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临床试验/NCT03119129
NCT03119129Unknown不适用

The Development and Evaluation of the Ho'Ouna Pono Drug Prevention

Hawaii Pacific University0 个研究点目标入组 486 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
486
主要终点
Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey

研究概览

简要总结

The purposes of this study are to complete the development of a video-enhanced, school-based drug prevention program for rural Hawaiian youth (Ho'ouna Pono) using community-based participatory research principles and practices, and to test the efficacy and adoption of the full intervention across all middle/intermediate schools on Hawai'i Island. These purposes will be accomplished through three specific aims. AIM 1 (Year 1) is to complete the Ho'ouna Pono drug prevention curriculum initially developed and validated in a NIDA-funded pilot/feasibility study (R34 DA031306). To date, five professionally filmed video vignettes depicting drug-related problem situations specific to rural Hawaiian youth and seven interactive classroom lessons have been created, implemented in randomly selected intervention schools, and preliminarily evaluated using a pre-test, post-test control group design. Aim 1 enhances and builds upon this work by producing two new video vignettes, re-editing a "Behind the Scenes" video, developing new classroom curricular components, and synthesizing the new content with the existing curriculum. AIM 2 (Years 2-3) is to evaluate the fully conceived curriculum across all middle/intermediate schools on Hawai'i Island (N = 15) using a dynamic wait-listed control group design (Brown, Wyman, Guo, & Peña, 2006). Using this design, schools will be randomly assigned to four cohorts, and cohorts will be randomly assigned to receive the curriculum at designated times staggered across the two-year evaluation period. All participating youth will be measured at six designated time points across the two-year evaluation period. Because of the staggered implementation of the curriculum, intervention effects will differ by cohort, and earlier time points will include control schools for the initial cohorts receiving the intervention. All participating youth will receive pre-tests prior to curriculum implementation and post-tests upon curriculum completion, with youth attending schools in Cohorts 1-3 receiving follow-up evaluations. AIM 3 (Year 4) is to assess community, systemic, and curricular factors related to the implementation, adoption, and sustainability of the curriculum within public middle/intermediate schools on Hawai'i Island.

The present study is the result of seven consecutive years of NIDA-funded pre-prevention and translational pilot/feasibility drug prevention research focused on rural Hawaiian youth and communities. The overall outcome of this study will be an empirically supported, culturally grounded drug prevention curriculum relevant to Native Hawaiian and Pacific Islander youth. This study addresses the lack of prevention interventions for Native Hawaiians and other Pacific Islanders (NHOPIs) and indigenous youth populations, and directly contributes to the development of an indigenous prevention science (Okamoto, Helm, et al., 2014). It has implications for informing indigenous, Pacific Islander, and rural health disparities and health equity promotion.

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
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Grades 6-8 in a public or public-charter middle, intermediate, or multi-level school on Hawai'i Island -

排除标准

  • 未提供

研究组 & 干预措施

Cohort 3

Experimental

Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, AY 2017-2018

干预措施: Ho'ouna Pono Drug Prevention Curriculum (Behavioral)

Cohort 4

Experimental

Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2017-2018

干预措施: Ho'ouna Pono Drug Prevention Curriculum (Behavioral)

Cohort 1

Experimental

Four middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 2, Academic Year (AY) 2016-2017

干预措施: Ho'ouna Pono Drug Prevention Curriculum (Behavioral)

Cohort 2

Experimental

Three middle or intermediate schools receiving the Ho'ouna Pono curriculum in Quarter 3, AY 2016-2017

干预措施: Ho'ouna Pono Drug Prevention Curriculum (Behavioral)

结局指标

主要结局

Number of participants using drug resistance strategies as measured by the Ho'ouna Pono Survey

时间窗: 30 days

Strategies (e.g., refuse, explain, avoid, leave) used by youth to resist offers to use drugs in the home, school, or community.

Recent substance use

时间窗: 30 days

Use of alcohol, cigarettes, marijuana, and other drugs over the past month.

次要结局

未报告次要终点

研究者

发起方
Hawaii Pacific University
申办方类型
Other
责任方
Sponsor

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