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临床试验/NCT05731713
NCT05731713进行中(未招募)不适用

Discovering Our Story, to Develop the Journey of Transformation

University of Washington1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2023年12月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
182
试验地点
1
主要终点
Change in patterns of 30 day substance use assessed by self-report

研究概览

简要总结

The investigators will conduct a waitlist control trial to test the efficacy of the Journey of Transformation-Native Youth Health Leadership Program (JOT) in terms of delaying or reducing tobacco and other substance use and improving sexual health.

详细描述

This study assesses a new curriculum that will be available to students in the tenth grade. The lessons will include traditional storytelling and other Native American cultural arts activities (i.e., drum making, film making, field trips), as well as Traditional Ecological Knowledge (TEK) activities. This study also assesses how well the curriculum explains leadership skills, Native American cultural arts, the natural environment, and promotes healthy decision-making around health and relationships.

Participants are assigned to a health class that starts the curriculum in the fall or to a health class that will start the curriculum in the winter. Participants will:

Week 1. Complete a 15-20- minute online survey about healthy relationships, drug use, youth leadership skills, and connecting with Native communities.

Weeks 1 - 3. Meet with a study educator up to two times to set goals around health, healthy relationships and how to reduce or avoid alcohol, tobacco, or other drug use.

Weeks 1 - 12 (months 1-3). As part of the class, attend up to ten health sessions on healthy behaviors and health promotion. Learn new skills around youth leadership, storytelling, and traditional health practices. The sessions will highlight connection to tribal traditions.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
13 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Attends an off-reservation boarding school in the tenth grade at time of enrollment

排除标准

  • 未提供

研究组 & 干预措施

Immediate group

Experimental

Study participants in the immediate group will be randomly assigned to start the intervention immediately at the beginning of the fall trimester.

干预措施: Journey of Transformation-Native Youth Health Leadership Program curriculum (Behavioral)

Waitlist group

Experimental

Study participants in the waitlist group will be randomly assigned to start the intervention at the beginning of the winter trimester.

干预措施: Journey of Transformation-Native Youth Health Leadership Program curriculum (Behavioral)

结局指标

主要结局

Change in patterns of 30 day substance use assessed by self-report

时间窗: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)

Patterns of substance use (Monitoring the Future \[MTF\] 30-day self-report assessed on an ordinal scale \[0 occasions, 1-2 occasions, 3-5 occasions, 6-9 occasions, 10-19 occasions, 20-39 occasions, 40 or more occasions\]). Substances include tobacco, alcohol, marijuana, stimulants, inhalants, opioids, and other drugs.

Change in sexual behavior assessed by self-report

时间窗: Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only)

Primary sexual behaviors assessed by items from the Adolescent Sexual Activity Index

次要结局

  • Change in intentions to use alcohol, cigarettes, and marijuana in the next year (assessed by Monitoring the Future [MTF])(Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only))
  • Change in the Specific Event Drug and Alcohol Refusal Self-Efficacy (SEDARE) Measure(Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only))
  • Change in the Sexual Health and Reproductive Empowerment for Young Adults Scale (self-efficacy) (Upadhyay et al., 2020)(Baseline to 3-month (post-intervention) follow-up; Baseline to 6-month follow-up; Baseline to 12-month follow-up (immediate group only))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Teresa Evans-Campbell

Associate Professor: School of Social Work

University of Washington

研究点 (1)

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