Development of UP2UTobacco for High School Youth (UP2UTobacco)

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

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Electronic Cigarette Use; Tobacco Use Cessation
• Intervention / Treatment: Behavioral: UP2UTobacco

• Study Type: Interventional
• Enrollment (Actual): 597
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Treatment Control
Experimental: UP2UTobacco; Youth Brief Tobacco Intervention	Behavioral: UP2UTobacco; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Past 30-day point prevalence abstinence	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?"	past 30-day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Past 7-day point prevalence abstinence	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?"	past 7 days

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: Virginia Foundation for Healthy Youth

Publications and helpful links

General Publications

• Little MA, Mallawaarachchi I, Pilehvari A, Velmurugan P, Wester AG, Wiseman KP. Do perceptions of harm and addictiveness influence adolescent's willingness to use various tobacco and nicotine products? Tob Prev Cessat. 2025 Jun 27;11. doi: 10.18332/tpc/204746. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: May 20, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Smoking; Health Behavior; Vaping; Tobacco Use; Tobacco Use Cessation
• Other Study ID Numbers: SBS4719

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No