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NCT Number: NCT05370391

Comprehensive Behavioral Intervention for Tics

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.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33124, United States

Location status: Recruiting

Location contact

Jill Ehrenreich-May, Ph.D.

PRINCIPAL_INVESTIGATOR

Madison Bigler, B.A.

CONTACT

[email protected]

3052849852 ext. 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. Clinical Global Impression (CGI) - Severity Scale Scores

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

    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.

  2. Clinical Global Impression (CGI) - Improvement Scores

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

    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

  3. 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.

    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.

  4. Premonitory Urge Tic Scale (PUTS)

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

    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.

  5. 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.

    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.

  6. 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.

    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.

  7. 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.

    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.

  8. 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.

    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.

  9. 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.

    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.

  10. 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.

    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.

Secondary outcomes

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

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

    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.

  2. Tic Accommodation and Reactions Scale (TARS) Scores

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Ibarra, Psy.D.

CONTACT

[email protected]

305-284-2712

Madison Bigler, B.A.

CONTACT

[email protected]

305-284-2712

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Comprehensive Behavioral Intervention for Tics (CBIT) for Youth With Tics and Related Emotional Disorders

Acronym: CBIT

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 11, 2022
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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