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RecruitingNCT06194305Updated Jul 22, 2026

Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

A Phase 2 interventional study of CBIT in Tourette Syndrome and Persistent Tic Disorder, sponsored by University of Minnesota. Recruiting at 2 sites in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-22.

Sponsored by University of Minnesota · Phase 2, Interventional, and Health services research

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
10 Years to 17 Years
Sex
All
01

Study 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

02

Conditions studied

  • Tourette Syndrome
  • Persistent Tic Disorder

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03

In context

Tourette Syndrome

240 studies on the registry are indexed under Tourette Syndrome; 40 are open to participants now.

This study's planned enrollment of 100 is above the median of 36 across 183 interventional studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

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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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 4 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.

Exclusion criteria

Exclusion Criteria:

  • Inability to undergo MRI (e.g., metal in body, claustrophobia, orthodontia) and/or EEG.
  • Active suicidality Previous diagnosis of psychosis, cognitive disability, or structural brain disease that in the investigator opinion would impede participation.
  • History of seizure disorder
  • Active substance abuse or dependence.
  • Presence of another psychiatric or medical condition requiring immediate treatment and/or for which delay of treatment to focus on tics would be clinically inappropriate. Participants will not be excluded for comorbidities that commonly occur with TS (e.g., ADHD, OCD, anxiety) provided that this criterion is met, as only 10-15% of patients with TS have no comorbidities.
  • Concurrent psychotherapy focused on tics and/or involving procedures that overlap with CBIT (e.g., habit reversal therapy, exposure therapy targeting repetitive behaviors).
  • Psychotropic medication changes in the past 4 weeks and/or plans to change medication during the study period through post-treatment assessment.
  • ≥ 4 previous sessions of CBIT.
05

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    CBIT group

    Participants with chronic TICs

    Other: CBIT

Interventions

  • OtherCBIT

    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.

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What researchers measure

Primary outcomes

  1. Change in the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS).

    The YGTSS is a clinician-rated measure that will be scored by a study Independent Evaluator. For each participant, the severity of tics over the past 1 week will be measured using the sing a data-dYGTSS Total Tic Score, which ranges from ranges from 0-50. Outcome will be reported as change from baseline to post-treatment, change from baseline to 1-month post-treatment, and change from post-treatment to 1-month post-treatment.

    Time frame: 27 weeks

Secondary outcomes

  1. Change resting-state fMRI connectivity of the brain

    For each participant, signal intensity (unitless measure) will be measured using fMRI during a state of rest. Signal intensity will be measured within established resting-state brain networks. Analysis will compare within- subject change in signal intensity in these networks from pre- to post treatment; these variables will be entered into multivariate prediction models to identify the relationships between signal intensities and YGTSS Total Tic Scores.

    Time frame: 27 weeks

  2. neural, behavioral, and psychosocial changes associated with change in tic severity post-CBIT

    A data- driven approach will be used to model longitudinal change across multiple key indices to inform reasons for tic severity reduction while identifying therapeutic targets that could be engaged in future research.

    Time frame: 27 weeks

  3. Quality of Life: PROMIS Pediatric Profile-49

    Description: For each participant, quality of life will be measured using the PROMIS Pediatric Profile-49 questionnaire. Each item is scored from 1-5, and scores are added together to measure overall quality of life and functioning across specific domains. Scores will be PROMIS scores will be entered into linear mixed models to see which are related to baseline YGTSS and change in baseline to post-treatment YGTSS.

    Time frame: 27 weeks

  4. Components of CBIT sessions

    Recordings of CBIT session videos will be reviewed to measure the specific components of CBIT that therapists use in units of time (i.e., minutes) and frequency (e.g., number of times the therapist delivers each component across sessions). Generalized linear mixed models will be used to model the association between CBIT components and change on the YGTSS.

    Time frame: 27 weeks

  5. Identify CBIT process elements that contribute to response

    code CBIT session videos to capture observable therapist and patient behaviors.

    Time frame: 27 weeks

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Feb 2029, 57 months after the start.

Of 19 phase 2 interventional studies under Tourette Syndrome, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 42. This study's planned 57 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2023
First posted
Jan 8, 2024
StartActual
Apr 25, 2024
Primary completionEst.
Feb 19, 2029
CompletionEst.
Feb 19, 2029
Last update
Jul 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06194305
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jan 8, 2024
Start date
Apr 25, 2024
Primary completion
Feb 19, 2029 (estimated)
Completion
Feb 19, 2029 (estimated)
Last update
Jul 22, 2026

Study contacts

Sonya Wang, MD
Contact
ticlab@umn.edu
612-301-1454
Christine Conelea, PhD, LP
principal investigator · University of Minnesota
Deanna Greene, PhD
principal investigator · University of California, San Diego
Sonya Wang, MD
principal investigator · University of Minnesota

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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