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Journal of Abnormal Child Psychology, Vol. 28, No. 6, 2000, pp. 483–505 Psychosocial Treatment Strategies in the MTA Study: Rationale, Methods, and Critical Issues in Design and Implementation 1 Karen C. Wells, 2,16 William E. Pelham, Jr., 3 Ronald A. Kotkin, 4 Betsy Hoza, 5 Howard B. Abikoff, 6 Ann Abramowitz, 7 L. Eugene Arnold, 8 Dennis P. Cantwell, 9 C. Keith Conners, 2 Rebecca Del Carmen, 10 Glenn Elliott, 11 Laurence L. Greenhill, 12 Lily Hechtman, 13 Euthymia Hibbs, 10 Stephen P. Hinshaw, 14 Peter S. Jensen, 12 John S. March, 2 James M. Swanson, 4 and Ellen Schiller 15 Received July 7, 1999; revision received January 15, 2000; accepted February 2, 2000 The Collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (ADHD), the MTA, is the first multisite, cooperative agreement treatment study of children, and the largest psychiatric/psychological treatment trial ever conducted by the National Institute of Mental Health. It examines the effectiveness of Medication vs. Psychosocial treatment vs. their combination for treatment of ADHD and compares these experimental arms to each other and to routine community care. In a parallel group design, 579 (male and female) ADHD children, aged 7–9 years, 11 months, were randomly assigned to one of the four experimental arms, and then received 14 months of prescribed treatment (or community care) with periodic reassessments. After delineating the theoretical and empirical rationales for Psychosocial treatment of ADHD, we describe the MTA’s Psychosocial Treatment strategy applied to all children in two of the four experimental arms (Psychosocial treatment alone; Combined treatment). Psychosocial treatment consisted of three major components: a Parent Training component, a two-part School Intervention component, and a child treatment component anchored in an intensive Summer Treatment Program. Components were selected based on evidence of treatment efficacy and because they address comprehensive symptom targets, settings, comorbidities, and functional domains. We delineate key conceptual and logistical issues faced by clinical researchers in design and implementation of Psychosocial research with examples of how these issues were addressed in the MTA study. KEY WORDS: attention deficit/hyperactivity disorder; psychosocial treatment; parent training; school inter- vention; summer treatment program. 1 The MTA is a cooperative treatment study performed by six inde- pendent research teams in collaboration with the staff of the Divi- sion of Clinical and Treatment Research of the National Institute of Mental Health (NIMH), Rockville, Maryland and the Office of Spe- cial Education Programs (OSEP) of the U.S. Department of Educa- tion (DOE). The NIMH Principal Collaborators are Peter S. Jensen, M.D., L. Eugene Arnold, M.Ed., M.D., John E. Richters, Ph.D., Joanne B. Severe, M.S., Donald Vereen, M.D., and Benedett´ o Vitiello, M.D. Principal Investigators and Co-investigators from the six sites are as follows: University of California at Berkeley/San Francisco (UO1 MH50461): Stephen P. Hinshaw, Ph.D., Glen R. Elliott, M.D., Ph.D.; Duke University (UO1 MH50447): C. Keith Conners, Ph.D., Karen C. Wells, Ph.D., John S. March, M.D., M.P.H.; University of California at Irvine/Los Angeles (UO1 MH50440): James M. Swanson, Ph.D.; Dennis P. Cantwell, M.D.; Timothy Wigal, Ph.D.; Long Island Jewish Medical Center/Montreal Children’s Hospital (UO1 MH50453): Lily Hechtman, M.D.; New York State Psychiatric Institute/Columbia University/Mount Sinai Medical Center (UO1 MH50454): Laurence L. Greenhill, M.D., Jeffrey H. Newcorn, M.D.; New York University School of Medicine, NYU Child Study Center: Howard B. Abikoff, Ph.D.; University of Pittsburgh (UO1 MH50467): William E. Pelham, Ph.D., Betsy Hoza, Ph.D. Helena C. Kraemer, Ph.D. (Stanford Uni- versity) is statistical and design consultant. The OSEP/DOE Principal Collaborator is Ellen Schiller, Ph.D. 2 Duke University Medical Center, Durham, North Carolina. 3 State University of New York, Buffalo, New York. 483 0091-0627/00/1200-0483$18.00/0 C 2000 Plenum Publishing Corporation
Transcript

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Journal of Abnormal Child Psychology PL119-228205 October 6, 2000 12:4 Style file version July 26, 1999

Journal of Abnormal Child Psychology, Vol. 28, No. 6, 2000, pp. 483–505

Psychosocial Treatment Strategies in the MTA Study:Rationale, Methods, and Critical Issuesin Design and Implementation1

Karen C. Wells,2,16 William E. Pelham, Jr.,3 Ronald A. Kotkin, 4 Betsy Hoza,5

Howard B. Abikoff, 6 Ann Abramowitz, 7 L. Eugene Arnold,8 Dennis P. Cantwell,9

C. Keith Conners,2 Rebecca Del Carmen,10 Glenn Elliott, 11 Laurence L. Greenhill,12

Lily Hechtman,13 Euthymia Hibbs,10 Stephen P. Hinshaw,14 Peter S. Jensen,12

John S. March,2 James M. Swanson,4 and Ellen Schiller15

Received July 7, 1999; revision received January 15, 2000; accepted February 2, 2000

The Collaborative Multimodal Treatment Study of Children with Attention Deficit HyperactivityDisorder (ADHD), the MTA, is the first multisite, cooperative agreement treatment study of children,and the largest psychiatric/psychological treatment trial ever conducted by the National Instituteof Mental Health. It examines the effectiveness of Medication vs. Psychosocial treatment vs. theircombination for treatment of ADHD and compares these experimental arms to each other and toroutine community care. In a parallel group design, 579 (male and female) ADHD children, aged7–9 years, 11 months, were randomly assigned to one of the four experimental arms, and thenreceived 14 months of prescribed treatment (or community care) with periodic reassessments. Afterdelineating the theoretical and empirical rationales for Psychosocial treatment of ADHD, we describethe MTA’s Psychosocial Treatment strategy applied to all children in two of the four experimentalarms (Psychosocial treatment alone; Combined treatment). Psychosocial treatment consisted of threemajor components: a Parent Training component, a two-part School Intervention component, and achild treatment component anchored in an intensive Summer Treatment Program. Components wereselected based on evidence of treatment efficacy and because they address comprehensive symptomtargets, settings, comorbidities, and functional domains. We delineate key conceptual and logisticalissues faced by clinical researchers in design and implementation of Psychosocial research withexamples of how these issues were addressed in the MTA study.

KEY WORDS: attention deficit /hyperactivity disorder; psychosocial treatment; parent training; school inter-vention; summer treatment program.

1The MTA is a cooperative treatment study performed by six inde-pendent research teams in collaboration with the staff of the Divi-sion of Clinical and Treatment Research of the National Institute ofMental Health (NIMH), Rockville, Maryland and the Office of Spe-cial Education Programs (OSEP) of the U.S. Department of Educa-tion (DOE). The NIMH Principal Collaborators are Peter S. Jensen,M.D., L. Eugene Arnold, M.Ed., M.D., John E. Richters, Ph.D., JoanneB. Severe, M.S., Donald Vereen, M.D., and Benedett´o Vitiello, M.D.Principal Investigators and Co-investigators from the six sites are asfollows: University of California at Berkeley/San Francisco (UO1MH50461): Stephen P. Hinshaw, Ph.D., Glen R. Elliott, M.D., Ph.D.;Duke University (UO1 MH50447): C. Keith Conners, Ph.D., Karen C.Wells, Ph.D., John S. March, M.D., M.P.H.; University of California

at Irvine/Los Angeles (UO1 MH50440): James M. Swanson, Ph.D.;Dennis P. Cantwell, M.D.; Timothy Wigal, Ph.D.; Long Island JewishMedical Center/Montreal Children’s Hospital (UO1 MH50453): LilyHechtman, M.D.; New York State Psychiatric Institute/ColumbiaUniversity/Mount Sinai Medical Center (UO1 MH50454): Laurence L.Greenhill, M.D., Jeffrey H. Newcorn, M.D.; New York UniversitySchool of Medicine, NYU Child Study Center: Howard B. Abikoff,Ph.D.; University of Pittsburgh (UO1 MH50467): William E. Pelham,Ph.D., Betsy Hoza, Ph.D. Helena C. Kraemer, Ph.D. (Stanford Uni-versity) is statistical and design consultant. The OSEP/DOE PrincipalCollaborator is Ellen Schiller, Ph.D.

2Duke University Medical Center, Durham, North Carolina.3State University of New York, Buffalo, New York.

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0091-0627/00/1200-0483$18.00/0C© 2000 Plenum Publishing Corporation

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484 Wells et al.

Attention Deficit Hyperactivity Disorder (ADHD) isone of the most common and impairing of the childhoodpsychiatric disorders. Nationwide prevalence estimates in-dicate that between 3% and 5% of all children meet diag-nostic criteria for the disorder (Szatmari, 1992) and thatyoungsters with the disorder comprise one third to one halfof all referrals to child mental health facilities (Popper,1988). In addition to its central features of inattention,hyperactivity, and impulsivity, ADHD is usually associ-ated with one or more co-morbid conditions, associatedfeatures, or functional deficits or a combination of these,which add to the impairment picture and complicate the as-sessment and treatment strategy (Barkley, 1996; Conners& Erhardt, 1998; Hinshaw, 1994). Furthermore, despitethe early prevailing view that ADHD was a time-limiteddisorder of prepuberty, prospective studies on psychiatricclinic samples have revealed ADHD to be a chronic dis-order in a substantial majority of children who have thediagnosis, with antisocial outcomes, substance abuse, andcontinued attentional, family, interpersonal, and occupa-tional difficulties persisting into adolescence and adult-hood (Klein & Manuzza, 1991; Weiss & Hechtman, 1993).

Since the 1960s, considerable research effort hasevaluated psychopharmacologic (Swanson, 1993) andpsychosocial (Hinshaw, Klein, & Abikoff, 1998) treat-ments for ADHD, and the short-term efficacy, as well asthe limitations, of these treatments are established. Never-theless, important questions remain regarding long-termeffectiveness. Furthermore, differential treatment effectsacross different subgroups of children, as well as differentsymptom and functional domains, need to be addressed(Richters et al., 1995). Because the answers to such ques-tions can only be pursued via large-scale efforts that gener-ate sufficient sample sizes for powerful tests of treatmenteffectiveness, the NIMH launched a multisite clinical trialof Multimodal Treatment of children with ADHD. Theneed for such a trial was emphasized by the Institute of

4University of California, Irvine, California.5Purdue University, Lafayette, Indiana.6New York University Medical Center, New York, New York.7Emory University School of Medicine, Atlanta, Georgia.8Ohio State University, Columbus, Ohio.9Deceased.

