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| Name | Class |
|---|---|
| Georgetown University | OTHER |
| University of Colorado, Denver | OTHER |
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The purpose of this study is to determine whether a new treatment, Unstuck and On Target (UOT), works better, worse, or the same as the best treatment that is available now, Contingency Behavioral Management (CBM), for low income children with Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD).
This project will compare the effectiveness of an innovative community-based cognitive-behavioral Executive Functioning (EF) treatment, Unstuck and On Target (UOT) to the current standard of care, a Contingency Behavioral Management (CBM) program in typically underserved children with ASD or ADHD. Minimizing the impact of EF deficits in these pediatric disorders has broad public health implications, providing the opportunity for improvement in the real-world, long-term outcomes that stakeholders have told the investigators are most important to them: more educational and vocational success, more functional independence and improved Activities of Daily Living skills, and better physical health, with reduced morbidity and mortality. The health disparity that this project addresses is the poorer outcomes and limited treatment choices associated with being a child from a low-income family who also has ADHD or ASD. The research questions are:
Patients with ASD and ADHD will be recruited for the study from school systems. Half will receive UOT and half will receive CBM. Researchers will recruit interested Title 1 schools that serve very different and diverse populations. Recruitment will occur in several stages. Specifically, school districts will invite individual schools to participate in the trial that have a sufficient number of qualifying children. Interested schools will then contact families and provide information about the study. Interested families will initiate contact with study staff, and individual schools will be entered into the study if they have three or more patients whose families contact study staff. Children will then be scheduled for cognitive/diagnostic evaluation. Recruitment will continue until the target enrollment is reached, and all remaining interested families from enrolled schools are included. Subjects with appropriate assent and consent will be evaluated for eligibility and their school will be randomly assigned to treatment condition.
Cognitive problem-solving abilities, flexibility, planning and organizing, self-regulation, behavior problems, coping skills, and the child's use of non-routine urgent medical care will be measured before and after treatment through a multi-method, multi-informant format, including parent report, blinded classroom observations and blinded direct child measures. Researchers chose measures that have the greatest relevance to functional outcomes and "real world" functioning. Rather than define a single outcome, researchers chose multiple outcome variables, anticipating differential impacts of the treatment modalities on the outcome domains. All of the measures and observations will be gathered at pre- and post-treatment time-points in each treatment year.
Data will be analyzed using a Statistical Package for the Social Sciences (SPSS) v20 and R. A comparison of baseline characteristics will be performed between the treatment groups to assess that the randomization was successful. The characteristics will include demographics as well as the direct child assessments and the behavioral scales. These comparisons will be performed using standard statistical methods, such as t-tests for continuous variables or (exact) chi-squares for dichotomous variables. If any characteristic is unbalanced between treatments, which will be possible with the sample size, secondary analyses will adjust for that characteristic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UOT Students and Parents | Experimental | Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools |
|
| PATSS Students and Parents | Experimental | Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unstuck and on Target (UOT) | Behavioral | Unstuck and on Target (UOT) is a novel and innovative cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. UOT is the first contextually-based EF treatment that targets flexibility, goal-setting and planning through a cognitive-behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Parents, teachers, and interventionists will be taught to model and support flexibility across settings. Children will also participate in a peer group intervention setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Classroom Observation total raw score at termination of intervention | 15-20 minute classroom observation conducted by a treatment-blind research assistant for every study participant during the academic school day. The following behaviors are coded: Social reciprocity, Following Rules, Transitions, Gets Stuck, Negativity/Overwhelm, and Classroom Participation. | Baseline, 7-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Wechsler Abbreviated Scale of Intelligence--II Block Design- T-score at termination of intervention (post testing) and 1 year later (long-term follow-up) | A standardized, normed timed visual construction task that requires efficient nonverbal cognitive problem solving. | Baseline, 7-8 months, 19-20 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Kenworthy, Ph.D. | Children's National Health Services | Principal Investigator |
