Psychotherapy for Anxiety in Children With Autism Spectrum Disorder

Autism spectrum disorders (ASD) are common neurodevelopmental syndromes affecting 1% of U.S.
children. Comorbid anxiety disorders affect 40 to 50% of children with ASD, causing
substantial distress and impairment over and above that caused by ASD alone. Although
standard practice cognitive-behavioral therapy (CBT) has been established as an efficacious
and safe treatment for anxiety disorders among typically developing youth, its utility in
comorbid cases with ASD remains unknown. To date, no studies have experimentally compared
standard practice CBT to a cognitive-behavioral intervention that has been personalized for
children with a comorbid presentation of anxiety and ASD. Accordingly, we are proposing a
randomized controlled trial to be conducted at three treatment sites to evaluate the efficacy
of personalized CBT for anxiety in ASD (Behavioral Intervention for Anxiety in Children with
Autism: BIACA) relative to standard practice CBT for anxiety (Coping Cat program).
Furthermore, this study will employ a waitlist control group to assess the efficacy of each
CBT arm relative to the absence of treatment (i.e., a Waitlist control arm). The proposed
research will: (1) examine the efficacy of BIACA relative to Coping Cat, which represents
standard practice treatment, and the efficacy of both these treatments relative to a waitlist
control group, (2) evaluate the maintenance of treatment gains, (3) examine the impact of
personalized intervention on functional outcomes. A total of 201youth across 3 study
locations (ages 8-13 years) with ASD and co-occurring anxiety will be randomly assigned to
one of the three conditions. The three recruitment sites for this study are University of
California, Los Angeles, the University of South Florida (USF), and Temple University.
Considering the rising number of children diagnosed with ASD together with the frequency and
severity of comorbid anxiety, the proposed work is tailored to the unique needs of youth with
ASD and will provide a timely contribution to public health efforts.

Inclusion Criteria:

- Outpatient boys and girls with ASD between the ages 8-13 years at consent/assent.

- The child meets criteria for ASD.

- The child meets criteria for clinically significant anxiety symptoms.

- The child has a Full Scale and Verbal Comprehension Intelligence Quotient >70 as
assessed on the Wechsler Intelligence Scale for Children-IV or another acceptable
Intelligence Quotient test.

Exclusion Criteria:

- Receiving concurrent therapy targeting anxiety, social skills training with homework,
or behavioral interventions (e.g., applied behavior analysis). This excludes academic
tutoring, occupational therapy, speech therapy, school counseling that is no more than
60 minutes per week in duration, school aides, and social skills training groups that
do not include homework and are no more than 60 minutes/week in duration.

- (a) Current clinically significant suicidality or (b) individuals who have engaged in
suicidal behaviors within 6 months will be excluded and referred for appropriate
clinical intervention.

- Child has been nonresponsive to an adequate trial of CBT for anxiety within the
previous 2 years.

- Lifetime bipolar disorder, schizophrenia or schizoaffective disorder.

- Initiation of an antidepressant medication within 12 weeks before study enrollment or
an antipsychotic medication 6 weeks before study enrollment or the child has changed
the dose of an established medication within 8 weeks before study enrollment (4 weeks
for antipsychotic) or during psychotherapy (unless the dose is lowered because of side
effects).