Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
Primary Purpose
Autism, Autism Spectrum Disorder (ASD, Asperger's Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy (CBT) for Irritability
Sponsored by
About this trial
This is an interventional treatment trial for Autism focused on measuring Autism, Irritability, Disruptive Behavior, Aggression, Behavior Therapy, Cognitive Behavioral Therapy
Eligibility 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
Sites / Locations
- Yale Child Study Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive behavior therapy
Arm Description
Outcomes
Primary Outcome Measures
ABC Irritability Scale
Parent rating of irritability and disruptive behavior that has been often used in studies with children with ASD
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01631851
Brief Title
Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
Official Title
Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Autism Spectrum Disorder (ASD, Asperger's Disorder, Pervasive Developmental Disorder (PDD-NOS)
Keywords
Autism, Irritability, Disruptive Behavior, Aggression, Behavior Therapy, Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavior therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy (CBT) for Irritability
Other Intervention Name(s)
Anger Control Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
ABC Irritability Scale
Description
Parent rating of irritability and disruptive behavior that has been often used in studies with children with ASD
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Sukhodolsky, Ph.D.
Organizational Affiliation
Yale University, Child Study Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19242384
Citation
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):413-421. doi: 10.1097/CHI.0b013e3181985050.
Results Reference
background
PubMed Identifier
19858761
Citation
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; 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 Dec;48(12):1143-54. doi: 10.1097/CHI.0b013e3181bfd669. Erratum In: J Am Acad Child Adolesc Psychiatry. 2010 Jul;49(7):727.
Results Reference
background
Learn more about this trial
Cognitive-Behavioral Therapy for Irritability in Adolescents With High Functioning Autism Spectrum Disorder
We'll reach out to this number within 24 hrs