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临床试验/NCT03491865
NCT03491865撤回不适用

Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages

Real Prevention, LLC2 个研究点 分布在 1 个国家开始时间: 2018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
状态
撤回
试验地点
2
主要终点
Smoking and Vaping Use

研究概览

简要总结

In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers.

In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping.

详细描述

In Phase I, participants will participate in pilot and usability tests of the curriculum prototype. For the pilot test, teachers and students will use the curriculum prototype and then be interviewed about it. For the usability test, students and teachers will use the revised curriculum and be interviewed/complete short survey. Teachers will provide consent and students will have parental consent and their own assent.

In Phase II, a group randomized trial will be conducted during Spring semester 2020 among 9th grade student in 27 high schools in the Hillsborough County Public School system randomly assigned to treatment and control (14 treatment and 13 control). All students will complete a pretest survey. Students in two health classes in treatments schools will participate in the REAL media Plus curriculum and complete a short immediate posttest survey to rate their experience. All students will then complete two posttests. Students will have parental consent and provide their own assent.

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

入选标准

  • Attendance at participating schools; 9th grade student status (for student participants, both phase 1 and 2); status as a teacher/counselor (for phase 1); written parental consent and assent from students (phase 1 and 2); written consent from counselors/teachers (phase 1); and all individuals must be willing to participate.

排除标准

  • Exclusion criteria include the inability to speak or read American English, use a computer, or navigate the Internet and, for youth, lack of parental consent.

研究组 & 干预措施

REAL media Plus

Experimental

Participants in this group will be assigned to use the REAL media Plus curriculum.

干预措施: REAL media Plus curriculum (Behavioral)

programming as usual

No Intervention

Participants in this group will participate in their usual school curriculum. They will have the opportunity to use the REAL media Plus curriculum at the conclusion of the study.

结局指标

主要结局

Smoking and Vaping Use

时间窗: Change in llifetime (e.g., ever tried) use from baseline to 9 months post baseline

Change in 5-item Lifetime Substance Use Measure Self reported lifetime use of (e.g., whether you ever tried) cigarettes and vaping. Response options include Yes and No.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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