10National Institutes of Mental Health, Rockville, Maryland.11University of California, San Francisco, California.12New York State Psychiatric Institute, Columbia University, New York,

New York.13Montreal Children’s Hospital, Montreal, Quebec, Canada.14University of California, Berkeley, California.15U.S. Department of Education, Washington, DC.16Address all correspondence to Karen C. Wells, P.O. Box 3320, Duke

University Medical Center, Durham, North Carolina 27710; e-mail:[email protected].

Medicine (1989) and by theNational Plan for Researchon Child and Adolescent Mental Disorders(National Ad-visory Mental Health Council, 1990).

The NIMH Collaborative Multisite MultimodalTreatment Study of Children with Attention Deficit Hy-peractivity Disorder (MTA Study) (Richters et al., 1995)is a six-site cooperative agreement that has been in thefield since 1992. The background and rationale (Richterset al., 1995); the experimental design (Arnold et al., 1997a,1997b); the major questions and assessment strategies(Hinshaw et al., 1997); the medication treatment approach(Greenhill et al., 1996); and the primary, intent-to-treat,outcome (MTA Cooperative Group, 1999a), and modera-tor/mediator analyses (MTA Cooperative Group, 1999b)for the study have been previously published and will notbe recapitulated in detail here. Briefly, the MTA study’sgoal is to examine the short- and, more importantly, long-term comparative effects of 14 months of systematic, well-delivered treatment (medication alone vs. psychosocialtreatment alone vs. a combination of medication and psy-chosocial treatment) on ADHD children’s primary symp-toms, comorbid conditions, and impairment. A fourthgroup receiving community-based treatment allows fora comparison of these intensive manual-based treatmentsto treatment delivered in the community. Between 1992and 1994, 579 children, aged 7–9 years, 11 months, wererecruited at participating sites in the United States andCanada (Montreal). All children had primary diagnoses ofADHD, combined type, using DSM-IV criteria. In addi-tion, comorbid aggressive-spectrum disorders (54%), anx-iety disorders (33.5%), and affective disorders (3.8%) oc-curred in the MTA sample at the percentages indicated.Of the sample, 61% were Caucasian, 20% were AfricanAmerican, and 8% were Hispanic. Eighty percent weremale and 20% were female. Children were randomly as-signed to one of the four experimental arms. Half of thesample (289 subjects) received psychosocial treatment,which was essentially identical for the psychosocial onlyand the combined psychosocial-medication arms. This re-port summarizes the psychosocial treatment strategy forthese two arms.

THEORETICAL RATIONALE FORPSYCHOSOCIAL TREATMENT FOR ADHD

The Nature and Course of the Disorder

As noted earlier, in addition to its core symptoms ofinattention, hyperactivity, and impulsivity, ADHD is as-sociated with a number of comorbid conditions and addi-tional features, which are displayed across many settings.Primary and associated symptoms manifest in different

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dominant constellations in the home, school, and com-munity settings and provoke impairment in precisely thedomains of functioning that are essential to mastery of themajor developmental tasks of childhood (Richters et al.,1995). These comorbid conditions and associated featuresadd to the clinical complexity of ADHD and have signif-icant implications for treatment.

Chief among the complicating comorbid conditionsare Oppositional Defiant Disorder (35–60% of ADHDcases in clinical and epidemiological samples); ConductDisorder (30–50% of ADHD cases); Specific LearningDisabilities (10–26% of ADHD cases when conservativedefinitions of LD are employed); and anxiety (25–40%)(Barkley, 1996; Biederman, Faraone, & Lapey, 1992;Hinshaw, 1992; Conners & Erhardt, 1998). In addition,a number of other conditions, many having prognosticsignificance, have been identified.

Within the school domain, the vast majority ofADHD children have significant problems with schoolbehavior and performance, as noted by low rates of on-task behavior in the classroom (Abikoff, Gittelman-Klein,& Klein, 1977), academic task completion (Pfiffner &Barkley, 1990), and by low rates of positive exchangeswith teachers and higher rates of negativity (Whalen,Henker, & Dotemoto, 1980). These patterns of behaviorcontribute to high rates of academic underachievement,placement in special education services, grade retention,and school dropout (Barkley, DuPaul, & McMurray, 1990;Barkley, Fisher, Edelbrock, & Smallish, 1990; Hinshaw,1992). These negative school outcomes occur even in theabsence of a specific learning disability.

Within the family domain, the parent–child interac-tions of ADHD children and adolescents with their moth-ers and fathers are frequently disturbed and conflictual,and family life is often characterized by discord and dishar-mony. Parents of ADHD children display more negativereactivity, more commanding directive behavior, and lesspositive responsivity to ADHD children than do parentsof normal children (Anderson, Hinshaw, & Simmel, 1994;Danforth, Barkley, & Stokes, 1991; Johnston, 1996). Fam-ily life is characterized by more parenting stress and a de-creased sense of parenting self-competence (Fisher, 1990;Mash & Johnston, 1990), increased alcohol consumptionin parents (Pelham & Lang, 1993), decreased extendedfamily contacts (Cunningham, Benness, & Siegel, 1988),and increased rates of maternal depression and maritalconflict, separation, and divorce (Befera & Barkley, 1984;Barkley, Fisher, et al., 1990; Barkley, Fisher, Edelbrock,& Smallish, 1991). Although disrupted parent–child in-teraction is probably not etiologic in ADHD, it may havea primary, causal role in the development, escalation, andmaintenance of the oppositional and aggressive behavior

that is characteristic of ODD and CD (Patterson, 1982;Patterson, Reid, & Dishion, 1992). As noted earlier, ODDand CD have very high comorbidity rates in ADHD, andsome research has documented that the presence of ODDis associated with much of the parent–child interactionalconflicts in ADHD families (Barkley, Anastopoulos,Guevremont, & Fletcher, 1992; Fletcher, Fisher, Barkley,& Smallish, 1996). Nevertheless, parental intrusivenessand overstimulation in the infant–child relationship aresignificant early antecedents of later hyperactivity inkindergarten (Jacobvitz & Sroufe, 1987), and parents andchildren with ADHD alone still display interactions thatare deviant from normal (Fletcher et al., 1996; Johnston,1996). These findings suggest that intervening in parent–child interactions may be important with pure ADHD aswell as ADHD comorbid with ODD and CD.

The relationship between parent–child conflict andthe aggressive behavior displayed by many ADHD chil-dren becomes even more important considering evidencethat aggression and other signs of conduct disorder medi-ate the increased risk for later substance abuse, criminality,and antisocial spectrum disorders in adulthood (Lynskey& Fergusson, 1995; Hinshaw, 1994; Klein & Manuzza,1991). In addition, high rates of negativity in parent–childinteractions are related to dysfunction across domains andsettings. Anderson et al. (1994) demonstrated that mater-nal negativity predicted noncompliance in a classroom anda play setting, as well as laboratory stealing. Dornbuschand colleagues (Dornbusch, Ritter,Leiderman, Roberts, &Fraleigh, 1987) have shown in an epidemiological sam-ple that a harsh parenting style is negatively associatedwith grades in school, whereas a warm but structuredparenting style is positively associated with grades. Suchfindings have implications for treatment planning and as-sessment of treatment outcome and emphasize that in-creasingly complex interactional and transactional modelsare necessary for understanding etiology, escalation, andpersistence of symptoms.

ADHD children also display clear impairment inpeer relationships. ADHD children are overwhelming-ly rejected by their peers (Asarnow, 1988; Erhardt &Hinshaw, 1994; Milich & Landau, 1982; Pelham &Bender, 1982). This social rejection develops after onlybrief periods of peer exposure (Bickett & Milich, 1990;Erhardt & Hinshaw, 1994) and is very persistent onceestablished. The disturbed peer relationships do not ap-pear to be either related to nonbehavioral variables suchas physical attractiveness (Erhardt & Hinshaw, 1994) orto social skills deficits per se (Whalen & Henker, 1992).Rather it is the socially noxious, aggressive, and uncoop-erative behaviors of ADHD children that seem to provokepeer rejection. Noncompliance and aggression emerge as

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the strongest predictor of peer rejection, explaining up to46% of the variance in negative peer nominations (Erhardt& Hinshaw, 1994) for ADHD boys. Likewise, highly ag-gressive ADHD boys show markedly higher levels of peerrejection than do low-aggressive ADHD boys, who never-theless also suffer from peer rejection (Hinshaw &Melnick, 1995). Given the strong predictive power of neg-ative peer status for a variety of maladaptive outcomesin adolescence and adulthood, including conduct distur-bance, substance abuse disorders, school failure and drop-out, and delinquent offenses (Ollendick, Weist, Borden, &Green, 1992; Parker & Asher, 1987), and given that theseadolescent and adult outcomes are characteristic of ADHDchildren (Klein & Manuzza, 1991; Weiss & Hechtman,1993), the importance of successful intervention in this do-main has been strongly emphasized (Conners & Erhardt,1998; Hinshaw, 1994).

Because of the variegated symptoms associated withADHD across multiple domains and the likely complexinteraction among a host of child, family, and peer vari-ables in predicting escalation and maintenance of symp-toms in the short run as well as poor long-term outcome,leading researchers in the field increasingly emphasizethat treatment programs must be directed to a variety offunctional domains in addition to primary ADHD symp-toms (Abikoff & Hechtman, 1996; Conners & Erhardt,1998; Conners & Wells, 1986; Hinshaw, 1994; Pelham& Hinshaw, 1992). From a theoretical perspective, treat-ments that influence multiple domains and predictorsacross multiple settings will have the greatest chance of re-versing the course of this disorder. Specifically, treatmentsthat target aggression, coercive family interactions andfamily disharmony, poor peer relationships, and academicdeficits and failure, in addition to core ADHD symptoms,are of great theoretical importance. Because psychoso-cial treatments, including classroom behavioral interven-tion (Pfiffner & Barkley, 1998), behavioral parent training(McMahon & Forehand, in press), and intensive child in-tervention utilizing contingency management (Pelham &Hoza, 1996) have proven successful (McMahon & Wells,1998), multicomponent psychosocial treatments have the-oretical significance in reversing the risks and long-termoutcomes associated with ADHD, especially if combinedwith stimulant medication.

EMPIRICAL RATIONALE FORPSYCHOSOCIAL TREATMENT

A large literature attests to the short-term efficacyof behavioral intervention approaches with ADHD, as re-viewed in detail by Pelham and Murphy (1986), Pelham

and Hinshaw (1992), and Hinshaw et al. (1998). Thesestudies have fallen into two categories—direct contin-gency management, usually implemented by profession-als in specialized treatment settings, and clinical behaviortherapy, involving training parents and consulting to teach-ers to become contingency managers with their children.

Direct Contingency Management

Direct contingency management studies typicallyemploy single-subject experimental designs implementedin special schools (e.g., Pfiffner, Rosen, & O’Leary, 1985),psychiatric inpatient settings (e.g., Wells, Conners, Imber,& Delameter, 1981), or intensive summer treatment pro-grams (Hoza, Pelham, Sams, & Carlson, 1992). In thesestudies, the contingency management strategies are gen-erally more intensive than in clinical behavior therapyand are implemented directly in the specialized settingby a paraprofessional, a consulting professional or an ex-pert teacher rather than by a parent or a teacher (Pelham,Wheler, & Chronis, 1998). Because of the experimentalcontrol available in such settings, the short-term behav-ioral gains reported from these studies are often largerthan those obtained with clinical behavior therapy. Nev-ertheless, academic productivity is not always improved(Pelham et al., 1993), and treatment gains disappear whencontingencies are removed in these short-term treatmentprograms. Direct contingency management produces sig-nificant improvements over baseline, with effects roughlyequivalent to low-dose medication alone (Carlson, Pelham,Milich, & Dixon, 1992). In addition, the combination oflow-dose medication and direct contingency managementcan produce effects nearly identical to those produced withhigh-dose medication alone (Carlson et al., 1992) leadingsome clinical researchers to suggest that the addition ofPsychosocial to Medication treatment can result in low-ering the dose of medication (and thereby lowering thepotential for undesirable side effects) otherwise requiredto control symptoms at higher doses (Pelham et al., 1990;1998). Nevertheless, the addition of contingency manage-ment to medication has not produced significant incre-ments to medication-related gains (Hinshaw et al., 1998).

Clinical Behavior Therapy

Studies evaluating clinical behavior therapy have typ-ically employed between-group designs and involved par-ent training and teacher consultation as typically imple-mented by clinicians working in outpatient settings(Anastopoulos, Shelton, DuPaul, & Guevremont, 1993;

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Barkley et al., 1992; Firestone, Kelly, Goodman, & Davey,1981; Horn, Ialongo, Popvich, & Perdatto, 1987; Horn,Ialongo, Greenberg, Packard, & Smith-Winberry, 1990;Horn et al., 1991; Klein & Abikoff, 1997; Pelham et al.,1988; Pisterman et al., 1989, 1992). Although a numberof different comparison and control groups have been em-ployed, and variations in treatment parameters and dura-tion across studies exist, several conclusions can be drawnfrom this work. Clinical behavior therapy yields statisti-cally and clinically significant improvements across manydomains of outcome, in both home and school settings, onrating scales and on observed behavior. Nevertheless, theacute improvements that are obtained with clinical be-havior therapy alone are typically not as large as thoseobtained in acute studies of medication (Hinshaw et al.,1998; Pelham et al., 1998). Furthermore, normalizationof all problems typically is not achieved with clinical be-havior therapy alone, although significantly, aggressiveclassroom behavior is normalized with behavior therapyalone (Abikoff & Gittelman, 1984). Recently, Klein andAbikoff (1997) showed evidence for the superiority ofcombined behavioral and medication treatment over ei-ther treatment alone on a few measures in a reanalysis ofthe full sample of a prior study (Gittelman et al., 1980).In addition, combination treatment produced significantnormalization effects on all observational measures.

In summary, there is considerable empirical supportfor the short-term efficacy of behavioral treatment forsymptoms of ADHD. Effects achieved with behavior ther-apy are usually not as great as with relatively high dosesof stimulant medication. Evidence for the additive or syn-ergistic effects of treatment combining medication andbehavioral treatment is equivocal (Abikoff & Hechtman,1994), although a recent reanalysis of one of the largestsample studies showed some evidence for additive ef-fects on a limited number of measures (Klein & Abikoff,1997). Taken together, these findings provide some empir-ical support for the theoretical rationale for psychosocialtreatment presented earlier and speak to the importanceof a lengthier, more intensive treatment trial investigat-ing psychosocial intervention alone and as an adjunct topharmacological treatment.

LIMITATIONS OF PHARMACOLOGICALAPPROACHES

The short-term efficacy of stimulant medication forADHD is well established (Swanson, 1993), and someauthors consider stimulant drug treatment to be the treat-ment of choice for this disorder (Klein & Abikoff, 1997).Nevertheless, there are limitations to the exclusive use of

pharmacological treatment alone for ADHD (Pelham &Hinshaw, 1992; Wells, 1987). First, not all ADHD chil-dren show a positive response to stimulant medication.In group studies, 10–30% show an adverse response orno response to a single stimulant (Swanson, McBurnett,Christian, & Wigal, 1995), although the response ratetends to be higher if two or more are tried. Of those whodo respond, many do not show enough improvement fortheir behavior to fall within the normal range on eitherrating scales or behavioral observations. Secondly, stim-ulant medication does not maximally affect the full rangeof symptomatology. Although positive effects are usuallyfound on measures of attention, activity, and impulsivity(Conners & Erhardt, 1998) and to a lesser extent on con-duct problems (McMahon & Wells, 1998; Hinshaw, 1994),salutary effects are more inconsistent for such crucial di-mensions as academic achievement or poor peer relation-ships (Pelham & Hinshaw, 1992; Swanson et al., 1995;Whalen et al., 1989). Moreover, there is little evidencethat treatment with stimulant medication alters the poorlong-term course of ADHD (Weiss & Hechtman, 1993).

Another important issue regarding medication treat-ments has to do with the acceptability of such treatment forsome families. Participation in randomized clinical trialsis affected by family attitudes towards medication, bothpro and con. For example, in a two-site study (Hechtmanand Abikoff, 1995) comparing stimulant medication aloneto multimodal treatment (stimulant medication and mul-ticomponent psychosocial treatment), 21% of 1,216 par-ents who called to inquire about the study declined fur-ther assessment because they did not want medication.Subsequently, 6.7% of the parents of the 112 children,who otherwise met study entry criteria, declined to partic-ipate because they did not want medication. Similarly, ina Canadian study of Methylphenidate treatment of ADHDchildren (Schachar, Tannock, Cunningham & Corkum,1997), nine of 14 families who met diagnostic criteria forstudy entry but did not agree to participate, did not want torisk having their children assigned to the Methylphenidategroup.

In the MTA study, which randomized to medicationalone and psychosocial treatment alone, about 6% of oth-erwise eligible subjects declined study entry because theydid not want medication. (However, about 17% declinedbecause they did not want toforegomedication. Thus, ac-ceptability of medication treatment cuts both ways.) Like-wise, 9% of medication treatment subjects refused medi-cation once the treatment trial began, even though they hadaccepted random assignment to the medication treatmentcondition (MTA Cooperative Group, 1999b).

These figures should be considered lower-bound es-timates of medication unacceptability because all three

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488 Wells et al.

studies were advertised as involving possible medication;undoubtedly many families who did not wish medicationscreened themselves out by not calling. It seems reason-able to conclude that at least 20–25% of families with achild who has ADHD harbor opinions about medicationvs. psychosocial treatment firm enough to preclude anywillingness to consider one or another type of treatment.Presumably, this 25% represents one extreme of a prefer-ence/attitude spectrum, so that additional families harborpreferences and attitudes of a less rigid nature.

PSYCHOSOCIAL TREATMENT IN THE MTASTUDY: DESCRIPTION OF COMPONENTS

For all of the reasons noted here, there continues tobe a need for treatment alternatives or adjuncts to pharma-cological treatment of ADHD. Psychosocial Treatment inthe MTA Study was designed as an intensive and lengthy(14-month) intervention combining the best features of di-rect contingency management and clinical behavior ther-apy. Psychosocial Treatment consisted of three majorcomponents: a Parent Training component; a School In-tervention component; and a Summer Treatment Program,designed to provide intensive contingency managementand skills training directly to the child. These componentswere chosen because they address comprehensive settings(home, school, and community), comorbidities (e.g., Op-positional behavior, Aggressive behavior), and domainsof function (e.g., peer relationships, parent–child inter-actions, family relationships); and, because of evidencefor their efficacy in the ADHD literature (for reviews seeBarkley, 1998; Conners & Erhardt, 1998; Hinshaw et al.,1998; Pelham et al., 1998). Staff required to implementthe three treatment components included the following:(1) Therapist-Consultants (Ph.D. level), who each car-ried 12 cases, provided the Parent Training and TeacherConsultation components for each case, and supervisedthe paraprofessional aides who worked with each childin the School Intervention and Summer Treatment Pro-gram; (2) paraprofessionals (undergraduates) who servedas trained classroom aides in the School Intervention andas trained camp counselors in the Summer Treatment Pro-gram; (3) special education teachers who implemented theacademic components of the Summer Treatment Program;(4) a Parent Training supervisor (Ph.D. level), who super-vised Therapist-Consultants in all aspects of the ParentTraining program and in general case management; (5) anEducational Consultant (Ed.D or Ph.D.), who supervisedTherapist-Consultants in all aspects of the School Inter-vention, and the implementation of the academic compo-nent of the Summer Treatment Program.

The Psychosocial Treatment was developed by a Psy-chosocial Committee with expert representatives fromeach of the six study sites and NIMH. Once the overallPsychosocial strategy was approved, subcommittees of ex-perts in each of the three major treatment components (i.e.,Parent Training, School Intervention, and Summer Treat-ment Program) developed manuals for each componentwhich were then used to train and supervise interventionstaff at each site.

Treatment was carefully integrated across the threecomponents to form the overall Psychosocial Treatmentstrategy. In addition, as will become evident in the fol-lowing section, there were many similarities of specifictreatment procedures across the three components. Forexample, point systems were used in the School Interven-tion, in the home token economy taught in Parent Trainingand in the Summer Treatment Program. Likewise, par-ents and teachers learned the behavioral skills involvedin giving clear instructions and establishing age appropri-ate rules, using positive attention and praise in the homeand classroom, using time-out at home and at school, andusing response-cost procedures. All of these skills andtechniques also were used by the trained paraprofession-als who implemented the Summer Treatment Program.The following is a brief description of the three majorcomponents of Psychosocial Treatment.

Parent Training

Parent Training was delivered by Ph.D. level psy-chologists or other comparable professionals, who werereferred to as Therapist-Consultants. Each full-timeTherapist-Consultant treated 12 cases divided betweentwo, six-family, parent groups in each annualcohort.Of the12 cases carried annually by each Therapist-Consultant,six were Psychosocial Treatment alone cases, and six wereCombined Treatment cases. (Therapist-Consultants alsoprovided the School Consultation, described later, for eachof their 12 cases and supervised the paraprofessionals forthe same 12 cases.) Parent Training began immediately af-ter randomization and began with group sessions (lasting1.5–2 hr) three times per month, and individual sessionsonce a month. Group sessions were gradually tapered tomonthly meetings over the course of the 14-month treat-ment period for a total of 27 group sessions. Each fam-ily also received eight 1-hr individual sessions over the14-month intervention period. Individual sessions oc-curred in weeks when there was not a scheduled groupsession. If available, both parents were invited to attendall sessions. “Parent” was defined as primary caretaker,whether actual parent or not.

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In each Parent Training group, three of the six fami-lies were in the Psychosocial Treatment alone experimen-tal condition and the other three were in the CombinationTreatment condition. This was done to insure that the Par-ent Training delivered in the two experimental conditionswas identical. Although necessary to achieve experimen-tal control, one disadvantage of this approach was that ineach Parent Training group, some parents’ children werereceiving medication and some were not. A decision wasmade to minimize references to medication by stoppingdiscussion of these issues in the Parent Training groups,and referring parents’ medication-related comments andquestions to their individual Parent Training sessions andto their next medication visit.

