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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cognitive behavioral therapy
Usual community care
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)

Secondary Outcome Measures

Behavioral observations of social responsiveness

Full Information

First Posted
November 12, 2008
Last Updated
February 1, 2013
Sponsor
University of California, Los Angeles
Collaborators
Organization for Autism Research
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1. Study Identification

Unique Protocol Identification Number
NCT00789932
Brief Title
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Acronym
BIACA-2
Official Title
Cognitive Behavioral Therapy for Core Autism Symptoms in School-Aged Children: A Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Organization for Autism Research

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
cognitive behavioral therapy
Intervention Description
32 weeks of CBT, 1.5 hours weekly.
Intervention Type
Behavioral
Intervention Name(s)
Usual community care
Intervention Description
16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.
Primary Outcome Measure Information:
Title
ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)
Time Frame
8 months (post-treatment)
Secondary Outcome Measure Information:
Title
Behavioral observations of social responsiveness
Time Frame
8 months (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Wood, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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

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