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

December 10, 2015 updated by: John Piacentini, Tourette Association of America

Behavior Therapy for Children With Chronic Tic Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

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

  • United States
    • California
      • Los Angeles, California, United States, 90402
        • UCLA Child OCD, Anxiety, and Tic Disorders Program
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53211
        • University of Wisconsin-Milwaukee

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

9 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in tic severity
Time Frame: 10-22 weeks
10-22 weeks
Reduction in tic-related impairment and distress (measured at Week 10)
Time Frame: measured at week 10
measured at week 10

Secondary Outcome Measures

Outcome Measure
Time Frame
Tic severity and associated impairment and distress (measured at Week 36 follow-up)
Time Frame: measured at week 36 follow-up
measured at week 36 follow-up
Changes in neurocognitive function (measured at Week 10)
Time Frame: measured at week 10
measured at week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tourette Association of America

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: John Piacentini, PhD, University of California at Los Angeles

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

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

December 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

December 14, 2015

Last Update Submitted That Met QC Criteria

December 10, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH070802 (U.S. NIH Grant/Contract)
  • DSIR 84-CTS (Division of Services and Intervention Research)

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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