Creating a Computerized Self-administered Version of Comprehensive Behavioral Intervention for Tics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
研究概览
简要总结
Tic Disorders (including Tourette Disorder) are relatively common in school-age children and for some children can lead to significant psychosocial and physical impairment and diminished quality of life. Non-pharmacological treatments have been shown to be effective for reducing tics in some children. These treatment options are desired by parents, but are not widely available. The investigators recently developed an online, computerized, self-administered version of CBIT called TicHelper.com. The current study will test the efficacy of TicHelper.com in a randomized clinical trial.
详细描述
Effective non-pharmacological treatment options such as comprehensive behavioral intervention for tics (CBIT) have been shown to be effective for reducing tics in some children with chronic tic disorders, including Tourette's disorder. Although effective, many parents and children do not have access to a provider trained in these therapies and practical barriers such as travel and high costs for ongoing therapy limit treatment dissemination and utilization.The investigators recently developed an online, computerized, self-administered version of CBIT called TicHelper.com. This program is an 8-week online program designed to teach children and families empirically-supported tic management skills. The current study will test the efficacy of TicHelper.com in a randomized clinical trial in which 64 children with Tourette's Disorder or a persistent (chronic) tic disorder will be randomly assigned to 8-weeks of TicHelper.com (N=32) or an 8-week internet resource control condition (N=32). Tic symptoms will be assessed by a condition-blind independent evaluator at baseline, post-treatment, and 1-month follow-up. Information regarding patient acceptability of the program will also be collected. This project will test whether TicHelper.com is an efficacious and acceptable way to teach tic-management skills for children with tics.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child and parent are English speaking.
- •Child meets diagnostic criteria for Tourette's disorder or persistent (chronic) motor or vocal tic disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition.
- •Child scores >70 on a brief intelligence test
- •Child currently engages in at least one motor and/or vocal tic multiple times per day
- •Clinician rated tic severity score of > 3 (mildly ill or worse)
- •Child is unmedicated for tics or associated conditions or has been on stable psychotropic medication for at least 6 weeks with no changes or planned changes in dosage.
- •Family has daily access to a personal computer with internet access and software meeting TicHelper minimum system requirements.
排除标准
- •A Yale-Global Tic Severity Scale (YGTSS) score > 30
- •Child scores < 70 on intelligence test
- •Child meets diagnostic criteria for substance abuse or dependence or conduct disorder (within past 3 months) according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition.
- •Current or past non-drug treatment for tics that consisted of 4 or more sessions of habit reversal training or CBIT.
- •Child has lifetime diagnosis of mania or psychotic disorder
- •Child has any serious psychiatric or neurological condition not currently being managed, managed ineffectively, or requiring more immediate treatment other than that provided by the study.
研究组 & 干预措施
TicHelper
In this condition, participants will be provided with a secure username and login information for TicHelper.com. Participants will be asked to log in and use TicHelper.com for 8 weeks as instructed by the program (TicHelper recommends 30-60 minutes of website and therapeutic activity per day). TicHelper.com consists of 3 modules: Education, Assessment, and Intervention. The education module provides information about tic disorders and treatment. The assessment module tracks progress through the program. The intervention module uses interactive activities to teach tic management skills including habit reversal training (HRT). During HRT, patients learn to become more aware of tics and pre-tic sensations and to subsequently interrupt tics. Participants will also learn ways to interact with each other regarding tics, to identify and alter tic-worsening factors, and relaxation strategies to reduce stress.
干预措施: TicHelper (Behavioral)
Internet-Based Resources Condition
Participants who are assigned to the Internet-Based Resources (IBR) condition will receive a collection of materials with inks to the best available online resources about tic disorders and their treatment. The sites that are provided use a variety of online print, video, and animation materials to teach patients about various aspects of chronic tic disorders and their management. Participants will will be asked to explore and use the website information over the course of 8 weeks in any manner they find helpful. Participants will be asked to spend 30-60 minutes per day reviewing and discussing the information provided.
干预措施: Internet Based Resources (Other)
结局指标
主要结局
Change in the Total Tic Severity Score on the Yale Global Tic Severity Scale (YGTSS)
时间窗: Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up)
Clinician interview to assess overall severity of tics
次要结局
- Change in overall tic severity on the Clinician Global Impressions-Severity Scale(Baseline, Week 8 (post-treatment), Week 12 (1-month follow-up))
- Clinician Global Impressions-Improvement Scale(Week 8 (post-treatment))
- Clinician Global Impressions- Improvement Scale(Week 12 (1-month follow-up))
研究者
Mike Himle
Associate Professor
University of Utah