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）：本II期SBIR建议在我们成功的I期活动的基础上进行扩展，以完成开发并测试一种针对慢性抽动障碍（CTD;包括抽动秽语障碍）儿童及其家庭的创新计算机治疗产品的疗效。CTD是一类神经精神疾病，发生在0.6%-3%的学龄儿童中，可导致身体，社会，学术和人际功能的严重损害以及生活质量降低。目前，CTD还没有治愈方法，但是在大规模随机对照试验中;一种被称为抽动综合行为干预（CBIT）的非药物治疗被证明可以减少抽动，而没有与药物治疗相关的不良副作用。治疗师指导的，经验验证的CBIT协议是可用的;然而，绝大多数希望CBIT的人没有机会获得在提供这种干预方面受过培训的治疗师。鉴于患有CTD的儿童需要非药物治疗选择、潜在最终用户对此类治疗的渴望以及缺乏接受过充分治疗培训的从业者，显然需要创新的传播模式。在我们最近完成（并成功）的第一阶段项目之后，目前的提案将CBIT干预的两个主要开发商与PsycTech有限公司合作，最终完成开发和测试一个高度可访问和相对便宜的计算机化自助版本的CBIT。我们第一阶段项目的结果表明，TICHELPER的原型版本在可行性、可接受性和可用性方面得到了专业人员和最终用户（CTD儿童及其父母）的高度评价。I期初步研究的结果也表明，TICHELPER可有效减少CTD的核心症状。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，我们将充分开发和测试Tic Helper的功效。该第二阶段提案旨在（1）与最终用户一起使用迭代反馈过程来开发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）转化为自我管理的在线格式，以及（2）在随机对照试验中比较TICHELPER与基于互联网的资源（IBR）条件的疗效。