Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth

该提案是对NIH资助的临床试验和NOT-OD-20-087指南的回应 受新冠肺炎影响的人体研究，并申请使用PA-18-591 对现有NIH拨款和合作协议的行政补充(家长管理 补充临床试验(可选)，通过家长奖R01AA023754群加斯维克(工具箱)： 阿拉斯加原住民青年预防酗酒/自杀风险，由PAR-14-620资助： 美洲原住民健康促进和疾病预防干预。 由于新奇的SARS-CoV-2(新冠肺炎)公共卫生突发事件造成的困难 我们的临床试验在偏远和与世隔绝的阿拉斯加原住民社区进行，目前 关机。这一行政补充将允许继续收集数据、重新启动 在最终社区5中实施干预，并提供持续的监督和 目前活跃的4个SAMHSA资助的干预试验社区的忠诚度评估。 虽然对四个积极干预社区的干预现在由4个SAMSHA原住民提供资金 连接拨款，最终的社区5干预是家长拨款的原始内容，而不是 以前的行政补充，由NIAAA资助。此外，我们目前还不能 暂停必要的研究人员。这些工作人员正在积极监督 目前活跃在COVID期间的4个自杀/酒精风险预防干预措施进行研究 具有保真度评估的标准。这些工作人员正在从事持续的研究过程。 在数据收集之前收集了4年的数据，关闭了。补充资金将允许 美国将完成以下目标：1)全面实施干预在最终的NIAAA R01试验社区，资金来自最初的父母资助，启动是在那里 被突发公共卫生事件打断；2)完成所有试验的数据收集 被大流行中断的社区；3)分析已完成的预防试验 结果。

The proposal is in response to NOT-OD-20-087 Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19, and applied for using PA-18-591 Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional), through parent award R01AA023754 Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth, funded through PAR-14-620: Interventions for Health Promotion and Disease Prevention in Native American Populations. Due to the hardship created by the novel SARS-CoV-2 (COVID-19) public health emergency our clinical trial, taking place in remote and isolated Alaska Native communities, is currently shutdown. This administrative supplement would allow to continue data collection, re-startup intervention implementation in the final Community 5, and provide ongoing supervision and fidelity assessment in the 4 currently active SAMHSA funded intervention trial communities. While intervention in four active intervention communities is now funded by 4 SAMSHA Native Connections grants, the final Community 5 intervention is original to the parent grant and not the previous administrative supplement, and is funded by NIAAA. Further, we are not currently able to suspend research staff who are essential. These staff are engaged in active supervision of the 4 currently active during COVID suicide/alcohol risk preventative interventions to research standards with fidelity assessment. These staff are engaged in the continuing research process with 4 years of data collected prior to data collection shut down. Supplemental funding will allow us to accomplish the following objectives: 1) fully implement the intervention in the final NIAAA R01 trial community, with funding coming from the original parent grant, where startup was interrupted by the public health emergency; 2) complete data collection across all trial communities interrupted by the pandemic and; 3) analyze the completed prevention trial outcomes.