 2011; accepted December 2011)

Abstract

Background: Children who show disproportionate difficulty with the pragmatic as compared with the structuralaspects of language are described as having pragmatic language impairment (PLI) or social communication disorder(SCD). Some children who have PLI also show mild social impairments associated with high-functioning autism orautism spectrum disorder (ASD). There is little robust evidence of effectiveness of speech–language interventionswhich target the language, pragmatic or social communication needs of these children.Aims: To evaluate the effectiveness of an intensive manualized social communication intervention (SCIP) forchildren who have PLI with or without features of ASD.Methods & Procedures: In a single-blind RCT design, 88 children with pragmatic and social communication needsaged 5;11–10;8, recruited from UK speech and language therapy services, were randomly assigned in a 2:1 ratioto SCIP or to treatment-as-usual. Children in the SCIP condition received up to 20 sessions of direct interventionfrom a specialist research speech and language therapist working with supervised assistants. All therapy contentand methodology was derived from an intervention manual. A primary outcome measure of structural languageand secondary outcome measures of narrative, parent-reported pragmatic functioning and social communication,blind-rated perceptions of conversational competence and teacher-reported ratings of classroom learning skillswere taken pre-intervention, immediately post-intervention and at 6-month follow-up. Analysis was by intentionto treat.Outcomes & Results: No significant treatment effect was found for the primary outcome measure of structurallanguage ability or for a measure of narrative ability. Significant treatment effects were found for blind-ratedperceptions of conversational competence, for parent-reported measures of pragmatic functioning and socialcommunication, and for teacher-reported ratings of classroom learning skills.Conclusions & Implications: There is some evidence of an intervention effect on blind and parent/teacher-reportedcommunication outcomes, but not standardized language assessment outcomes, for 6–11-year-old children whohave pragmatic and social communication needs. These findings are discussed in the context of the increasinglycentral role of service user outcomes in providing evidence for an intervention. The substantial overlap betweenthe presence of PLI and ASD (75%) across the whole cohort suggests that the intervention may also be applicableto some verbally able children with ASD who have pragmatic communication needs.

Keywords: language impairment, pragmatics, social communication disorder, treatment, randomized controlledtrial

Address correspondence to: Catherine Adams, Human Communication and Deafness Group, Ellen Wilkinson Building, University ofManchester, Oxford Road, Manchester M13 9PL, UK; email: catherine.adams@manchester.ac.uk

International Journal of Language & Communication DisordersISSN 1368-2822 print/ISSN 1460-6984 online c© 2012 Royal College of Speech and Language Therapists

DOI: 10.1111/j.1460-6984.2011.00146.x

234 Catherine Adams et al.

What is already known?Children who have pragmatic and social communication needs are at risk of long term behavioural and socialdisadvantage. These children often have additional autism spectrum conditions and/or high-level languageimpairments. There are no randomized controlled trials of speech-language intervention for these children.

What this paper adds:This paper reports evidence of an effect of intensive, specialist supervised speech and language therapy in improvingoverall conversational competence and functional social communication skills for school-age children who havepersistent pragmatic and social communication needs. There was no effect of treatment on structural language skills.The majority of children with pragmatic difficulties also had a history of autism spectrum disorder or pervasivedevelopmental disorder. Parent and teacher outcomes were important measures in the context of the implementationof a complex intervention where measurement of pragmatic and social communication skills remain challenging.

Background

Pragmatic language impairment (PLI) is present whenchildren have disproportionate difficulty with thepragmatic domain of language in relation to relativestrength in grammar and phonology (Bishop 2000).Pragmatic features of PLI include verbosity, excessivetopic switching, a tendency to dominate verbal interac-tions, poor adjustment to listeners’ prior knowledge andlimited application of inference in naturalistic interac-tion (Bishop and Adams 1989, Adams 2001). Symptomscharacteristic of specific language impairment (SLI)are also present in PLI with some children presentingsemantic errors, word-finding difficulties and persistentdifficulty with receptive language. High-level languagedeficits such as poor comprehension of non-literallanguage and narratives and stories are also evident(Botting and Adams 2005). As a group, children whohave PLI (CwPLI) present considerable heterogeneityin social communication and language skills, in bothpattern and severity. The full profile of PLI emerges inthe early school years as the disparity between structuraland social language functioning becomes clear.

The pragmatic characteristics of CwPLI are similarto those reported in high-functioning children whohave autism spectrum disorder (HF-ASD) or pervasivedevelopmental disorder (PDD1) (Landa 2000). PLI andHF-ASD may share other abnormalities of communica-tion such as use of stereotyped phrases, intonation andnon-verbal interaction. As with CwPLI, a significantproportion of children who have HF-ASD also have aprofile of language impairment similar to SLI (Kjelgaardand Tager-Flusberg 2001). There is consequentlycontroversy surrounding the use of PLI as a diagnosisdistinct from HF-ASD, since the two groups may notbe distinguishable in terms of social communicationand social interaction deficits. It has been suggestedthat CwPLI are typically differentiated from CwHF-ASD by the absence of repetitive/restricted behaviours(Bishop 1998, Leyfer et al. 2008). In addition, since thepattern of communication deficits seen in PLI clearlyextends beyond the pragmatics domain, there is increas-ing consensus that the term ‘social communication

disorder (SCD)’ may be a more appropriate descriptor.In proposals for the fifth edition of the Diagnostic andStatistical Manual of the American Psychiatric Associa-tion (n.d.), SCD is categorized as a subtype of LanguageImpairment with features that closely match the descrip-tion of PLI provided by Bishop and colleagues in earlierwork. The diagnostic overlaps remain unresolved. Inthe current study, the term ‘children who have PLI(CwPLI)’ will be used to describe children with a patternof pragmatic and social communication needs similar tothose described by Bishop (2000) and the SCD profile inDSM-5.

The number of children who have significant needsin pragmatics and social communication is rising in linewith increased identification of broader ASD conditions(Baird et al. 2006). Botting and Conti-Ramsden (1999)identified 22% of children attending UK special-ist language units as having PLI. Emerging evidencesuggests that pragmatic difficulties in the primary schoolyears may be related to emotional and behaviour difficul-ties, high referral rates to educational psychology services(Mackie and Law 2010), longer-than-usual time spentin special provision (Botting et al. 1998), and specificdifficulty in forming adult relationships in later life(Whitehouse et al. 2009).

The need for adequate communication interven-tions as preventative measures is therefore consider-able. Single case studies of CwPLI (Adams 2001) andSCD (Timler et al. 2005, Brinton et al. 2005) haveshown positive effects of intervention on specific aspectsof communication such as conversational skills; a casestudy series (Adams et al. 2006) reported a signal ofchange as a result of intensive speech–language therapyfor six CwPLI. There have been no trials of speech–language interventions for CwPLI (Law et al. 2003). Theaims of the present study were to examine the effective-ness of an intensive manualized social communica-tion speech and language intervention in improving(1) language skills and (2) observed functionalpragmatic ability and broader social communicationof CwPLI within a small-scale randomized controlledtrial.

RCT of speech/language therapy for children with pragmatic language impairment 235

Methods

The two-arm parallel-group randomized controlled trialwas carried out in accordance with the NHS ResearchGovernance Framework for Health and Social Care(NHS 2005) and was approved by the Northernand Yorkshire NHS Research Ethics Committee (RECNo. 07/MRE03/3). All parents gave written informedconsent for their child’s participation. Informed consentwas also gained from the child (where able), their school,class teacher and learning support assistant (LSA) andthe relevant local authorities.

Participants

The study was powered on the basis of a pilot studyof the intervention (n = 6; Adams et al. 2006). Thisdemonstrated a clinically significant standardized effectsize for the Clinical Evaluation of Language Fundamen-tals (CELF-4; Semel et al. 2006) of 0.62 (differencein means of 3.1 with an SD of 5, based on the sumof two subtests only). Therefore, target recruitment forthe current study was set at 99 participants, providing> 80% power to detect a standardized effect size of 0.6in CELF-4 as the primary outcome.

Speech and language therapists (SLTs) across theNorth West of England and South East Scotland referredto the trial any children on their caseloads aged 6 yearsto 10 years 11 months who met the following inclusioncriteria:

• Pragmatic communication problems as observedby the child’s SLT (including a minimum of twoout of five pragmatic behaviours from a socialcommunication behaviour checklist (SCBC, seeappendix A).

• Attending mainstream primary educationprovision and identified as having SpecialEducational Needs (England) or AdditionalSupport Needs (Scotland).

• English as the primary language of communica-tion and learning.

• Agreement with the child’s school to accommo-date intervention and assessment visits.

• No current diagnosis of core autism.• Currently receiving regular, on-going attention

from SLT services and able to cooperate with directintervention.

• No evidence of severe difficulties in emotionaldevelopment, behaviour needs, unintelligibility orhearing.

All referred children were assessed for eligibility andincluded in the study if they met the following screeningcriteria:

• A score in the communication impairedrange (≤ 58) on the General CommunicationComposite (GCC) of the Children’s Communica-tion Checklist—Second Edition (CCC-2; Bishop2003), a measure functional communicationincluding pragmatics completed by parents.

• A score ≥ 5th centile on Raven’s ColouredProgressive Matrices (RCPM; Raven 1979), atest of non-verbal perceptual/analogical reasoningskills.

Screening assessments were carried out by aresearcher in the child’s school with one or both parentspresent.

The Social Interaction Deviance Composite (SIDC)of the CCC-2 and the Social Communication Question-naire Lifetime version (SCQ) (Rutter et al. 2003), aparent questionnaire which asks about the history ofdiagnostic features of autism, were also completed toprovide information on group characteristics but werenot used as part of the inclusion criteria. An SCQ cut-off score of ≥15 is considered indicative of a history ofPDD, and a cut-off score of ≥22 is considered indicativeof a history of ASD (Berument et al. 1999).2

Randomization, blinding and schedule ofassessments

Following screening and baseline (T1) assessments, aresearcher at the University of Manchester, who wasnot independent of the study, randomly assigned eachchild to SCIP intervention or treatment-as-usual (TAU)in a 2:1 ratio, stratified by age group (6;00–8;11 or9;00–10;11). A 2:1 ratio was used to improve powerfor later moderator and mediator exploratory analyses.Allocation used three possible permuted blocks of sizethree:

1: SCIP TAU SCIP2: SCIP SCIP TAU3: TAU SCIP SCIP

A new block was selected after every three children inthe same age band.

