Cognitive Behavioral Therapy for Anxiety Disorders in Adolescents With Autism

This study will further examine a treatment plan for adolescents with autism spectrum
disorderS (ASD) and anxiety. Many children who have an autism spectrum disorder experience
substantial anxiety that can cause impairment above that of an ASD alone. Few studies have
examined effective treatment options for anxiety in this population. In typically developing
youth, Cognitive Behavioral Therapy (CBT) is considered the gold standard for treating
anxiety. But, in order to address the unique needs of children with ASD, this study utilizes
a modified CBT treatment plan which includes social skills and parent training. In our past
studies, this cognitive-behavioral treatment plan has been effective in kids with ASD and
anxiety compared to kids who did not receive any treatment.The current study compares this
modified treatment plan to other treatment options in the community. The experimental
component of this study is being assigned to 1 of 2 groups. The first group will receive CBT
immediately for a period of 16 weeks. The second group will have to wait 16 weeks before
receiving CBT. During this time period, children may receive any other services in the
community. Overall, all adolescents receive the same type of therapy; it's matter of whether
he/she receives it immediately or after a wait period. Sixteen weekly sessions comprise CBT.
All therapy and assessments associated with this study will be free of charge.

Inclusion Criteria:

1. Outpatient children with an autism spectrum disorder (see #2 below) between the ages
11-16 years.

2. Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or PDD-NOS using
scores from the Autism Diagnostic Interview-Revised and the Childhood Autism Rating
Scale.

3. Meets DSM-IV criteria for a diagnosis of one of the following anxiety disorders:
separation anxiety disorder (SAD), generalized anxiety disorder (GAD), social phobia,
or obsessive compulsive disorder (OCD) as determined by the ADIS-IV-C/P (with CSR 4)
and all available information.

4. Minimum score of 13 on the PARS Severity Scale; this score indicates clinically
significant anxiety symptom severity (RUPP, 2002) and has been used in recent major
clinical trials (e.g., Walkup et al., 2008).

5. Child has a Full Scale and Verbal Comprehension IQ > 80 as assessed on a commonly
used IQ test.

6. Subjects with co-morbid depression, ADHD, tic disorder or disruptive behavior
disorders will be acceptable as long as the anxiety disorder is primary (i.e., most
impairing/distressing).

Exclusion Criteria:

1. Receiving concurrent psychotherapy, social skills training, or behavioral
interventions (e.g., applied behavior analysis). Families will have the option of
discontinuing such services to enroll in the study.

2. New Treatments: Initiation of an antidepressant within 12 weeks before study
enrollment or an antipsychotic 6 weeks before study enrollment. No new alternative
medications, nutritionals or therapeutic diets within 6 weeks of study enrollment.

3. Established Treatment changes: Any change in established psychotropic medication
(e.g., antidepressants, anxiolytics) within 8 weeks before study enrollment (6 weeks
for antipsychotic). Alternative medications that might have behavioral effects must
be stable for 6 weeks prior to the study baseline assessment. Any medications that
the adolescent is on must remain stable during treatment. If a potential participant
is taking psychotropic medication at the time of the phone evaluation or the first
in-person study assessment and wishes to discontinue this medication to enter the
study, the patient will be asked to discuss this option with their prescribing
physician to determine whether medication discontinuation would be safe and in the
adolescent's best interest. In addition, we will obtain the patient's written consent
to contact their treating clinician to determine the appropriateness of study
participation. We will not influence the decision patients make with their
prescribing physician. All pharmacotherapy recommendations will be made in
consultation with Dr. Murphy.

4. (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.

5. Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance
abuse in past 6 months.

6. Unwillingness of parents to make the commitment to accompany their child for multiple
study visits.

7. Presence of a significant and/or unstable medical illness which might lead to
hospitalization during the study.