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NCT Number: NCT07801989

Alaska Alliance for Community Engagement Phase II: Partnership for Action Toward Health

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identify as a permanent resident of the study community
  • Be a youth between the ages of 12-17 years or an adult 18+
  • Be able to provide written informed consent

Exclusion criteria

  • Does not have permanent residence in the community or has lived in the community less than 5 years
  • Is unable to provide written informed consent

Treatment and study plan

Tools for Arctic Health Promotion

Behavioral

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.

Primary outcomes

  1. Perceived Stress Scale Questionnaire will measure individual-level indicators of stress that we hypothesize will decrease over time with intervention participation

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  2. General Life Satisfaction Scale will measure individual level indicators of life satisfaction that we hypothesize will increase with intervention participation

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  3. We will assess if depression decreases with intervention participation using the PHQ-9 Questionnaire

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  4. We will assess if anxiety symptoms decrease with intervention participation using the GAD-7

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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

  5. We will assess if food security increases using the food security index from the PhenX Toolkit

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  6. We will assess if cultural efficacy increases with individual intervention participation using the Cultural Efficacy Scale.

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  7. We will assess how the intervention increases individual protective factors using the Multi-Cultural Mastery Scale

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  8. We will assess how intervention participation increases social and cultural connectedness using the Awareness of Connectedness Scale

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

  9. We will assess how the intervention increases reasons for life and meaning and purpose using the Reasons for Life Scale

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

Secondary outcomes

  1. We will assess the increase in community-level factors that are protective and contribute to health outcomes using the Protective Community Scale

    Time frame: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)

    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.

Other outcomes

  1. We will assess changes to a stress biomarker, cortisol, using Salimetrics OnTimePoint SalivaTM Collection Management application system.

    Time frame: Day 1 (baseline), 8 months (T2) and at 20 months (T3)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Robinson, MPH

CONTACT

[email protected]

731-400-3539

Stacy Rasmus, PhD

CONTACT

[email protected]

907-328-8919

Sponsors and collaborators

Lead sponsor

University of Alaska Fairbanks

Other

Registry information

Official study title

Alaska Alliance for Community Engagement Phase II: Protecting Health in the American Arctic: Implementing Localized Solutions to Promote Health and Prevent Chronic Disease in Rural Alaska

Acronym: AK ACE-PATH

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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