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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The CBIT (or CBIT-JR) intervention consists of a minimum of 6 sessions of 50-minutes each week in an individual or group setting.
University of Miami
Coral Gables, Florida, United States
RECRUITINGClinical 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.
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.
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.
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.
Youth Quality of Life (YQOL) Instrument - Short Form (SF) Scores
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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.
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.
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.
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.
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.
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.
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.
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.