Exposure-Focused Family-Based CBT for Youth With ASD and Comorbid Anxiety

Autism spectrum disorders affect as many as 1 out of 88 children and are related to
significant impairment in social, adaptive, and school functioning. Co-occurring conditions,
such as anxiety, are common and may cause substantial distress and impairment beyond that
caused by the autism diagnosis. Many children with anxiety disorders, especially those on the
autism spectrum, do not receive evidence based treatment, which has fueled the development
and evaluation of cognitive-behavioral therapy (CBT). Accordingly, we are proposing a
randomized controlled trial to examine the efficacy of exposure based CBT that heavily
incorporates parents (EF-CBT) relative to a TAU condition (TAU) in 50 youth ages 6-12 years
with ASD and comorbid anxiety disorder(s).

Inclusion Criteria:

- Outpatient children with an autism spectrum disorder between the ages 6-12 years.

- Meets criteria for a diagnosis of one of the following anxiety disorders: generalized
anxiety disorder, separation anxiety disorder, social phobia, specific phobia, panic
disorder or obsessive-compulsive disorder.

- Minimum score of 12 on the Pediatric Anxiety Rating Scale - Severity Scale.

- Child has a Full Scale and Verbal Comprehension IQ > 80.

Exclusion Criteria:

- Current clinically significant suicidality or engagement in suicidal behaviors within
the last 6 months.

- Presence of any clinical features requiring a higher level of care (inpatient or
partial hospital treatment).

- Any lifetime diagnosis (meeting DSM-IV criteria) of bipolar disorder, schizophrenia or
schizoaffective disorder; or Substance abuse in the past 6 months.

- Initiation of an antidepressant medication within 10 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 6 weeks before study enrollment (4 weeks
for antipsychotic) or during psychotherapy (unless the dose is lowered because of side
effects). If the child is on a medication, she or he can remain on it at its current
dose. While in their treatment arm, children randomized to the EF-CBT condition will
not be able to continue or initiate psychosocial interventions targeting
anxiety(psychotherapy, certain types of social skills training, applied behavior
analysis targeting anxiety). Those in the TAU arm will be able to seek out
psychiatric/psychological services at their discretion.