A Phase 1 interventional study of Tools for Arctic Health Promotion in Chronic Disease, Mental Health and Caridovascular Disease, sponsored by University of Alaska Fairbanks. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by University of Alaska Fairbanks · Phase 1, Interventional, and Prevention
The AK ACE-PATH Phase II study aims to pilot and implement a novel intervention, Tools for Arctic Health Promotion (TAHP), to address Alaska Native (AN) community priorities related to local health and community-level resilience.
In Phase I of AK ACE, community partners identified and prioritized local stressors through a consensus-based process. Building on these findings, Phase II will implement interventions targeting the highest-priority stressors through modules designed to improve health outcomes.This study addresses a critical gap in understanding local health and mental health among AN populations facing rapid social change and overlapping public health challenges. The project focuses on developing community-driven solutions to improve physiological and mental health, particularly among youth, and to prevent chronic disease across the lifespan in rural Alaska. To achieve these goals, the study will develop and implement Tools for Arctic Health Promotion (TAHP), a novel intervention integrating data-driven tools and evidence-based community strategies. TAHP will support structured community engagement and deliver manualized health activities to approximately 410 adults and youth across five rural AN communities. The TAHP intervention will be evaluated through a feasibility pilot in one community and a paired dynamic waitlisted design (DWLD) across four additional communities. Behavioral and biological measures will assess individual- and community-level impacts on chronic disease prevention and mental health promotion.
781 studies on the registry are indexed under Chronic Disease; 144 are open to participants now.
This study's planned enrollment of 360 is above the median of 140 across 582 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →University of Alaska Fairbanks is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study will enroll 360 participants from four unique community settings to receive the TAHP intervention. The study design will make use of a dynamic wait-listed design (DWLD) with 360 participants assessed with behavioral and community-level measures at four time points: baseline (B), intervention midpoint (T1), Intervention end (T2) and 12-month follow-up (T3).
Behavioral: Tools for Arctic Health Promotion
The TAHP intervention will utilize a valid measure of rural AN community-level protective factors (Allen, et al., 2025), and an evidence-based toolkit containing strategies proven to increase mental health and well-being in rural AN communities (Allen, Charles, et al., 2023). A formalized community engaged process will generate new intervention activities that integrate cutting-edge science to address local health priorities.
Perceived Stress Scale Questionnaire will measure individual-level indicators of stress that we hypothesize will decrease over time with intervention participation
The NIH Toolbox Perceived Stress Scale is a standardized tool designed to assess how unpredictable, uncontrollable, and overloaded individuals feel in their lives. We will analyze how individual stress indicators are mitigated over time by intervention participation.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
General Life Satisfaction Scale will measure individual level indicators of life satisfaction that we hypothesize will increase with intervention participation
The NIH Toolbox General Life Satisfaction Scale is a tool designed to assess an individual's cognitive evaluation of their life experiences and overall satisfaction. We will assess how the intervention mitigates life satisfaction with individuals who participate.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess if depression decreases with intervention participation using the PHQ-9 Questionnaire
The Patient Health Questionnaire 9 (PHQ-9) measures the frequency of depressed mood and anhedonia over the past two weeks. We will assess how the intervention impacts depressive symptoms with individual participation.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess if anxiety symptoms decrease with intervention participation using the GAD-7
The Generalized Anxiety Disorder 7-Item (GAD-7) Screener will be given at every time point to assess how the intervention mitigates anxiety with individual participants
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess if food security increases using the food security index from the PhenX Toolkit
The PhenX Toolkit includes standardized measures for assessing food security, which is crucial for understanding social determinants of health. We will use items from the standardized food security tools to evaluate how food access impacts health outcomes and if food security increases with individual participation in the intervention.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess if cultural efficacy increases with individual intervention participation using the Cultural Efficacy Scale.
The Cultural Efficacy Scale developed by Gonzalez, Sittner, and Walls in 2022 measures individuals' comfort and access to cultural and traditional resources, particularly within Indigenous communities. This scale consists of 7-8 items, each with a range of response options from "strongly disagree" to "strongly agree." We will analyze the data to link cultural efficacy with mental health outcomes (depression and anxiety), highlighting the protective effects of engagement in the intervention.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess how the intervention increases individual protective factors using the Multi-Cultural Mastery Scale
The Multicultural Mastery Scale, developed by Allen and Mohatt, assesses coping strategies through self-mastery and communal mastery dimensions. It includes subscales that differentiate between mastery related to family and friends, highlighting the importance of social networks. We will utilize data from this scale to determine how the intervention increases positive coping and builds social networks connections in individuals who participate.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess how intervention participation increases social and cultural connectedness using the Awareness of Connectedness Scale
The Awareness of Connectedness Scale (ACS), developed by Mohatt and Fok, measures an individual's awareness of their interrelatedness with family, community, and the natural environment. This scale is particularly focused on cultural aspects of wellness and healing among Alaska Native people, providing insights into their social and ecological connections. We will utilize data from the scale to assess the intervention impacts on building connectedness among individual participants.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess how the intervention increases reasons for life and meaning and purpose using the Reasons for Life Scale
The Reasons for Life Scale (RFL), developed by Allen and Rasmus, focuses on cultural strengths and protective factors against suicide, particularly among Alaska Native people. It emphasizes resilience, cultural teachings, and community recognition as vital components in promoting mental health and preventing suicide. We will utilize data from scale to assess how the intervention promotes reasons for life and associates with mental health outcomes (depression and anxiety) in individuals who participate in activities.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess the increase in community-level factors that are protective and contribute to health outcomes using the Protective Community Scale
The Protective Community Scale (PCS), developed by Wexler, Allen, and Rasmus, aims to identify community-level protective factors that can reduce suicide risk among Alaska Native youth. This scale is part of a broader effort to enhance resilience in these communities through culturally relevant measures and community engagement. We will analyze data from the PCS to determine if the intervention has mitigated environmental stressors and increased community protection.
Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
We will assess changes to a stress biomarker, cortisol, using Salimetrics OnTimePoint SalivaTM Collection Management application system.
To measure the impacts of our intervention on biological outcomes, we will assess biomarkers associated with allostatic load - cortisol as an indicator of physiological stress response. These biomarkers will allow us to evaluate whether participation in the intervention is associated with reduced chronic stress burden and improved mental health (anxiety and depression) over time. Our proposed saliva collection protocol will involve our research team members administering the saliva kits with youth and adult participants over a 3-day period with multiple tests to capture cortisol levels throughout the day. Multi-day cortisol levels will be averaged to determine a baseline, and the same process will be used for saliva collection and measurement of cortisol levels at each time point.
Time frame: Day 1 (baseline), 8 months (T2) and at 20 months (T3)
Plan to share: No
Start is estimated for Sep 2026; primary completion for Oct 2028, 25 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Alaska Fairbanks