All assessments (delivery, coding and scoring) werecompleted by a research assistant (RA) blind totreatment allocation; however, families, schools andthose delivering intervention could not be blind totreatment allocation. At assessment points, children,parents and schools were reminded that the RA wasblind to treatment allocation and that anything relatedto this should not be discussed with them. Question-naires completed by parents or teachers (CCC-2, PROand TRO—see the outcome measures) were returned

236 Catherine Adams et al.

by post to a researcher who was not involved withtheir child’s intervention. Reassessments were carriedout in the child’s school within 2 weeks followingthe completion of intervention/TAU (T2) and at6 months following the completion of interven-tion/TAU (T3). SCIP intervention began within 4weeks of pre-intervention (T1) assessment.

Interventions

Participants in the SCIP group ceased their usualtreatment as provided by their local SLT services forthe experimental intervention period. The experimentaltreatment was an intensive manualized social communi-cation intervention with content within a principledframework aimed at remediation of impairments insemantics and high-level language skills, pragmaticdifficulties, and social interaction and social cueinterpretation (Adams and Gaile 2012). The researchintervention manual provided procedures for planningintervention and establishing appropriate goals as wellas all intervention activities. For each child, between16 and 20 individual face-to-face one hour sessionsof intervention (up to three sessions per week) weredelivered in school over the course of one schoolterm. Parent/teacher input was solicited throughout thesetting of goals and intervention period. Each childtherefore received an individualized intervention derivedfrom the manual, but within a specified framework,as outlined above, so as to ensure that interventionchoices were consistent. Two specialist research speechand language therapists (RSLT) (one at each of the twolocations) and five specially trained therapy assistants(ThAs) (England n = 4, Scotland n = 1) delivered theexperimental treatment. Treatment fidelity, measured byaudit of planned intervention sessions versus receivedsessions and adherence to written activity procedureas stated in the manual (both across 10% of sample)was at ≥ 80% for both measures. A detailed andprecise account of the experimental SCIP interven-tion, including rationale, the process of manualization,implementation, intervention components, individu-alization procedures, required level of practitionerexpertise and treatment fidelity measures, is providedin Adams et al. (2012).

Children allocated to TAU continued with thetreatment being provided by their local SLT services.This provision was documented through telephoneliaison with these services (data obtained for 27/29children). Thirteen of these children (48%) receivedLearning Support Assistant (LSA) support provided bythe Education Authority plus SLT contact or contactfrom another communication professional. Ten ofthese children received direct individual or group-basedintervention. Seventeen SLTs reported general training

for LSAs; three had provided training to LSAs aimedat the management of an individual child. Children inboth arms continued to receive support from their LSAs(and/or classroom support for learning) throughout thestudy.

Post-intervention, children in the SCIP interventionarm were referred back to their local SLT services foron-going care. Provision post-intervention to 6-monthfollow-up was documented through telephone liaisonwith local SLT services obtained for 21/29 children inthe TAU arm and for 47/59 children in the SCIP arm.Of these children 17 (81%) in the TAU arm, and 30(63%) in the SCIP arm, received SLT contact. Of thesechildren, 12 (57% of TAU; 26% of SCIP) childrenfrom each arm were reported to have received directindividual or group specialist intervention.

After 6-month follow-up (T3) measures, all SLTs ofchildren allocated to TAU received a manual interven-tion plan based on what the child would have receivedhad they been in the SCIP intervention arm.

Outcome measures

The primary outcome measure was predefined as theCELF-4 (Semel et al. 2006) Core Language StandardScore (CLSS) as a recognized, reliable and standard-ized measure of general language ability, which can beadministered blind to treatment allocation. The relevantsubtests were completed with each participant (takinginto account age at that time point) to allow the calcula-tion of composite core language scores (see appendixA).

Secondary outcome measures were:

• Targeted Observation of Pragmatics in Children’sConversation (TOPICC; Adams et al. 2011): asemi-structured task that allows for the rating ofoverall quality of interaction in conversation (thesame task was used in Bishop and Adams 1989).Each participant was video recorded discussing astandard series of three photographs of events withan RA who used a series of question prompts.The aim of the task was to obtain a sample ofnatural conversation with the child. Three sets ofphotographs were used in rotation for each partici-pant at T1, T2 and T3. Following completionof all outcome measurement, the video recordedconversations were rated by a trained, indepen-dent assessor, blind to treatment allocation, atthe University of Manchester. The assessor wasasked to make a judgement of overall conversa-tional skills of the child, rating them as improved,stayed the same or got worse from T1 to T3.A proportion of T1 and T3 videos (37% of totalavailable; n = 29, TAU n = 10, SCIP n = 19) were

RCT of speech/language therapy for children with pragmatic language impairment 237

rated independently by a second assessor also blindto group status. Raters were asked to considerthe overall impact of any pragmatic behaviourson the overall quality of interaction. The inter-rater reliability for the raters was Cohen’sκ = 0.68, indicating a substantial inter-rateragreement for overall impression of conversationchange.

