Clinical trial NCT06194305: Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics
Official title: Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Tourette Syndrome
Persistent Tic Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 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.

Primary outcomes:
measure: Change in the Total Tic Score on the Yale Global Tic Severity Scale (YGTSS).
timeFrame: 27 weeks
Secondary outcomes:
measure: Change resting-state fMRI connectivity of the brain
timeFrame: 27 weeks
measure: neural, behavioral, and psychosocial changes associated with change in tic severity post-CBIT
timeFrame: 27 weeks
measure: Quality of Life: PROMIS Pediatric Profile-49
timeFrame: 27 weeks
measure: Components of CBIT sessions
timeFrame: 27 weeks
measure: Identify CBIT process elements that contribute to response
timeFrame: 27 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California
state: California
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Christine Conelea, PhD, LP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Deanna Greene, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Sonya Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: