Chronic tic disorders (CTD), including Tourette Syndrome (TS), are neurobehavioral disorders characterized by a persistent pattern of motor and vocal tics. Tics can be brief, rapid and darting movements or more complex and purposeful in appearance. Vocal tics can be simple (e.g., sniffing, grunting) or more complex sounds (e.g., words and phrases). Tics wax and wane over time with peak severity in early teens. Childhood tic disorders can be associated with considerable distress, discrimination, and social and academic impairment, with impairment into adulthood observed in some cases. The exact causes of CTD are unknown with both genetic and environmental factors implicated in etiology. Substantial evidence implicates dysfunction of cortical-subcortical pathways involving the thalamus, basal ganglia and the frontal cortex. Behavioral/environmental factors may play a role in tic maintenance and generalization. The standard treatment for tic suppression is medication, particularly centrally acting dopamine blocking drugs. However, these medications are associated with a range of adverse effects that can result in poor compliance and premature treatment termination. Preliminary work by investigators listed on this application suggests that habit reversal training (HRT) is a promising intervention for tics. HRT is a multicomponent behavioral treatment based on awareness training and competing response. It can be applied in combination with medication and/or as a monotherapy. While initial HRT results are encouraging, studies to date have all been case studies or small randomized trials. Large trials are needed to demonstrate HRT efficacy. In response to PA 00-094 (Early Identification and Treatment of Mental Disorders in Children and Adolescents), this application describes a multisite investigation to evaluate the efficacy of a manualized HRT program for tic reduction in youngsters with CTD. To conduct this study, the Tourette Syndrome Association (TSA) assembled a Behavioral Sciences Consortium (BSC), a multidisciplinary group of investigators representing some of the leading TS research programs in the country including Yale, Massachusetts General Hospital (MGH)/Harvard, UCLA, and Johns Hopkins. Two additional centers, Wilford Hall Medical Center (WHMC) and the University of Wisconsin-Milwaukee (UWM), have investigators with specific expertise in HRT. The mission of the BSC is to develop, test, and disseminate behavioral interventions for patients with CTD. In this study, 120 youngsters with CTD will be randomly assigned to 8 sessions (10 weeks) of HRT or comparison psychosocial treatment followed by 3 monthly booster sessions for responders. The primary outcome will be change in tic severity assessed by blind clinician raters. The effects on overall functioning, quality of life, and possible predictors of treatment outcome will also be explored. Working under subcontract to TSA, JHU, UCLA, and UWM will serve as recruitment sites while investigators from MGH, WHMC, and Yale will provide specific quality assurance and assessment services via separate subcontracts, and a DSMB will be assembled for data and safety monitoring purposes. The Yale Infomatics group will provide data management services.
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