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阿拉斯加土著青年的自杀干预 (BeWeL)

2026年10月22日 更新者:Elizabeth D'Amico、RAND

两种以文化为中心的自杀干预措施对阿拉斯加土著青年的比较效果

Two interventions will be delivered virtually to American Indian/Alaska Native youth who have been hospitalized with suicidal attempt, suicidal ideation, or associated risk behaviors, including alcohol-related injury.

研究概览

详细说明

The investigators will conduct a randomized controlled trial whereby Alaska Native (AN) youth who are hospitalized for suicide risk will be randomly assigned to either Qungasvik/Tools for Life or Tools for Life + Motivational Interviewing Social Network (MISN) intervention after their baseline survey, and followed up at 3-, 6-, and 12 months. All youth will receive Tools for Life and two 30-minute virtual follow-up visits (at 2- and 6-weeks post intervention) focused on connectivity to culture and obtaining support from intergenerational social networks in their home communities. Half of the youth will also receive MISN in addition to Tools for Life. Both interventions will be delivered virtually by a wellness team comprised of Alaska Native community behavioral health aides, prevention specialists and/or Elders who function in their communities as natural healers.

研究类型

介入性

注册 (实际的)

302

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Alaska
      • Bethel、Alaska、美国、99559
        • Yukon-Kuskokwim Health Corporation
      • Fairbanks、Alaska、美国、99559
        • Tanana Chiefs Conference

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 24年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Self-identify as Alaska Native youth
  • Between the ages of 14 and 24
  • Admitted to the hospital for suicide attempt, ideation, or associated risk behaviors including alcohol-related injury or acute intoxication

Exclusion Criteria:

-

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Tools for Life

All youth will receive the Tools for Life (Qungasvik) intervention. Tools for Life is an evidence-based, community-developed intervention focused on providing protective cultural experiences for Alaska Native youth to address suicide risk and alcohol use.

Tools for Life focuses on empowering youth to learn more about their culture and their identity.

有源比较器:Tools for Life + Motivational Interviewing Social Network intervention (MISN)

Half of the youth will will also receive MISN in addition to the Tools for Life intervention. MISN is an evidence-based treatment that augments motivational interviewing with personal social network composition and structure visualization as a means to cultivating healthy social networks and cultural worlds.

Tools for Life focuses on empowering youth to learn more about their culture and their identity. MISN focuses on helping youth get support from their community and social networks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Suicide intent/risk
大体时间:Change from baseline to 3 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

Change from baseline to 3 months
Suicide intent/risk
大体时间:Change from baseline to 6 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

Change from baseline to 6 months
Suicide intent/risk
大体时间:Change from baseline to 12 months

We will use the Suicidal Ideation Attributes Scale (SIDAS) [0 = Never, 10 = Always]

Change from baseline to 12 months
Depression
大体时间:Change from baseline to 3 months

Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

Change from baseline to 3 months
Depression
大体时间:Change from baseline to 6 months

Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

Change from baseline to 6 months
Depression
大体时间:Change from baseline to 12 months

Patient Health Questionnaire (PHQ-9) [0 -not at all to 3-nearly every day]

Change from baseline to 12 months
Anxiety
大体时间:Change from baseline to 3 months

Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

Change from baseline to 3 months
Anxiety
大体时间:Change from baseline to 6 months

Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

Change from baseline to 6 months
Anxiety
大体时间:Change from baseline to 12 months

Generalized Anxiety Disorder scale (GAD-7) [0 -not at all to 3-nearly every day]

Change from baseline to 12 months
Frequency of alcohol use
大体时间:Change from baseline to 3 months

Number of days used in the past 30 days. [ 0 to 30]

Change from baseline to 3 months
Frequency of alcohol use
大体时间:Change from baseline to 6 months

Number of days used in the past 30 days [ 0 to 30]

Change from baseline to 6 months
Frequency of alcohol use
大体时间:Change from baseline to 12 months

Number of days used in the past 30 days [ 0 to 30]

Change from baseline to 12 months
Alcohol use consequences
大体时间:Change from baseline to 3 months

Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Change from baseline to 3 months
Alcohol use consequences
大体时间:Change from baseline to 6 months

Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Change from baseline to 6 months
Alcohol use consequences
大体时间:Change from baseline to 12 months

Number of times in the past 3 months youth experience 4 different alcohol consequences [0 = Never to 6 = 20 or more times]

Change from baseline to 12 months

次要结果测量

结果测量
措施说明
大体时间
Sobriety self-efficacy
大体时间:Change from baseline to 3 months

Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

Change from baseline to 3 months
Sobriety self-efficacy
大体时间:Change from baseline to 6 months

Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

Change from baseline to 6 months
Sobriety self-efficacy
大体时间:Change from baseline to 12 months

Three items ask how sure youth are about staying sober from alcohol from 1= def drink to 5 = def not drink

Change from baseline to 12 months
Intentions to be sober from alcohol
大体时间:Change from baseline to 3 months

Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

Change from baseline to 3 months
Intentions to be sober from alcohol
大体时间:Change from baseline to 6 months

Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

Change from baseline to 6 months
Intentions to be sober from alcohol
大体时间:Change from baseline to 12 months

Youth report on intentions to be sober in the next 6 months from 1 = def yes to 4 = def no

Change from baseline to 12 months
Social network composition
大体时间:Change from baseline to 3 months

Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking).

Change from baseline to 3 months
Social network composition
大体时间:Change from baseline to 6 months

Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking).

Change from baseline to 6 months
Social network composition
大体时间:Change from baseline to 12 months

Participants will be asked to name 15 contacts ("alters") who are at least 18 years of age. Participants will rate each of the 15 people on the same set of questions with categorical response options (about demographics, relationship quality, likelihood to use drugs, etc.). For each participant, the selected responses will be summed across all of the network alters and divided by 15 to produce network composition percentages of the whole set of alters named by the participant (% of AI/ANs, % who engage in heavy drinking).

Change from baseline to 12 months
Social network structure
大体时间:Change from baseline to 3 months

Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Change from baseline to 3 months
Social network structure
大体时间:Change from baseline to 6 months

Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Change from baseline to 6 months
Social network structure
大体时间:Change from baseline to 12 months

Participants will rate the relationship strength between each of the 15 named alters. For each alter pair participants will rate if the two people know each other and, if yes, have individuals connected recently. Measures of network structure (i.e., network "connectedness") will be constructed from the set of evaluations for each participant. For example, network "density" will be constructed for the network overall, which is calculated by summing the number of alter pairs who know each other and dividing by the total number of possible ties among 15 alters (105). Individual alter "centrality" will be calculated by summing the number of connections each individual alter has with other alters in the network.

Change from baseline to 12 months
Time spent around peers who use alcohol
大体时间:Change from baseline to 3 months

Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

Change from baseline to 3 months
Time spent around peers who use alcohol
大体时间:Change from baseline to 6 months

Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

Change from baseline to 6 months
Time spent around peers who use alcohol
大体时间:Change from baseline to 12 months

Participants will report on how much time is spent around peers who drink from 0 = never to 3 = often

Change from baseline to 12 months
Awareness of connectedness
大体时间:Change from baseline to 3 months

Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Awareness of connectedness
大体时间:Change from baseline to 6 months

Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Awareness of connectedness
大体时间:Change from baseline to 12 months

Youth report on feelings of connectedness to community, family and environment from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months
Community protective factors
大体时间:Change from baseline to 3 months

Youth Community Protective Factors Scale. Youth report on feelings about different protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Community protective factors
大体时间:Change from baseline to 6 months

Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Community protective factors
大体时间:Change from baseline to 12 months

Youth Community Protective Factors Scale Youth report on feelings about different community protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months
Individual protective factors
大体时间:Change from baseline to 3 months

Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Individual protective factors
大体时间:Change from baseline to 6 months

Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Individual protective factors
大体时间:Change from baseline to 12 months

Youth report on feelings about different individual protective factors from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months
Reasons for life
大体时间:Change from baseline to 3 months

Brief Reasons for Life Scale from 1 not at all important to 5 very important

Change from baseline to 3 months
Reasons for life
大体时间:Change from baseline to 6 months

Brief Reasons for Life Scale from 1 not at all important to 5 very important

Change from baseline to 6 months
Reasons for life
大体时间:Change from baseline to 12 months

Brief Reasons for Life Scale from 1 not at all important to 5 very important

Change from baseline to 12 months
Reflective processes
大体时间:Change from baseline to 3 months

The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Change from baseline to 3 months
Reflective processes
大体时间:Change from baseline to 6 months

The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Change from baseline to 6 months
Reflective processes
大体时间:Change from baseline to 12 months

The Reflective Processes scale taps a culturally patterned type of awareness and youth report from from 1 = strongly agree to 5 strongly disagree

Change from baseline to 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年12月22日

初级完成 (实际的)

2026年1月31日

研究完成 (实际的)

2026年1月31日

研究注册日期

首次提交

2022年4月29日

首先提交符合 QC 标准的

2022年4月29日

首次发布 (实际的)

2022年5月4日

研究记录更新

最后更新发布 (实际的)

2026年10月27日

上次提交的符合 QC 标准的更新

2026年10月22日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The investigators will share only deidentified, aggregate data.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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