Actively Recruiting

Phase 2
Age: 10Years - 17Years
All Genders
ID06194305

Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Led by University of Minnesota · Updated on 2025-07-14

100

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying pediatric patients aged 10 to 17 years with chronic motor and/or vocal tics, including Tourette Syndrome and Persistent Tic Disorder. These conditions can impact daily functioning, emotional health, and quality of life. The study aims to understand which bio-behavioral factors predict and relate to how well patients respond to Comprehensive Behavioral Intervention for Tics (CBIT), a structured treatment focusing on tic management skills. Participants will undergo an 8-session course of CBIT delivered weekly over about 10 weeks. CBIT includes psychoeducation about tics, functional interventions, competing response training to inhibit tics, social support from caregivers or teachers, motivational enhancements, and homework involving self-monitoring and practice. All sessions will be video recorded to analyze treatment components and processes. Throughout the study, participants will be assessed on tic severity using the Yale Global Tic Severity Scale and undergo neural, behavioral, and psychosocial evaluations, including resting-state brain connectivity via fMRI. Quality of life and treatment session components will be measured at 27 weeks to identify factors linked to response. Participants will also complete daily homework logs and have their treatment adherence monitored, with the entire process designed to evaluate the most effective elements of CBIT.

CONDITIONS

Brief Title

Multimodal Profiling of Response to Pediatric Comprehensive Behavioral Intervention for Tics

Who Can Participate

Age: 10Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 10-17 years at time of enrollment.
  • Current chronic motor and/or vocal tics lasting at least 1 year without a tic-free period longer than 3 consecutive months.
  • Tics not caused by a medical condition or substance effects.
  • At least moderate tic severity with Yale Global Tic Severity Scale total score ≥14 (or ≥9 for motor or vocal tics only).
  • Full scale IQ greater than 70.
  • English fluency to understand study measures and instructions.
  • Stable psychotropic medication use for at least 6 weeks with expected stability during the study.
  • Participants receiving non-tic psychotherapy overlapping with CBIT must refrain from such therapy during the study post-enrollment.
  • All concurrent treatments will be monitored.
Not Eligible

You will not qualify if you...

  • Inability to undergo MRI or EEG (e.g., metal in body, claustrophobia, orthodontia).
  • Active suicidality.
  • Previous diagnosis of psychosis, cognitive disability, or structural brain disease that impedes participation.
  • History of seizure disorder.
  • Active substance abuse or dependence.
  • Another psychiatric or medical condition requiring immediate treatment or where delay of treatment for tics is inappropriate.
  • Concurrent psychotherapy focused on tics or overlapping with CBIT.
  • Psychotropic medication changes in the past 6 weeks or planned changes during the study.
  • Four or more previous CBIT sessions attended.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 10 weeks

Participants receive 8 weekly CBIT sessions over 10 weeks involving psychoeducation, functional interventions, competing response training, social support, motivational enhancements, and homework assignments.

8 weekly visits (in-person)

Follow-up

Duration - 17 weeks

Participants are monitored for changes in tic severity, brain connectivity, neural, behavioral, and psychosocial outcomes, and quality of life after completing CBIT.

Trial Site Locations

Total: 2 locations

1

University of California

San Diego, California, United States, 92093

Actively Recruiting

2

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

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Research Team

S

Sonya Wang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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