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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00486551
Other study ID # 0102012121
Secondary ID 1R03MH067845
Status Completed
Phase N/A
First received
Last updated
Start date August 2001
Est. completion date January 2006

Study information

Verified date January 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 11 Years to 16 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Anger control training


Locations

Country Name City State
United States Yale University School of Medicine, Child Study Center New Haven Connecticut

Sponsors (3)

Lead Sponsor Collaborator
Yale University National Institute of Mental Health (NIMH), Tourette Association of America

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View 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. — View 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. — View 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: 10.109 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary CGI-I assigned by clinician unaware of treatment assignment three months
Primary Parent rated disruptive behavior three months
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