Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Part of paid clinical trials in San Diego, California.

Sponsor
University of Minnesota
Study ID
NCT06194305
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • CBIT — OTHER
    Participants will receive 8 sessions delivered weekly over 10 weeks. All sessions will be video recorded. CBIT components are: 1) Psychoeducation about tics, 2) Functional interventions, 3) Competing response (CR) training, 4) Social support: supportive people (e.g., parent, teacher) , 5) Motivational enhancements, 6) Homework: is assigned each session and typically involves self-monitoring and CR practice. Participants will complete a brief daily homework tracking log in REDCap.

Study Details

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

Key Dates

Start date
Apr 25, 2024
Status verified
Jul 2025
Primary completion
Feb 19, 2029
Completion
Feb 19, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: CBIT group
    Participants with chronic TICs

Primary Outcome Measure

Change in the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS). [ Time Frame: 27 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of CaliforniaSan DiegoCalifornia92093
Deanna Greene, PhD
[email protected]
Deanna Greene, PhD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55414
Christine Conelea, PhD, LP (PRINCIPAL_INVESTIGATOR)

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By research site
University of California· San Diego, CAUniversity of Minnesota· Minneapolis, MN

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