Community Based Intervention for Children With ADHD and ASD

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.

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.