Developing and Testing the Feasibility of Voice Over Internet Protocol Delivered

抽动症综合行为干预 (CBIT) 是针对抽动秽语综合征 (TS) 儿童的一种新兴治疗方法，针对儿童和成人的单独随机试验已证明其有效；然而，由于训练有素的治疗提供者有限，许多 TS 儿童的家庭无法获得该服务。最近的研究表明，视频会议交付的 CBIT 与面对面交付一样有效，并且两种方式都有效。尽管传统视频会议很有效，但仍存在局限性，包括缺乏便携性、易于访问、需要第三方诊所和成本。增加访问的更新、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 直接传送到患者家中。因此，拟议研究的广泛、长期目标是通过开发和测试 VoIP 提供的 CBIT 的可行性和初步功效来增加 CBIT 的获取。具体来说，该项目旨在修改通过 VoIP 管理抽动的现有 CBIT 协议，评估抽动严重程度评定量表（通过 VoIP 和面对面管理的耶鲁全球抽动严重程度量表 (YGTSS)）的跨模态可靠性，确定 VoIP 修改版本 CBIT 的可接受性、可用性和可行性，并确定 VoIP 修改 CBIT 与候补名单对照相比减少 TS 儿童抽动的初步功效条件。作为探索性目标，本研究将调查治疗结果的潜在相关性，包括可用的家用计算机设备（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。原始 CBIT 手册将进行修改以适用于 VoIP。然后，经过 VoIP 修改的治疗方法将在 4 名儿童中进行试点测试，以确定初步效果，以及是否需要进一步修改。在试验之前，将评估主要结果指标——耶鲁全球抽动严重程度量表的跨模态可靠性。为了测试干预措施的初步效果，将招募 20 名主要诊断为 TS 或慢性抽动障碍的儿童（9-17 岁）进行 VoIP 提供的 CBI 的随机、观察者盲态、候补对照试验。在 10 周的急性治疗期或候补名单控制条件下，参与者将通过 Skype(c) 被随机分配到每周 8 次的 CBIT-VoIP 课程。拟议的研究与 NIMH 服务和干预研究部门概述的高度优先领域一致，因为拟议的研究旨在调整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.