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

Autism Spectrum Disorder Clinical Trial

— BIACA-2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789932
• Other study ID #: OAR-UCLA-2009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 12, 2008
• Last updated: February 1, 2013
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 11 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

Behavioral:
• cognitive behavioral therapy
32 weeks of CBT, 1.5 hours weekly.
• Usual community care
16 weeks of community care, 16 weeks of CBT, 1.5 hours/week.

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Organization for Autism Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADIS-C/P (Anxiety Disorder Interview Schedule for Children and Parents)		8 months (post-treatment)	No
Secondary	Behavioral observations of social responsiveness		8 months (post-treatment)	No