- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486551
Anger Control Training for Youth With Tourette Syndrome
January 27, 2022 updated by: Yale University
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06520
- Yale University School of Medicine, Child Study Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
CGI-I assigned by clinician unaware of treatment assignment
Time Frame: three months
|
three months
|
Parent rated disruptive behavior
Time Frame: three months
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lawrence D Scahill, Ph.D., Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2001
Study Completion (Actual)
January 1, 2006
Study Registration Dates
First Submitted
June 12, 2007
First Submitted That Met QC Criteria
June 13, 2007
First Posted (Estimate)
June 14, 2007
Study Record Updates
Last Update Posted (Actual)
February 11, 2022
Last Update Submitted That Met QC Criteria
January 27, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genetic Diseases, Inborn
- Basal Ganglia Diseases
- Movement Disorders
- Neurodegenerative Diseases
- Heredodegenerative Disorders, Nervous System
- Neurodevelopmental Disorders
- Syndrome
- Disease
- Attention Deficit and Disruptive Behavior Disorders
- Tourette Syndrome
- Tic Disorders
Other Study ID Numbers
- 0102012121
- 1R03MH067845 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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