Group Sessions

The Parent Training program was based on a sociallearning theory approach and was modeled on ParentTraining programs proven effective in previous research(Barkley, 1997; McMahon & Forehand, in press). Al-though those programs typically focus solely on teaching

Table I. Group Parent Training Sessions

Intensive treatment phase

Session 1 Structured clinical interview, review of ADHD and introduction to treatmentSession 2 Setting up school/home daily report cardSession 3 Overview of social learning and behavior management principles and review of DRCSession 4 Attending and “special playtime”Session 5 Rewarding and ignoring skills in “special playtime” and “catch your child being good”Session 6 Using positive skills and Premack principle to increase targets: catch child being good and independent playSession 7 Giving effective commands to children, establishing behavior rules, and attending and rewarding compliance to instructionsSession 8 Time-out procedureSession 9 Home token economy 1Session 10 Home token economy 2Session 11 Response costSession 12 Planned activities training and setting generalizationSession 13 Stress, anger, and mood management 1Session 14 Stress, anger, and mood management 2Session 15 Peer programming in home and schoolSession 16 Preparing for the new school yearSession 17 Parent skills for academic/school support at home compliance

Generalization and integration phase

Session 18 Review of attending, rewarding, ignoring skills; review of “special time”Session 19 Review of commands, house rules, and time-outSession 20 Review of home token economy and response costSession 21 Review of academic support /homework programs at homeSession 22 Planning for the second summerSession 23 Review of the first scripted parent–teacher meetingSession 24 Review of the second scripted parent–teacher meetingSession 25 Review of the third scripted parent–teacher meetingSession 26 A final review of the scripted parent–teacher meetingsSession 27 Preparing parents to coordinate work with the schools and problem-solving school issues

parents behavior management techniques and run from8 to 12 sessions over 3 or 4 months, in the MTA study,27 group sessions (and 8 individual sessions) were pro-vided over 14 months. Modules were included on topicsnot typically found in other standard Parent Training pro-grams. Thus, in addition to standard behavior managementskills, parents were also taught (1) techniques for stress,anger, and mood management, which could be applied indisciplinary encounters with their children as well as inother arenas of life; (2) strategies for assisting their chil-dren with friendships and peer interactions that built onareas addressed directly with the child in the STP; and(3) skills for interacting with the school at multiple levels.These specialized Parent Training sessions were carefullycoordinated with the interventions occurring in the othertwo components (School Intervention and Summer Treat-ment Program).

An outline of the Consecutive Group Parent Trainingsessions is given in Table I. The first 17 sessions consti-tuted the intensive treatment phase in which new skillswere introduced in each session. Basic behavior man-agement skills began with teaching parents how to setup a school/home Daily Report Card in concert with the

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child’s teacher. This was done first in order to facilitatethe beginning of the School Intervention (see later sec-tion). Thereafter, parents were taught standard behaviormanagement skills of attending to, rewarding, and posi-tively reinforcing prosocial child behaviors; giving effec-tive commands and rules; and using time-out and responsecost as consequences for negative child behaviors. Parentsalso learned to implement a home token economy system,skills for fostering peer relationships, and skills for sup-porting academic homework performance and transition toa new school year. In addition, two sessions were devotedto stress, anger, and mood management for parents espe-cially in the context of disciplinary encounters with theirchild. Sessions 18–21 represented the generalization andintegration phase; previously learned skills were reviewedwith emphases on integration of the whole program intoa comprehensive behavior management plan for the childand family, and maintenance of treatment programs overtime. Sessions 22–27 heavily emphasized teaching andmodeling for parents, skills involved in the parents takingover the advocacy and consulting role for their child in theschool, and in summer planning for their child. In ParentTraining sessions, role-playing was used to help prepareparents to conduct a meeting with school personnel re-garding setting up a Daily Report Card and behavior man-agement plan for their child. Therapist-Consultants andparents then participated together in an actual school meet-ing. Later, parents met with the teacher independently, andthe results of the meeting were reviewed in the next ParentTraining Group session.

Each session began with a review of the previousweeks’ homework assignments. Then the Therapist-Consultant introduced the new content using didactic pre-sentation, modeling, role-playing, and group discussion.Homework pertaining to the newly introduced skills wasassigned, and the session ended with group planningaround implementation of the new homework assignment.

Individual Sessions

Eight individual sessions were scheduled duringweeks with no group sessions. Thus, in the beginning therewere three group sessions and one individual session foreach family per month. As with the group sessions, indi-vidual sessions were gradually tapered over time.

The purpose of the individual sessions was to re-view and support the parent training skills taught in groupsessions, to fine-tune skills with each family, and to prob-lem solve obstacles to compliance with the homeworkand overall program. To allow for more individualizationand clinical flexibility, individual sessions were scripted

for process, rather than for content of the sessions. Theprocess for each individual session involved greeting thefamily and orienting them to the session; if the child waspresent, doing a brief (5-min) observation of parent–childinteraction to check on relevant skills taught in group ses-sions; reviewing with the parents the skills taught in the lastfour group sessions and how the practice and use of thoseskills were going at home; problem-solving with parentsimpediments to use of good parenting skills; and reviewingfamily’s own agendas. Solutions to problems with imple-menting skills were designed to address the nature of theproblem. For example, parents who were not implement-ing skills due to faulty understanding were given a clearer,individualized presentation of the skill. Parents who werenot implementing skills due to a high life-stress level,were helped with stress management. The manual pro-vided general instructions to Therapist-Consultants abouthow to assess the nature of the problem, if any, and how tochoose the correct level of problem solution. For four ofthe eight individual sessions, the child as well as the parentattended, so that the Therapist-Consultant could interviewthe child to assess his view of progress.

Telephone Sessions

Weekly 15-min phone sessions were held betweenthe Therapist-Consultant and the parent during treatment.The purpose of the phone sessions was to prompt and sup-port implementation of homework and to provide generalsupport.

School Intervention

The School Intervention had two main components—Teacher Consultation throughout the school year and theIrvine Paraprofessional Program in the fall of the secondschool year. School Intervention was designed to work inconcert with two supporting components: Parent Trainingin communicating with school personnel and the Sum-mer Treatment Program. The components were integratedby continuity of staff. Under the supervision of an Edu-cational Consultant, the same Therapist-Consultants whoprovided Parent Training also provided Teacher Consul-tation and supervised the school paraprofessional aides,who had doubled as counselors during the Summer Treat-ment Program. In general, the Therapist-Consultant andthe teacher devised the specific components and proce-dures for the School Intervention for each child, and theparaprofessionals implemented the procedures and servedas classroom aides for the teacher. The Parent Training and

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Summer Treatment Program supporting components ofthe School Intervention are described in the correspondingsections of this paper. The Teacher Consultation and Para-professional Program components are described below.

Teacher Consultation

Over the 14 months of treatment, Therapist-Consultants met with teachers about 16 times: biweeklyin the spring of the first year (at the start of treatment)and 10 times in the fall and winter of the second schoolyear. Initially, and again at the beginning of the secondschool year, the first goal was to establish a Daily ReportCard that would be coupled with a home-based reward sys-tem implemented by parents as part of the Parent Trainingprogram. Once the Daily Report Card was established, theTherapist-Consultant provided consultation to the teacherregarding basic behavioral principles and classroom in-terventions as appropriate. During a preliminary teacherskills assessment, the teacher helped choose the prioritiesfor consultation. The goal was that, by the end of consulta-tion, the teacher would have skills in the following areas:classroom rules and enforcement procedures, contingentattention and ignoring, clear commands and soft repri-mands, individualizing instructional materials, modifyingclass structure, school-based reinforcement, classroom to-ken economies, Premack principle, group-based contin-gencies, response cost, and time-out. The positive inter-ventions were emphasized and generally presented first,but in response to an emergent situation, the Therapist-Consultant could flexibly jump ahead to the “Stage II”interventions of response cost or time-out or both. To-ward the end of treatment, Therapist-Consultants helpedthe teachers to develop a program that the teacher couldmaintain without further intervention of the therapist.

Over the summer between the two school years oftreatment, the children attended the Summer TreatmentProgram (described hereafter) and the Therapist-Consul-tants consulted with Summer Treatment Program teachersand supervised the paraprofessionals (who were function-ing as counselors during the Summer Treatment Program),in both classroom interventions and activity groups. At theend of the summer, the Therapist-Consultant worked withparents, as described in the Parent Training component, todevelop strategies for implementing the Daily Report Cardin the child’s new classroom and to establish a cooperativerelationship with the new teacher.

Paraprofessional Program

The University of California-Irvine ParaprofessionalProgram is an educational intervention based on behav-

ior modification techniques (Kotkin, 1995, in press). Itis a modification of a program developed by Swansonand Simpson at the UC Irvine Child Development Centerfor implementation in the general education classroom,and has been in operation for over 16 years (Swanson,1992). The Irvine Paraprofessional Program was selectedas a promising practice in a competition conducted by theFederal Resource Center of the University of Kentucky,sponsored by the United States Department of Education’sOffice of Special Education Programs (Burcham, Carlson,& Milich, 1993). It is designed to address classroom prob-lems such as staying on task, interacting with others, com-pleting work, and shifting activities. Techniques of behav-ior modification (frequent prompting and reinforcement)are used to decrease the frequency of the problem behav-iors and increase the frequency of appropriate classroombehaviors.

The Paraprofessional Program was implemented inthe fall of the second school year. However, prior to actualimplementation of the Paraprofessional Program, para-professionals received training and supervision in threepreparatory phases. First, during spring of the child’s firstschool year, paraprofessionals received extensive trainingin the necessary skills to assess and implement the be-havioral intervention. Second, the paraprofessionals tookpart in supervised field experience in the subjects’ class-rooms, during which they observed children, practicedcollecting data regarding interactions and target behaviors,and worked as classroom aides. Third, during the Sum-mer Treatment Program, the paraprofessionals worked ascamp counselors and teachers’ aides with the children inthe study. All paraprofessionals worked part of the time inthe Summer Treatment Program classrooms in order to re-ceive more supervised experience in the implementationof behavioral management techniques in an educationalsetting.

Once the three training phases were completed, theparaprofessionals implemented the procedures outlinedbelow for a period of 12 weeks in the fall of the chil-dren’s second school year. Each paraprofessional was as-signed two children, and thus spent the morning in onechild’s classroom and the afternoon in the other’s class-room. The paraprofessionals provided direct interventionfor the target child, and served as an instructional aide tothe teacher for all children in the classroom. The para-professionals also kept data on target children’s progress,implemented the changes to the child’s Daily Report Cardthat were decided by the teacher and Therapist-Consultantas needed, and attended weekly supervision meetings withthe Therapist-Consultants and Educational Consultant.

