Treatment of Anxiety in Late Adolescents With Autism

Autism spectrum disorders (ASD) affect approximately 1.1% of late adolescents and young
adults, making it one of the most common neurodevelopmental disorders. Comorbid anxiety
disorders affect many higher-functioning adolescents and young adults with ASD, causing
substantial distress and impairment over and above that caused by an ASD diagnosis alone.
While cognitive-behavioral therapy (CBT) is a first-line treatment for anxiety disorders
among typically developing late adolescents, and work by the investigative team supports its
utility in children with ASD and comorbid anxiety, very few evidence-based treatment
approaches exist for late adolescents with ASD and comorbid anxiety. Accordingly, the
investigators are proposing to develop a CBT protocol for clinical anxiety that is
personalized to the unique clinical characteristics of late adolescents (ages 16-21 years)
with ASD namely, the Treatment of Anxiety in Late Adolescents with Autism (TALAA). Initial
TALAA development efforts will focus on adapting relevant treatment elements from an
efficacious CBT program for early adolescents with ASD and comorbid anxiety to the
characteristics and clinical needs of the age group. Developmentally appropriate, novel
treatment components will be added, including those focusing on fostering successful
transitions to adulthood (e.g., work readiness). In response to the NIH Roadmap Initiative,
attention will be paid to protocol adaptability with varying clinical presentations. Measures
of treatment integrity and competence will be developed. Thereafter, protocol and measure
development will be refined through our experiences treating 8 young adults (ages 16-21
years) with ASD and comorbid anxiety disorder(s) as well as through clinician, patient, and
expert feedback. The feasibility of implementing TALAA will then be examined in the context
of a pilot study incorporating all the features of the planned future efficacy trial
comparing TALAA to treatment as usual, but with a limited sample size (N=44).

Inclusion Criteria:

- Outpatient males and females with ASD between the ages 16-21 years at consent/assent.

- The individual meets criteria for ASD.

- The individual meets criteria for clinically significant anxiety symptoms.

- Meets criteria for a diagnosis of one of the following anxiety disorders: separation
anxiety disorder (SAD), specific phobia, panic disorder (PD), generalized anxiety
disorder (GAD), social phobia (SP), or obsessive compulsive disorder (OCD) and has a
minimum score of 14 on the Hamilton Anxiety Scale.

- Person has a Full Scale IQ approximation > 70 as assessed by the Wechsler Abbreviated
Scale for Intelligence-II two or four sub-test form.

Exclusion Criteria:

- Receiving concurrent psychotherapy focused on anxiety.

- 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).

- (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.

- Lifetime bipolar disorder, schizophrenia or schizoaffective disorder, or substance
abuse in past 6 months.