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CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS (BIACA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00280670
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : April 2, 2012
Information provided by (Responsible Party):
Jeffrey J. Wood, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autistic Disorder Asperger Syndrome Anxiety Disorders Behavioral: Cognitive-behavioral therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy Behavioral: Cognitive-behavioral therapy
Cognitive behavioral therapy for children with autism and anxiety.

No Intervention: Waitlist

Primary Outcome Measures :
  1. Score on anxiety diagnostic interview after treatment or waitlist [ Time Frame: post-treatment ]
  2. Score on anxiety rating scale after treatment or waitlist [ Time Frame: post-treatment ]

Secondary Outcome Measures :
  1. Score on daily living skills rating scale after treatment or waitlist [ Time Frame: post-treatment ]
  2. Score on children's social functioning and service use after treatment or waitlist [ Time Frame: post-treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00280670

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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Jeffrey J Wood, Ph.D. University of California, Los Angeles
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jeffrey J. Wood, Professor, University of California, Los Angeles Identifier: NCT00280670    
Other Study ID Numbers: R03MH075806-01 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Anxiety Disorders
Autistic Disorder
Asperger Syndrome
Pathologic Processes
Mental Disorders
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders