Back to resultsComprehensive Behavioral Intervention for Tics (CBIT)
Primary Purpose
Tic Disorders
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Behavioral Intervention for Tics (CBIT)
Sponsored by
About this trial
This is an interventional treatment trial for Tic Disorders
Eligibility Criteria
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).
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Comprehensive Behavioral Intervention for Tics (CBIT)
Arm Description
Experimental: Comprehensive Behavioral Intervention for Tics (CBIT) Group Participants in this group will receive the CBIT intervention for up to 6 weeks.
Outcomes
Primary Outcome Measures
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05370391
Brief Title
Comprehensive Behavioral Intervention for Tics
Acronym
CBIT
Official Title
Comprehensive Behavioral Intervention for Tics (CBIT) for Youth With Tics and Related Emotional Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive Behavioral Intervention for Tics (CBIT)
Arm Type
Experimental
Arm Description
Experimental: Comprehensive Behavioral Intervention for Tics (CBIT) Group
Participants in this group will receive the CBIT intervention for up to 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Behavioral Intervention for Tics (CBIT)
Intervention Description
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 Information:
Title
Clinical Global Impression (CGI) - Severity Scale Scores
Description
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.
Title
Clinical Global Impression (CGI) - Improvement Scores
Description
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.
Title
Parent Tic Questionnaire (PTQ)
Description
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.
Title
Premonitory Urge Tic Scale (PUTS)
Description
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.
Title
Youth Quality of Life (YQOL) Instrument - Short Form (SF) Scores
Description
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.
Title
Yale Global Tic Severity Scale (YGTSS) - Total Tic Scores
Description
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.
Title
Yale Global Tic Severity Scale (YGTSS) - Total Motor Tic Scores
Description
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.
Title
Yale Global Tic Severity Scale (YGTSS) - Total Phonic Tic Score
Description
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.
Title
Yale Global Tic Severity Scale (YGTSS) - Overall Tic Related Impairment Scores
Description
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.
Title
Yale Global Tic Severity Scale (YGTSS) - Global Severity Score
Description
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 Outcome Measure Information:
Title
Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores
Description
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.
Title
Tic Accommodation and Reactions Scale (TARS) Scores
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aileen Kangavary, B.A.
Phone
3059849852
Ext
1
Email
camatprogram@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Study Director
Facility Information:
Facility Name
University of Miami
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer M Canovas, B.A.
Phone
305-284-9852
Ext
1
Email
camatprogram@miami.edu
First Name & Middle Initial & Last Name & Degree
Jill Ehrenreich-May, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comprehensive Behavioral Intervention for Tics
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