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临床试验/NCT05360888
NCT05360888已完成不适用

Comparative Effectiveness of Two Culturally-Centered Suicide Interventions for Alaska Native Youth

RAND2 个研究点 分布在 1 个国家目标入组 302 人开始时间: 2022年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
RAND
入组人数
302
试验地点
2
主要终点
Anxiety

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
14 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Tools for Life + Motivational Interviewing Social Network intervention (MISN)

Active Comparator

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.

干预措施: Tools for Life + MISN (Behavioral)

Tools for Life

Active Comparator

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.

干预措施: Tools for Life (Behavioral)

结局指标

主要结局

Anxiety

时间窗: Change from baseline to 12 months

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

Alcohol use consequences

时间窗: Change from baseline to 12 months

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

Frequency of alcohol use

时间窗: Change from baseline to 12 months

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

Suicide intent/risk

时间窗: Change from baseline to 12 months

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

Depression

时间窗: Change from baseline to 12 months

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

Suicide intent/risk

时间窗: Change from baseline to 6 months

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

Depression

时间窗: Change from baseline to 3 months

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

Suicide intent/risk

时间窗: Change from baseline to 3 months

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

Depression

时间窗: Change from baseline to 6 months

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

Anxiety

时间窗: Change from baseline to 3 months

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

Anxiety

时间窗: Change from baseline to 6 months

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

Frequency of alcohol use

时间窗: Change from baseline to 3 months

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

Frequency of alcohol use

时间窗: Change from baseline to 6 months

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

Alcohol use consequences

时间窗: Change from baseline to 3 months

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

Alcohol use consequences

时间窗: Change from baseline to 6 months

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

次要结局

  • Intentions to be sober from alcohol(Change from baseline to 12 months)
  • Awareness of connectedness(Change from baseline to 12 months)
  • Individual protective factors(Change from baseline to 12 months)
  • Reasons for life(Change from baseline to 12 months)
  • Reflective processes(Change from baseline to 12 months)
  • Sobriety self-efficacy(Change from baseline to 12 months)
  • Time spent around peers who use alcohol(Change from baseline to 12 months)
  • Social network composition(Change from baseline to 12 months)
  • Social network structure(Change from baseline to 12 months)
  • Community protective factors(Change from baseline to 12 months)
  • Sobriety self-efficacy(Change from baseline to 3 months)
  • Sobriety self-efficacy(Change from baseline to 6 months)
  • Intentions to be sober from alcohol(Change from baseline to 3 months)
  • Intentions to be sober from alcohol(Change from baseline to 6 months)
  • Social network composition(Change from baseline to 3 months)
  • Social network composition(Change from baseline to 6 months)
  • Social network structure(Change from baseline to 3 months)
  • Social network structure(Change from baseline to 6 months)
  • Time spent around peers who use alcohol(Change from baseline to 3 months)
  • Time spent around peers who use alcohol(Change from baseline to 6 months)
  • Awareness of connectedness(Change from baseline to 3 months)
  • Awareness of connectedness(Change from baseline to 6 months)
  • Community protective factors(Change from baseline to 3 months)
  • Community protective factors(Change from baseline to 6 months)
  • Individual protective factors(Change from baseline to 3 months)
  • Individual protective factors(Change from baseline to 6 months)
  • Reasons for life(Change from baseline to 3 months)
  • Reasons for life(Change from baseline to 6 months)
  • Reflective processes(Change from baseline to 3 months)
  • Reflective processes(Change from baseline to 6 months)

研究者

发起方
RAND
申办方类型
Other
责任方
Sponsor

研究点 (2)

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