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Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Institute of Mental Health (NIMH).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00218777
First received: September 21, 2005
Last updated: December 4, 2007
Last verified: April 2007
  Purpose

This study will determine the effectiveness of cognitive behavior therapy (CBT) with habit reversal training (HRT) in treating chronic tic disorders (CTDs) in children and adolescents.


Condition Intervention Phase
Tourette Syndrome
Tic Disorders
Behavioral: Comprehensive Behavioral Intervention for Tics
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Behavior Therapy for Children With Chronic Tic Disorders

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Reduction in tic severity
  • Reduction in tic-related impairment and distress (measured at Week 10)

Secondary Outcome Measures:
  • Tic severity and associated impairment and distress (measured at Week 36 follow-up)
  • Changes in neurocognitive function (measured at Week 10)

Estimated Enrollment: 120
Study Start Date: December 2004
Detailed Description:

CTDs and Tourette syndrome are neurobehavioral disorders that are characterized by a persistent pattern of motor and vocal tics. Tics are intermittent movements or sounds that occur repeatedly. They can be either brief, rapid, and darting movements or more purposeful movements, such as repetitively locking and unlocking a door. Vocal tics can be simple, as in sniffing or grunting, or more complex, such as complete words or phrases. Tic disorders can cause considerable distress in affected children, and can lead to social and academic impairment. If left untreated, CTDs can last into adulthood. The standard treatment for suppressing CTDs is medication; dopamine-blocking drugs are used most commonly. These medications, however, are associated with a range of adverse effects that can result in poor treatment compliance and premature treatment termination. Recent research suggests that HRT may be an effective, lower risk treatment for CTDs. HRT is a behavioral treatment based on increasing awareness of one's behaviors and replacing unwanted behaviors with less bothersome ones. This study will determine the effectiveness of CBT with HRT in treating CTDs in children and adolescents.

Participants in this double blind study will be randomly assigned to receive either CBT plus HRT or standard care, which will consist of psychoeducation and supportive therapy. All participants will partake in 8 sessions of their assigned therapy over the course of 10 weeks. After the initial 10 weeks, those who responded to treatment will report back to the study site for 3 monthly booster sessions. Changes in tic severity, effects of the therapies on overall functioning and quality of life, and possible predictors of treatment outcome will be assessed.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets DSM-IV diagnostic criteria for chronic tic disorder (chronic motor or vocal tic disorder or Tourette syndrome)
  • Score of at least 3 on the Clinical Global Impressions Severity Scale
  • Score of at least 14 on the Yale Global Tic Severity Scale (YGTSS) or at least 10 for individuals with motor tics only
  • Unmedicated or currently on a stable medication treatment for tics, obsessive compulsive disorder (OCD), ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for the duration of study participation
  • Child speaks English

Exclusion Criteria:

  • Score greater than 30 on the YGTSS
  • IQ less than 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
  • Meets DSM-IV criteria for substance abuse or dependence within the 3 months prior to study entry
  • Meets DSM-IV criteria for conduct disorder within the 3 months prior to study entry
  • Lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, or psychotic disorder
  • Any serious psychiatric, psychosocial, or neurological condition (i.e., OCD, ADHD, major depressive disorder, anxiety, severe aggression, or family discord) requiring immediate treatment other than what is provided in the current study (i.e., medication, school intervention, or family therapy)
  • Previous treatment with four or more sessions of HRT for tics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218777

Locations
United States, California
UCLA Child OCD, Anxiety, and Tic Disorders Program
Los Angeles, California, United States, 90402
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Wisconsin
University of Wisconsin-Milwaukee
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Investigators
Principal Investigator: John Piacentini, PhD University of California at Los Angeles
  More Information

Additional Information:
No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00218777     History of Changes
Other Study ID Numbers: R01 MH70802, DSIR 84-CTS
Study First Received: September 21, 2005
Last Updated: December 4, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Chronic tic disorder
Motor tics
Vocal tics

Additional relevant MeSH terms:
Disease
Tic Disorders
Tics
Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Mental Disorders Diagnosed in Childhood
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014