Recruiting

Comprehensive Behavioral Intervention

Sponsor:

University of Miami

Code:

NCT05370391

Conditions

Tic Disorders

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT)

Study Details

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

Study ID

NCT05370391

Start date

Sep 9, 2022

Status verified date

Jan, 2026

Completion date

Jan 31, 2027

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Not accepted

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Comprehensive Behavioral Intervention for Tics (CBIT)

Experimental: Comprehensive Behavioral Intervention for Tics (CBIT) Group

Participants in this group will receive the CBIT intervention for up to 6 weeks.

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT)

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

Primary outcome measure

  • Clinical Global Impression (CGI) - Severity Scale Scores [ Time Frame: Change from baseline CGI-S scores to 12 weeks. ]
  • Clinical Global Impression (CGI) - Improvement Scores [ Time Frame: Change from baseline CGI-I scores to 12 weeks from the start of treatment. ]
  • Parent Tic Questionnaire (PTQ) [ Time Frame: Change from pre-screen PTQ scores, to baseline, to 6 weeks, and 12 weeks from the start of treatment. ]
  • Premonitory Urge Tic Scale (PUTS) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Change from pre-screen YGTSS Global Severity Score, to 6 weeks, and 12 weeks from the start of treatment. ]

Central Contacts and Locations

Central contacts

Danielle Ibarra, Psy.D.

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

Madison Bigler, B.A.

305-284-2712camatprogram@miami.edu

Locations

University of Miami

Recruiting

Coral Gables, Florida, United States, 33124

Contacts

Madison Bigler, B.A.

3052849852camatprogram@miami.edu

Principal Investigator:

Jill Ehrenreich-May, Ph.D.

More Information

Sponsor

University of Miami

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-01-29.