Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• Age 10-17 years at time of enrollment.

• Current chronic motor and/or vocal tics, defined as tics for at least 1 year without a tic-free period of more than 3 consecutive months. Tics must not be due to a medical condition or the direct physiological effects of a substance.

• At least moderate tic severity, defined as a Yale Global Tic Severity Scale total score ≥14 (≥9 for those with motor or vocal tics only).

• Full scale IQ greater than 70.

• Child participant required to have English fluency to ensure comprehension of study measures and instructions.

• To increase external validity of findings, we will include participants taking psychotropic medications that have been stable for 6 weeks and expect to remain stable for the study period. Individuals receiving non-tic related psychotherapy involving procedures that overlap with CBIT can be eligible to participate if they refrain from receiving treatment once enrolled through the post-treatment assessment. All concurrent treatments will be monitored.

Locations
United States
California
University of California
RECRUITING
San Diego
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Sonya Wang, MD
ticlab@umn.edu
612-301-1454
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2029-02-19
Participants
Target number of participants: 100
Treatments
Experimental: CBIT group
Participants with chronic TICs
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov

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