Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 10 to 17

Understanding how kids respond to a behavioral intervention for tics

Official title: Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Run by University of Minnesota · NCT06194305 · Data updated 2026-11-12

This study is testing a program called CBIT to see if it can help kids aged 10-17 manage their tics better.

Quick facts

PhasePhase 2
Study typeInterventional
Ages10 Years to 17 Years
SexAll
Enrollment100 (estimated)
SponsorUniversity of Minnesota
Academic / other
Locations2 sites (San Diego, California and 1 other locations)
StatusRecruiting
StartedApril 25, 2024
Main results expectedFebruary 19, 2029
Study endsFebruary 19, 2029
Registry record updatedJuly 22, 2026
Trial IDNCT06194305 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 10-17 with chronic motor and/or vocal tics that have persisted for at least one year.

Probably not a fit

Patients whose tics are due to a medical condition or substance effects may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Comprehensive Behavioral Intervention for Tics (CBIT) in children aged 10-17 with chronic motor and/or vocal tics. Participants will undergo an 8-session manualized CBIT program, which focuses on teaching tic management skills through competing response training. The study aims to identify bio-behavioral predictors of response to the intervention by assessing neural, behavioral, psychosocial, and global functioning over time. Video recordings of the sessions will be analyzed to measure the CBIT process and its impact on tic severity.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for children with Tourette Syndrome and Persistent Tic Disorder, enhancing their quality of life.

How similar studies have gone: Previous studies have shown promising results for behavioral interventions like CBIT in managing tics, indicating a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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:

* 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.

Where it's running

  • University of California
    San Diego, California, United States
    Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States
    Recruiting

Study contacts

  • Principal investigator: Christine Conelea, PhD, LP — University of Minnesota
  • Study coordinator: Sonya Wang, MD
  • Email: ticlab@umn.edu
  • Phone: 612-301-1454

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.