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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00218777 |
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 |
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Tourette Syndrome Tic Disorders |
Behavioral: Comprehensive Behavioral Intervention for Tics |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Behavior Therapy for Children With Chronic Tic Disorders |
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.
Ages Eligible for Study: | 9 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | R01 MH70802, DSIR 84-CTS |
Study First Received: | September 21, 2005 |
Last Updated: | December 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00218777 History of Changes |
Health Authority: | United States: Federal Government |
Chronic tic disorder Motor tics Vocal tics |
Ganglion Cysts Basal Ganglia Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Neurodegenerative Diseases Brain Diseases Dyskinesias |
Tics Signs and Symptoms Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Movement Disorders Mental Disorders Mental Disorders Diagnosed in Childhood Neurologic Manifestations |
Disease Basal Ganglia Diseases Nervous System Diseases Central Nervous System Diseases Tourette Syndrome Tic Disorders Neurodegenerative Diseases Brain Diseases Dyskinesias Tics |
Signs and Symptoms Heredodegenerative Disorders, Nervous System Pathologic Processes Genetic Diseases, Inborn Movement Disorders Mental Disorders Syndrome Mental Disorders Diagnosed in Childhood Neurologic Manifestations |