Understanding how kids respond to a behavioral intervention for tics
Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics
This study is testing a program called CBIT to see if it can help kids aged 10-17 manage their tics better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT06194305 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 10-17 with chronic motor and/or vocal tics that have persisted for at least one year.
Not a fit: Patients whose tics are due to a medical condition or substance effects may not benefit from this study.
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 performed: Previous studies have shown promising results for behavioral interventions like CBIT in managing tics, indicating a potential for success in this approach.
Eligibility criteria
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 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. 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 6 weeks and/or plans to change medication during the study period through post-treatment assessment. * ≥ 4 previous sessions of CBIT.
Where this trial is running
San Diego, California and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.