Voice Over Internet Protocol Delivered Behavior Therapy for Tourette Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks
研究概览
简要总结
The purpose of this research is to examine the preliminary efficacy, feasibility, and acceptability of Voice over Internet Protocol delivered behavior therapy for Tourette Syndrome through in a randomized waitlist-controlled trial.
详细描述
A Comprehensive Behavioral Intervention for Tics (CBIT) is an emerging treatment for children with Tourette Syndrome (TS) and has been shown to be efficacious in separate randomized trials with children and adults; however, many families of children with TS are prevented from accessing it due to limited availability of adequately trained treatment providers. Recent research has shown that videoconference-delivered CBIT is as effective as face to face delivery, and that both modalities are efficacious. Despite its effectiveness, traditional videoconferencing has limitations including lack of portability, ease of access, the need for third party clinics, and cost. A newer, more convenient alternative to increase access is the use of Voice over Internet Protocol (VoIP) transmission, allowing for the direct delivery of CBIT to patients' homes.
Therefore the objective of this study (the final phase of a three-phase project) is to establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition. As an exploratory aim, the current study will investigate potential correlates of treatment outcome, including home computer equipment available (i.e., web camera type, microphone type, internet upload speed, and type of internet connection), prior computer experience, and comfort with study computer equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Resides in the state of Wisconsin
- •Ages 8-17
- •Meets DSM-IV-TR diagnostic criteria for Chronic Tic Disorder (CMVT or TS)
- •Clinical global Impressions - Severity Score greater than or equal to 4 (moderately ill)
- •YGTSS Total Score greater than or equal to 14 and less than 30 OR Total Score greater than or equal to 10 and less than 20 if CTD with motor tics only
- •Unmedicated or on stable medication treatment for tics, OCD, ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for duration of study participation
- •Fluent English speaker
排除标准
- •YGTSS Total Tic Score > 30 (for any score exceeding 30 on the YGTSS, the research team determined the appropriateness of the patient's participation in the study, taking into account the patient's global functioning)
- •WASI-Vocab subtest T-Score < 37
- •DSM-IV substance abuse or dependence or Conduct Disorder within the past 3 months
- •Lifetime DSM-IV diagnosis of Pervasive developmental disorder, Mania, or Psychotic Disorder
- •Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current
- •Previous treatment with HRT for tics (four or more sessions)
- •Lack of a functional, and accessible home computer, and high speed (i.e., cable/DSL) internet connection
- •Refusal to sign a release of information form for the child's local primary care physician, mental health professional, or neurologist.
结局指标
主要结局
Change from baseline in Yale Global Tic Severity Scale (YGTSS) total tic severity scores at 10 weeks
时间窗: Baseline, 10-week (post-treatment)
The YGTSS is a clinician-rated tic severity measure, featuring a total severity score, with a rating from 0 to 50, and independent subtotals for motor and vocal tics each with ratings from 0 to 25. It also features a tic-related 0-50 point impairment scale.
次要结局
- Change from baseline on the Clinical Global Impressions-Severity scale at 10 weeks(Baseline, 10-week (post-treatment))
- Treatment response rate using the Clinical Global Impressions-Improvement scale at 10 weeks(10-week (post-treatment))
研究者
Emily Ricketts
Doctoral Student
University of Wisconsin, Milwaukee