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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00789932
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : February 5, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: cognitive behavioral therapy Behavioral: Usual community care Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Study Start Date : September 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents) [ Time Frame: 8 months (post-treatment) ]

Secondary Outcome Measures :
  1. Behavioral observations of social responsiveness [ Time Frame: 8 months (post-treatment) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders