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

Primary Purpose

Autistic Disorder, Asperger Syndrome, Anxiety Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cognitive-behavioral therapy
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy

Waitlist

Arm Description

Outcomes

Primary Outcome Measures

Score on anxiety diagnostic interview after treatment or waitlist
Score on anxiety rating scale after treatment or waitlist

Secondary Outcome Measures

Score on daily living skills rating scale after treatment or waitlist
Score on children's social functioning and service use after treatment or waitlist

Full Information

First Posted
January 20, 2006
Last Updated
March 28, 2012
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00280670
Brief Title
CBT for Comorbid Anxiety Disorders in Children With Autism, Asperger Syndrome, or PDD-NOS
Acronym
BIACA
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder, Asperger Syndrome, Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Title
Waitlist
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy
Intervention Description
Cognitive behavioral therapy for children with autism and anxiety.
Primary Outcome Measure Information:
Title
Score on anxiety diagnostic interview after treatment or waitlist
Time Frame
post-treatment
Title
Score on anxiety rating scale after treatment or waitlist
Time Frame
post-treatment
Secondary Outcome Measure Information:
Title
Score on daily living skills rating scale after treatment or waitlist
Time Frame
post-treatment
Title
Score on children's social functioning and service use after treatment or waitlist
Time Frame
post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey J Wood, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19309326
Citation
Wood JJ, Drahota A, Sze K, Har K, Chiu A, Langer DA. Cognitive behavioral therapy for anxiety in children with autism spectrum disorders: a randomized, controlled trial. J Child Psychol Psychiatry. 2009 Mar;50(3):224-34. doi: 10.1111/j.1469-7610.2008.01948.x.
Results Reference
derived
Links:
URL
http://www.autism.ucla.edu
Description
UCLA Center for Autism Research and Treatment

Learn more about this trial

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

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