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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00280670
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 55
• Patients Per Site Per Month: 0.4

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cognitive Behavioral Therapy	Behavioral: Cognitive-behavioral therapy; Cognitive behavioral therapy for children with autism and anxiety.
No Intervention: Waitlist

Outcome Measures

Primary Outcome Measures

1. Score on anxiety diagnostic interview after treatment or waitlist [post-treatment]

2. Score on anxiety rating scale after treatment or waitlist [post-treatment]

Secondary Outcome Measures

1. Score on daily living skills rating scale after treatment or waitlist [post-treatment]

2. Score on children's social functioning and service use after treatment or waitlist [post-treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years to 11 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• UCLA Center for Autism Research and Treatment

Publications

None provided.

• Responsible Party: Jeffrey J. Wood, Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00280670
• Other Study ID Numbers: R03MH075806-01
• First Posted: Jan 23, 2006
• Last Update Posted: Apr 2, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Disease; Syndrome; Anxiety Disorders; Autistic Disorder; Asperger Syndrome

Study Results

No Results Posted as of Apr 2, 2012