Two major behavior modification interventions wereused as part of the Paraprofessional Program. The first

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system was the Paraprofessional Program Daily ReportCard. A list of 10 behaviors was developed: (1) gettingstarted, (2) interactions with others, (3) following rulesabout being quiet, (4) following rules about remainingseated, (5) attending to assigned work, (6) performingwork, (7) stopping and preparing for the next period,(8) following directions, (9) following classroom rules,and (10) individualized category. A set of target behaviors(typically 4–6) was generated for each child from this listby the Therapist-Consultant and teacher during a teacherconsultation visit. The program was initiated by prompt-ing and praising appropriate behaviors during prescribedtime intervals. At the end of specified time intervals (in-dividualized for each child by the Therapist-Consultantand the teacher), the paraprofessional awarded a tokento the child if the child met Daily Report Card criteriaduring that interval. The time interval was gradually in-creased over the course of treatment to shape appropriatebehavior and to prepare for teacher maintenance of theprogram. The second system was a merit badge systemin which target behaviors related to social skills (e.g., co-operation, communication) were reinforced by awardingmerit badge points. Parents provided graded home-basedrewards for Daily Report Card scores of 70, 80, and 90%,and for merit badge points.

Over the course of the Paraprofessional Program,shaping and fading were used. Initially paraprofession-als implemented Daily Report Cards. Then, they shiftedto helping teachers gradually take over the Daily Re-port Card. Therapist-Consultants worked with teachersand parents to develop a transition program in which theteacher and parents would have sole responsibility formaintaining the Daily Report Card. The goal was simul-taneously to train the target child to delay reinforcementand to develop a modification of the Daily Report Cardthat the teacher could use to continue an effective behav-ioral intervention without the help of the paraprofessional.In addition, Therapist-Consultants encouraged teachers tocollaborate with parents on home and classroom manage-ment strategies that would maintain the school treatment,and when possible, enlisted teachers to assist in trainingthe parents to collaborate with teachers.

Child-Based Treatment: SummerTreatment Program

The Summer Treatment Program (Pelham et al.,1996; Pelham & Hoza, 1996) is a well-known extensivelymanualized child-focused treatment program that inte-grates several empirically supported treatment compo-nents for ADHD. It was named in 1993 as a Model Pro-

gram in Service Delivery in Child and Family MentalHealth by the Section on Clinical Child Psychology andthe Division of Child, Youth, and Family Services of theAmerican Psychological Association. Despite its inten-sive treatment focus, it is structured to be an enjoyableexperience from the child’s perspective, much like a sum-mer camp.

The Summer Treatment Program in the MTA studywas an 8-week program that met daily on weekdays from8:00 am until 5:00 pm. Children were placed in age-matched groups of 12, and treatments were implementedby teams of two classroom staff and five paraprofessionalcounselors for each group. Groups stayed together forall activities so that children received intensive experi-ence in functioning as a group. Each group spent 3 hrdaily in classroom sessions and the remainder of each dayin recreationally based therapeutic group activities. TheSummer Treatment Program used a combination of inter-ventions aimed at improving children’s peer relationships,interactions with adults, academic performance, and self-efficacy. Each component is described as follows.

Point System

Children in the Summer Treatment Program earnedpoints for appropriate behavior and lost points for inappro-priate behavior as they engaged in activities throughout theday. Counselors gave children verbal feedback regardingtheir behavior as it occurred by announcing a point awardor loss. The behaviors included in the Summer TreatmentProgram point system were those commonly targeted forimprovement (e.g., helping peers, complying with adultinstructions) and reduction (e.g., teasing, noncompliance)in children with ADHD. The points that children earnedwere exchanged for privileges (e.g., weekly field trips),social honors (e.g., High Point Kid status), and home-based daily and weekly rewards. Point totals were usedto track response to treatment and systematic reliabilityand fidelity checks were made to ensure that counselorsadministered and recorded points reliably.

Positive Reinforcement and Appropriate Commands

In addition to the point system described in the pre-vious section, social reinforcement in the form of praiseand public recognition was ubiquitously employed to pro-vide a positive, supportive atmosphere for the children.Staff members also shaped appropriate behavior by issu-ing explicit commands with characteristics (e.g., brevity,specificity) that minimize noncompliance (Forehand &McMahon, 1981; Walker & Walker, 1991).

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Time Out

Children were disciplined for certain prohibited be-haviors (intentional aggression, intentional destruction ofproperty, and repeated noncompliance), with time-outfrom ongoing activities. The time-out program employedin the Summer Treatment Program involved having a childsit near the activity in which his or her group was engagedfor a period ranging from 5 to 60 min, depending on the ageof the child and the degree of the child’s compliance withthe time-out procedure. This time-out procedure differedfrom others in current use (cf. Barkley, 1990; Patterson,1975) in that the initial time assigned was relatively long(e.g., 20 min), but a child could earn a 50% time reductionfor serving the time-out immediately without complaint.This motivates children to comply with time-out and oftenprevents an escalation of negative behavior.

Peer Interventions

The Summer Treatment Program provided daily so-cial skills training via modeling, coaching, role-playing,and practice, with feedback and reinforcement given to fa-cilitate learning. The skills trained were selected from thewell-known social skills training programs of Michelson,Sugai, Wood, and Kazdin (1983) and Oden and Asher(1977).

Social skills training was included in the SummerTreatment Program even though evidence for its effective-ness is less consistent than for other behavioral strategies,especially for children who display behavioral excessesconcurrent with peer problems. As noted by Asher (1985,p. 162) “close inspection of even the successful studiessuggests that as many as 40% to 50% of the children maybe unaffected by [social] skill training.” The limited stud-ies of rejected and hyperactive children who display bothsocial skill performance deficits and behavioral excessesindicated that behavioral contingency management mustbe added to social skills training to produce improvements(Bierman, Miller, & Stabb, 1987; Pelham & Bender, 1982;see Landau & Moore, 1991, for a review). Others have ar-gued that behavioral contingency management, combinedwith stimulant medication and academic interventions,optimizes improvements (Krehbiel & Milich, 1986). Inthe Summer Treatment Program, all of these interventionswere implemented simultaneously with the exception thatonly children in the combined arm received medication.

Even when it produces improvements, social skillstraining typically does not normalize the peer relationsof ADHD children (Krehbiel & Milich, 1986, Pelham& Milich, 1984), perhaps due to the salience of reputa-

tion effects in children’s peer groups (Hymel, Wagner,& Butler, 1990; Price & Dodge, 1989). Price and Dodge(1989, p. 349) have argued, therefore, that effective in-terventions must provide ample opportunity for a child’speer group to observe him/her “performing highly salientreputation disconfirming behaviors (e.g., prosocial behav-iors).” This may be accomplished via structured coopera-tive tasks that require ongoing interaction between a childand his peers. Preliminary evidence (Bierman & Furman,1984) has suggested that combining social skills trainingwith other approaches such as cooperative tasks addressesthis goal. Therefore, in the MTA study, the Summer Treat-ment Program peer intervention package included dailysessions in which children worked cooperatively in smallgroups to achieve a superordinate goal.

Furthermore, the lack of normalization of peer rela-tionships in children with ADHD implicates the need fornovel interventions that focus ondyadic relations(Bukowski & Hoza, 1989). The development of one ortwo meaningful, positive dyadic relationships may com-pensate for poor peer group relations (Furman & Robbins,1985). Hence, in the Summer Treatment Program, eachchild was paired with a buddy with whom his or her goalwas to form a close friendship. Children and their buddiesengaged in a variety of activities both on site and outsideof the STP and met regularly with adult “buddy coaches”who assisted them in working out relationship problems.In addition, a child could give some of his own earnedpoints to his buddy, thus enabling the buddy to attend theweekly outing in the event that the buddy’s own earnedpoints were insufficient to attend.

Finally, children also learned group problem-solvingskills in the Summer Treatment Program. Group problem-solving discussions were called by counselors or by chil-dren whenever the need arose and lasted until a resolutionwas reached and a contract signed. The problem-solvingapproach employed was initially developed by Spivak andcolleagues (Spivak, Platt, & Shure, 1976) and has been ap-plied in other camp-like settings (Rickard & Dinoff, 1965).

Sports Skills Training

Children with ADHD typically do not know and fol-low the rules of games, and they have poor motor skills(Pelham et al., 1990). Poor abilities in these domainscontribute to their social rejection and low self-esteem(Pelham & Bender, 1982). In light of the emphasis thatchildren, especially boys, place on sports competence, oneperiod each day in the Summer Treatment Program wasdevoted to small-group sports skills training, and two pe-riods were devoted to playing age-appropriate sports and

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games. Techniques that have been developed to optimizeskill training for young children were employed. Researchshows that children whose coaches employ these posi-tive, effective methods of teaching have greater increasesin self-esteem through sports engagement than childrenwhose coaches do not (Smoll, Smith, Barnett, & Everett,1993).

Daily Report Cards

Daily Report Cards are among the most ubiquitousinterventions that have been employed with ADHD chil-dren (Pelham & Hinshaw, 1992), and numerous stud-ies have documented their effectiveness (e.g., O’Leary,Pelham, Rosenbaum, & Price, 1976). In the STP, individ-ualized target behaviors were derived for both academicand recreational group settings. Parents provided daily andweekly home-based rewards to reinforce their children forreaching report card goals. In addition, as a complementto the Summer Treatment Program-based Daily ReportCards, parents in the MTA devised home-based Daily Re-port Cards to target home problems and children receivedbonus points in the Summer Treatment Program for meet-ing home criteria. This strategy was called the Reverse-Daily Report Card.

Classrooms

To address problematic classroom behavior and per-formance, children in the Summer Treatment Programspent 1 hr daily in each of three classrooms conducted byspecial education teachers and aides. The first one hourwas spent in a classroom modeled after an academic spe-cial education classroom; the second hour in a computer-assisted-instructional classroom; and a third hour wasspent in an art class.

Behavior in the academic classroom was managedusing a response-cost system whereby each student be-gan the hour with a fixed sum of points, and children lostpoints when they broke classroom rules. Children alsoearned points for assignment completion and accuracy.Classroom staff used a slightly modified version of theSTP time-out program. The contents of the academic seat-work assignments were individualized according to eachchild’s academic needs.

In the computer classroom, children worked on a va-riety of academic skills using desktop computers and com-mercially available software. Instructional programs werefitted to each child’s needs, and typically included read-ing, arithmetic, and written language. In addition to theclassroom reward/response-cost system described in the

previous paragraph, children who completed all of theirtasks in the computer-assisted classroom were rewardedwith time to play educational or entertaining computergames.

A third hour was spent each day in art class, wherechildren worked on a variety of projects (e.g., painting,sculpting, and drawing). Given that many ADHD chil-dren have their greatest school behavior difficulties in less-structured classes such as art, music, library, and physi-cal education, the Summer Treatment Program art classafforded an opportunity to work on children’s problemsduring less-structured time periods.

Individualized Programs

If the standard interventions provided by the STP didnot produce the desired behavior change for a child, a func-tional analysis of the problematic behavior was conductedand an individualized program developed. Individualizedprograms involved modifications to existing componentsof the Summer Treatment Program, or the addition of newcomponents.

