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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeffrey J. Wood, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00280670
First received: January 20, 2006
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Autistic Disorder
Asperger Syndrome
Anxiety Disorders
Behavioral: Cognitive-behavioral therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Score on anxiety diagnostic interview after treatment or waitlist [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
  • Score on anxiety rating scale after treatment or waitlist [ Time Frame: post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on daily living skills rating scale after treatment or waitlist [ Time Frame: post-treatment ] [ Designated as safety issue: No ]
  • Score on children's social functioning and service use after treatment or waitlist [ Time Frame: post-treatment ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2005
Study Completion Date: August 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy Behavioral: Cognitive-behavioral therapy
Cognitive behavioral therapy for children with autism and anxiety.
No Intervention: Waitlist

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.

  Eligibility

Ages Eligible for Study:   7 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280670

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jeffrey J Wood, Ph.D. University of California, Los Angeles
  More Information

Additional Information:
No publications provided by University of California, Los Angeles

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeffrey J. Wood, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00280670     History of Changes
Other Study ID Numbers: R03-MH075806-01
Study First Received: January 20, 2006
Last Updated: March 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Autistic Disorder
Asperger Syndrome
Mental Disorders
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on April 17, 2014