Comprehensive Behavioral Intervention for Tics

NCT05370391 | Recruiting

• 1 other identifier: 20210853
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this protocol is to examine treatment outcomes of youth receiving the Comprehensive Behavioral Intervention for Tics (CBIT) and better understand the predictors, moderators, mediators and/or mechanisms of change for this intervention.

Conditions

Tic Disorders

Outcome Measures

Primary Outcomes (10)

• Clinical Global Impression (CGI) - Severity Scale Scores

  A single-item clinician-reported measure used to assess the severity of the youth's illness at the time of assessment. The CGI-S is rated on a 7-point scale ranging from 1 (slight psychiatric illness) to 7 (extremely severe psychiatric illness). Higher scores indicate greater symptom severity.

  Change from baseline CGI-S scores to 12 weeks.

• Clinical Global Impression (CGI) - Improvement Scores

  A single-item clinician-reported measure used to assess clinical changes in youth symptomology over the course of treatment. The CGI-I is rated on a 7-point scale ranging from 1 (very much improved since the initiation of treatment) to 7 (very much worse since the initiation of treatment). Higher scores indicate greater symptom improvement since baseline

  Change from baseline CGI-I scores to 12 weeks from the start of treatment.

• Parent Tic Questionnaire (PTQ)

  A 28-item parent-reported measure used to assess the frequency and intensity of different motor and vocal tic symptoms in youth. The PTQ evaluates tic frequency on a 4-point scale, ranging from 1 (constant) to 4 (weekly), and intensity on a 3-point scale, ranging from 1 (mild) to 3 (very noticeable). This is done for each presenting tic. Composite total scores on the PTQ range from 2-138. Higher summed composite score indicating more tics.

  Change from pre-screen PTQ scores, to baseline, to 6 weeks, and 12 weeks from the start of treatment.

• Premonitory Urge Tic Scale (PUTS)

  A 10-item self-reported measure that assess the severity of premonitory urges. The PUTS is rated on a 4-point scale ranging from 1 (not at all true) to 4 (very much true). Total scores range from 10-40 with higher scores indicating greater symptom severity.

  Change from baseline PUTS scores, to 6 weeks, to 12 weeks from the start of treatment.

• Youth Quality of Life (YQOL) Instrument - Short Form (SF) Scores

  A 15-item self-reported measure of quality of life for youth ages 11-18. The YQOL-SF is rated on a 10-point scale from 0 (not at all) to 10 (very much). Scores range from 0 to 100, with higher scores indicating a higher quality of life.

  Change from baseline YQOL Scores, to 6 weeks, to 12 weeks from the start of treatment.

• Yale Global Tic Severity Scale (YGTSS) - Total Tic Scores

  The YGTSS is a clinician-rated interview assessing both motor and phonic tic symptoms across 5 domains: total number, frequency, intensity, complexity, and interference. Items from each domain for motor and phonic tics are summed to produce the YGTSS Total Tic Score, which ranges from 0-50. Higher scores on the YGTSS - Total Tic Score suggests greater tic severity.

  Change from pre-screen YGTSS Total Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.

• Yale Global Tic Severity Scale (YGTSS) - Total Motor Tic Scores

  The YGTSS is a clinician-rated interview assessing both motor and phonic tic symptoms across 5 domains: total number, frequency, intensity, complexity, and interference. Items from each domain for motor tics are summed to produce the YGTSS Total Motor Tic Score, which ranges from 0-25. Higher scores on the YGTSS - Total Motor Score suggests greater motor tic severity.

  Change from pre-screen YGTSS Total Motor Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.

• Yale Global Tic Severity Scale (YGTSS) - Total Phonic Tic Score

  The YGTSS is a clinician-rated interview assessing both motor and phonic tic symptoms across 5 domains: total number, frequency, intensity, complexity, and interference. Items from each domain for phonic tics are summed to produce the YGTSS Total Phonic Tic Score, which ranges from 0-25. Higher scores on the YGTSS - Total Phonic Score suggests greater phonic tic severity.

  Change from pre-screen YGTSS Total Phonic Tic Scores, to 6 weeks, and 12 weeks from the start of treatment.

• Yale Global Tic Severity Scale (YGTSS) - Overall Tic Related Impairment Scores

  The YGTSS is a clinician-rated interview assessing both motor and phonic tic symptoms across 5 domains: total number, frequency, intensity, complexity, and interference. The YGTSS includes a separate impairment scale that reflects overall tic-related impairment, ranging from 0-50. Higher scores on this scale suggests greater tic impairment.

  Change from YGTSS Overall Tic Related Impairment Scores pre-screen, to 6 weeks, and 12 weeks from the start of treatment.

• Yale Global Tic Severity Scale (YGTSS) - Global Severity Score

  The YGTSS is a clinician-rated interview assessing both motor and phonic tic symptoms across 5 domains: total number, frequency, intensity, complexity, and interference. The YGTSS includes a separate global severity scale that ranges from 0-100. Higher scores on this scale suggests greater global tic severity.

  Change from pre-screen YGTSS Global Severity Score, to 6 weeks, and 12 weeks from the start of treatment.

Secondary Outcomes (2)

• Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores

  Change from baseline RCADS-P scores, to 6 weeks, to 12 weeks from the start of treatment.

• Tic Accommodation and Reactions Scale (TARS) Scores

  Change from baseline TARS scores, to 6 weeks, to 12 weeks from the start of treatment.

Study Arms (1)

Comprehensive Behavioral Intervention for Tics (CBIT)

EXPERIMENTAL

Experimental: Comprehensive Behavioral Intervention for Tics (CBIT) Group Participants in this group will receive the CBIT intervention for up to 6 weeks.

Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT) BEHAVIORAL

The CBIT (or CBIT-JR) intervention consists of a minimum of 6 sessions of 50-minutes each week in an individual or group setting.

Comprehensive Behavioral Intervention for Tics (CBIT)

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A current diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Tic disorder (e.g., Tourette's Disorder/syndrome, Persistent (Chronic) Motor or Vocal Tic Disorder, or Provisional Tic Disorder) or caregiver/youth report of clinically impairing tic symptoms
• Ability for youth to speak/read English sufficiently
• At least one parent/caregiver available to sign study consent forms, remain present during assessments, and fill out study questionnaires in English.

You may not qualify if:

• A current diagnosis of psychosis, bipolar disorder, intellectual disability, acute suicidality, alcohol/substance dependence, or eating disorder.
• Youth currently receiving psychotherapy elsewhere and/or have previously received CBIT.
• Currently suicidal or who have engaged in suicidal behaviors within the past 6 months will be excluded
• Youth currently taking psychotropic medication for a co-morbid psychiatric illness will be included without a wash-out period (to not delay treatment).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33124, United States

RECRUITING

MeSH Terms

Conditions

Tic Disorders

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jill Ehrenreich-May, Ph.D.

  University of Miami

  STUDY DIRECTOR

Central Study Contacts

Danielle Ibarra, Psy.D.

CONTACT

305-284-2712; d.ibarra@umiami.edu

Madison Bigler, B.A.

CONTACT

305-284-2712; camatprogram@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Psychology

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 11, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)