Autism Spectrum DisorderNCT03003286
Community Based Intervention for Children With ADHD and ASD
A study testing Unstuck and on Target (UOT) and Parents and Teachers Supporting Students (PATSS) in people with Autism Spectrum Disorder and Attention Deficit-Hyperactivity Disorder, run by Lauren Kenworthy at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder, Attention Deficit-Hyperactivity Disorder, Executive Function
- What is being tested?
- Unstuck and on Target (UOT) and Parents and Teachers Supporting Students (PATSS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2014to 5 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The investigators will recruit children who are referred by teachers and staff at their school for concerns of flexibility (rather than those who are responding to an advertisement), so that the research will have a "real world" group of children to test the effectiveness of the treatments.
- The recruited participants will have symptoms of ASD or ADHD, will be receiving a combination of mainstream and special education supports, and will qualify to attend pull-out groups in school. All the schools involved are eligible for Title 1 governmental support, indicating that the children are from primarily low-income communities, although the investigators will not be requiring that participant's families themselves meet income cutoffs.
- Potential participants will be evaluated individually and included in the study if they achieve a Full Scale IQ score>70, a verbal mental age>6 years old, and meet DSM-IV-TR criteria for either a Autism Spectrum Disorder or ADHD. IQ and verbal mental age will be measured with the Wechsler Abbreviated Scale of Intelligence, 2nd addition (WASI-2) Verbal, Performance and Full Scale IQ scores (represented as Standard Scores: mean=100; SD=15).
- To evaluate for ASD, research-valid clinical psychologists will administer the Autism Diagnostic Observation Schedule, Second Edition Module 3 (ADOS-2), a gold standard structured play/conversational interview that elicits symptoms of ASD. It produces non-standardized raw scores; higher scores indicate more symptoms. To be included in the study, each child must obtain an ADOS diagnostic algorithm >'ASD' threshold and parents will be asked to complete the Social and Communication Questionnaire (SCQ). In order to include the full autism spectrum, these criteria are relatively inclusive.
- To confirm diagnosis of ADHD, parents will complete the ADHD portion of the MINI-Kid ADHD interview with a trained interviewer, and their child must meet DSM-IV criteria for any Attention Disorder. The researchers will include children who had observable symptoms in two of three settings. As all children will be referred for the study because teachers or staff at their school observed symptoms, the children will have to also meet criteria on the MINI-Kid interview or the trained clinician completing their testing will have to observe notable symptoms, or both, for the child to be included in the study.
Who cannot join
- Participants will be excluded from the study if they have a diagnosis of bipolar disorder, schizophrenia, or major depression that is currently preventing them from participating in classroom activities.
- Students with anxiety, mild depression, obsessive-compulsive disorder or other problems that do not prevent them from participating in the majority of classroom activities will not be excluded.
- Exclusion will be determined through a two-stage process: First, participants will be screened for comorbid symptoms using the Child Behavior Checklist (CBCL). The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems. Parents rate their child for how true each item is now or within the past 6 months. One of the PIs, both of whom are licensed psychologists with active clinical practices, will follow-up with a child's teacher if a child scores above a T score of 75 on any of the six DSM-oriented scales other than Attention Deficit/Hyperactivity Problems (Affective Problems; Anxiety Problems; Somatic Problems; Oppositional Defiant Problems; and Conduct Problems).
- The investigators will ask teachers targeted questions to determine to what degree the identified symptoms interfere with the child's ability to participate in the classroom activities or in the treatment group such as "Do you feel that the child can participate in most classroom activities? If not, why? Can they listen to and follow written and verbal instructions? Can they participate in activities with other children when given structure and support?" However, because the school programs involved in this study use an inclusion model, students in these mainstream classrooms are unlikely to meet exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Research Institude, Children's National Heath System
Washington D.C., District of Columbia, 20010
About this study
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).
Read the detailed description
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:
- Which works better for low-income children with ASD, UOT or CBM? Researchers will test the comparative effectiveness of UOT to CBM treatments with low-income children with ASD.
- Which works better for low-income children with ADHD, UOT or CBM? Researchers will test the comparative effectiveness of UOT to CBM with low-income children with ADHD, a new patient population for UOT.
- Are the effects of UOT and CBM sustained 9-12 months after treatment? Researchers will assess whether any benefits ascribed to the interventions are maintained about a year after the treatment is completed.
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.
- Being tested
- Unstuck and on Target (UOT), Parents and Teachers Supporting Students (PATSS)
- Keywords
- Contingency Behavior Management, Flexible, Unstuck, Low Income, Behavior, Coping, Disparity, Problem Solving, Self-Control, impulsive, intervention
- Medical subject headings
- Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Behavior, Self-Control, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unstuck and on Target (UOT)Behavioural
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.
Parents and Teachers Supporting Students (PATSS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| UOT Students and Parents | Experimental | Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools Receives: Behavioral: Unstuck and on Target (UOT) |
| PATSS Students and Parents | Experimental | Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools Receives: Behavioral: Parents and Teachers Supporting Students (PATSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 7-8 months
Secondary outcomes (8)
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.
Measured: Baseline, 7-8 months, 19-20 months
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 7-8 months, 19-20 months
Parent Feedback Form - Acceptability total raw score
Parent ratings of acceptability of the intervention
Measured: 7-8 months
Child Feedback-Acceptability raw score
Child ratings of acceptability of the intervention
Measured: 7-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study start13 Sep 2014
- Primary completion5 Aug 2017
- Study completion5 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lauren Kenworthy
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University, University of Colorado, Denver
- Responsible party
- Sponsor-investigator, Lauren Kenworthy, Children's National Research Institute
- Investigators
- Lauren Kenworthy, Ph.D., Principal investigator, Children's National Health ServicesLaura Anthony, Ph.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003286
- Sponsor's protocol ID
- AD-1304-7379
- Status last verified
- Apr 2018
- First submitted
- 21 Nov 2016
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th Edition, Text Revision. 2000.
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.
Delis DC, Kaplan E, Kramer JH. Delis Kaplan executive function system (D-KEFS). San Antonio, TX: The Psychological Corporation. 2001.
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.
PubMed 12638065Gioia 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.
PubMed 12759822Mather N, Wendling BJ. Woodcock-Johnson IV tests of achievement: Examiner manual standard and extended batteries. Rolling Meadows, IL: Houghton Mifflin Harcourt. 2014.
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.
PubMed 23402704Wells 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.
PubMed 11104313Anthony 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.
PubMed 42165016
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Intervention for Children With ADHD and ASD
- ClinicalTrials.gov ID
- NCT03003286
- Acronym / sponsor ID
- AD-1304-7379
- Keywords
- Contingency Behavior Management, Flexible, Unstuck, Low Income, Behavior, Coping, Disparity, Problem Solving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Lauren KenworthyUniversity, hospital or other
- Collaborators
- Georgetown University, University of Colorado, Denver
- Study start
- 13 Sep 2014 (actual)
- Primary completion
- 5 Aug 2017 (actual)
- Study completion
- 5 Aug 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- Which works better for low-income children with ASD, UOT or CBM? Researchers will test the comparative effectiveness of UOT to CBM treatments with low-income children with ASD.
- Which works better for low-income children with ADHD, UOT or CBM? Researchers will test the comparative effectiveness of UOT to CBM with low-income children with ADHD, a new patient population for UOT.
- Are the effects of UOT and CBM sustained 9-12 months after treatment? Researchers will assess whether any benefits ascribed to the interventions are maintained about a year after the treatment is completed.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UOT Students and Parents | Experimental | Behavioral: Unstuck and on Target (UOT)Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools |
| PATSS Students and Parents | Experimental | Behavioral: Parents and Teachers Supporting Students (PATSS)Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The investigators will recruit children who are referred by teachers and staff at their school for concerns of flexibility (rather than those who are responding to an advertisement), so that the research will have a "real world" group of children to test the effectiveness of the treatments.
- The recruited participants will have symptoms of ASD or ADHD, will be receiving a combination of mainstream and special education supports, and will qualify to attend pull-out groups in school. All the schools involved are eligible for Title 1 governmental support, indicating that the children are from primarily low-income communities, although the investigators will not be requiring that participant's families themselves meet income cutoffs.
- Potential participants will be evaluated individually and included in the study if they achieve a Full Scale IQ score>70, a verbal mental age>6 years old, and meet DSM-IV-TR criteria for either a Autism Spectrum Disorder or ADHD. IQ and verbal mental age will be measured with the Wechsler Abbreviated Scale of Intelligence, 2nd addition (WASI-2) Verbal, Performance and Full Scale IQ scores (represented as Standard Scores: mean=100; SD=15).
