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临床试验/NCT05081843
NCT05081843已完成不适用

Tobacco Initiation Prevention for Pittsburgh and Rural Area High School Students

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
318
试验地点
2
主要终点
Percentage of Eligible 9th Grade Students Recruited to Participate in the Study

研究概览

简要总结

This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.

详细描述

Specific Aim 1: To assess 9th grade students' preferences for delivery of the web-based media literacy tobacco prevention program. Investigators will conduct focus groups with 9th grade students in each high school. Students will be shown clips from the program and asked to provide feedback about the preferred frequency and setting for the program.

Specific Aim 2: Investigators will conduct a pilot trial of the intervention via a cluster randomized controlled trial. The control group will receive their usual health education curriculum. The intervention group will receive their usual health education curriculum with the addition of the intervention. All students will be asked to complete a pre-test, a post-test, and two follow-up surveys (approximately 4 and 12 months post-intervention). Feasibility endpoints will include overall program completion, recruitment/attendance rates, and retention rates. Acceptability outcomes will assess student perceptions toward the intervention. A sub-aim will be to conduct focus groups and interviews with students, teachers, and administrators to assess implementation barriers and facilitators.

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 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 9th grade student
  • enrolled at participating Pittsburgh-area school

排除标准

  • Inability to read the surveys

结局指标

主要结局

Percentage of Eligible 9th Grade Students Recruited to Participate in the Study

时间窗: 1 month

Parents will be asked to return an opt out form if they do not want their student to participate. Students will provide assent if they wish to participate. Recruitment will be determined by calculating the percentage of eligible 9th grade students not opted out by their parents that also provide assent.

Percentage of Participants Retained Through the Final Data Collection

时间窗: 12 months

Retention will be calculated as the percentage of 9th grade students who completed the baseline survey and also completed the 12 month follow-up survey.

Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program

时间窗: post-test immediately following completion of the intervention

Acceptability of the intervention will be assessed with closed-ended and open-ended items on the post-test survey immediately following completion of the intervention. Students will be asked on a 5-point Likert scale with responses ranging from Strongly Agree to Strongly Disagree (with a neutral middle) their agreement about the following: "I enjoyed AD IT UP," "I understood AD IT UP," "AD IT UP was easy to use," "I tried my hardest when I was doing AD IT UP," "I think AD IT UP would be helpful to other kids my age," "I would recommend AD IT UP to a friend," and "I agree with AD IT UP's message." An answer of "Strongly Agree" or "Agree" on these items indicates high and moderate acceptability, respectively. Each of these items will be assessed individually, not as an overall scale. Open-ended items will ask: what the student would change about AD IT UP, what the student liked about AD IT UP, what made AD IT UP fun, and what made AD IT UP not fun.

次要结局

  • Changes in Intention to Use Tobacco Products(baseline vs. 12 month follow-up)
  • Changes in Attitudes Toward Tobacco Products(baseline vs. 12 month follow-up)
  • Changes in Normative Beliefs About Tobacco Products(baseline vs. 12 month follow-up)
  • Change in Tobacco-related Media Literacy(baseline vs. 12 month follow-up)

研究者

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

Jaime Sidani

Associate Professor

University of Pittsburgh

研究点 (2)

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