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.

Public Health Relevance

In response to the SARS-CoV-2 (COVID-19) public health emergency our clinical trial, taking place in remote and isolated Alaska Native communities, is currently shutdown and we anticipate prolonged delays in research progress to support participant health and safety, and increased costs when communities reopen. This administrative supplement will fund staff and resources, including funds for increased transportation costs to restart our work as soon authorities allow us and it is safe to do so, for two years beyond the end date of the parent project.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Research Project (R01)
Project #
3R01AA023754-05S1
Application #
10165338
Study Section
Program Officer
Freeman, Robert
Project Start
2015-08-10
Project End
2021-07-31
Budget Start
2020-09-05
Budget End
2021-07-31
Support Year
5
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Alaska Fairbanks
Department
Type
Organized Research Units
DUNS #
615245164
City
Fairbanks
State
AK
Country
United States
Zip Code
99775
Allen, James; Rasmus, Stacy M; Fok, Carlotta Ching Ting et al. (2018) Multi-Level Cultural Intervention for the Prevention of Suicide and Alcohol Use Risk with Alaska Native Youth: a Nonrandomized Comparison of Treatment Intensity. Prev Sci 19:174-185
Stanley, Linda R; Swaim, Randall C; Kaholokula, Joseph Keawe'aimoku et al. (2017) The Imperative for Research to Promote Health Equity in Indigenous Communities. Prev Sci :
Philip, Jacques; Ford, Tara; Henry, David et al. (2016) Relationship of Social Network to Protective Factors in Suicide and Alcohol Use Disorder Intervention for Rural Yup'ik Alaska Native Youth. Interv Psicosoc 25:45-54
Wexler, Lisa; Chandler, Michael; Gone, Joseph P et al. (2015) Advancing suicide prevention research with rural American Indian and Alaska Native populations. Am J Public Health 105:891-9
Henry, David; Dymnicki, Allison B; Mohatt, Nathaniel et al. (2015) Clustering Methods with Qualitative Data: a Mixed-Methods Approach for Prevention Research with Small Samples. Prev Sci 16:1007-16
Fok, Carlotta Ching Ting; Henry, David; Allen, James (2015) Research Designs for Intervention Research with Small Samples II: Stepped Wedge and Interrupted Time-Series Designs. Prev Sci 16:967-77
Henry, David; Fok, Carlotta Ching Ting; Allen, James (2015) Why Small is Too Small a Term: Prevention Science for Health Disparities, Culturally Distinct Groups, and Community-Level Intervention. Prev Sci 16:1026-32
Fok, Carlotta Ching Ting; Henry, David; Allen, James (2015) Maybe Small Is Too Small a Term: Introduction to Advancing Small Sample Prevention Science. Prev Sci 16:943-9