Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

NCT06194305 | Recruiting Phase 2

• 1 other identifier: NEUR-2023-32286
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Tourette Syndrome; Persistent Tic Disorder

Outcome Measures

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.

  27 weeks

Secondary Outcomes (5)

• Change resting-state fMRI connectivity of the brain

  27 weeks

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

  27 weeks

• Quality of Life: PROMIS Pediatric Profile-49

  27 weeks

• Components of CBIT sessions

  27 weeks

• Identify CBIT process elements that contribute to response

  27 weeks

Study Arms (1)

CBIT group

EXPERIMENTAL

Participants with chronic TICs

Other: CBIT

Interventions

CBIT OTHER

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.

CBIT group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (2)

University of California

San Diego, California, 92093, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Christine Conelea, PhD, LP

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Deanna Greene, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Sonya Wang, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonya Wang, MD

CONTACT

612-301-1454; ticlab@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study does not involve treatment randomization so participants and all study personnel will be aware that participants are receiving CBIT. An Independent Evaluator will conduct pre-, post-treatment and 3-month follow-up assessments. This IE will be masked to information related to CBIT progress (e.g., visit attendance, specific content of sessions, therapist/supervisor perspectives on patient progress, CBIT session documentation). The IE will complete the primary outcome measure (YGTSS).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: January 8, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): February 19, 2029
• Study Completion (Estimated): February 19, 2029
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (2)