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

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ClinicalTrials.gov Identifier: NCT01631851
Recruitment Status : Active, not recruiting
First Posted : June 29, 2012
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Denis Sukhodolsky, Yale University

Study Description
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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 Phase
Autism Autism Spectrum Disorder (ASD Asperger's Disorder Pervasive Developmental Disorder (PDD-NOS) Behavioral: Cognitive-Behavioral Therapy (CBT) for Irritability Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
Study Start Date : May 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cognitive behavior therapy 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
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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
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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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
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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


Locations
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United States, Connecticut
Yale Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Denis Sukhodolsky, Ph.D. Yale University, Child Study Center
More Information
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Publications:

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Responsible Party: Denis Sukhodolsky, Research Scientist, Yale University
ClinicalTrials.gov Identifier: NCT01631851    
Other Study ID Numbers: 0102012121-B
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Keywords provided by Denis Sukhodolsky, Yale University:
Autism
Irritability
Disruptive Behavior
 Aggression
Behavior Therapy
Cognitive Behavioral Therapy
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Developmental Disabilities
 Asperger Syndrome
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders