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临床试验/NCT05396911
NCT05396911已完成不适用

Testing an Anti-Tobacco Intervention to Reduce Tobacco and Nicotine Use Among High School Students

University of Virginia1 个研究点 分布在 1 个国家目标入组 597 人开始时间: 2022年4月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
597
试验地点
1
主要终点
Past 30-day point prevalence abstinence

研究概览

简要总结

Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based youth brief tobacco intervention for 9th grade students.

This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the intervention and developing the text messages. The second phase of the study evaluates the brief intervention, UP2UTobacco, through a cluster randomized controlled trial that compares UP2UTobacco to a no treatment control. It is hypothesized that the UP2UTobacco will produce greater abstinence at the 6-month follow-up compared to the no treatment control.

Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.

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
14 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Enrolled in the selected physical education or health class selected for participation in the study.

排除标准

  • 未提供

研究组 & 干预措施

UP2UTobacco

Experimental

Youth Brief Tobacco Intervention

干预措施: UP2UTobacco (Behavioral)

No Treatment Control

No Intervention

结局指标

主要结局

Past 30-day point prevalence abstinence

时间窗: past 30-day

The primary outcome measure in this study is self-reported past 30-day abstinence from cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, and pipe tobacco. Past 30-day abstinence will be determined for each product by a "No" response to the question, "In the past 30 days, have you used a \<insert tobacco product name\>, even one or two times or puffs?"

次要结局

  • Past 7-day point prevalence abstinence(past 7 days)

研究者

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

Melissa Little, PhD, MPH

Associate Professor, Department of Public Health Sciences

University of Virginia

研究点 (1)

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Development of UP2UTobacco for High School Youth | 临床试验