Community Based Intervention for Children With ADHD and ASD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03003286|
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Attention Deficit-Hyperactivity Disorder Executive Function||Behavioral: Unstuck and on Target (UOT) Behavioral: Parents and Teachers Supporting Students (PATSS)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Community Based Intervention for Children With ADHD and ASD|
|Actual Study Start Date :||September 13, 2014|
|Actual Primary Completion Date :||August 5, 2017|
|Actual Study Completion Date :||August 5, 2017|
Experimental: UOT Students and Parents
Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools
Behavioral: 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.
Experimental: PATSS Students and Parents
Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools
Behavioral: 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.
- 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.
- 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 ]A standardized, normed timed visual construction task that requires efficient nonverbal cognitive problem solving.
- 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 ]Standardized, normed, executive function tasks
- 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 ]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.
- 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 ]A short questionnaire was created by researchers for parents to report how often problems with flexibility interfere with daily adaptive functioning.
- 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 ]Parent ratings of participant's executive function-related behaviors
- 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 ]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.
- Parent Feedback Form - Acceptability total raw score [ Time Frame: 7-8 months ]Parent ratings of acceptability of the intervention
- Child Feedback—Acceptability raw score [ Time Frame: 7-8 months ]Child ratings of acceptability of the intervention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03003286
|United States, District of Columbia|
|Children's Research Institude, Children's National Heath System|
|Washington, District of Columbia, United States, 20010|
|Principal Investigator:||Lauren Kenworthy, Ph.D.||Children's National Health Services|
|Principal Investigator:||Laura Anthony, Ph.D.||University of Colorado Anschutz Medical Center|