• A pragmatics rating scale (CCC-PRAG), derived,a priori, from the CCC-2. Two highly special-ist RSLTs provided face validity for this scale byidentifying a list of 18 items which in their viewwas closely related to the content of SCIP interven-tion. An autism-type communication problemsscale (CCC-AUT), consisting of 18 items nottargeted by SCIP intervention directly, was alsoidentified as a control for predictable bias byparents in the experimental intervention arm.Parents completing the CCC-2 would be unawareof separate PRAG/AUT lists embedded withinit. CCC-PRAG and AUT lists are shown inappendix A. Scores are sums of rated items,converted from CCC-2 scoring to a single polarity,with higher scores indicating greater impairment.Split-half reliability (internal consistency) of bothCCC-PRAG and CCC-AUT scales were in theacceptable range (Cronbach’s α for CCC-PRAG= 0.82; for CCC-AUT α = 0.80). Parentscompleted CCC-PRAG/AUT lists at home within2 weeks following the completion of intervention(T2) and at 6 months following the completionof intervention (T3). Completed CCCs werereturned by post to a researcher who was notinvolved in the child’s intervention.

• The Expression, Reception and Recall of NarrativeInstrument (ERRNI; Bishop 2004) was used as ameasure of ability to interpret, remember and tella pictured narrative. Standardized scores are givenfor initial telling of the story (ERRNI-I), storyrecall (ERRNI-R) and comprehension (ERRNI-C). The ERRNI story was alternated at each timepoint (therefore the same story was used at T1and T3).

• Parent-reported outcome (PRO): parents wereasked, via a questionnaire, to state their judgmentsabout the current status of their child’s LanguageSkills (PRO-LS), Social Communication (PRO-SC), Social Situations (PRO-SS) and PeerRelationships (PRO-PR) and to rate whether thesehave improved, stayed the same or got worsesince pre-intervention (T1). Parents completedPRO questionnaires at home within 2 weeksfollowing the completion of intervention (T2)and at 6 months following the completionof intervention (T3).

• Teacher-reported outcome (TRO): teachers wereasked, via a questionnaire, to state their judgmentsabout the current status of the child’s classroomlearning skills (TRO-CLS) and to rate whetherthese have improved, stayed the same or got worsesince pre-intervention (T1). Teachers completedTRO questionnaires at school at 6 monthsfollowing the completion of intervention (T3)only.

Statistical analysis

Analysis was by intention to treat3 and was undertakenafter completion of all T3 assessments. For the primaryoutcome, and secondary outcomes CCC-2 PRAG/AUTand ERRNI, analysis was by linear regression withadjustment for age and the corresponding T1 measure.Analysis for TOPICC, PRO and TRO was by logisticregression with similar adjustment for age and thecorresponding T1 measure.

Results

Participants were recruited between April 2007 andApril 2008 in England and between October 2007 andSeptember 2008 in Scotland. All assessments occurredwithin schedule.

Figure 1 shows the trial profile. The study under-recruited participants (final n = 88) compared with thetarget. Fifty-nine participants were randomly assignedto the SCIP group and 29 participants were randomlyassigned to the TAU group. In the SCIP group57 participants received intended treatment and wereanalysed for the primary outcome. In the TAU group28 participants received the intended treatment andwere analysed for the primary outcome. Attritionwas therefore 3/88 (3%) for the primary endpoint.One participant who withdrew from the study duringintervention also withdrew consent for their T1 data tobe used.

Table 1 shows baseline demographic and clinicalcharacteristics for each group. The groups were wellmatched on age, demographics, CELF-4 CLSS andCCC-2 GCC. Mean Raven’s Progressive ColouredMatrices mid-point percentile score were slightly higherin the SCIP than in the TAU group. Scores on the SCQshowed that 75% of participants scores (76% of SCIPand 73% of TAU) fell within the range indicative ofthe child having PDD or ASD features at some stage indevelopment.

Primary outcome

The primary outcome measure was CELF-4 CLSS.Figure 2 shows the spread of CELF-4 CLSS scores atT1, T2 and T3 for SCIP and TAU groups.

238 Catherine Adams et al.

Figure 1. Trial profile. SCIP, Social Communication Intervention Project.

Figure 2. CELF-4 Core Language Standard Score at T1, T2 and T3 for TAU and SCIP intervention groups. The dotted line is at the CELF-4CLSS population mean of 100; and the dashed line is at the cut-off between normal range (≥ 80) and language impaired (< 80).

RCT of speech/language therapy for children with pragmatic language impairment 239

Table 1. Baseline demographic and clinical characteristics of each groupc

Whole group SCIP TAUn = 87 n = 59 n = 28

75 boys, 12 girls 52 boys, 7 girls 23 boys, 5 girls

Mean SD Range Mean SD Range Mean SD Range

Age (months) 100.5 15.0 71–128 100.9 15.1 71–128 99.6 14.8 74–125NRS ‘ABC1’ demographicsb

Middle to high areaa 30 (34%) 18 (31%) 12 (43%)Middle to low areaa 49 (56%) 34 (58%) 15 (54%)Mixed areaa 8 (9%) 7 (12%) 1 (4%)

SCBC (n = 80) 4.4 0.7 3–5 4.4 0.7 3–5 4.4 0.7 3–5CCC-2 GCC 29.3 12.0 6–57 29.5 12.1 6–57 28.8 12.0 7–56RCPM percentilee 53.5 28.6 5–96 49.2 28.9 5–96 62.6 26.2 17.5–96CELF-4 CLSSd 72.6 18.3 40–114 71.3 16.8 40–112 75.3 21.2 40–114Language impaired CELF-4CLSSd < 80 (n = 56)

61.6 11.2 40–79 62.3 10.5 40–79 59.7 13.2 40–79

Not language impairedCELF-4 CLSSd ≥ 80 (n = 31)

92.4 9.9 81–114 91.7 8.0 81–112 93.3 12.4 81–114

CCC-PRAG (n = 86) 34.5 10.0 10–54 34.2 9.9 15–54 35.2 10.3 10–50CCC-AUT 28.1 10.2 6–49 27.9 10.6 8–49 28.4 9.6 6–44ERRNI-Id 90.9 17.4 64–135 90.3 17.4 65–135 92.1 17.6 64–122ERRNI-Rd 86.4 18.2 64–136 85.8 17.2 64–131 87.7 20.3 64–136ERRNI-Cd 87.7 16.0 64–125 87.2 16.6 64–125 88.7 14.8 64–115SCQ (n = 84)∗ 20.3 7.9 2–37 20.3 7.7 3–37 20.2 8.3 2–33

Non-ASD SCQ ≤ 14a 21 (25%) 14 (24%) 7 (27%)PDD-NOS SCQ 15–22a 23 (27%) 17 (29%) 6 (23%)ASD SCQ ≥ 22a 40 (48%) 27 (47%) 13 (50%)

Notes: an (%).bArea based on postcode. Middle to high areas include ≥ C2 only; middle to low areas include ≤ C1 only; and mixed areas included a range from A/B to D/E.cn = 87 as one child withdrew without giving permission to use the data.dStandard scores have a population mean = 100.eRCPM percentile ranges transformed into percentile midpoints, e.g. 5th–10th percentile becomes 7.5th percentile∗SCQ scores ≥ 15 are considered indicative of PDD-NOS; and scores ≥ 22 are considered indicative of ASD.NRS, National Readership Survey (NRS Ltd); SCBC, Social Communication Behaviour Checklist; CCC-2 GCC, Children’s Communication Checklist-2 General CommunicationComposite; RCPM, Ravens Coloured Progressive Matrices; CELF-4 CLSS, Clinical Evaluation of Language Fundamentals Core Language Standard Score; CCC-PRAG, Pragmaticsrating scale; CCC-AUT, Autism-Communication Rating Scale; ERRNI-I/R/C, Expression, Reception and Recall of Narrative Instrument Initial Telling/Story Recall/ComprehensionStandard Score; SCQ, Social Communication Questionnaire.

Using linear regression, comparison was madebetween the TAU and SCIP groups on the CELF-4CLSS at T2 and T3 with adjustment for age and theCELF-4 CLSS at T1. No significant treatment effectwas found at T2 (p = 0.78) or T3 (p = 0.87). Theestimated group difference at T2 was 0.5 (95% CI =–3.1 to 4.1) and at T3 was 0.3 (95% CI = –3.7 to 4.4).

Given that a large proportion (36%) of participantswere found to have CELF-4 CLSS well within thenormal range (CELF-4 CLSS > 80) at baseline, a furtherexploratory comparison was made for the subgroup ofchildren who scored in the low ability/language impairedrange (CELF-4 CLSS < 80) at baseline. Conclusionswere similar: the estimated group differences (95% CI)at T2 and T3 were 3.9 (–1.3 to 8.9) and 1.4 (–4.8 to7.6) respectively.

Secondary outcomes

Table 2 shows the results of secondary outcomes at T2.No significant treatment effects were found for CCC-

PRAG/AUT or ERRNI at T2. However, parent ratings(PRO) showed significant differences by treatmentgroup in favour of SCIP at T2.

Table 3 shows the results of secondary outcomesat T3. TOPICC, CCC-PRAG, PRO-SC and PRO-SS, and TRO-CLS showed significant differences bytreatment group in favour of SCIP at T3. However,no significant treatment effects were found for CCC-AUT, ERRNI, PRO-LS or PRO-PR at T3. Note thatfor PRO-PR numbers in the control group were toosmall for analysis by logistic regression.

Discussion

This is the first randomized controlled trial investigatingthe effectiveness of intervention for children who havePLI. The first aim was to establish the effects of theSCIP intervention compared with TAU on standardizedlanguage assessment.

The primary outcome, a standardized measure ofoverall language performance (CELF-4 CLSS), did

240 Catherine Adams et al.

Table 2. Secondary outcomes at Time 2

SCIP TAU Effecta

n Mean (SD) n Mean (SD) Mean difference (95% CI) p

CCC-PRAG 49 30.9 (10.2) 21 29.4 (11.4) 0.7 (–3.3 to 4.6) 0.74CCC-AUT 50 26.3 (10.8) 21 23.3 (8.9) 1.6 (–2.1 to 5.3) 0.39ERRNI-I 57 90.9 (17.8) 28 90.9 (17.3) 0.31 (–6.9 to 7.5) 0.93ERRNI-R 57 91.2 (20.2) 28 88.3 (21.2) 3.7 (–4.7 to 12) 0.38ERRNI-C 57 89.1 (13.9) 28 87.1 (12.9) 2.4 (–3.3 to 8.1) 0.41

n (%) improved n (%) improved Odds ratio (95% CI)

PRO-LS 50 38 (76) 19 4 (21.1) 11.9 (3.3–42.7) < 0.001∗∗

PRO-SC 48 35 (72.9) 20 7 (35) 5 (1.6–15.2) 0.005∗∗

PRO-SS 47 27 (57.4) 21 3 (14.3) 8.7 (2.2–34.2) 0.002∗∗

PRO-PRb 40 20 (48.8) 18 1 (5.6)

Notes: aMean difference by linear regression or odds ratio by logistic regression.bNumbers improved in the control group too small to compute odds ratio.∗∗p < 0.01.Abbreviations are as given in table 1, except for PRO-LS/SC/SS/PR, Parent Reported Outcome—Language Skills/Social Communication/Behaviour in Social Situations/Peer Relation-ships.

not show a significant intervention effect for SCIPcompared with TAU, nor did a secondary standard-ized measure of narrative ability (ERRNI). The identifi-cation of a single, predefined standardized outcomemeasure, which was sensitive enough to capture changein pragmatic impairment, although highly desirable,was not easily achievable for this complex group. Overone-third of participants recruited were found to beperforming well within the normal range on CELF-4CLSS (and ERRNI) at pre-intervention assessment.A further exploratory comparison was therefore madefor the subgroup of children who scored in the lowability/language impaired range (CELF-4 CLSS < 80)at baseline. This comparison showed a trend in favourof intervention, but had insufficient power to detect

plausible differences between groups. Inspection of thestandard score increments and confidence intervals onCELF-4 CLSS also indicate that very large changes inraw scores (larger than those considered clinically signifi-cant) would be required to show shift in standard scores.

Despite CELF-4 CLSS being a recognized, reliableand objective test of general language function, someCwPLI in this study had functional difficulties withlanguage processing that were evident to teachers andparents but which were not detected by standardizedlanguage tests. Further, some CwPLI functioned in thenormal range across all language tasks and did notpresent concern to teachers or parents, except in thepragmatics and social communication domain. Furthercharacterization of the PLI ‘population’ may therefore be

Table 3. Secondary outcomes at Time 3

SCIP TAU Effecta

n Mean (SD) n Mean (SD) Mean difference (95% CI) p

CCC-PRAG 39 27.9 (12.9) 16 33.5 (9.0) 5.5 (0.04–10.9) 0.049∗

CCC-AUT 41 24.3 (11.4) 16 24.1 (9.6) 0.13 (–4.8 to 5.1) 0.96ERRNI-I 57 97.2 (14.8) 28 100.8 (13.8) 3.3 (–2.5 to 9.1) 0.27ERRNI-R 57 93.7 (20.9) 28 93.5 (23.2) 0.58 (–8.7 to 9.9) 0.90ERRNI-C 57 91.6 (14.5) 28 93.4 (15.5) 1.4 (–4.7 to 7.5) 0.64

n (%) improved n (%) improved Odds ratio (95% CI)TOPICC 51 22 (43.1) 27 5 (18.5) 0.3 (0.1–0.9) 0.04∗

PRO-LS 38 26 (68.4) 16 7 (43.8) 2.9 (0.9–9.9) 0.09PRO-SC 38 28 (73.7) 16 4 (25.0) 8.0 (2.1–31.1) 0.003∗∗

PRO-SS 38 24 (63.2) 15 3 (20.0) 7.4 (1.7–31.8) 0.007∗∗

PRO-PR 38 24 (63.2) 14 7 (50.0) 1.6 (0.5–5.7) 0.46TRO-CLS 40 30 (75.0) 18 8 (44.4) 3.7 (1.2–12.1) 0.03∗

Notes: aMean difference by linear regression or odds ratio by logistic regression.∗p < 0.05; ∗∗ p < 0.01.Abbreviations are as given in tables 1 and 2, except TRO-CLS, Teacher Reported Outcome—Classroom Learning Skills.

RCT of speech/language therapy for children with pragmatic language impairment 241

required to understand the true nature and occurrenceof underlying language impairments as well as develop-ment of sensitive, valid and objective measures of highlevel language outcomes. The content of CELF-4 CLSSwas also ultimately relatively far removed from theintervention goals in SCIP which emerged for individu-als over time. These tended to be at the levels of activityand participation, reflecting the priorities of parentsand teachers whose input was solicited throughout thesetting of goals and intervention period.

The second aim was to explore any notable effectsof the SCIP intervention compared with TAU, onobserved functional pragmatic ability and broader socialcommunication.

