Development of UP2UTobacco for High School Youth

Not Applicable

Active, not recruiting

• Conditions: Tobacco Use Cessation; Electronic Cigarette Use; Tobacco Use
• Interventions: Behavioral: UP2UTobacco

• Registration Number: NCT05396911
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-04
• Study First Submitted: 2022-05-20
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 432

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UP2UTobacco	UP2UTobacco	Youth Brief Tobacco Intervention

Primary Outcome Measures

Name	Time	Method
Past 30-day point prevalence abstinence	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 Outcome Measures

Name	Time	Method
Past 7-day point prevalence abstinence	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?"

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States