Chronic DiseasePhase 1AK ACE-PATHNCT07801989
Alaska Alliance for Community Engagement Phase II: Partnership for Action Toward Health
A Phase 1 study testing Tools for Arctic Health Promotion in people with Chronic Disease and Mental Health, run by University of Alaska Fairbanks at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Mental Health, Caridovascular Disease
- What is being tested?
- Tools for Arctic Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to 30 Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alaska Fairbanks
Fairbanks, Alaska, 99775
Maria Stejskal, 907-474-6230, mtrussell@alaska.edu
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Tools for Arctic Health Promotion
- Keywords
- Alaska Native, rural health, prevention, chronic disease, extreme weather, community resilience
- Medical subject headings
- Chronic Disease, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tools for Arctic Health PromotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Enrollment in TAHP | Experimental | 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). Receives: Behavioral: Tools for Arctic Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
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
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.
Measured: Day 1 (baseline), 4 months (T1), 8 months (T2) and at 20 months (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study design to address the primary research questions 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). As a variant of a stepped wedge group-randomized trial (SWGRT), the DWLD is a repeated measures, longitudinal intervention research design that makes use of an intervention implementation roll out crossover design. In the DWLD, each community receives both a baseline condition-essentially a wait-list control condition-and an intervention condition. In this study's implementation of the DWLD, the timing of crossover from baseline control to intervention condition is randomized.
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alaska Fairbanks
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801989
- Sponsor's protocol ID
- 6922-06-CH-S001
- Acronym
- AK ACE-PATH
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Allen J, Charles B, Fok CCT, Lee K, Grogan-Kaylor A; Qungasvik Team; Rasmus S. Culturally grounded strategies for suicide and alcohol risk prevention delivered by rural Alaska Native communities: A dynamic wait-listed design evaluation of the Qungasvik intervention. Am J Community Psychol. 2023 Mar;71(1-2):184-197. doi: 10.1002/ajcp.12621. Epub 2022 Oct 10.
PubMed 36214726
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07801989
- Acronym / sponsor ID
- AK ACE-PATH / 6922-06-CH-S001
- Keywords
- Alaska Native, rural health, prevention, chronic disease, extreme weather, community resilience
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- University of Alaska FairbanksUniversity, hospital or other
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design to address the primary research questions 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). As a variant of a stepped wedge group-randomized trial (SWGRT), the DWLD is a repeated measures, longitudinal intervention research design that makes use of an intervention implementation roll out crossover design. In the DWLD, each community receives both a baseline condition-essentially a wait-list control condition-and an intervention condition. In this study's implementation of the DWLD, the timing of crossover from baseline control to intervention condition is randomized.
| Arm | Type | Receives |
|---|---|---|
| Enrollment in TAHP | Experimental | Behavioral: Tools for Arctic Health PromotionThe 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). |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tools for Arctic Health PromotionThe 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. | Behavioural | Enrollment in TAHP |
Primary outcome
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.
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.
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.
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
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.
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.
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.
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.
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Background: PubMed 36214726Allen J, Charles B, Fok CCT, Lee K, Grogan-Kaylor A; Qungasvik Team; Rasmus S. Culturally grounded strategies for suicide and alcohol risk prevention delivered by rural Alaska Native communities: A dynamic wait-listed design evaluation of the Qungasvik intervention. Am J Community Psychol. 2023 Mar;71(1-2):184-197. doi: 10.1002/ajcp.12621. Epub 2022 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tools for Arctic Health Promotion in people with Chronic Disease and Mental Health, run by University of Alaska Fairbanks at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacy Rasmus, PhD (907-328-8919, smrasmus@alaska.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.