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Clinical Trials/NCT05396911
NCT05396911
Completed
Not Applicable

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

University of Virginia1 site in 1 country597 target enrollmentApril 4, 2022

Overview

Phase
Not Applicable
Intervention
UP2UTobacco
Conditions
Tobacco Use Cessation
Sponsor
University of Virginia
Enrollment
597
Locations
1
Primary Endpoint
Past 30-day point prevalence abstinence
Status
Completed
Last Updated
12 days ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2022
End Date
February 28, 2026
Last Updated
12 days ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Melissa Little, PhD, MPH

Associate Professor, Department of Public Health Sciences

University of Virginia

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

UP2UTobacco

Youth Brief Tobacco Intervention

Intervention: UP2UTobacco

No Treatment Control

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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