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临床试验/NCT03682900
NCT03682900已完成不适用

Expanding the Click City Tobacco Prevention Program to Include E-cigarettes and Other Novel Tobacco Products

Oregon Research Behavioral Intervention Strategies, Inc.2 个研究点 分布在 1 个国家目标入组 2,673 人开始时间: 2019年10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
2,673
试验地点
2
主要终点
Change in Behavioral Intentions to Vape E-cigarettes

研究概览

简要总结

The goal of this study is to modify a smoking prevention program for 5th and 6th grade students to also target vaping e-cigarettes. Aims were to modify the program along with associated materials and to conduct a trial with 5th grade students in the school setting to see how well the updated program worked. Students either participated in the four-week computer based program or continued with their usual tobacco prevention curriculum.

This study showed that students who received the computer program reduced their intentions and willingness to use e-cigarettes or smoke in the future more than did students who used their usual tobacco curriculum.

详细描述

Given the increase in prevalence of e-cigarette use among youth, investigators modified a smoking prevention program to not only target smoking but also vaping e-cigarettes. Investigators conducted a pragmatic randomized trial with 5th grade students in schools across Arizona and Oregon to evaluate the effectiveness of the updated program in a "real-world" setting. Forty-five schools were randomized to the intervention condition, wherein students used the updated version of Click City®: Tobacco, or the control condition, wherein students were taught their usual tobacco prevention curriculum. Students in the intervention schools decreased their intentions and willingness to use e-cigarettes and cigarettes significantly, as compared to students in control schools. The intervention also significantly changed all etiological mechanisms. The effects on all outcomes of the intervention were similar as a function of state (Arizona vs Oregon), gender, ethnicity (Hispanic vs not Hispanic), and historical timing (prior to school closures in 2020 vs after schools re-opened in 2022). The intervention was also more effective for at-risk students, as defined by student's previous tobacco use, current family use and/or high in sensation seeking. Close to 90% of the students completed the entire program, and most completed it in 3 to 4 weeks, the expected time frame. The effectiveness of the updated Click City®: Tobacco was demonstrated in a "real world" setting and findings suggested that all students can potentially benefit from the program.

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

入选标准

  • A 5th grade student in one of the recruited schools
  • Student speaks English as a first or second language
  • Passive parental consent to participate

排除标准

  • Special needs students identified by the classroom teacher as a student who would not understand the questionnaire or the program
  • Teacher indicates that they cannot comprehend English.

结局指标

主要结局

Change in Behavioral Intentions to Vape E-cigarettes

时间窗: baseline; six months

Measured by two items, assessing the student's intentions regarding vaping e-cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with potential range from 2 to 10. A higher score means a worse outcome.

Change in Willingness to Smoke Cigarettes

时间窗: baseline; six weeks

Measured by four items, assessing the student's willingness to smoke cigarettes if the opportunity presented itself ("with a group of kids with cigarettes available" and "with kids who are smoking and you want to be a part of the group". Willingness to smoke was assessed for two levels, "try a few puffs" and "smoking the whole cigarette". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.

Change in Behavioral Intentions to Smoke Cigarettes

时间窗: baseline; six weeks

Measured by two items assessing the student's intentions to smoke cigarettes as a teen or as a grown-up. Responses were on a five-point scale ranging from "definitely not" (1) to "definitely will" (5). The scale was created by summing the two items with a potential range from 2 to 10. A higher score means a worse outcome.

Change in Willingness to Vape E-cigarettes

时间窗: baseline; six weeks

Measured by four items, assessing the student's willingness to vape e-cigarettes if the opportunity presented itself (with a group of kids with e-cigaretes available and with kids who are vaping and you want to be a part of the group. Willingness to vape was assessed for two levels, "try a few vapes" and "try vaping several times in a row". Responses were on a five point scale, "not at all willing" (1) to "very willing" (5) and were summed for the two scenarios and two levels, yielding a scale from 4 to 20. A higher score means a worse outcome.

次要结局

  • Change in Normative Social Images of Vapers(baseline; six weeks)
  • Change in Perception of Friends Approval of Vaping(baseline; six weeks)
  • Change in Perception of Risk of Second-hand Smoke Exposure(baseline; six weeks)
  • Change in Perception of Risk of Second-hand Vape Exposure(baseline; six weeks)
  • Change in Perception of Risk of Vaping Each E-cigarette(baseline; six weeks)
  • Change in Perception of Risk of Addiction From Vaping(baseline; six weeks)
  • Change in Perception of Risk of Difficulty Quitting Vaping(baseline; six weeks)
  • Change in Favorable Social Images of Smokers(baseline; six weeks)
  • Change in Favorable Social Images of E-cigarette Vapers(baseline; six weeks)
  • Change in Normative Social Images of Smokers(baseline; six weeks)
  • Change in Perception of Risk of Cumulative Consequences of Vaping(baseline; six weeks)
  • Change in Perception of Risk of Addiction From Smoking(baseline; six weeks)
  • Change in Perception of Control Over Quitting Smoking(baseline; six weeks)
  • Change in Perception of Friends Approval of Smoking(baseline; six weeks)
  • Change in Perception of Risk of Cumulative Consequences of Smoking(baseline; six weeks)
  • Change in Perception of Risk of Smoking Each Cigarette(baseline; six weeks)
  • Change in Perception of Control Over Vaping(baseline; six weeks)
  • Change in Perception of Risk of Difficulty Quitting Smoking(baseline; six weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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