Development of UP2UTobacco for High School Youth

NCT05396911 | Completed

• 1 other identifier: SBS4719
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Tobacco Use; Electronic Cigarette Use

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Past 7-day point prevalence abstinence

  past 7 days

Study Arms (2)

UP2UTobacco

EXPERIMENTAL

Youth Brief Tobacco Intervention

Behavioral: UP2UTobacco

No Treatment Control

NO INTERVENTION

Interventions

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.

Also known as: Youth Brief Tobacco Intervention

UP2UTobacco

Eligibility Criteria

• Age: 14 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Virginia: lead
• Virginia Foundation for Healthy Youth: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• 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.

  PMID: 40584776 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use; Vaping

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Public Health Sciences

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 31, 2022
• Study Start: April 4, 2022
• Primary Completion: May 31, 2025
• Study Completion: February 28, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)