Comprehensive Behavioral Intervention for Tics

BEHAVIORAL

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.