Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

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

Study Overview

• Status: Recruiting
• Conditions: Tourette Syndrome; Persistent Tic Disorder
• Intervention / Treatment: Other: CBIT

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sonya Wang, MD; Phone Number: 612-301-1454; Email: ticlab@umn.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92093
      • Recruiting
      • University of California
      • Contact: Deanna Greene, PhD; Email: deannagreene@ucsd.edu
      • Principal Investigator: Deanna Greene, PhD
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Principal Investigator: Christine Conelea, PhD, LP
      • Contact: Sonya Wang; Email: ticlab@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CBIT group; Participants with chronic TICs

Other: CBIT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	27 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	27 weeks
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.	27 weeks
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.	27 weeks
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.	27 weeks
Identify CBIT process elements that contribute to response	code CBIT session videos to capture observable therapist and patient behaviors.	27 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Sonya Wang, MD, University of Minnesota; Principal Investigator: Christine Conelea, PhD, LP, University of Minnesota; Principal Investigator: Deanna Greene, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2024
• Primary Completion (Estimated): February 19, 2029
• Study Completion (Estimated): February 19, 2029

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 14, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Genetic Diseases, Inborn; Neurodegenerative Diseases; Neurodevelopmental Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Basal Ganglia Diseases; Tic Disorders; Tourette Syndrome
• Other Study ID Numbers: NEUR-2023-32286

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No