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

This study is currently recruiting participants.

Verified June 2012 by Yale University

Sponsor:

Information provided by (Responsible Party):

Denis Sukhodolsky, Yale University

ClinicalTrials.gov Identifier:

NCT01631851

First received: June 27, 2012

Last updated: NA

Last verified: June 2012

History: No changes posted

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:

Genetics Home Reference related topics: Asperger syndrome

MedlinePlus related topics: Asperger Syndrome Autism Developmental Disabilities

U.S. FDA Resources

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:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:

Sukhodolsky DG, Vitulano LA, Carroll DH, McGuire J, Leckman JF, Scahill L. Randomized trial of anger control training for adolescents with Tourette's syndrome and disruptive behavior. J Am Acad Child Adolesc Psychiatry. 2009 Apr;48(4):413-21.

Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Stigler KA, Bearss K, Butter E, Swiezy NB, Sukhodolsky DD, Ramadan Y, Pozdol SL, Nikolov R, Lecavalier L, Kohn AE, Koenig K, Hollway JA, Korzekwa P, Gavaletz A, Mulick JA, Hall KL, Dziura J, Ritz L, Trollinger S, Yu S, Vitiello B, Wagner A; the Research Units on Pediatric Psychopharmacology Autism Network. Medication and Parent Training in Children With Pervasive Developmental Disorders and Serious Behavior Problems: Results From a Randomized Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2009 Oct 23; [Epub ahead of print]

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:	June 27, 2012
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 May 23, 2013

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