ClinicalTrials.gg
RecruitingNCT05370391CBITUpdated Jan 29, 2026

Comprehensive Behavioral Intervention for Tics

An interventional study of Comprehensive Behavioral Intervention for Tics (CBIT) in Tic Disorders, sponsored by University of Miami. Recruiting at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by University of Miami · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
5 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tic Disorders

Browse trials for

03

In context

Tic Disorders

102 studies on the registry are indexed under Tic Disorders; 26 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 83 interventional studies indexed under Tic Disorders.

Browse Tic Disorders studies →

Lead sponsor

University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.

Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • A current diagnosis of a (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

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 (to not delay treatment).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study 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.

    Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)

Interventions

  • BehavioralComprehensive 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline CGI-S scores to 12 weeks.

  2. 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

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Secondary outcomes

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

    A 25-item self- and parent-reported scales measuring symptoms of anxiety and depression in youth. Items are rated on a 4-point scale from 1 (Never) to 4 (always) with scores ranging from 0 to 75. A score of 70 or higher indicates high severity, above clinical threshold.

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

  2. Tic Accommodation and Reactions Scale (TARS) Scores

    A 35-item parent-reported measure used to assess reactions and consequences that occur in response to youth' tics. Items focus on events at home, in school, and in other public places. The TARS is rated on a 4-point scale from 0 (not at all in the past week) to 3 (many times in the past week). Scores range from 0 to 105, with higher scores indicating greater frequency of reaction and consequences in response to their child's tics.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2022 (actual). Primary completion is estimated for Jan 2027, 52 months after the start.

Of 39 non-industry interventional studies with no phase under Tic Disorders, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 64. This study's planned 52 months is above that.

Counting every sponsor, half of 39 studies reached it within 28 months; a quarter within 16 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 12, 2022
First posted
May 11, 2022
StartActual
Sep 9, 2022
Primary completionEst.
Jan 31, 2027
CompletionEst.
Jan 31, 2027
Last update
Jan 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05370391
Responsible party
Jill May Ehrenreich (Professor, Department of Psychology, University of Miami) — Principal investigator
First posted
May 11, 2022
Start date
Sep 9, 2022
Primary completion
Jan 31, 2027 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Jan 29, 2026

Study contacts

Danielle Ibarra, Psy.D.
Contact
d.ibarra@umiami.edu
305-284-2712
Madison Bigler, B.A.
Contact
camatprogram@miami.edu
305-284-2712
Jill Ehrenreich-May, Ph.D.
study director · University of Miami

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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