| Laura Anthony, Ph.D. | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Research Institude, Children's National Heath System | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th Edition, Text Revision. 2000. | ||
| Background | Clopper CJ, Pearson, ES. The use of the confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413, 1934. | ||
| Background | Delis DC, Kaplan E, Kramer JH. Delis Kaplan executive function system (D-KEFS). San Antonio, TX: The Psychological Corporation. 2001. | ||
| 12638065 | Background | Gioia GA, Isquith PK, Kenworthy L, Barton RM. Profiles of everyday executive function in acquired and developmental disorders. Child Neuropsychol. 2002 Jun;8(2):121-37. doi: 10.1076/chin.8.2.121.8727. | |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D001519 | Behavior |
| D000068356 | Self-Control |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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|
| Parents and Teachers Supporting Students (PATSS) | Behavioral | The Contingency Behavior Management (CBM) intervention was developed by the researchers and called Parents and Teachers Supporting Students (PATSS) as a current best practice intervention that was comparable in design to Unstuck and on Target. The goal is to improve child behavioral outcomes by training parents, teachers and interventionists in core principles of behavior management like social learning and behavioral change. Children were also included in small group sessions where they identify their own behavior goals and meaningful reinforcers. |
|
| Change in Delis-Kaplan Executive Function System - Category Fluency and Switching Accuracy scaled scores at termination of intervention (post testing) and 1 year later (long-term follow-up) |
Standardized, normed, executive function tasks |
| Baseline, 7-8 months,19-20 months |
| Change in Executive Function Challenge Task - Flexibility and Planning raw scores at termination of intervention (post testing) and 1 year later (long-term follow-up) | Observations of participant behavior when confronted with 3 standardized tasks demanding flexibility and planning are coded on a 3-point scale for each task, and summed across tasks. | Baseline, 7-8 months, 19-20 months |
| Change in Flexibility Interference Questions Questionnaire total raw score at termination of intervention (post testing) and 1 year later (long-term follow-up) | A short questionnaire was created by researchers for parents to report how often problems with flexibility interfere with daily adaptive functioning. | Baseline, 7-8 months, 19-20 months |
| Change in Behavior Rating Inventory of Executive Function (BRIEF) - Parent Form - Shift, Plan/Organize, Emotional Control and Global Executive at termination of intervention (post testing) and 1 year later (long-term follow-up)Composite T-scores | Parent ratings of participant's executive function-related behaviors | Baseline, 7-8 months, 19-20 months |
| Change in The Child Behavior Checklist (CBCL) - Parent Report Externalizing Behaviors T-scores at termination of intervention (post testing) and 1 year later (long-term follow-up) | The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems, plus two open ended items to describe any additional problems, as well as 20 competence items covering positive, pro-social behaviors. Children's scores are expressed as T scores (mean=50; SD=10) on eight empirically based syndromes scales which are based on factor analyses: Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, and Aggressive Behavior. The CBCL will be used to track behavioral change at home as a result of the treatments. Researchers predict that UOT and CBM participants will improve equally on the Aggressive Behavior scale, but that UOT participants will improve more on the CBCL Affective Problems score than CBM participants. | Baseline, 7-8 months, 19-20 months |
| Parent Feedback Form - Acceptability total raw score | Parent ratings of acceptability of the intervention | 7-8 months |
| Child Feedback-Acceptability raw score | Child ratings of acceptability of the intervention | 7-8 months |
| 12759822 |
| Background |
| Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513. |
| Background | Mather N, Wendling BJ. Woodcock-Johnson IV tests of achievement: Examiner manual standard and extended batteries. Rolling Meadows, IL: Houghton Mifflin Harcourt. 2014. |
| 23402704 | Background | Weisz JR, Ugueto AM, Cheron DM, Herren J. Evidence-based youth psychotherapy in the mental health ecosystem. J Clin Child Adolesc Psychol. 2013;42(2):274-86. doi: 10.1080/15374416.2013.764824. Epub 2013 Feb 12. |
| 11104313 | Background | Wells KC, Pelham WE, Kotkin RA, Hoza B, Abikoff HB, Abramowitz A, Arnold LE, Cantwell DP, Conners CK, Del Carmen R, Elliott G, Greenhill LL, Hechtman L, Hibbs E, Hinshaw SP, Jensen PS, March JS, Swanson JM, Schiller E. Psychosocial treatment strategies in the MTA study: rationale, methods, and critical issues in design and implementation. J Abnorm Child Psychol. 2000 Dec;28(6):483-505. doi: 10.1023/a:1005174913412. |
| 42165016 | Derived | Anthony LG, Kenworthy L, Verbalis A, Safer-Lichtenstein J, Hardy KK, Ratto AB, Pugliese C, Strang JF, Myrick Y, Seese S, Cannon L, Werner MA, Alexander K, Naiman DQ, Troxel M, Dahlman T, Anthony BJ, Mikulich-Gilbertson SK. Addressing Disparities: A Pragmatic Comparative Effectiveness Trial of School-Based Executive Functioning Interventions. Evid Based Pract Child Adolesc Ment Health. 2026 Feb 26:10.1080/23794925.2026.2633981. doi: 10.1080/23794925.2026.2633981. Online ahead of print. |
| D012919 | Social Behavior |