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

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Brief Title

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

Official Title

Behavior Therapy for Children With Chronic Tic Disorders

Brief Summary

      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.
    

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 Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Reduction in tic severity

Secondary Outcome

 Tic severity and associated impairment and distress (measured at Week 36 follow-up)

Condition

Tourette Syndrome

Intervention

Comprehensive Behavioral Intervention for Tics


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

120

Start Date

December 2004

Completion Date

May 2007

Primary Completion Date

May 2007

Eligibility 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
      

Gender

All

Ages

9 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

John Piacentini, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00218777

Organization ID

R01MH070802

Secondary IDs

R01MH070802

Responsible Party

Principal Investigator

Study Sponsor

Tourette Association of America

Collaborators

 National Institute of Mental Health (NIMH)

Study Sponsor

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


Verification Date

December 2015