An interventional study of Comprehensive Behavioral Intervention for Tics in Tourette Syndrome and Tic Disorders, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
This K23 Career Development Award is designed to provide the training needed for the PI to achieve her long-term career goal of conducting independent, programmatic intervention research in developmental populations. The training will emphasize gaining expertise in higher-intensity, multi-method, within-subject data collection and analysis. This award builds on the PI's emerging experience in tic disorders and pediatric behavioral interventions, and her ability to quickly learn and apply advanced statistical methods. The award will extend the PI's training through the following short-term training goals: 1) multi-method data collection and integration (electronic momentary assessment [EMA], wearable devices, neurocognitive tasks), 2) leading and designing pediatric clinical trials, 3) managing and analyzing large, multilevel datasets, and 4) career development and contribution to the field. The PI has developed a training plan to accomplish these goals in concert with her mentors, a team of leading experts in the fields of psychiatry and psychology, who will closely monitor training through regular meetings. The highly structured training plan also includes a set of formal coursework and workshops for each training goal to complement the hands-on experience the PI will gain from leading the research project.
The objective of this proposal is to comprehensively map symptom change across time and during a behavioral intervention for youth with Persistent Tic Disorders (PTDs). PTDs affect approximately 1% of the population, can cause significant disability, have high rates of comorbidity, and are associated with a four-fold increase in suicide risk. Research has established that tic symptoms and their change over time are highly idiographic. However, first-line, evidence-based, existing interventions are "one-size-fits-all," and are only effective for 60% of patients. The current study aims to use advanced statistical methods and a novel theoretical framework to map the stability of tic patterns, along with systemic factors that relate to tic change over time. Study hypotheses, based on the literature and preliminary data, are that a) tic change patterns will be stable before intervention for all participants, b) disruption of stable patterns during the intervention phase will be associated with treatment response, and c) this disruption will depend on the specific driver of tic symptoms pre-intervention. N = 30 youth ages 12-17 with chronic tics will be recruited for the study. There will be three study phases: 1) pre-intervention (4 weeks), 2) intervention (8 weeks), and 3) post-intervention (4 weeks). Before and between each phase, participants will complete 4 traditional assessments to assess symptoms and treatment response. Throughout the 16 weeks of the study, we will collect EMA data focused on factors relevant to tics (4x per day), physiological data from wearable devices (passive, continuous), and neurocognitive task performance and tic video observation (1x per week). Results will inform efforts to develop individualized interventions for individuals with PTDs to improve treatment outcomes.
240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.
This study's planned enrollment of 30 is below the median of 36 across 183 interventional studies indexed under Tourette Syndrome.
Browse Tourette Syndrome studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
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Exclusion Criteria:
behavior therapy for tics
Behavioral: Comprehensive Behavioral Intervention for Tics
All participants will receive 8 sessions of CBIT following a published treatment manual.
Clinical scales of tic change
ecological momentary assessment outcomes of tic change
Time frame: 4 months
Started Mar 2025 (actual). Primary completion is estimated for May 2029, 49 months after the start.
Of 65 non-industry interventional studies with no phase under Tourette Syndrome, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 50. This study's planned 49 months is above that.
Counting every sponsor, half of 65 studies reached it within 33 months; a quarter within 22 and three quarters within 50.
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