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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014