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Principal Investigator: JAMES R. ALLEN
Organization: UNIVERSITY OF ALASKA FAIRBANKS
Fiscal Year: 2020
Award: $235,846
Funding agency: National Institute on Alcohol Abuse and Alcoholism
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.
Terms: <2019 novel coronavirus><2019-nCoV><21+ years old><Administrative Supplement><Adult><Adult Human><Affect><Alaska Indian><Alaska Native><Alaskan American><Alaskan Indian><Alaskan Native><Alaskan Native American><Alcohol Drinking><Alcohol consumption><Attitude><Award><COVID><COVID-19><COVID19><Characteristics><Clinical Trials><CoV disease><Code><Coding System><Communities><Community Trial><Cooperative Agreements><Data><Data Collection><Effectiveness of Interventions><Elderly><EtOH drinking><EtOH use><Evaluation><Exposure to><Family><Feeling suicidal><Funding><Grant><Health><Health Promotion><Individual><Interruption><Intervention><Intervention Community Trial><Intervention Strategies><Interview><Life><Measures><Modeling><NIAAA><NIH><National Institute on Alcohol Abuse and Alcoholism><National Institutes of Health><Native Americans><Outcome><Outcome Measure><Parents><Participant><Patient Self-Report><Pattern><Population><Preventative intervention><Prevention intervention><Prevention trial><Preventive Intervention><Process><Randomization trial><Research><Research Resources><Resources><SAMHSA><SARS-CoV-2><SARS-CoV2><SARS-associated coronavirus 2><SARS-coronavirus-2><SARS-related coronavirus 2><Safety><Salutogenesis><Self-Report><Severe acute respiratory syndrome coronavirus 2><Social Network><Study Subject><Substance Abuse and Mental Health Services Administration><Suicidal thoughts><Suicide><Supervision><Techniques><Testing><Transportation><Treatment Efficacy><U-Series Cooperative Agreements><United States National Institutes of Health><United States Substance Abuse and Mental Health Services Administration><Videotape><Work><Wuhan coronavirus><Youth><Youth 10-21><Yup'ik><Yupik><adulthood><advanced age><alcohol ingestion><alcohol intake><alcohol prevention><alcohol product use><alcohol risk><alcohol use><alcoholic beverage consumption><alcoholic drink intake><authority><base><community intervention><community planning><corona virus disease><corona virus disease 2019><coronavirus disease><coronavirus disease 2019><cost><design><designing><disease prevention><disorder prevention><elders><ethanol consumption><ethanol drinking><ethanol ingestion><ethanol intake><ethanol product use><ethanol use><fatal attempt><fatal suicide><geriatric><human subject><intent to die><intervention efficacy><interventional strategy><late life><later life><native youth><novel><older adult><older person><pandemic><pandemic disease><parent grant><parent project><peer><prevent alcohol><preventing alcohol><preventional intervention strategy><promoting health><prospective><protective factors><public health emergency><randomized trial><response><senior citizen><suicidal ideation><suicidal risk><suicidal thinking><suicidality><suicide ideation><suicide risk><theories><therapeutic efficacy><therapeutically effective><therapy efficacy><thoughts about suicide>