Community Based Intervention for Children With ADHD and ASD
Condition: Autism Spectrum Disorder; Attention Deficit-Hyperactivity Disorder; Executive Function
MeSH terms: Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Unstuck and on Target (UOT); Parents and Teachers Supporting Students (PATSS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Contingency Behavior Management; Flexible; Unstuck; Low Income; Behavior; Coping; Disparity; Problem Solving; Self-Control; impulsive; intervention