Comprehensive Behavioral Intervention for Tics (CBIT) for Youth With Tics and Related Emotional Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Parent Tic Questionnaire (PTQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: Comprehensive Behavioral Intervention for Tics (CBIT) (Behavioral)
结局指标
主要结局
Parent Tic Questionnaire (PTQ)
时间窗: 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.
Yale Global Tic Severity Scale (YGTSS) - Total Phonic Tic Score
时间窗: 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.
Clinical Global Impression (CGI) - Severity Scale Scores
时间窗: 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
时间窗: 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
Premonitory Urge Tic Scale (PUTS)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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) - Global Severity Score
时间窗: 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.
Yale Global Tic Severity Scale (YGTSS) - Overall Tic Related Impairment Scores
时间窗: 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.
次要结局
- Revised Children's Anxiety and Depression Scale - Child and Revised Parent Short (RCADS-25/RCADS-P-25) Scores(Change from baseline RCADS-P scores, to 6 weeks, to 12 weeks from the start of treatment.)
- Tic Accommodation and Reactions Scale (TARS) Scores(Change from baseline TARS scores, to 6 weeks, to 12 weeks from the start of treatment.)
研究者
Jill May Ehrenreich
Professor, Department of Psychology
University of Miami