NCT07801989

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_1

Timeline
32mo left

Started Sep 2026

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Sep 2026Apr 2029

First Submitted

Initial submission to the registry

August 25, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

September 21, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

2.1 years

First QC Date

August 25, 2026

Last Update Submit

August 30, 2026

Conditions

Keywords

Alaska Nativerural healthpreventionchronic diseaseextreme weathercommunity resilience

Outcome Measures

Primary Outcomes (9)

  • 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.

    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.

    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.

    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

    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.

    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.

    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.

    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.

    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.

    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

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

Other Outcomes (1)

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

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

Study Arms (1)

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).

Behavioral: Tools for Arctic Health Promotion

Interventions

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.

Enrollment in TAHP

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alaska Fairbanks

Fairbanks, Alaska, 99775, United States

Location

Related Publications (1)

  • 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.

    PMID: 36214726BACKGROUND

MeSH Terms

Conditions

Chronic DiseasePsychological Well-Being

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPersonal SatisfactionBehavior

Central Study Contacts

Stacy Rasmus, PhD

CONTACT

Hannah Robinson, MPH

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2026

First Posted

September 3, 2026

Study Start

September 21, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

April 30, 2029

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations