NCT00486551

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

First QC Date

June 12, 2007

Last Update Submit

January 27, 2022

Conditions

Tourette SyndromeChronic Tic DisorderOppositional Defiant DisorderADHD

Keywords

Anger control trainingCognitive behavioral therapyBehavior therapyTourette SyndromeRandomized trialAngerAggression

Outcome Measures

Primary Outcomes (2)

  • CGI-I assigned by clinician unaware of treatment assignment

    three months

  • Parent rated disruptive behavior

    three months

Interventions

Anger control trainingBEHAVIORAL

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale University School of Medicine, Child Study Center

New Haven, Connecticut, 06520, United States

Location

Related Publications (4)

  • 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.

    PMID: 12500082BACKGROUND

  • 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.

    PMID: 15930061BACKGROUND

  • 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.

    PMID: 16554257BACKGROUND

  • 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.

    PMID: 19242384RESULT

Related Links

MeSH Terms

Conditions

Tourette SyndromeTic DisordersOppositional Defiant DisorderAttention Deficit Disorder with HyperactivityAggression

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Denis G Sukhodolsky, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

  • Lawrence D Scahill, Ph.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2007

First Posted

June 14, 2007

Study Start

August 1, 2001

Study Completion

January 1, 2006

Last Updated

February 11, 2022

Record last verified: 2022-01

Locations

US(1)