Significant intervention effects were found for SCIPintervention compared with TAU for overall conversa-tional quality (TOPICC) between baseline and 6-month follow-up. This finding is important given thatit was achieved using blind rater perceptions. It iscarefully noted, however, that approximately half ofthe intervention group were rated as not improved onthis measure, indicating that only some CwPLI arelikely to be able to adapt conversational style with ashort period of intervention. It would be important toidentify, in further research, variables associated withpotential for change in order to adopt differentialmanagement strategies. TOPICC ratings were based onblind perceptions of change between baseline and 6-month follow-up suggesting the intervention effect ismaintained well beyond the end of intensive therapy forthese children who did show change.

Significant intervention effects were also found forSCIP intervention compared with TAU for non-blindparent-reported social communication, social behaviourand language skills immediately following intervention.These effects were maintained at 6-month follow-up forsocial communication and behaviour in social situations.Significant intervention effects were also found for non-blind teacher ratings of classroom learning skills at 6-month follow-up (measured at T3 only).

Non-blind parent-reported pragmatic functioning(CCC-PRAG) showed a significant intervention effectcompared with TAU at 6-month follow-up, but notimmediately following intervention. It might thereforebe that skills learned in an intensive period of therapytake time to be consolidated in broader contexts, whichwould contribute to a possible ‘sleeper effect’ where theeffects of treatment may be undetectable on immediatepost-test but become apparent on later testing. CCC-PRAG was composed of a diverse list of pragmaticskills, not all of which could have been addressed in anysingle individual’s intervention. It was not unexpectedtherefore that this finding just achieved significance.

It is important to note that between-conditioneffects on non-blind parent and teacher-reported

measures were subject to bias and therefore need tobe interpreted with great caution. In this study weaimed to mitigate bias by extracting two sets of items,CCC-PRAG (behaviours targeted in the intervention)and CCC-AUT (not targeted in the intervention) fromCCC-2 assessments. The hypothesis that interventionwhich targeted pragmatics should show an effect onCCC-PRAG only was confirmed. Parent report was ableto differentiate effects for these two aspects of communi-cation.

Differential effects across categories were alsodemonstrated within Parent Reported Outcomes, wherefindings were not universally in favour of interven-tion across individual items. Although careful attentionwas given to the method of reporting to attemptto control halo effects, it is possible that parents inthe intervention group were biased to report positivechanges in aspects of intervention which they perceivedas central to therapy, but, in practice, interventioncontained multiple integrated components and thesewere not explicitly labelled by therapists. Further,exploration of outcome measures indicates that thereis convergence in the types of functional communica-tion changes observed by parents across measures (CCC-PRAG/PRO) and good agreement between parentCCC raters and blind TOPICC raters (Adams et al.2011).

Delivering a complex individualized speech–language intervention to a relatively heterogeneouspopulation, in the context of all the variables of real-life school environments was exceptionally challeng-ing and there are several potential limitations andpossibilities for bias which have to be controlled. TheTAU group received less direct specialist interventionthan participants receiving SCIP (Adams et al. 2012)making it difficult to attribute intervention effects to thespecific content of SCIP rather than increased specialistattention. However, the TAU group continued to receiveSLT support via LSAs in a training/consultancy modelwhich is widely used in UK mainstream SLT services.Thus, this was a fair comparison of the experimentaltreatment to the care that would have been receivedwere the trial not to have taken place and therefore hasecological validity.

In this study, the developer of the SCIP interventionand the TOPICC outcome measure is also the evaluatorof the intervention in this trial. As such, a potential forsystematic bias related to conflict of interest may exist(Petrosino and Soydan 2005). However, the trial wasrigorous with respect to blinding and pre-definition ofoutcome measures.

These findings highlight important implications forfuture studies of interventions for complex developmen-tal constructs such as PLI and SCD. This complexitymeans that it is unlikely that there will be uniform

242 Catherine Adams et al.

outcome effects across participants due to differentialprofiles of impairment and rates of development (Koeniget al. 2009). Obtaining a balance in outcome measuresbetween sensitivity to change in performance increments(where potential measureable outcomes are many) andmeaningful functional communication change is a realchallenge in intervention trials such as these. TheTOPICC method of using blind rater perception ofoverall conversational quality holds promise as a way ofcapturing change across a complex population present-ing with wide ranging impairments that impact on thequality of conversation in different ways. However, thereis a need to develop measures which are specific andsensitive to the perceived needs of the children fromthe service users’ perspective too. Therefore, parent orteacher-reported outcomes may ultimately be a morepowerful primary outcome measure in a study such asthis.

Conclusions and clinical implications

The overall conclusions are that it is likely thatthe intervention provided in SCIP is effective atimproving overall conversational quality (but notstructural language skills) in 6–11 year olds who havesignificant pragmatic and social communication needscompared with TAU.

SCIP is perceived by parents and teachers as effectiveat improving some functional pragmatic and socialcommunication skills at home, and classroom learningskills, for these children.

The implications are that, with carefully targetedspecialist intervention, there is potential for some changein some school-aged children who have persistentpragmatic and social communication needs, even with abrief period of speech and language therapy. The amountof therapy offered was constrained by the experimen-tal model; in reality, some children may require longerperiods of intervention to consolidate gains made inthe intensive period of therapy. Changes in individualchildren varied widely and a further stage of enquirywould be to investigate factors which contribute to thisfinding.

