- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00280670
CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS (BIACA)
March 28, 2012 updated by: Jeffrey J. Wood, University of California, Los Angeles
This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating anxiety symptoms, social problems, and adaptive behavior deficits in children with autism spectrum disorders.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Anxiety disorders are commonly diagnosed in children with autism, Asperger syndrome (AS), and pervasive developmental disorder not otherwise specified (PDD-NOS).
Anxiety disorders contribute to children's functional impairment over and above the functional deficits attributable to autism, AS, and PDD-NOS.
Thus, investigators have called for the development of anxiety treatments for this population (Attwood, 2003).
Cognitive behavioral therapy (CBT) has been found to be efficacious for anxiety disorders in typically developing children.
This pilot study will advance the field by providing an estimate of the treatment effects of CBT for anxiety disorders among children with autism, AS, or PDD-NOS.
The sample will include 20 children aged 7-11 years with autism, AS, or PDD-NOS and a comorbid anxiety disorder.
Children will be randomly assigned to immediate treatment or a 3-month waitlist.
The manualized CBT program includes traditional anxiety treatment components including coping skills training (e.g., cognitive restructuring), in vivo exposure, operant procedures, and parent training.
Additional treatment components have been added to enhance intervention response in children with AS or PDD-NOS, including emotion education, social skills/friendship skills training, and peer tutoring/mentoring modules.
Trained graduate students with expertise in CBT and developmental disabilities will serve as therapists.
Treatment fidelity will be checked using a session-by-session adherence checklist.
Treatment acceptability and consumer satisfaction will be assessed at posttreatment, providing guidance on the extent to which the manual will need to be revised.
Multiple measures of children's anxiety, including a structured diagnostic interview administered by an independent evaluator, will comprise the primary outcomes.
Children's social functioning, adaptive behavior, and service use will also be assessed to determine if CBT can affect relevant distal outcomes.
By comparing outcomes for children in the immediate treatment group versus those in the waitlist group, we will estimate effect sizes of CBT for this population.
Subsequently, power analyses will be conducted in planning for a larger clinical trial.
This study could contribute to public health efforts to address the mental health needs of the rising number of children diagnosed with autism-spectrum disorders.
If CBT is found to be efficacious, it will be the first evidence-based psychological treatment to be successfully adapted for children with autism, AS, and PDD-NOS.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California, Los Angeles
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 7 - 11 years of age
- Meet research criteria for a diagnosis of Asperger Syndrome or PDD-NOS
- Meet DSM-IV criteria for one of the following anxiety disorders: Separation Anxiety Disorder, Social Phobia, Obsessive-Compulsive Disorder
- If taking medication, have maintained a stable dose for 1 month prior to baseline assessment
Exclusion Criteria:
- Child has an IQ of less than 70
- Begin taking new medication(s) or current medication dose changes either (1) less than 1 month prior to baseline assessment, or (2) during the study period
- For any reason the child or parents appear unable to participate in the treatment program
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Waitlist
|
|
Experimental: Cognitive Behavioral Therapy
|
Cognitive behavioral therapy for children with autism and anxiety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on anxiety diagnostic interview after treatment or waitlist
Time Frame: post-treatment
|
post-treatment
|
Score on anxiety rating scale after treatment or waitlist
Time Frame: post-treatment
|
post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on daily living skills rating scale after treatment or waitlist
Time Frame: post-treatment
|
post-treatment
|
Score on children's social functioning and service use after treatment or waitlist
Time Frame: post-treatment
|
post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeffrey J Wood, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
January 20, 2006
First Submitted That Met QC Criteria
January 20, 2006
First Posted (Estimate)
January 23, 2006
Study Record Updates
Last Update Posted (Estimate)
April 2, 2012
Last Update Submitted That Met QC Criteria
March 28, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R03MH075806-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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