Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial (BIACA-2)

This study has been completed.

Sponsor:

Collaborator:

Organization for Autism Research

Information provided by (Responsible Party):

Jeffrey J. Wood, University of California, Los Angeles

ClinicalTrials.gov Identifier:

NCT00789932

First received: November 12, 2008

Last updated: February 1, 2013

Last verified: February 2013

History of Changes

Purpose

This study is designed to examine the efficacy of a cognitive behavioral therapy (CBT) program for treating core autism symptoms, social and emotional problems, and adaptive behavior deficits in children with autism spectrum disorders.

Condition	Intervention	Phase
Autism Spectrum Disorder	Behavioral: cognitive behavioral therapy Behavioral: Usual community care	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Autism

U.S. FDA Resources

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

Primary Outcome Measures:

ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents) [ Time Frame: 8 months (post-treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Behavioral observations of social responsiveness [ Time Frame: 8 months (post-treatment) ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	September 2008
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CBT	Behavioral: cognitive behavioral therapy 32 weeks of CBT, 1.5 hours weekly.
Active Comparator: Usual Care	Behavioral: Usual community care 16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.

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 autism, 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 80
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: NCT00789932

Locations

United States, California
UCLA
Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Organization for Autism Research

Investigators

Principal Investigator:

Jeffrey Wood, PhD

University of California, Los Angeles

More Information

No publications provided

Responsible Party:	Jeffrey J. Wood, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00789932 History of Changes
Other Study ID Numbers:	OAR-UCLA-2009
Study First Received:	November 12, 2008
Last Updated:	February 1, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013

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