Department of Psychiatry and Behavioral Sciences, University of Washington, 6200 NE 74th St, Bldg. 29, St. 100, Box 357920, Seattle, WA, 98115, USA.
A J Drexel Autism Institute, Drexel University, 3020 Market Street, Philadelphia, 19104, USA.
BMC Psychiatry. 2022 Jul 16;22(1):478. doi: 10.1186/s12888-022-04105-9.
There are a growing number of evidence-based interventions (EBIs) for autistic individuals, but few are successfully implemented with fidelity in under-resourced communities and with families from traditionally disenfranchised groups. Implementation science offers tools to increase EBI use in communities, but most implementation strategies are designed specific to a single EBI. It is not feasible to develop a new implementation strategy each time a new EBI is introduced in the community. Therefore, to test the effectiveness and generalizability of implementation strategies we are developing and testing a multifaceted implementation strategy with three EBIs concurrently. The goal of this protocol paper is to describe the randomized field trial of an implementation strategy for use across autism EBIs, diverse settings and participants, with the goal of increasing rapid uptake of effective practices to reach our most vulnerable children.
We developed a multifaceted implementation strategy called Using Novel Implementation Tools for Evidence-based intervention Delivery (UNITED) to facilitate the implementation and sustainment of three EBIs in under-resourced settings. We will compare fidelity to, and effectiveness of, each intervention [Mind the Gap (MTG), Remaking Recess (RR), Self-Determined Learning Model of Instruction (SDLMI)] with and without UNITED in a randomized field trial. Randomization will be stratified using a minimization allocation method. We will train community practitioners using remote delivery of modules specific to the intervention, and active coaching via Zoom for at least 6 sessions and up to 12 as dictated by each EBI. Our primary outcome is fidelity to each EBI, and our secondary outcome is at the child or family level (family empowerment for MTG, child peer social engagement for RR, and adolescent self-determination for SDLMI, respectively). We will measure progress through the implementation phases using the Stages of Implementation Completion and cost-effectiveness of UNITED.
The results of this study will provide rigorous data on the effectiveness and generalizability of one relatively light-touch implementation strategy in increasing use of autism EBIs and associated outcomes in diverse under resourced public service settings for underrepresented autistic youth.
Mind the Gap: Clinicaltrials.gov Identifier: NCT04972825 (Date registered July 22, 2021); Remaking Recess: Clinicaltrials.gov Identifier: NCT04972838 (Date registered July 22, 2021); Self-Determined Learning Model of Instruction: Clinicaltrials.gov Identifier: NCT04972851 (Date registered July 22, 2021).
针对自闭症个体的循证干预措施（EBIs）越来越多，但在资源匮乏的社区中，很少有措施能够成功地以保真度实施，并且很少有措施能够在传统上被剥夺权利的群体的家庭中实施。实施科学为在社区中增加 EBI 的使用提供了工具，但大多数实施策略都是针对单一 EBI 设计的。每次在社区中引入新的 EBI 时，都开发新的实施策略是不可行的。因此，为了测试我们正在开发和测试的实施策略的有效性和普遍性，我们正在同时使用三种 EBI 来测试一种多方面的实施策略。本方案的目的是描述一种针对自闭症 EBI、不同环境和参与者的实施策略的随机现场试验，目的是加快有效实践的采用，以惠及我们最弱势的儿童。
我们开发了一种称为“使用新型实施工具促进循证干预交付（UNITED）”的多方面实施策略，以促进资源匮乏环境中三种 EBI 的实施和维持。我们将在随机现场试验中比较有和没有 UNITED 的情况下，每种干预措施（Mind the Gap [MTG]、Remaking Recess [RR]、Self-Determined Learning Model of Instruction [SDLMI]）的保真度和效果。随机化将使用最小化分配方法进行分层。我们将使用特定于干预措施的远程模块对社区从业人员进行培训，并通过 Zoom 进行积极的辅导，每个 EBI 最多进行 12 次，具体取决于每个 EBI。我们的主要结果是每种 EBI 的保真度，我们的次要结果是在儿童或家庭层面（MTG 的家庭赋权、RR 的儿童同伴社交参与和 SDLMI 的青少年自我决定）。我们将通过实施阶段的进展来衡量使用 UNITED 的效果和成本效益。
这项研究的结果将为一种相对轻触的实施策略在增加使用自闭症 EBI 以及相关结果方面的有效性和普遍性提供严格的数据，这种策略适用于代表性不足的自闭症青年的各种资源匮乏的公共服务环境。
Mind the Gap：Clinicaltrials.gov 标识符：NCT04972825（注册日期：2021 年 7 月 22 日）；Remaking Recess：Clinicaltrials.gov 标识符：NCT04972838（注册日期：2021 年 7 月 22 日）；Self-Determined Learning Model of Instruction：Clinicaltrials.gov 标识符：NCT04972851（注册日期：2021 年 7 月 22 日）。
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