These findings may provide some support for theconclusions of a recently reported trial of interven-tion for children with SLI (McCartney et al. 2011),which concluded that the effects of a specialist interven-tion can be lost whilst attempting to embed it withina consultancy training model. In the present study’sTAU condition, children received less direct interven-tion but continued to receive SLT support from LSAs viaa consultancy model. Many children had received thissupport for a long period of time and continued to doso. In the SCIP condition, direct therapy was intensivelyprovided using a model of specialist SLT provisionsupported by specially trained assistants (with additional

indirect support). In future work it will be important toinclude estimates of cost-effectiveness and the resourcesrequired to support alternative models of delivery. Itwould be essential to look at the balance between a moreintensive, mixed direct/indirect, specialist-led provisionwhich has the potential to produce outcomes desired byservice users and the more indirect SLT models whichare generally provided over longer periods and whosepotential for achieving desired outcomes is unknown.

Although resources prevented the use of goldstandard autism diagnostic procedures such as theAutism Diagnostic Observation Schedule (ADOS; Lordet al. 2000), there is an indication that our PLI groupshowed a substantial overlap with children with HF-ASD/PDD and that SCIP may therefore also be arelevant intervention in addressing social communi-cation skills in this group. We emphasize thoughthat SCIP intervention is aimed at optimizing socialcommunication, it does not aim to ‘cure’ communica-tion impairments or change autistic symptomatology.The findings are suggestive of changes in children’scommunication skills which are perceived as meaning-ful to those living and working with the children daily.Such indicators are now seen as central to the aspirationof delivering services which are designed around thefamily (Department for Children, Schools and Families(DCSF) 2008).

Acknowledgements

This study was funded by the Nuffield Foundation (Grant Reference:EDU/32953) and sponsored by the University of Manchester.The authors gratefully thank the participating children, parents,schools, and referring speech and language therapy services in theNorth West of England and in the South East Scotland area. Theyacknowledge the cooperation of the Centre for Integrated HealthcareResearch, Queen Margaret University, Edinburgh; and the supportand guidance from their study advisory committee (Sue Roulstone,Bonnie Brinton, Martin Fujiki and Geoff Lindsay). Declaration ofinterest: The authors report no conflicts of interest. The authorsalone are responsible for the content and writing of the paper. Theintervention described in this paper is currently in preparation forpublication in book form by two of the authors (Adams and Gaile).

Notes

1. The term ‘PDD’ is likely to be subsumed under ASD in DSM-5;therefore, it will not be used from this point. Note that it doesappear in the SCQ assessment used in this study. The proportionof children with historical ASD and PDD on this assessment willbe interpreted as all falling into a broader ASD definition (seethe Results).

2. SCQ Lifetime scores are based on parent report of autism featureswhich have occurred in the child’s lifetime; it is probable that thebehavioural and social profile of the child in the current studywill have changed to some degree over time, so no definitivediagnosis of current autism functioning can be derived.

3. Outcome data for all randomized participants were included inanalysis where available.

RCT of speech/language therapy for children with pragmatic language impairment 243

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244 Catherine Adams et al.

Appendix A

Table A1. Social Communication Behaviour Checklist (SCBC)used for recruitment purposes only

Yes/no

The child has trouble understanding and interpreting the social context and friendship, e.g. social roles, emotionsThe child has trouble understanding and/or using non-verbal aspects of communication, e.g. facial expression, intonationThe child has trouble with aspects of conversation, e.g. beginning and ending, taking turns, giving relevant and sufficient informationThe child makes bizarre, tangential or inappropriate commentsThe child has difficulty using and understanding non-literal language

Table A2. CELF-4 Core Language Scale subtests by age

Ages 5–8;11 Ages 9–12

Concepts and following directions Concepts and following directionsWord structure Recalling sentencesRecalling sentences Formulating sentencesFormulating sentences Word classes 2 (receptive and expressive)

Table A3. Children’s Communication Checklist-2 Pragmatics(PRAG) and Autism-communication (AUT) subscales (derivedfrom Bishop 2003)

(a) CCC-2 PRAG

1 Gets confused when a word used with a different meaning2 Includes over-precise information3 It’s hard to make sense of what he is saying even though the words are clear4 It’s difficult to stop him or her from talking5 Tells people things they know already6 Gets the sequence of events muddled up when trying to tell a story7 Doesn’t explain what he is talking about to someone who doesn’t share their experiences8 Can be hard to tell if she is talking about something real or make believe9 Talks to people too readily10 Takes in just one or two words in a sentence and so misinterprets11 Moves the conversation to a favourite topic, even if others not interested12 Talks repetitively about things that no one is interested in13 Uses terms like ‘he’ or ‘it’ without making it clear what s/he is talking about14a Talks to others about their interests rather than his own15 When answering a question, provides enough information without being over precise16 Realises the need to be polite17 Talks about his friends, shows an interest in what they say and do18 Keeps quiet in situations where someone else is trying to talk or concentrate19 You can have an enjoyable, interesting conversation with her20 Explains a past event clearly

Note: aReversed polarity from this point.