Cognitive Behavioral Therapy for Core Autism Symptoms in... | NCT00789932

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

NCT00789932

Sponsor

University of California, Los Angeles

Status

Completed

Last Update Posted

Feb 5, 2013Estimated

Enrollment

20Actual

Phase

Phase 1Phase 2

Conditions

Autism Spectrum Disorder

Interventions

cognitive behavioral therapy
Usual community care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Nov 12, 2008

First Submission Date that Met QC Criteria

Nov 12, 2008

First Posted Date

Nov 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2013

Last Update Posted Date

Feb 5, 2013Estimated

Name	Class
Organization for Autism Research	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CBT	Experimental		Behavioral: cognitive behavioral therapy
Usual Care	Active Comparator		Behavioral: Usual community care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cognitive behavioral therapy	Behavioral	32 weeks of CBT, 1.5 hours weekly.	CBT

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Wood, PhD	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA		Los Angeles	California	90095	United States

Condition Browse Module

MeSH Terms

ID	Term
D000067877	Autism Spectrum Disorder

Ancestor Terms

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided