Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280670
Status:
COMPLETED
Last Update Posted:
2012-04-02
First Post:
2006-01-20
Brief Title:
CBT for Comorbid Anxiety Disorders in Children With Autism Asperger Syndrome or PDD-NOS
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIACA
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 childrens 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 eg 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 skillsfriendship skills training and peer tutoringmentoring 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 childrens anxiety including a structured diagnostic interview administered by an independent evaluator will comprise the primary outcomes Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None