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

该提案是对NOT-OD-20-087 NIH资助的临床试验指南的回应， 受COVID-19影响并申请使用PA-18-591的人类受试者研究 现有NIH赠款和合作协议的行政补充（家长管理 Supp临床试验可选），通过母公司授予R 01 AA 023754 Qungasvik（昆加斯维克）： 预防阿拉斯加土著青年的酒精/自杀风险，通过PAR-14-620资助： 美国土著居民健康促进和疾病预防的干预措施。 由于新型SARS-CoV-2（COVID-19）突发公共卫生事件造成的困难， 我们的临床试验，发生在偏远和孤立的阿拉斯加原住民社区，目前正在 关机该管理补充将允许继续数据收集，重新启动 在最后的社区5中实施干预，并提供持续的监督和 在4个目前活跃的SAMHSA资助的干预试验社区进行忠诚度评估。 虽然四个积极干预社区的干预措施现在由4个SAMSHA土著人提供资金， 连接赠款，最终社区5干预是原来的父母补助金，而不是 以前的行政补充，并由NIAAA资助。此外，我们目前无法 暂停必要的研究人员。这些工作人员积极监督 目前在COVID自杀/酒精风险预防干预研究期间活跃的4个 标准与忠诚度评估。这些工作人员从事持续的研究进程 在数据收集关闭之前收集了4年的数据。补充资金将使 我们要实现以下目标：1）在最终的NIAAA中全面实施干预措施 R 01试验社区，资金来自最初的父母补助金，创业公司是 因突发公共卫生事件中断; 2）完成所有试验的数据收集 受大流行中断的社区; 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.