NCT00280670

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

3.6 years

First QC Date

January 20, 2006

Last Update Submit

March 28, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • Score on anxiety diagnostic interview after treatment or waitlist

    post-treatment

  • Score on anxiety rating scale after treatment or waitlist

    post-treatment

Secondary Outcomes (2)

  • Score on daily living skills rating scale after treatment or waitlist

    post-treatment

  • Score on children's social functioning and service use after treatment or waitlist

    post-treatment

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL
Behavioral: Cognitive-behavioral therapy

Waitlist

NO INTERVENTION

Interventions

Cognitive behavioral therapy for children with autism and anxiety.

Cognitive Behavioral Therapy

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • years of age
  • Meet research criteria for a diagnosis of 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

You may not qualify if:

  • Child has an IQ of less than 70
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Wood JJ, Drahota A, Sze K, Har K, Chiu A, Langer DA. Cognitive behavioral therapy for anxiety in children with autism spectrum disorders: a randomized, controlled trial. J Child Psychol Psychiatry. 2009 Mar;50(3):224-34. doi: 10.1111/j.1469-7610.2008.01948.x.

Related Links

MeSH Terms

Conditions

Autistic DisorderAsperger SyndromeAnxiety Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeffrey J Wood, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 23, 2006

Study Start

January 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2009

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations