Development of UP2UTobacco for High School Youth

Tobacco Use Clinical Trial

— UP2UTobacco  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05396911
• Other study ID #: SBS4719
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 432
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Electronic Cigarette Use
• Tobacco Use
• Tobacco Use Cessation

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	Virginia Foundation for Healthy Youth

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	past 30-day
Secondary	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	past 7 days