Process Issues in Psychosocial Treatment

Although the previous section describes the contentof the technical treatment components, there was alsomuch attention paid to various process issues in the clini-cal implementation of these components. Implementationof an experimental protocol with real patients and theirfamilies, teachers and schools requires attention to all theaspects of relationship and clinical nuance that are re-quired in any effective clinical work. Without attention toclinical processes, it would be impossible to elicit the co-operation of parents, and especially teachers, and schoolswhose participation in the treatment is entirely voluntary.

Therapist-Consultants paid great attention to estab-lishing a collaborative working relationship with parentsand teachers. They did not present themselves as the ex-perts who were there to tell parents and teachers what todo. Rather parents and teachers were approached with theattitude that they were the experts on their children, andthat we had some special knowledge about treatments thatwork for ADHD. By joining forces we could work togetherto help the ADHD child, which was everyone’s commongoal. Therapist-Consultants also paid great attention todiffusing any blame-oriented messages that might other-wise come through in parent and teacher training. ADHDwas presented to parents and teachers using a chronic dis-ease metaphor: an illness that is nobody’s fault, but thatparents and teachers are instrumental in treating.

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Parents in the MTA study displayed a wide rangeof baseline parenting skill. Likewise, teachers across thestudy displayed a widely varying level of baseline be-havior management skill and control of their classrooms.In the Parent Training program, parents were treated ingroups and were, therefore, exposed to the same presen-tation of basic material. However, Therapist-Consultantswere sensitive to acknowledging the preexisting skills ofsome parents who were often invited to give examples ingroup meetings of how they implemented certain skills.Other less-knowledgeable parents were given much praiseand support for trying new skills. In many groups, thesupport and encouragement of other parents in the groupseemed to be a critical aspect of treatment motivation,especially for these less-knowledgeable parents.

The attitude with which teachers were approachedwas even more crucial. Because Therapist-Consultantswere in the classroom at the pleasure of the teacher, it wasimportant to join with the teacher around a common goal ofhelping the child, and also, making the teacher’s life easier.Therapist-Consultants often presented classroom behav-ior management strategies to the teacher as a “review”so as not to assume that the teacher was not knowledge-able about these strategies. The Therapist-Consultant em-pathized with teachers about the difficulties inherent in theteaching profession and offered the treatment protocols inthe context of help and assistance to often overburdenedand stressed teachers. When teachers complained aboutthe extra burden of implementing treatment protocols foronly one child, Therapist-Consultants tried to help theteacher see that by implementing the protocol, the ADHDchild would, over time, improve in his classroom symp-toms and become less of a burden for the teacher. Likewise,by implementing classroom-wide behavior managementstrategies she could, over time, reduce the overall level ofdisruption in the classroom, thereby improving the levelof general control in the classroom and the level of dailystress that she experienced.

Despite the best efforts of the Therapist-Consultantsto establish collaborative working relationships with par-ents and teachers, there were, as in all clinical work, casesin which parents and teachers were not highly motivatedor compliant with the treatment procedures. For exam-ple, in the Psychosocial alone and Combined treatmentgroups, only 63 and 61% of cases, respectively, attendedat least 75% of the Psychosocial treatment (MTA Co-operative Group, 1999b). In addition, there were somechildren, usually the most highly aggressive, who werevery difficult and unpleasant to treat. For example, at onesite, a paraprofessional was injured when a very aggres-sive child threw a book at her as she was implementing aclassroom time-out with the teacher and assistant princi-

pal. These cases were discouraging for the treatment staff,and it became important over time to address staff frustra-tion and negative feelings toward some families in weeklysupervision sessions. Group supervision was the best for-mat because it allowed all Therapist-Consultants at a siteto share frustrations associated with their most difficultcases, to brainstorm as a group about how to approachthese families, and to gain support from one another andthe supervisors.

PSYCHOSOCIAL TREATMENT IN THEMTA STUDY: KEY ISSUES IN DESIGNAND IMPLEMENTATION

In addition to the fundamental criterion that eachcomponent of Psychosocial Treatment must have priorevidence of treatment efficacy, the Psychosocial Commit-tee of the MTA study attempted to identify key conceptualand logistical issues, and develop treatment principles forPsychosocial Treatment to address limitations of previ-ous research and to guide the overall plan for treatmentdesign. After much debate and discussion, the followingkey issues were identified: (1) Maximize treatment effec-tiveness; (2) Promote generalization; (3) Integrate Psy-chosocial treatment components; (4) Adapt treatments tothe real clinical world; (5) Balance adherence to manu-alized treatment protocols with individualized treatment;(6) Use treatment algorithms to standardize clinical de-cision making; (7) Integrate Psychosocial treatment withPsychopharmacologic treatment for the combined treat-ment arm; and (8) Assure treatment fidelity. Because thesekey issues have general relevance to the design of psy-chosocial treatments in clinical trials, they are identifiedin the following sections, along with illustrations of spe-cific solutions in each key area developed for the MTAstudy.

Maximize Treatment Effectiveness

As reviewed earlier, clinical behavior therapy pro-duces significant, but moderate effect sizes smaller thanthose obtained with medication alone. Contingency man-agement procedures, although less exportable, producelarger effect sizes than clinical behavior therapy does.This suggests that, just as effects of medication can beenhanced by increasing the dosage, the effects of behav-ioral treatment can be maximized by increasing the power,intensity, and range of the treatment. Therefore, Psycho-social treatment in the MTA study was designed to com-bine the best features of power and control obtained in

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studies of direct contingency management within a moretraditional clinical context.

One way this was accomplished was through the useof the intensive Summer Treatment Program (8 weeksof treatment delivered by trained, paraprofessional coun-selors, 10 hr/day) with its rapid, simultaneous introductionof multiple behavioral interventions early in each child’s14-month treatment period. This intensive, multiimpacttreatment specifically was designed to produce maximumbehavioral change upon which later clinical change effortscould be built, and to reinforce parents and children earlyon for positive change efforts.

Over the 14-month intervention period, treatmentwas implemented in a variety of settings (home, school,and peer group) by trained (e.g., paraprofessional) and“nonexpert” (parents and teachers) persons. In order tomaximize the range and impact of treatment, the threecomponents (School Intervention, Parent Training, andSummer Treatment Program) were designed specificallyto address a full range of primary symptoms as well as co-morbidities, and functional deficits in the children. Eachchild and family was exposed to this standard, manual-ized treatment protocol. In addition, each child’s individ-ual primary and comorbid symptoms were assessed bythe Therapist-Consultant in collaboration with the parentand the teacher. These were then addressed in the contextof the standard treatment technologies. For example, ifa child had comorbid Oppositional Defiant Disorder, thesymptoms associated with this disorder (e.g., verbal de-fiance, noncompliance to rules and adult-issued instruc-tions, argumentativeness) were targeted for intervention inthe school–home Daily Report Card, on the home tokeneconomy and on the child’s point system in the SummerTreatment Program. Likewise, children with comorbidConduct Disorder had the specific behavioral symptomsassociated with this diagnosis targeted in the behavioralprograms (e.g., physical aggression, stealing). Occasion-ally, specific comorbid symptoms became the target ofintensive treatment efforts on the part of the clinical team.For example, one child who was very physically aggres-sive in school, required a great deal of teacher, Therapist-Consultant, and weekly team planning time devoted todeveloping and refining a concerted behavioral programin school for aggression. Several people were involved inimplementing the behavioral plan (the teacher, the para-professional, and the parent). However, the techniques uti-lized were the standard techniques available in the protocol(Time-out in the classroom backed up by extended time-out in the principal’s office; parent praise, Daily ReportCard, and token economy points for increasing intervals ofnon-aggression in class.) Likewise, children with comor-bid anxiety disorders had symptoms of anxiety targeted in

behavioral programs (e.g., parent praise and points earnedon Daily Report Card and token economy for school atten-dance in school-avoidant children). Where mandated byclinical ethics, children displaying serious symptoms ofcomorbid disorders (e.g., severe Obsessive–CompulsiveDisorder or Depression) not treatable by techniques avail-able in the protocol, were referred outside the study forclinically indicated treatment. All such decisions weremade by a national panel of representatives from each ofthe six sites and NIMH that met in weekly teleconferencedesigned to review and make standard decisions across allthree treatment arms on these cases.

Promote Generalization

Three forms of generalization, across settings, acrosssymptom domains, and across time (maintenance of treat-ment effects), are critical to the clinical effectiveness ofany treatment program. In spite of the fact that the impor-tance of specifically studying and programming for gener-alization with the disruptive behavior disorders was high-lighted over 20 years ago (Stokes & Baer, 1977), virtuallyno studies have examined long-term maintenance of be-havioral treatments for ADHD. Studies employing single-subject designs often show that acute effects of treatmentdissipate as soon as contingencies are withdrawn. Regard-ing setting generalization (e.g., across classrooms, fromhome to school or from school to home), the limited num-ber of studies that have examined this question show littleevidence for “spontaneous” generalization from treated tountreated settings. In the absence of evidence to the con-trary, the general operating assumption among Psychoso-cial researchers has been that improvements derived fromtreatments applied in one setting only, will be specificto that setting and will not be maintained once the treat-ment has been withdrawn (Barkley, 1998; Pelham et al.,1998). Therefore, generalization must be specifically pro-grammed.

In the Psychosocial Treatment of the MTA study,many specific strategies and techniques were employedto promote generalization. As already noted, treatmentwas directly applied in many settings by parents, teachers,and paraprofessional personnel, who were all specificallytrained regarding how to implement treatment in thosesettings. Moreover, parents specifically were trained andshaped to be their own “school consultants” during thecourse of the Parent Training program, learning how toset up and conduct a meeting with the school, how to setup a Daily Report Card program with the teacher, monitorand revise the Daily Report Card over time as necessary,and generally function as school advocates for their child.

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Multiple behaviors, symptoms, and functional do-mains also were targeted in each setting to address themany relevant behavioral excesses and deficits of ADHD(impulsive, inattentive behavior; oppositional and aggres-sive behavior; social skills; peer interactions; parent–childinteractions; sports-skills deficits; academic deficits;homework problems). In addition, treatments were specif-ically coordinated across settings. For example, in theSummer Treatment Program, children received Daily Re-port Cards similar to those set up for them in the previ-ous and subsequent school years. The Daily Report Cardswere sent home daily to the parents describing the kindof day the child had at camp and in the school. Parentsprovided back-up reinforcers at home, thus linking thehome with the school and the summer camp. Also, in aReverse-Daily Report Card strategy, parents monitoredsimilar target behaviors at home during the evening hoursin the summer, and sent the Reverse-Daily Report card tocamp every morning where the camp staff provided back-up reinforcers. Thus, Summer Treatment Program staffand parents were involved in a coordinated effort to mon-itor and reinforce similar target behaviors across settings.Likewise, in the Summer Treatment Program, each childwas paired with a buddy specifically to promote dyadicfriendships. Buddy pairs spent time together in the Sum-mer Treatment Program, and parents of the buddy pairswere encouraged to arrange play dates for the buddies out-side of the program. This was done specifically to promotegeneralization of treatment effects around social skills andfriendship skills in the Summer Treatment Program, to thenatural environment of home and neighborhood.

