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OpenTrials
Completed

NCT Number: NCT00280670

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

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.

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Key information

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

Cognitive behavioral therapy for children with autism and anxiety.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: BIACA

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Jan 23, 2006
Registry last updated
Apr 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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