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Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Eligibility criteria revisedv8
  2. Re-verified, no change to tracked fieldsv7
  3. Phase: Not applicable to Phase 2v6
  4. Eligibility criteria expanded, about 68 words
    • Site contacts updated at 1 of 2 sites
    v5
  5. Start date: Feb 19, 2024 to Apr 25, 2024v4
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  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jan 1, 2029 to Feb 19, 2029
    • Start date changed from estimate of Jan 15, 2024 to Feb 19, 2024
    • Site details revised at 2 of 2 sites
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Tourette Syndrome and Persistent Motor/Vocal Tic Disorder affect 1-3% of youth and can be associated with impaired functioning, emotional and behavioral problems, physical pain, diminished quality of life, and peer victimization. Chronic tics are the primary symptom. Comprehensive Behavioral Intervention for Tics (CBIT) is a manualized treatment focused on tic management skills. During the core CBIT procedure, competing response training, patients learn to inhibit tics by engaging in a competing motor action. The overall objective of this study is to identify bio-behavioral predictors and correlates of response and the most potent aspects of CBIT. Participants with chronic tics will complete a manualized course of 8-session CBIT. Neural, behavioral, psychosocial, and global functioning will be assessed longitudinally to examine predictors and correlates of response. CBIT sessions will be video recorded. CBIT process will be measured with a video-based behavioral coding scheme that will be refined and validated during years 1-2 using archival CBIT videos
Trial Details
NCT Number NCT06194305
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Tourette Syndrome, Persistent Tic Disorder
Related terms Tourette Syndrome
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov