Creating a computerized self-administered version of Comprehensive Behavioral Int

创建综合行为智能的计算机化自我管理版本

• 批准号: 8848891
• 负责人: Michael B Himle
• 金额: $ 42.05万
• 依托单位: PSYC TECH, LTD
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8848891
• 关键词: Address; Adrenergic Agonists; Adverse effects; Adverse event; Age; Antipsychotic Agents; Area; Award; Behavior Therapy; Behavioral; Child; Chronic; Clinical; Clinical Trials; Comorbidity; Computers; Data; Development; Disease; Dose; Family; Feedback; Fees; Frequencies; Gilles de la Tourette syndrome; Habits; Health; Impairment; Individual; Internet; Intervention; Lead; Marketing; Measures; Medication Management; Modeling; Monitor; Motor Tics; Parents; Participant; Patients; Pattern; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Pilot Projects; Process; Protocols documentation; Provider; Quality of life; Randomized Clinical Trials; Randomized Controlled Trials; Relaxation Therapy; Research; Resources; School-Age Population; Self-Administered; Severities; Site; Small Business Innovation Research Grant; Strategic Planning; Symptoms; Testing; Therapeutic; Tic disorder; Time; Training; Travel; Visit; Vocal Tics; Work; active method; base; commercialization; comparative efficacy; computerized; cost; cost effective; efficacy testing; follow-up; impression; improved; indexing; innovation; neuropsychiatry; preference; programs; prototype; psychosocial; response; satisfaction; secondary outcome; self help; social; usability

DESCRIPTION (provided by applicant): This Phase II SBIR proposes to expand upon our successful Phase I activities to finalize development and test the efficacy of an innovative computer-based treatment-delivery product for children with Chronic Tic Disorders (CTD; including Tourette Disorder) and their families. CTD represents a class of neuropsychiatric disorders, occurring in 0.6-3% of school-aged children that can lead to significant impairments in physical, social, academic, and interpersonal functioning and reduced quality of life. Currently, there is no cure for CTD, however in large-scale randomized controlled trials; a non-pharmacological treatment known as Comprehensive Behavioral Interventions for Tics (CBIT) was shown to reduce tics without the adverse side effects associated with pharmacotherapy. A therapist-guided, empirically validated CBIT protocol is available; however the vast majority of individuals who desire CBIT do not have access to therapists trained in the delivery of this intervention. Given the need for non-pharmacological treatment options for children with CTD, a desire for such treatments by potential end-users, and the absence of practitioners adequately trained in the treatment, there is a clear need for innovative modes of dissemination. Following our recently completed (and successful) Phase I project, the current proposal partners two of the primary developers of the CBIT intervention with PsycTech Ltd., to finalized development and test a highly accessible and relatively inexpensive computerized self-help version of CBIT. Results from our Phase I project demonstrated that a prototype version of TICHELPER received high ratings from both professionals and end-users (children with CTD and their parents) on indices of feasibility, acceptability, and usability. Results from the Phase I pilot study also sho that TICHELPER was effective for reducing core CTD symptoms. Phase I results strongly justify Phase II, during which we will fully develop and test the efficacy of Tic Helper. This Phase II proposal aims to (1) use an iterative feedback process with end-users to develop the remaining core components of the CBIT protocol (i.e., relaxation training, function-based intervention, and the fully developed habit reversal module to address core CTD symptoms) into a self-administered online format, and (2) to compare the efficacy of TICHELPER to an Internet-Based Resources (IBR) condition in a randomized controlled trial.

描述(由申请人提供)：该第二阶段SBIR计划扩展我们成功的第一阶段活动，以最终完成开发并测试一种创新的基于计算机的治疗-交付产品的有效性，该产品适用于患有慢性抽动障碍(CTD；包括抽动障碍)的儿童及其家庭。CTD是一种神经精神障碍，发生在0.6%-3%的学龄儿童中，可导致身体、社会、学习和人际功能的严重障碍，并降低生活质量。然而，在大规模的随机对照试验中，目前还没有治愈CTD的方法；一种被称为抽搐综合行为干预(CBIT)的非药物治疗被证明可以减少抽搐，而不会出现与药物治疗相关的不良副作用。治疗师指导的、经验性验证的CBIT方案是可用的；然而，绝大多数希望CBIT的人无法接触到接受过这种干预提供培训的治疗师。鉴于CTD儿童需要非药物治疗方案，潜在的最终用户希望进行这种治疗，而且缺乏受过充分治疗培训的从业人员，因此显然需要创新的传播方式。继我们最近完成(并成功)的第一阶段项目之后，目前的提案与两名CBIT干预的主要开发人员一起与心理技术有限公司合作，以完成开发并测试高度可访问且相对便宜的CBIT自助计算机化版本。我们第一阶段项目的结果表明，TICHELPER的原型版本在可行性、可接受性和可用性指标上获得了专业人员和最终用户(CTD儿童及其父母)的高度评价。第一阶段试点研究的结果还表明，TICHELPER在减少核心CTD症状方面是有效的。第一阶段的结果有力地证明了第二阶段的合理性，在此期间，我们将全面开发和测试Tic Helper的疗效。这项第二阶段的建议旨在(1)使用与最终用户的迭代反馈过程，将CBIT协议的其余核心组件(即放松训练、基于功能的干预和完全开发的习惯逆转模块以解决核心CTD症状)开发为自我管理的在线形式，以及(2)在随机对照试验中比较TICHELPER和基于互联网的资源(IBR)条件的疗效。