Y-BTI + Text Messaging for Quitting Smoking

(UP2UTobacco Trial)

Overseen By Taylor Reid, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Virginia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

432 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Y-BTI + Text Messaging for Quitting Smoking?

Research shows that text messaging interventions can help young people quit smoking. For example, a study found that a text messaging program for adolescents led to a decrease in smoking days and cigarettes smoked, and increased intentions not to smoke in the future. ^{1 2 3 4 5}

Is the Y-BTI + Text Messaging treatment safe for humans?

The text messaging interventions for smoking cessation, like SmokeFreeTeen and others, have been used in various studies without reports of safety concerns, suggesting they are generally safe for humans. ^{1 2 3 4 6}

How is the Y-BTI + Text Messaging treatment for quitting smoking different from other treatments?

The Y-BTI + Text Messaging treatment is unique because it combines a brief tobacco intervention specifically designed for youth with a text messaging component, which is a scalable and engaging way to support smoking cessation among teens. This approach leverages the accessibility and familiarity of text messaging to provide ongoing support and motivation, which is not commonly found in traditional smoking cessation programs. ^{1 2 4 6 7}

Eligibility Criteria

This trial is for 9th grade students enrolled in selected physical education or health classes. It aims to help them quit smoking, including traditional tobacco use and vaping. There are no specific exclusion criteria, so all students in these classes can participate.

Inclusion Criteria

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

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation

Qualitative roundtable discussions with 9th grade students to adapt an existing young adult brief tobacco intervention for youth

4 weeks

Multiple group discussions

Treatment

Evaluation of the UP2UTobacco intervention through a cluster randomized controlled trial

6 months

Regular school-based sessions

Follow-up

Participants are monitored for abstinence from tobacco products at the 6-month follow-up

1 month

Treatment Details

Interventions

• Automated Text Messaging
• Youth Brief Tobacco Intervention

Trial Overview The study tests a Youth Brief Tobacco Intervention (Y-BTI) combined with automated text messaging (ATM) against Y-BTI alone, ATM alone, and no treatment. The goal is to see which method helps students stop using tobacco most effectively after six months.

Participant Groups

Group I: UP2UTobacco Experimental Treatment 1 Intervention

Youth Brief Tobacco Intervention

Group II: No Treatment Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Virginia Foundation for Healthy Youth

Collaborator

Trials

1

Recruited

430+

Findings from Research

The study evaluates the effectiveness of a text message program called 'This is Quitting' for helping young adults (ages 18-24) quit vaping, with a primary outcome of 30-day abstinence measured 7 months after enrollment.

Initial results from a pilot sample of 269 participants showed that 16.2% of those using the text message intervention achieved abstinence compared to 8.3% in the control group, indicating a promising potential for this intervention in promoting vaping cessation among young adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Quit Vaping Text Message Program in Promoting Abstinence Among Young Adult E-Cigarette Users: Protocol for a Randomized Controlled Trial. Graham, AL., Jacobs, MA., Amato, MS., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Dropout, response, and abstinence outcomes of a national text-messaging smoking cessation intervention for teens, SmokeFreeTeen. [2021]

2. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of a Quit Vaping Text Message Program in Promoting Abstinence Among Young Adult E-Cigarette Users: Protocol for a Randomized Controlled Trial. [2020]

3. Canada pubmed.ncbi.nlm.nih.gov

Dropout and Abstinence Outcomes in a National Text Messaging Smoking Cessation Intervention for Pregnant Women, SmokefreeMOM: Observational Study. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Text Message Delivered Peer Network Counseling for Adolescent Smokers: A Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Development and Outcomes of a Text Messaging Tobacco Cessation Intervention With Urban Adolescents. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Collecting outcome data of a text messaging smoking cessation intervention with in-program text assessments: How reliable are the results? [2019]

7. England pubmed.ncbi.nlm.nih.gov

User satisfaction with the structure and content of the NEXit intervention, a text messaging-based smoking cessation programme. [2018]