Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders (CBIT-Trainer)

摘要（项目2 R44 MH 111450 - 03 A1） 抽动障碍（Tic disorders，TDs）是一类以不自主抽动为特征的神经发育障碍， 影响1%-3%的人口2并造成严重痛苦的运动和发声抽搐1， 3 -9抽搐综合行为干预（CBIT）是一种 经临床验证的行为抽搐管理技术的集合，现在是 国际上推荐作为TD 10、15、16患者的一线干预。虽然CBIT 是有效的，患者高度期望，8，17-19，由于缺乏训练有素的 8，17 -19在目前的第二阶段SBIR项目中，我们成功地雇用了一个利益相关者- 了解CTAP实施框架21和迭代开发流程， 培训治疗师管理CBIT（CBIT培训师）和试点的交互式在线程序 用CBIT-Naïve治疗师的样本测试了这个项目。试点测试的结果超过了 我们启动项目最后阶段的先验标准，即进行大规模的 CBIT培训师的测试，检查治疗师和患者的结果，使用有效性- 实施混合方法23进行随机对照非劣效性试验 将CBIT-Trainer与黄金标准的面对面BTI培训（BTI）进行比较。主要和 临床试验的次要目的是（1）比较CBIT-Trainer与面对面BTI， 治疗师管理CBIT核心成分的能力;（2）比较患者对 CBIT由通过现场BTI或CBIT培训师培训的治疗师治疗时;以及（3）识别 治疗师级别的促进者/采用CBIT培训师以及实施和维持的障碍 CBIT作为培训后TD患者的一线干预措施。

Abstract (Project 2R44MH111450-03A1) Tic disorders (TDs) are a class of neurodevelopmental disorders characterized by involuntary motor and vocal tics1 that affect 1%-3% of the population2 and cause substantial distress, interference and disability.3-9 Comprehensive Behavioral Intervention for Tics (CBIT) is an empirically-validated collection of behavioral tic management techniques that is now internationally recommended as a first-line intervention for patients with TD 10,15,16. Although CBIT is effective and highly desired by patients,8,17-19 it is not widely available due to a lack of trained providers.8,17-19 Within the current Phase II SBIR project, we successfully employed a stakeholder- informed CTAP implementation framework21 and iterative development process to create an interactive online program for training therapists to administer CBIT (CBIT-Trainer) and pilot tested the program with a sample of CBIT-Naïve therapists. Results from the pilot test surpassed our a priori criteria for initiation of the final stage of the project, which is to conduct a large-scale test of CBIT-Trainer, examining both therapist and patient outcomes, using an effectiveness- implementation hybrid approach23 to conduct a randomized controlled noninferiority trial comparing CBIT-Trainer to the gold-standard in-person BTI training (BTI). The primary and secondary aims of the clinical trial are to (1) compare CBIT-Trainer to the in-person BTI on therapists’ ability to administer the core components of CBIT; (2) to compare patient response to CBIT when treated by a therapist trained via the in-person BTI or CBIT-Trainer; and (3) to identify therapist-level facilitators/barriers to adopting CBIT-Trainer and to implementing and sustaining CBIT as a first-line intervention for TD patients after training.