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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Denis Sukhodolsky, Yale University
ClinicalTrials.gov Identifier:
NCT01631851
First received: June 27, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • ABC Irritability Scale [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Parent rating of irritability and disruptive behavior that has been often used in studies with children with ASD


Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631851

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

Locations
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
Investigators
Principal Investigator: Denis Sukhodolsky, Ph.D. Yale University, Child Study Center
  More Information

Publications:
Responsible Party: Denis Sukhodolsky, Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT01631851     History of Changes
Other Study ID Numbers: 0102012121-B
Study First Received: June 27, 2012
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Autism
Irritability
Disruptive Behavior
Aggression
Behavior Therapy
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Autistic Disorder
Developmental Disabilities
Asperger Syndrome
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014