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Completed

NCT Number: NCT05396911

Development of UP2UTobacco for High School Youth

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.

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Key information

Age range

14 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22904, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

UP2UTobacco

Behavioral

The universal prevention program was designed as a group intervention to include components of effective tobacco control programs for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilizing a Socratic teaching style and evoking participation using the principles of motivational interviewing. UP2UTobacco targets all tobacco products with the goals to enhance motivation for youth to quit tobacco or remain tobacco-free, reduce intentions to use tobacco, promote peer discussions around the impact of using tobacco, and correct cognitive misperceptions around tobacco use.

Other names: Youth Brief Tobacco Intervention

Primary outcomes

  1. Past 30-day point prevalence abstinence

    Time frame: 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?"

Secondary outcomes

  1. Past 7-day point prevalence abstinence

    Time frame: past 7 days

    The primary outcome measure in this study is self-reported past 7-day abstinence from cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, and pipe tobacco. Past 7-day abstinence will be determined for each product by a "No" response to the question, "In the past 7days, have you used a <insert tobacco product name>, even one or two times or puffs?"

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Virginia Foundation for Healthy Youth

Registry information

Official study title

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

Acronym: UP2UTobacco

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 31, 2022
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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