Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children
Recruitment status was Active, not recruiting
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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 |
- Reduction in tic severity
- Reduction in tic-related impairment and distress (measured at Week 10)
- 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 |
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 |
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| 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 | |
| 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:
|
Tic Disorders Tics Tourette Syndrome Movement Disorders Central Nervous System Diseases Nervous System Diseases Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Signs and Symptoms Basal Ganglia Diseases Brain Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 22, 2013