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Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01631851
Recruitment Status : Unknown
Verified July 2014 by Denis Sukhodolsky, Yale University.
Recruitment status was:  Recruiting
First Posted : June 29, 2012
Last Update Posted : July 8, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
In addition to the core symptoms, children and adolescents with Autism Spectrum Disorder (ASD) often exhibit disruptive behavior problems including irritability, tantrums, noncompliance, and aggression. This is a pilot study of Cognitive-Behavioral Therapy, also known as Anger Control Training, in adolescents with high-functioning ASD. CBT teaches children to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance. This form of CBT has been well-studied in typically developing children with disruptive behavior and we are investigating if this treatment can be feasible and helpful, with appropriate modifications, for irritability and disruptive behavior in ASD.

Condition or disease Intervention/treatment
Autism Autism Spectrum Disorder (ASD Asperger's Disorder Pervasive Developmental Disorder (PDD-NOS) Behavioral: Cognitive-Behavioral Therapy (CBT) for Irritability

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Behavioral: Cognitive-Behavioral Therapy (CBT) for Irritability
    CBT is an individually administered behavioral interventions aimed at reducing irritability and disruptive behavior. There are 10 to 12 weekly sessions that are conducted with the child and the parent. During these sessions children are taught to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance.
    Other Name: Anger Control Training

Outcome Measures

Primary Outcome Measures :
  1. ABC Irritability Scale [ Time Frame: 1 week ]
    Parent rating of irritability and disruptive behavior that has been often used in studies with children with ASD

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • DSM-IV diagnosis of autistic disorder, Asperger's disorder, or PDD-NOS
  • presence of disruptive behaviors such as irritability and anger outbursts
  • IQ above 80
  • Unmedicated or on stable medication

Exclusion Criteria:

  • medical or psychiatric condition that would require alternative treatment
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631851

Contact: Denis Sukhodolsky, Ph.D. (203) 785-6446 denis.sukhodolsky@yale.edu
Contact: Erin MacDonnell (203) 737-3439 erin.macdonnell@yale.edu

United States, Connecticut
Yale Child Study Center Recruiting
New Haven, Connecticut, United States, 06520
Contact: Denis Sukhodolsky, Ph.D.    203-785-6446    denis.sukhodolsky@yale.edu   
Sponsors and Collaborators
Yale University
Principal Investigator: Denis Sukhodolsky, Ph.D. Yale University, Child Study Center
More Information

Responsible Party: Denis Sukhodolsky, Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT01631851     History of Changes
Other Study ID Numbers: 0102012121-B
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014

Keywords provided by Denis Sukhodolsky, Yale University:
Disruptive Behavior
Behavior Therapy
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
Asperger Syndrome
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders