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OpenTrials
Completed

NCT Number: NCT00789932

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCLA

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

32 weeks of CBT, 1.5 hours weekly.

Usual Community Care

Behavioral

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

Primary outcomes

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

    Time frame: 8 months (post-treatment)

Secondary outcomes

  1. Behavioral observations of social responsiveness

    Time frame: 8 months (post-treatment)

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Organization for Autism Research

Registry information

Acronym: BIACA-2

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 13, 2008
Registry last updated
Feb 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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