NCT00789932

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Typical duration for phase_1

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

3.2 years

First QC Date

November 12, 2008

Last Update Submit

February 1, 2013

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

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

    8 months (post-treatment)

Secondary Outcomes (1)

  • Behavioral observations of social responsiveness

    8 months (post-treatment)

Study Arms (2)

CBT

EXPERIMENTAL
Behavioral: cognitive behavioral therapy

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual community care

Interventions

cognitive behavioral therapyBEHAVIORAL

32 weeks of CBT, 1.5 hours weekly.

CBT
Usual community careBEHAVIORAL

16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.

Usual Care

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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeffrey Wood, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)