Regarding maintenance programming, the ParentTraining Program was structured such that the first 17 ses-sions introduced new skills in each session and the nextfour sessions reviewed and integrated all skills into a com-prehensive, coherent treatment package. The concept ofADHD as a “chronic condition” was emphasized to par-ents and teachers throughout treatment. The importance ofcontinuing to implement treatment strategies once the for-mal therapy ended was accentuated. In the third phase oftreatment, parents were asked to anticipate future homeand peer problems and to rehearse plans for how theymight be addressed. Parent Training sessions specificallyaddressed the concept that parents would need to be schooladvocates and “teacher consultants” for their children overthe course of many years, and parents specifically role-played and rehearsed in treatment sessions, how to dealwith various school-related scenarios that might arise inthe future. In addition, parents were taught to monitor theschool program and to continue the Daily Report Cardin subsequent school years. Parent Training sessions oc-curred weekly at first and were faded over time to once

a month so that parents could gradually adjust to moreindependence in problem solving.

In the School Intervention, direct intervention wasprovided in the natural school environment. Within theschool, intervention was provided across a variety of set-tings (classroom, lunchroom, and recess). The teacher wasinvolved in decision-making processes to assure that thebehaviors selected for intervention were socially valid(i.e., important to the teacher and, therefore, likely tobe reinforced by the teacher once the paraprofessionalwas withdrawn). Once target behaviors were selected, thetrained paraprofessionals’ use of appropriate behavioralinterventions in the classroom served as a model for teach-ers to use effective strategies.

To promote setting generalization from the SummerTreatment Program to the classroom, the teacher and para-professional specifically targeted relevant social skillstaught in the Summer Treatment Program through the useof the merit badge token system that reinforced the samesocial skills in the regular school classroom. Because theparaprofessional working in the child’s classroom had alsofunctioned as a Summer Treatment Program counselorthe previous summer, the paraprofessional could readilyprompt and reinforce these social skills in the classroom.

In the School Intervention, procedures were alsomore intensive initially and gradually faded over time.During the second school year, the paraprofessional wasin the classroom for a half day, each day for 12 weeks.The paraprofessional initially implemented the behaviormanagement plan with the child. Over time, the parapro-fessional gradually shifted control of the program over tothe teacher, so that the teacher could carry the programforward independently once the paraprofessional left theclassroom. In addition, Therapist-Consultant visits to theteacher gradually faded over time as the parent learnedskills for taking over the teacher consultation. All thesestrategies were designed gradually to turn control of thebehavioral strategies over to natural caregivers (parents;teachers) who could carry strategies forward once the pro-fessional team was no longer available.

Integrate Psychosocial Treatment components

Given that treatment consisted of three major treat-ment components implemented across multiple settingsand target behaviors, it was deemed very important thattreatment components be carefully integrated. Many ofthe strategies and techniques listed here for promotinggeneralization also had the impact of integrating treat-ment efforts across treatment components and settings.In addition, the Parent Training, School Intervention, and

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Fig. 1. Flow of psychosocial treatment.

Summer Treatment Program were carefully designed toflow seamlessly over the course of the 14-month treat-ment period and to coordinate and complement treatmentefforts across the settings (see Fig. 1). Parent Training andSchool Intervention began simultaneously in the springof the study entry year for each subject with close co-operation between the Therapist-Consultant, the teacher,and the parent in setting up the initial Daily Report Cardsystem, coordinating the teacher’s and parents’ efforts atmonitoring target behaviors in the school and providingback-up consequences at home. The Summer TreatmentProgram commenced at the beginning of the first sum-mer and employed camp counselors who later went onto become the paraprofessional aides who implementedschool intervention in the fall of the second school year.Thus, children and counselors developed a relationshipover the summer, and the counselors gained a knowl-edge of and experience with implementing behavioral pro-grams for the child in the Summer Treatment Programthat could carry over into the regular school classroom inthe fall. Therapist-Consultants not only ran Parent Train-ing groups, but also conducted the teacher consultationcomponent of the School Intervention and handled all as-pects of case management for all cases that they followed.The Therapist-Consultants also supervised the camp coun-selor/paraprofessional who worked with the Therapist-Consultants’ cases in the Summer Treatment Program andSchool Intervention in weekly supervision sessions; in ad-dition, the Therapist-Consultants received weekly super-vision in joint meetings with a Parent Training Supervi-sor and an Educational Consultant so that the supervision

of the Parent Training and School Intervention compo-nents could be tightly coordinated. At a cross-site level,all site supervisors and intervention staff received super-vision in a weekly national conference call chaired by theprimary writers of each treatment manual who were allon the call and could discuss integration issues as theyarose.

Target behaviors were coordinated across settingswhere this made sense so that the child could receive con-sistent reinforcement (and punishment) for the same tar-get behaviors across caregivers and settings. Treatmentstrategies were similarly coordinated so that where possi-ble the same strategy could be implemented across settingsand caregivers. For example, a child might receive pointsfrom the teacher on his Daily Report Card at school, andpoints from his mother on his home token economy athome for the same target behavior. Likewise, Daily Re-port Card points earned at school, were transferred ontothe home token economy at home so that the parents’ totalreinforcement strategy could be coordinated. Teachers andparents received training in similar techniques of behaviormanagement as applicable in the respective environments.For example, teachers and parents both learned strategiesfor praising prosocial behavior, using effective commandsand instructions, implementing time-out, and implement-ing point systems as appropriate for the classroom andhome environments. Summer Treatment Program coun-selors used similar behavioral strategies. The goal and ef-fect of all these structural integration strategies was tocoordinate carefully treatment planning across time, set-tings, caregivers, and treatment components.

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Adapt Treatments to “Real-World” Clinical Reality

Many of the psychosocial treatment strategies usedfor ADHD originally were developed in academic centersunder highly controlled, laboratory-like conditions andevaluated on small samples. Although such studies areinitially necessary to establish the efficacy of treatmentprocedures, certain accommodations were needed to im-plement a broad-scale, lengthy intervention with severalhundred subjects in the MTA study. Therapist-Consultantssaw families in outpatient, group-treatment in an officesetting. Snacks and refreshments were provided, espe-cially if groups were held in the early evening hours. Par-ent Training sessions were audiotaped, and parents whomissed sessions were invited to make them up by lis-tening to tapes in the office at another appointment. Atsome sites, cab or bus fare was provided for some fam-ilies, and families were assisted in making baby-sittingarrangements to enable the families’ full participation intreatment.

In the School Intervention, careful attention was paidto establish a relationship with the teacher and assessingher current procedures for classroom behavior manage-ment. Then, rather than foisting a demanding protocolon the teacher, Therapist-Consultants and paraprofession-als attempted to assist her in using whatever additionalstrategies from the School Intervention protocol that shewas able and willing to use. In setting up the Daily Re-port Card, Therapist-Consultants negotiated the monitor-ing interval that the teacher felt she could reasonably im-plement in her classroom, and the Therapist-Consultantsand paraprofessionals then attempted to shape the childto that monitoring interval over time. In general, the atti-tude promoted among the study staff was that we were inthe school at the pleasure of the teacher, and that our rolewas to provide assistance and consultation, not to imposedemands.

Manual-Driven versus Individualized Treatment

In multisite, clinical trials, it is necessary to haveclear specification of the independent variables to insuretreatment fidelity and reduce cross-site variability. On theother hand, because a key purpose of multisite trials is togenerate data with broad generalizability and applicabil-ity to practice, heterogeneity of participants is prioritizedwith regard to such important variables as social classand comorbid diagnoses, among others (Jensen, 1993).This heterogeneity in the study sample introduces the needfor some clinical flexibility in implementing standardizedtreatments.

In the MTA study, detailed session by session manu-als for Parent Training, School Intervention, and the Sum-mer Treatment Program were developed, and staff at allsix sites received training and ongoing supervision in themanualized treatments. At the same time, behavioral treat-ments were individualized to address the clinical realitiesof each child and family. For example, specific target be-haviors in home, school, and summer camp were selectedto address the particular symptoms of ADHD and the spe-cific comorbid symptoms and functional deficits displayedby each child. Parents and teachers were asked to de-velop individualized reward menus that included knownreinforcers for each child. The duration and timing ofmonitoring intervals on Daily Report Cards, home tokeneconomies, and point systems outside of home were indi-vidualized to address the needs of each child and family.Some very distractible, inattentive children had very shortmonitoring intervals, whereas other children were able tofunction with longer monitoring intervals. Although allfamilies had some form of home token economy, somefamilies were able to implement detailed, complex sys-tems; other families preferred more simple, straightfor-ward systems. The particular home token economy wasdeveloped for each family in consultation with theTherapist-Consultant to meet the needs and abilities ofeach family.

Parent Training was administered to all parents in agroup format, insuring that all families were exposed tothe standard, manualized protocol. However, each familyalso received eight individual sessions over the course of14 months. In individual sessions, Therapist-Consultantsworked out details of treatment procedures to meet theneeds and abilities of the particular family, and helpedfamilies problem solve obstacles to implementation ofprocedures in their particular family.

Within the Summer Treatment Program, all childrenwere on a point system, but there was room for some in-dividualization of target behaviors within the system. Inthe academic classroom and computer-assisted sessionsof the Summer Treatment Program, an academic plan wasset up for each child; the content of the academic seat-work assignments and the computer-assisted instructionalprograms were individualized according to each child’sacademic needs. Likewise, throughout the Summer Treat-ment Program, although misbehavior met with point lossfor all children, some children whose behavior was highlyaggressive or disruptive had individualized behavior man-agement plans using a menu of limit-setting strategiesavailable to the staff. In all of these ways and more, thebasic principles and strategies outlined in the treatmentmanuals were carefully followed with proper attention

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paid to the individual needs, target behaviors, motiva-tions, family stresses, and capacities of each child andfamily.

Treatment Algorithms to Guide ClinicalDecision-Making

Even with structured, manualized treatments, thereare many critical decision points that arise over the courseof treatment implementation. In a single-site clinical trial,such decision-making processes should at the very least,be recorded so that replication of treatment methods ispossible. In a multisite trial, it is important to developtreatment algorithms to guide clinical decision making sothat critical decision processes can be standardized acrosssites during the course of the trial. Otherwise, sites maydevelop their own clinical “culture” such that clinical de-cisions are made following idiosyncratic, internal rules.“Site drift” of this sort would promote site× treatment in-teractions in a multisite trial, threatening the validity andgeneralizability of the findings.

In the MTA Psychosocial Treatment, several treat-ment algorithms were developed and implemented acrossall sites to standardize response to common clinical sce-narios. For example, in the Daily Report Card programat school, if children’s performance fell below 75% for5 consecutive days, Therapist-Consultants automaticallywere triggered to problem solve the deterioration. First,the integrity of implementation was checked to insure thattreatment procedures were being applied as proscribed.Next, Stage I (positive reinforcement) strategies were ex-amined. If Stage I strategies were properly in place, theprogram escalated to Stage 2 strategies involving pun-ishment approaches in the classroom (e.g., time-out andresponse cost). All Therapist-Consultants at all sites fol-lowed the same algorithm in problem-solving Daily Re-port Card performance deterioration.

In the Parent Training Program, one individual“swing session” was allowed between baseline assessmentand the beginning of a new Parent Training group to assistearly enrolling families in setting up behavioral programswhile they waited for a new group to start. Likewise, abank of six “extra visits” was available upon request bya parent or a teacher during the wait period before thestart of treatment or in the last 5 months of treatment(when the program was fading), to provide acute assis-tance to caregivers. Another clinical algorithm was devel-oped for helping parents deal with acute clinical situationsor dangerous aggressive behavior; Therapist-Consultantswere allowed to jump ahead in the standard Parent Train-

ing sequence and choose control strategies and techniquesfrom later sessions (usually time-out or other punishmentstrategies).

Integrate Psychosocial and Medication Treatmentin Combined Treatment Arm

Just as algorithms were developed to guide clinicaldecision making within single treatment arms of the MTAstudy, it was necessary to develop protocols and guide-lines governing the integration of Psychosocial and Med-ication treatment in the Combined Treatment arm. First,the onset of Psychosocial Treatment coincided with the28-day medication titration trial for Combined arm sub-jects (Greenhill et al., 1996). Randomized, daily doseswitches with multiple repeats were, therefore, used inthe medication titration methodology, not only to reduceorder and sequence effects in the titration trial, but also tominimize the potential confound introduced by improve-ments created with Psychosocial Treatment for combinedarm subjects. During this 28-day period, the evaluationof the Daily Report Card had to take into considerationthe daily switches of the titration. Although this strategymade evaluation of the Daily Report Card more difficult,the strategy allowed the two treatments to be started si-multaneously, thus preserving comparability of treatmentduration to the two unimodal treatment arms, and alsogiving children and caregivers the immediate relief asso-ciated with medication while the more slowly cumulativeeffects of Psychosocial treatment had a chance to build.

Second, when combined arm subjects manifestedclinical deterioration over the course of treatment that werenot side effects of stimulant medication, a critical decisionwas necessary about how to manage these symptoms; thatis, with Medication or with Psychosocial management. Inthe MTA, it was decided to attempt to manage clinicaldeterioration in symptoms of combined arm subjects withPsychosocial treatments first, utilizing all strategies avail-able in the respective Psychosocial Treatment manuals(e.g., increasing control strategies; adding new clinicalsymptoms to point systems, Daily Report Cards, and to-ken economies, etc.). Only after targeted treatment effortswithin a prespecified period of time using Psychosocialstrategies failed, were medications changed.

Finally, Therapist-Consultants, Psychopharmacolo-gists, Psychosocial supervisors, Medication Manage-ment supervisors, and the Principal Investigator andCo-Investigators from each site, all met together in week-ly clinical team meetings throughout the course ofthe 14-month treatment trial. Individual children were

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discussed in these team meetings, allowing for carefulclinical coordination among all concerned with combinedtreatment implementation.

Assure Treatment Fidelity

In clinical trials, it is necessary not only to spec-ify clearly the independent variables, but also to assurethat they are implemented competently and as intended.The need for assuring treatment fidelity (within a con-text of appropriate, algorithmized clinical flexibility) isespecially great in a multisite trial, for all the reasonsnoted earlier. Within the MTA Psychosocial Treatment,great attention was paid to assuring fidelity of the var-ious treatment components. For each major component,an initial, intensive training effort was implemented. ForParent Training, all site supervisors traveled to Durham,NC for 3 days of training by the primary author of theParent Training manual (KCW). Likewise, for School In-tervention, site supervisors were trained by its senior au-thors (JMS and RAK). Finally, for the Summer TreatmentProgram, several supervisory staff from each site, trav-eled to Pittsburgh, PA for 1 week of training in the imple-mentation of the Summer Treatment Program by its maindevelopers (WEP and BH). Site supervisors then trainedTherapist-Consultants, and Summer Treatment Programcounselors/paraprofessionals at their sites in the manual-ized treatment procedures in formal training workshops ateach site.

For Parent Training, checklists were developed andincluded all relevant content topics and process prescrip-tions (e.g., role-plays exercises; paper and pencil tasks)for each session. Therapist-Consultants used these check-lists during the sessions as prompts. Supervisors live-observed initial sessions and then gradually faded (fol-lowing a planned fading schedule) to audiotape review ofsessions, and used the same checklists while observingor listening to assure Therapist-Consultant adherence totreatment procedures. In weekly group supervision meet-ing, supervisors helped Therapist-Consultant’s plan up-coming groups, and reviewed any issues or problems iden-tified in the monitoring of groups.

Previous Psychosocial research has indicated that“nonspecific” therapist factors (e.g., warmth and empathy)and the therapeutic alliance are important contributors tooutcome of therapy and are, therefore, important compo-nents of overall therapist competence. In the MTA, thesefactors specifically were attended to in supervision withTherapist-Consultants and were measured by both super-visor and parent ratings of Therapist-Consultant compe-

tence on these dimensions using a modified version ofthe Vanderbilt Therapeutic Alliance Scales. In addition,on a monthly basis, Therapist-Consultants rated parentson their level of engagement in sessions, completion ofhomework assignments, level of apparent comprehensionand motivation and global adherence to treatment. TheNIMH data center also tracked gross measures of parentadherence to treatment such as attendance at group andindividual sessions.

For the School Intervention component, similar fi-delity procedures were used. The Educational Consultantsat in on two consultation sessions between Therapist-Consultant and teacher, rating the Therapist-Consultanton aspects of the therapeutic relationship with the teacherand completing a session checklist for the particular ses-sion. Therapist-Consultants faxed a teacher-consultationmonitoring form to the data center each week reflectingthe consultation session number and skills reviewed inthe consultations that occurred that week. Supervisionsessions between Therapist-Consultants and paraprofes-sionals were also tracked and recorded. Teachers ratedTherapist-Consultants in the spring of the second year onthe therapist–teacher relationship and the therapists’ per-ceived helpfulness. Therapist-Consultants rated parapro-fessionals on their implementation of skills after each visitto the classroom. Therapist-Consultants and EducationalConsultants met in weekly school supervision meetingsto discuss specific issues in working with the parapro-fessional aides, establishing the Daily Report Card in theschool, and consulting to the teachers. Paraprofessionalswere tested on their mastery of didactic information at theend of their spring training program.

For the Summer Treatment Program component ofPsychosocial Treatment, Therapist-Consultants observedgroups for 60–90 min each day and filled out a check-list of procedures that counselors should perform in eachgroup. A 1-hr supervisory meeting between Therapist-Consultant and counselors then occurred each day to givefeedback about counselor performance. Counselors com-pleted weekly Treatment Reliability Quizzes to assesscounselor knowledge of procedures and behavioral princi-ples. Therapist-Consultants regularly reviewed DailyReport Card targets, individual program forms, and chil-dren’s daily point totals to insure correct program imple-mentation. Finally, the Educational Consultant observedthe Summer Treatment Program learning centers and com-pleted weekly treatment integrity and fidelity sheets, giv-ing feedback to the learning center staff members abouttreatment implementation. Weekly Classroom ReliabilityQuizzes insured correct knowledge of principles and pro-cedures of classroom intervention.

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DISCUSSION

The Psychosocial Treatment for the MTA study wasstructured as a comprehensive package of treatment strate-gies rather than a single treatment. The strategies includedin the package were selected based on careful reviewsof the literature on the most effective known treatmentsfor improving the symptoms, comorbidities, and func-tional impairments associated with ADHD. The strate-gies were selected to effect change across multiple symp-toms, settings and domains of function, and to promotemaintenance of treatment effects. The goal was to pro-vide maximum impact treatment in an intensive and highlyintegrated intervention, within certain limits imposed bycost and feasibility attendant to such a large-scale researcheffort.

In designing the MTA study’s large multisite pro-gram, clinicians and researchers worked together to bridgethe gap between the demands of scientific rigor and needsof clinicians working in “real-world” clinical settings(Arnold et al., 1997a, 1997b; Greenhill et al., 1996). In ad-dition, the study design took into account the most current,empirically based theoretical conceptions of the natureand course of ADHD. ADHD increasingly is conceptu-alized as a “chronic disease” with symptoms, comorbidi-ties, and impairments that multiply, intensify, and persistinto adolescence and even adulthood, and the treatmentof which may require intensive intervention in multipleareas of functioning in multiple settings over years ratherthan weeks or months (Barkley, 1996; Conners & Erhardt,1998).

Other conceptual and logistical issues were consid-ered key in developing principles to guide the design andimplementation of Psychosocial Treatment in the MTAstudy. Chief among these were the importance of promot-ing generalization of treatment effects all throughout treat-ment and the critical issues involved in careful integrationamong Psychosocial Treatment components and acrossPsychosocial and Medication treatments for children re-ceiving the combined treatment. Likewise, the scientificdemands for clear specification and fidelity of treatmentsin a multisite trial must be balanced with the need for clin-ical flexibility, and appropriate but standardized clinicaldecision making. The MTA study may be an exemplar forfuture researchers who also struggle with these key issues.

While the Psychosocial methods in the MTA may re-quire innovations in the clinical practices of mental healthprofessionals working with ADHD children and their fam-ilies, they are not beyond the reach of clinical practitionerswilling to embrace those innovations. For example, thestrategies in the Parent Training manual go beyond teach-ing parents how to manage their child in the home, extend-

ing also to the skills needed to collaborate with school staffon behalf of their child. Although this innovation requiresa longer treatment effort than the typical 8- to 10-sessionparent training program, it is one that can be implementedin a typical office practice setting. The Summer TreatmentProgram utilized in the MTA study is highly structured andmanualized and has been disseminated to many centersacross the United States. Pelham and Hoza (1996) haveshown that an abundance of undergraduate-level personnelare willing to work in a Summer Treatment Program forexperience, course credit, and a small stipend and have de-veloped methods for recruiting and training these students.Using undergraduates as camp counselors, Pelham andHoza (1996) have demonstrated that an ADHD child canattend an 8-week STP for a cost of approximately $3000—in the range that many parents spend for nontherapeuticsummer camps for their children. Likewise, many schoolshave school aides who provide nonspecific help to over-burdened teachers. The Irvine Paraprofessional Programhas demonstrated that these school aides can be trained tofunction as paraprofessionals in the use of behavior man-agement strategies. Trained paraprofessionals can providesupport to the teacher in developing and implementingeffective interventions for children with ADHD. A co-operative effort between mental health professionals andschools to provide specific training to these aides as wasdone in the MTA study represents the kind of bridge neces-sary to have an impact on the ADHD child across multipledomains and settings. These innovations represent the kindof service delivery vehicles that will increasingly be nec-essary to influence this significant childhood psychiatricdisorder.

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