- To evaluate for ASD, research-valid clinical psychologists will administer the Autism Diagnostic Observation Schedule, Second Edition Module 3 (ADOS-2), a gold standard structured play/conversational interview that elicits symptoms of ASD. It produces non-standardized raw scores; higher scores indicate more symptoms. To be included in the study, each child must obtain an ADOS diagnostic algorithm >'ASD' threshold and parents will be asked to complete the Social and Communication Questionnaire (SCQ). In order to include the full autism spectrum, these criteria are relatively inclusive.
- To confirm diagnosis of ADHD, parents will complete the ADHD portion of the MINI-Kid ADHD interview with a trained interviewer, and their child must meet DSM-IV criteria for any Attention Disorder. The researchers will include children who had observable symptoms in two of three settings. As all children will be referred for the study because teachers or staff at their school observed symptoms, the children will have to also meet criteria on the MINI-Kid interview or the trained clinician completing their testing will have to observe notable symptoms, or both, for the child to be included in the study.
Key exclusion criteria (4 listed)
- Participants will be excluded from the study if they have a diagnosis of bipolar disorder, schizophrenia, or major depression that is currently preventing them from participating in classroom activities.
- Students with anxiety, mild depression, obsessive-compulsive disorder or other problems that do not prevent them from participating in the majority of classroom activities will not be excluded.
- Exclusion will be determined through a two-stage process: First, participants will be screened for comorbid symptoms using the Child Behavior Checklist (CBCL). The CBCL for 6-18 year olds has 118 items that describe specific behavioral and emotional problems. Parents rate their child for how true each item is now or within the past 6 months. One of the PIs, both of whom are licensed psychologists with active clinical practices, will follow-up with a child's teacher if a child scores above a T score of 75 on any of the six DSM-oriented scales other than Attention Deficit/Hyperactivity Problems (Affective Problems; Anxiety Problems; Somatic Problems; Oppositional Defiant Problems; and Conduct Problems).
- The investigators will ask teachers targeted questions to determine to what degree the identified symptoms interfere with the child's ability to participate in the classroom activities or in the treatment group such as "Do you feel that the child can participate in most classroom activities? If not, why? Can they listen to and follow written and verbal instructions? Can they participate in activities with other children when given structure and support?" However, because the school programs involved in this study use an inclusion model, students in these mainstream classrooms are unlikely to meet exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unstuck and on Target (UOT)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. | Behavioural | UOT Students and Parents |
| Parents and Teachers Supporting Students (PATSS)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. | Behavioural | PATSS Students and Parents |
Primary outcome
Change in Classroom Observation total raw score at termination of intervention
Time frame: Baseline, 7-8 months
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.
8 secondary outcomes
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)
Time frame: Baseline, 7-8 months, 19-20 months
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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: Baseline, 7-8 months, 19-20 months
Parent Feedback Form - Acceptability total raw score
Time frame: 7-8 months
Child Feedback-Acceptability raw score
Time frame: 7-8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th Edition, Text Revision. 2000.
- BackgroundClopper CJ, Pearson, ES. The use of the confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413, 1934.
- BackgroundDelis DC, Kaplan E, Kramer JH. Delis Kaplan executive function system (D-KEFS). San Antonio, TX: The Psychological Corporation. 2001.
- Background: PubMed 12638065Gioia 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.
- Background: PubMed 12759822Gioia 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.
- BackgroundMather N, Wendling BJ. Woodcock-Johnson IV tests of achievement: Examiner manual standard and extended batteries. Rolling Meadows, IL: Houghton Mifflin Harcourt. 2014.
- Background: PubMed 23402704Weisz 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.
- Background: PubMed 11104313Wells 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.
- Derived from this study: PubMed 42165016Anthony 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Kenworthy, Ph.D. principal investigator
Children's National Health Services
Laura Anthony, Ph.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstuck and on Target (UOT) and Parents and Teachers Supporting Students (PATSS) in people with Autism Spectrum Disorder and Attention Deficit-Hyperactivity Disorder, run by Lauren Kenworthy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Classroom Observation total raw score at termination of intervention (time frame: Baseline, 7-8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03003286, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2018.