Abstract：
COVID-19 required many research teams to shift from in-person to remote assessments, which posed both procedural and theoretical challenges. While research has explored the utility of remote assessments for autism diagnosis from the perspective of families and clinicians, less is known about their application in clinical trials. This paper describes the development of a remote research assessment protocol for a randomized clinical trial focusing on the implementation of reciprocal imitation teaching (RIT) with toddlers in Part C early intervention. This project spans two phases. For Phase 1, our team developed and documented a series of steps utilizing user-centered design (UCD) strategies (e.g., recruiting potential users, creating a prototype, engaging in iterative development) for the purpose of redesigning an assessment protocol for a remote environment. For Phase 2, we examined preliminary outcomes of the redesign process. Primary end users (assessors) rated post-redesign usability and acceptability, while acceptability was examined using attrition data from secondary end users (family participants). Preliminary fidelity of implementation was also examined. The iterative redesign process allowed the research team to refine aspects of the assessment that ultimately led to promising preliminary ratings of usability, acceptability, and feasibility, as well as high fidelity. Preliminary data suggest that the redesigned assessment appears to be an acceptable, feasible, and usable tool for autism clinical trial research and that assessors can use it with fidelity. Further research is needed to examine the reliability and validity of the assessment, as well as implementation characteristics on a larger scale.
摘要：
COVID-19要求许多研究团队从亲自评估转向远程评估，这既提出了程序上的挑战，也提出了理论上的挑战。虽然研究已经从家庭和临床医生的角度探索了远程评估对自闭症诊断的效用，对它们在临床试验中的应用知之甚少。本文介绍了一项随机临床试验的远程研究评估方案的开发，该方案的重点是在C部分早期干预中对幼儿实施互惠模仿教学（RIT）。这个项目跨越两个阶段。对于阶段1，我们的团队开发并记录了一系列利用以用户为中心的设计(UCD)策略的步骤(例如，招募潜在用户，创建一个原型，从事迭代开发)，以重新设计远程环境的评估协议。对于第二阶段，我们检查了重新设计过程的初步结果。主要最终用户（评估人员）对重新设计后的可用性和可接受性进行了评级，而可接受性是使用次要最终用户(家庭参与者)的减员数据进行检查的。还审查了执行的初步保真度。迭代的重新设计过程使研究团队能够完善评估的各个方面，最终导致有希望的可用性初步评级。可接受性,和可行性，以及高保真度。初步数据表明，重新设计的评估似乎是可以接受的，可行,和自闭症临床试验研究的可用工具，评估人员可以保真度使用它。需要进一步的研究来检查评估的可靠性和有效性，以及更大规模的实施特征。
