Phase 2 N=33 Randomized Single-blind Treatment

Cognitive Behavioral Therapy (CBT) for Anxiety Disorders in Autism: Adapting Treatment for Adolescents

Anxiety Disorders in Youth With Autism, Asperger's Syndrome, and Pervasive Developmental Disorder Not Otherwise Specified

Bottom Line

View on ClinicalTrials.gov: NCT01177969 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Pediatric Anxiety Rating Scale. — 11.62; 14.04 units on a scale — p=.04

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cognitive-Behavioral Therapy (Behavioral); Wait-list (Behavioral)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: University of South Florida
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Pediatric Anxiety Rating Scale.	11.62; 14.04	.04 sig
SECONDARY Anxiety Disorders Interview Schedule: Child and Parent Versions	3.28; 4.04	.25

Summary

Comorbid anxiety disorders affect as many as 80% of youth with autism spectrum disorders, causing substantial distress and impairment over and above the autism spectrum diagnosis alone. Cognitive behavioral therapy (CBT) is the gold standard treatment among typically developing youth with an anxiety disorder and when adapted, shows promise in children with ASD and comorbid anxiety. However, there is currently no psychotherapy protocol tailored to meet the unique needs of young adolescents with Autism spectrum disorders (ASD) and comorbid anxiety. Given this, the present study seeks to develop and test a new CBT therapy in adolescents with autism and comorbid anxiety.

Eligibility Criteria

Inclusion Criteria

Outpatient adolescents with ASD (see below) between the ages 11-14 years.
Meets criteria for a diagnosis of autism, Asperger syndrome (AS), or Pervasive Developmental Disorder Not Otherwise Specified .
Meets 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).
Child has a Full Scale and Verbal Comprehension IQ≥85.

Exclusion Criteria

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.
Has started an antidepressant within 12 weeks before study enrollment or an antipsychotic 6 weeks before study enrollment.
Has changed established psychotropic medications (e.g., antidepressants, anxioloytics) within 8 weeks before study enrollment (6 weeks for antipsychotic).
Is currently suicidal or has been actively suicidal in the last 6 months.
Has been diagnosed with bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01177969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.