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

February 1, 2013 updated by: Jeffrey J. Wood, University of California, Los Angeles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 11 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Usual Care
Behavioral: Usual community care
16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.
EXPERIMENTAL: CBT
Behavioral: cognitive behavioral therapy
32 weeks of CBT, 1.5 hours weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)
Time Frame: 8 months (post-treatment)
8 months (post-treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
Behavioral observations of social responsiveness
Time Frame: 8 months (post-treatment)
8 months (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Organization for Autism Research

Investigators

  • Principal Investigator: Jeffrey Wood, PhD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

November 12, 2008

First Submitted That Met QC Criteria

November 12, 2008

First Posted (ESTIMATE)

November 13, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 5, 2013

Last Update Submitted That Met QC Criteria

February 1, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAR-UCLA-2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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