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临床试验/NCT01847183
NCT01847183已完成2 期

Evaluation of an Intranet-Based Alcohol Prevention Program in Middle School

Oregon Research Institute1 个研究点 分布在 1 个国家目标入组 2,300 人开始时间: 2012年11月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
2,300
试验地点
1
主要终点
Decrease intentions to get drunk from baseline to one week follow-up; from baseline to one-year follow-up and from baseline to two-year followup.

研究概览

简要总结

The purpose of this research is to create and evaluate the efficacy of an exciting (fun to use), and potentially disseminable computer-based prevention program, Click City®: Alcohol, for use by 7th graders with a booster in 8th grade students. The ultimate goal of Click City®: Alcohol is to prevent the onset of heavy drinking during high school and post-high school. Secondary goals of the program include decreasing students' intentions and willingness to engage in heavy drinking in high school. The proposed program is unique both in its delivery system and the development process.

Aim 1: The investigators plan to develop and test approximately 24 components over the first two years of the study.

Aim 2: The final Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period in 7th grade. This is followed by two booster sessions, consisting of a total of 5 components delivered over a one-week period in 8th grade. Educational newsletters to parents and teacher guides will accompany the program.

Aim 3: Following development, the investigators will conduct a group randomized trial to evaluate the efficacy of this program as compared to schools' usual alcohol prevention curriculum. The investigators plan to recruit, stratify and randomly assign 26 middle schools to one of the two conditions, Click City®: Alcohol and Usual Curriculum (UC). Students in the Click City®: Alcohol and yoked UC schools will be assessed prior to the beginning of the 7th grade program, following the 7th grade program, following the 8th grade booster, which would occur approximately one year after the 7th grade program, and a follow-up assessment in the 9th grade to assess long-term outcomes, one year after the 8th grade assessment.

详细描述

The proposed program is unique both in its delivery system and the development process. The program will be delivered in a computer game like format over a school-based intranet system (i.e., networked computers linked to a school-based server), which enables users to interact individually with the program and to share their experiences by receiving immediate feedback on both their own responses and those of their classmates' collective responses. The delivery of this computer-based programs assures fidelity of implementation. Each activity (component) ultimately included in the program will be continually developed and tested to assure that it is effective at changing the targeted theoretically based etiological mechanism (risk factor). Development will include an experimental assessment to evaluate the effectiveness of each component and only effective components will be included in the program. The 7th grade version of Click City®: Alcohol program will consist of 12 effective components delivered in six sessions over a three-week period. This will be followed by two 8th grade booster sessions, consisting of a total of 5 components delivered over a one-week period. Educational newsletters to parents and teacher guides will be developed to accompany the program. The investigators will conduct a randomized efficacy trial with 26 middle schools. Half of the schools will use the newly developed program and the other half will use the programs that they usually do to teach about Alcohol.

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
12 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •parents give passive consent for their students to participate. Students must attend a participating school.

排除标准

  • •non-English speakers, some special Ed students

研究组 & 干预措施

Click City®: Alcohol

Experimental

Receive the Click City®: Alcohol program as part of their school curriculum.

干预措施: Click City®: Alcohol (Behavioral)

Usual Curriculum

No Intervention

Students receive their usual alcohol curriculum

结局指标

主要结局

Decrease intentions to get drunk from baseline to one week follow-up; from baseline to one-year follow-up and from baseline to two-year followup.

时间窗: one week following intervention; one year following intervention: two years following intervention

Intention is measured by two items: Do you think you will get drunk (from drinking too much alcohol) when you are in high school? Do you think you will get drunk (from drinking too much alcohol) when you are older?

次要结局

  • Decrease willingness to get drink alcohol from baseline(one week following intervention; one year following intervention: two years following intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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