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临床试验/NCT05400135
NCT05400135Unknown不适用

Qungasvik (Toolbox): Prevention of Alcohol/Suicide Risk in Alaska Native Youth

University of Alaska Fairbanks2 个研究点 分布在 1 个国家目标入组 542 人开始时间: 2017年3月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
542
试验地点
2
主要终点
Change in Reflective Processes

研究概览

简要总结

For the past 20+ years the investigators have focused on addressing two interrelated public health issues, alcohol use disorder (AUD) and suicide in Alaska. There is no greater source of health disparity in American Indian and Alaska Native (AI/AN) communities than that involving AUD and suicide, and no greater necessity in addressing this disparity than the development of sustained, trusting, collaborative, and non-exploitive research relationships with those who historically experienced forced acculturation and exploitation. Yup'ik community leaders have made addressing AUD and suicide among their highest priorities. Working with Yup'ik community members, the investigators developed a multilevel (individual, family, peer, and community) intervention that uses a culturally-based AUD and suicide prevention framework. The Qungasvik (kung-az-vik; a Yup'ik word meaning 'toolbox') intervention is a Yup'ik AN approach to prevention organized and implemented utilizing a local indigenous theory of change and process model to build protective factors against AUD and suicide. The purposes of the proposed research are to: (a) validate results obtained from previous smaller intervention studies aimed at reducing the incidence of AUD and suicide in 12-18 year old Yup'ik Alaska Native (AN) youth; and (b) learn more about the relative importance of the individual, family, peer, and community variables that underscore the Qungasvik intervention. This study will: (a) assess the efficacy of the Qungasvik intervention through a two group community level trial using an interrupted time series design with wait-listed control, and (b) examine mechanisms of change in response to intervention. Specific aims (SA) of the project are to: (SA1) test the Qungasvik intervention efficacy through impact on the ultimate outcome variables of reasons for life and reflective processes on alcohol use consequences, and on suicidal ideation and alcohol use; (SA2) examine the mechanisms of change in response to the Qungasvik intervention through (a) self-report outcome measures of protective factors (b) social network assessment and (c) process evaluation; (SA3) test levels of fidelity of the implementation of the intervention with regard to the Yup'ik indigenous theory-driven intervention model outlined in the Qungasvik manual of operations.

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 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Alaska Native youth 12-21 years

排除标准

  • Children under the age of 12

结局指标

主要结局

Change in Reflective Processes

时间窗: Baseline, 1-year, 2-year, 3-year, 4-year

5 items, item separation reliability=.77. This measure is adapted from the adult Yup'ik Protective Factors scale5, and taps a culturally patterned type of awareness (ellangneq) used in thinking over potential negative consequences of alcohol misuse engaged by Alaska Native youth when considering reasons to not drink.

Change in Alcohol Consequences

时间窗: Baseline, 1-year, 2-year, 3-year, 4-year

The five-item CoNcise Inventory of Problems for Alaska Native Adolescents (NIP-AN-A), adaptation of the Adult NIP-AN, taps social, intrapersonal, impulse control, interpersonal and kinship loss. We adapted the Alcohol Quantity/Frequency/Binge Episode Measure (Q-F-BE) for use in rural Alaska. It assesses the quantity and frequency of drinking including binge drinking episodes which are defined as a consumption pattern of greater than four drinks on one occasion.

Change in Reasons for Life

时间窗: Baseline, 1-year, 2-year, 3-year, 4-year

5 items, =.78. This measure is an extension of constructs tapped in the Brief Reasons for Living Inventory for Adolescents, itself a modification of an adult measure, the Reasons for Living Inventory. RFL assess beliefs and experiences that make life enjoyable, worthwhile, and provide meaning. Items tap cultural/spiritual beliefs, sense of family responsibility, and others' assessment of the young person. The measure provides a positive psychology approach to assessing AN cultural values associated with protection from suicide.

Change in Rollnick's Readiness Ruler

时间窗: Baseline, 1-year, 2-year, 3-year, 4-year

An adaptation of the RRR will provide an analog scale assessment of motivation to remain abstinent.

次要结局

  • Change in Individual Protective Factors(Baseline, 1-year, 2-year, 3-year, 4-year)
  • Change in Peer Influences(Baseline, 1-year, 2-year, 3-year, 4-year)
  • Change in Family Protective Factors(Baseline, 1-year, 2-year, 3-year, 4-year)
  • Change in Community Protective Factors(Baseline, 1-year, 2-year, 3-year, 4-year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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