Community Based Intervention for Children With ADHD and ASD

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder, Attention Deficit-Hyperactivity Disorder, Executive Function

In brief

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).

Key facts

Study ID

NCT03003286

Run by

Lauren Kenworthy

People needed

148

Starts

2014-09-13

Expected to finish

2017-08-05

Last updated by the study team

2018-04-04

Who can join

Age: 8 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Research Institude, Children's National Heath System — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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