Developing and Testing the Feasibility of Voice Over Internet Protocol Delivered

抽动症综合行为干预(CBIT)是一种治疗多发性抽动症(TS)儿童的新兴疗法，在儿童和成人的单独随机试验中被证明是有效的；然而，由于受过充分培训的治疗提供者的供应有限，许多TS儿童家庭无法获得该疗法。最近的研究表明，视频会议提供的CBIT与面对面提供的CBIT一样有效，而且这两种方式都很有效。尽管传统的视频会议很有效，但它也有局限性，包括缺乏便携性、访问简便性、需要第三方诊所以及成本。增加接入的一个更新、更方便的替代方案是使用互联网协议语音(VoIP)传输，允许将CBIT直接发送到患者家中。因此，拟议研究的广泛和长期目标是通过开发和测试VoIP交付的CBIT的可行性和初步效果来增加获得CBIT的机会。具体地说，本项目旨在修改现有的CBIT协议，以通过VoIP实施抽搐，评估抽动严重程度评定量表、耶鲁大学全球抽动严重程度量表(YGTSS)通过VoIP和面对面实施的跨模式可靠性，确定VoIP修改版本的CBIT的可接受性、可用性和可行性，并建立与等待名单控制条件相比，VoIP修改的CBIT在减少TS儿童抽搐方面的初步疗效。作为一个探索性目标，本研究将调查治疗结果的潜在相关性，包括可用的家庭计算机设备(即网络摄像头类型、麦克风类型、互联网上传速度和互联网连接类型)、先前的计算机经验以及对研究计算机设备的舒适度。最初的CBIT手册将被改编用于VoIP。然后，将对4名儿童进行VoIP改良治疗的试点测试，以确定初步效果，以及是否需要进一步修改。在试验之前，将评估主要结果衡量标准--耶鲁全球抽动严重程度量表的跨模式可靠性。为了测试干预的初步效果，20名被诊断为TS或慢性抽动障碍的儿童(年龄9-17岁)将被招募参加VoIP提供的CBI的随机、观察者盲、等待名单对照试验。参与者将被随机分配到每周8次的CBIT-VoIP会议，通过Skype(C)在10周的急性治疗期或等待名单控制条件下进行。拟议的研究与NIMH服务和干预研究司概述的高度优先领域是一致的，因为拟议的研究旨在调整一种治疗方法，以用于创新的服务提供方式，并通过有效性研究和初步疗效试验来测试干预措施。

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 broad, long-term objective of the proposed research is to increase access to CBIT through developing and testing the feasibility and preliminary efficacy of VoIP-delivered CBIT. Specifically, this project seeks to modify the existing CBIT protocol for tics to be administered via VoIP, assess the cross-modality reliability of a tic severity rating scale, the Yale Global Tic Severity Scale (YGTSS) administered via VoIP and face to face, determine the acceptability, usability, and feasibility of the VoIP-modified version of CBIT, and establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with TS compared to a 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. The original CBIT manual will be adapted for use with VoIP. The VoIP-modified treatment will then be pilot tested with 4 children to determine initial effectiveness, and whether further modifications are needed. Prior to the trial, the cross-modality reliability of the primary outcome measure, the Yale Global Tic Severity Scale, will be assessed. To test preliminary efficacy of the intervention, 20 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 CBI. Participants will be randomly assigned to 8 weekly sessions of CBIT-VoIP through Skype(c) over a 10- week acute treatment period, or waitlist control condition. The proposed research is consistent with the areas of high priority outlined by the NIMH Division of Services and Intervention Research, as the proposed research seeks to adapt a treatment for use in an innovative service delivery modality, and test the intervention through both effectiveness research and a preliminary efficacy trial.