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Anger Control Training for Youth With Tourette Syndrome

Primary Purpose

Tourette Syndrome, Chronic Tic Disorder, Oppositional Defiant Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anger control training
Sponsored by
Yale University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Anger control training, Cognitive behavioral therapy, Behavior therapy, Tourette Syndrome, Randomized trial, Anger, Aggression

Eligibility Criteria

11 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Boys and girls, 11 to 16 years of age.
  2. Diagnosis of Tourette syndrome (TS) or chronic tic disorder (CTD).
  3. Significant level of disruptive behavior

Exclusion Criteria:

  1. Current diagnosis of Severe Major Depression, Bipolar Disorder, Pervasive Developmental Disorder, or Psychotic Disorder.
  2. Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder that may require more pressing treatment.
  3. Initiation or discontinuation of a psychotropic medication treatment within six weeks of enrollment in the study

Sites / Locations

  • Yale University School of Medicine, Child Study Center

Outcomes

Primary Outcome Measures

CGI-I assigned by clinician unaware of treatment assignment
Parent rated disruptive behavior

Secondary Outcome Measures

Full Information

First Posted
June 12, 2007
Last Updated
January 27, 2022
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH), Tourette Association of America
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1. Study Identification

Unique Protocol Identification Number
NCT00486551
Brief Title
Anger Control Training for Youth With Tourette Syndrome
Official Title
Anger Control Training for Youth With Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH), Tourette Association of America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical study of a cognitive-behavioral therapy known as anger control training in adolescents with Tourette Syndrome and explosive, disruptive behavior. ACT is compared to treatment as usual (TAU) in a randomized clinical trial.
Detailed Description
This is a randomized controlled study of a cognitive-behavioral, anger control training (ACT) in adolescents with Tourette Syndrome (TS) complicated by disruptive behavior. Disruptive behaviors in TS may take numerous forms including noncompliance, anger outbursts, and physical aggression. Anger outbursts in TS have been described as rage attacks or rage storms due to their high intensity and unpredictability in response to minimal provocation. Whether these behaviors are part of TS, related to comorbid conditions, or due to the burden of chronic illness is not clear. Nevertheless, these disruptive behaviors can result in significant functional impairment and often require clinical attention. The purpose of the ACT intervention is to improve the explosive and noncompliant behavior in adolescents with TS by enhancing affect regulation and social problem-solving skills. The treatment is based on anger control training which has been empirically supported for reducing aggressive behaviors and improving social functioning in aggressive youths. The primary outcome measures include the parent-rated Oppositional Defiant Scale and the Clinicians Global Improvement Score assessed by a clinician blind to treatment assignment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Chronic Tic Disorder, Oppositional Defiant Disorder, ADHD
Keywords
Anger control training, Cognitive behavioral therapy, Behavior therapy, Tourette Syndrome, Randomized trial, Anger, Aggression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Anger control training
Primary Outcome Measure Information:
Title
CGI-I assigned by clinician unaware of treatment assignment
Time Frame
three months
Title
Parent rated disruptive behavior
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Boys and girls, 11 to 16 years of age. Diagnosis of Tourette syndrome (TS) or chronic tic disorder (CTD). Significant level of disruptive behavior Exclusion Criteria: Current diagnosis of Severe Major Depression, Bipolar Disorder, Pervasive Developmental Disorder, or Psychotic Disorder. Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder that may require more pressing treatment. Initiation or discontinuation of a psychotropic medication treatment within six weeks of enrollment in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis G Sukhodolsky, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence D Scahill, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine, Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12500082
Citation
Sukhodolsky DG, Scahill L, Zhang H, Peterson BS, King RA, Lombroso PJ, Katsovich L, Findley D, Leckman JF. Disruptive behavior in children with Tourette's syndrome: association with ADHD comorbidity, tic severity, and functional impairment. J Am Acad Child Adolesc Psychiatry. 2003 Jan;42(1):98-105. doi: 10.1097/00004583-200301000-00016.
Results Reference
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PubMed Identifier
15930061
Citation
Sukhodolsky DG, do Rosario-Campos MC, Scahill L, Katsovich L, Pauls DL, Peterson BS, King RA, Lombroso PJ, Findley DB, Leckman JF. Adaptive, emotional, and family functioning of children with obsessive-compulsive disorder and comorbid attention deficit hyperactivity disorder. Am J Psychiatry. 2005 Jun;162(6):1125-32. doi: 10.1176/appi.ajp.162.6.1125.
Results Reference
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PubMed Identifier
16554257
Citation
Scahill L, Erenberg G, Berlin CM Jr, Budman C, Coffey BJ, Jankovic J, Kiessling L, King RA, Kurlan R, Lang A, Mink J, Murphy T, Zinner S, Walkup J; Tourette Syndrome Association Medical Advisory Board: Practice Committee. Contemporary assessment and pharmacotherapy of Tourette syndrome. NeuroRx. 2006 Apr;3(2):192-206. doi: 10.1016/j.nurx.2006.01.009.
Results Reference
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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
result
Links:
URL
http://childstudycenter.yale.edu/
Description
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Anger Control Training for Youth With Tourette Syndrome

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