跳至主要内容
临床试验/NCT07801989
NCT07801989尚未招募1 期

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

University of Alaska Fairbanks1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2026年9月21日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
360
试验地点
1
主要终点
Perceived Stress Scale Questionnaire will measure individual-level indicators of stress that we hypothesize will decrease over time with intervention participation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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).

干预措施: Tools for Arctic Health Promotion (Behavioral)

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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