Clinical trial NCT03003286: Community Based Intervention for Children With ADHD and ASD
Official title: Community Based Intervention for Children With ADHD and ASD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Attention Deficit-Hyperactivity Disorder
Executive Function
Keywords: Contingency Behavior Management
Flexible
Unstuck
Low Income
Behavior
Coping
Disparity
Problem Solving
Self-Control
impulsive
intervention
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Georgetown University
name: University of Colorado, Denver
First posted: 2016-12-28
Enrollment: 148
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 (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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Classroom Observation total raw score at termination of intervention
timeFrame: Baseline, 7-8 months
Secondary outcomes:
measure: 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)
timeFrame: Baseline, 7-8 months, 19-20 months
measure: 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)
timeFrame: Baseline, 7-8 months,19-20 months
measure: 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)
timeFrame: Baseline, 7-8 months, 19-20 months
measure: Change in Flexibility Interference Questions Questionnaire total raw score at termination of intervention (post testing) and 1 year later (long-term follow-up)
timeFrame: Baseline, 7-8 months, 19-20 months
measure: 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
timeFrame: Baseline, 7-8 months, 19-20 months
measure: 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)
timeFrame: Baseline, 7-8 months, 19-20 months
measure: Parent Feedback Form - Acceptability total raw score
timeFrame: 7-8 months
measure: Child Feedback-Acceptability raw score
timeFrame: 7-8 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's Research Institude, Children's National Heath System
state: District of Columbia
Study officials:
affiliation: Children's National Health Services
name: Lauren Kenworthy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado, Denver
name: Laura Anthony, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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