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临床试验/NCT03086434
NCT03086434已完成不适用

Intertribal Talking Circle for the Prevention of Substance Abuse in Native Youth

Florida State University0 个研究点目标入组 630 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
630
主要终点
Substance Use

研究概览

简要总结

This project will evaluate an after-school substance abuse prevention intervention, compared to a standard substance abuse education program, targeting 6th grade AI youth in three AI communities: Ojibwe/Chippewa in Minnesota, Choctaw in Oklahoma, and Lumbee in North Carolina.

A community-based participatory research approach will be used to culturally and technologically adapt the intervention. A two-condition controlled study will evaluate the efficacy of the intervention to increase AI youth Native self-reliance while decreasing AI youth substance use involvement. An adult training program second level intervention study will also be implemented to train tribal personnel from the three regional tribes on how to implement the intervention as a tribal program beyond the study period.

Effectiveness will be determined by a small partial cross-over randomized trial comparing the intervention to a wait-list control condition. Process evaluations will focus on the future adoption and implementation of the intervention, and recommendations for sustainable adaptations.

详细描述

The proposed study will consist of a 5-year plan: Year 1 has been completed and consisted of strengthening and extending community partnerships in each community and collecting data that will inform the cultural adaptation and tailoring of the intervention; Years 2, 3, and 4 will entail implementation by using a two-condition controlled study in which the culturally competent intervention is compared to standard care; and Year 5 will consist of final data collection, analysis of results, dissemination of results to local communities, and finalization of a sustainability plan for each Tribe.

Participants in the proposed study will consist of 540 male and female American Indian 6th grade students who represent at least three different Tribes - Choctaw, Ojibwe/ Chippewa, and Lumbee, in three different regions of the U.S. Participants will also include 70 tribal personnel (adults 18 and over) who be trained to implement the intervention in Years 3 & 4 of the project. Finally, 15-20 stakeholders and community partnership members will be interviewed at various stages of this project.

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
Single (Participant)

入排标准

年龄范围
10 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria for youth participants include:
  • AIl students enrolled in the 6th grade at each of the 3 regions
  • Active parental consent
  • Student willingness to participate and signed assent. Inclusion criteria for adult participants include: adults over 18 years of age currently employed as personnel, educators, and counselors at tribal schools among the three regions.

排除标准

  • Exclusion criteria include students who are not identified as American Indian, no active parental consent, and no signed assent.

结局指标

主要结局

Substance Use

时间窗: Change overtime at baseline, 6 months, 12 months

Self-report to substance use

次要结局

  • Native Self-Reliance(Change overtime at baseline, 6 months, 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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