Y-BTI + Text Messaging for Quitting Smoking

(UP2UTobacco Trial)

MA
TR
Overseen ByTaylor Reid, MPH
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Virginia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help 9th-grade students quit smoking by testing a Youth Brief Tobacco Intervention, a program designed to assist young people in quitting smoking. The researchers will adapt the program using student feedback to create effective messages and strategies. Students in selected physical education or health classes will either try the intervention or join a no-treatment group to determine if the program works better than doing nothing. The study seeks 9th graders interested in participating to help develop better ways to quit smoking. As an unphased trial, it offers students the opportunity to contribute to innovative strategies for quitting smoking.

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 prior data suggests that this intervention is safe for youth?

Research shows that the Youth Brief Tobacco Intervention (Y-BTI) is based on a method effective for young adults aged 18 to 20 in reducing tobacco use. This approach has a strong track record. While evidence is still being gathered on Y-BTI's effectiveness for younger teens, similar programs for youth have not raised major safety concerns. Additionally, nicotine replacement therapy, often used in quitting smoking, has been found safe for teenagers.

Overall, similar programs for young people have not reported serious side effects. This supports the safety of Y-BTI as a method to help high school students stop smoking.12345

Why are researchers excited about this trial?

Researchers are excited about the Youth Brief Tobacco Intervention (Y-BTI) because it combines traditional counseling techniques with modern technology to help young people quit smoking. Unlike most treatments that rely heavily on nicotine replacement therapies or prescription medications, Y-BTI focuses on behavioral change through brief interventions and personalized text messaging support. This innovative approach allows for real-time encouragement and accountability, which can be more engaging and accessible for youth. By leveraging technology in this way, the treatment has the potential to reach a wider audience and provide support right when individuals need it most.

What evidence suggests that this trial's treatments could be effective for quitting smoking?

Research has shown that short programs can help young people stop smoking. In past studies, 85% of participants found these programs useful for quitting. This trial will evaluate the Youth Brief Tobacco Intervention as one of the treatment arms. Group sessions have proven effective for individuals aged 18–20. Although direct evidence for 9th graders is limited, similar methods have succeeded with older teens. These programs are easy to implement in schools, offering a practical way to reduce smoking among teenagers.678910

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: UP2UTobaccoExperimental Treatment1 Intervention
Group II: No Treatment ControlActive Control1 Intervention

Find a Clinic Near You

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+

Published Research Related to This Trial

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.
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]

Citations

Evaluating the Effectiveness of Brief Interventions for Smoking ...Totally, 85% of the participants described brief smoking cessation intervention as helpful in quitting. Experience and a positive attitude were identified as ...
Systematic review: interventions to quit tobacco products for ...A RCT based on pharmacologic intervention reported a self-reported 7-day abstinence rate of 19.6% among nicotine patch users compared to ...
Development of a youth adapted Brief ...While substantial evidence demonstrates long-term effectiveness of youth cigarette smoking prevention and cessation programs, the evidence ...
Efficacy of a group-based brief tobacco intervention among ...Conclusions: The BTI was effective for people aged 18–20 years. The current study offers insight into components of interventions that might be ...
Smoking Cessation Interventions for Young AdultsData were analyzed descriptively to summarize the context, intervention, and outcome-related data from the included studies. The aim is to ...
Tobacco cessation interventions for young people - PMCThere is limited evidence that either behavioural support or smoking cessation medication increases the proportion of young people that stop smoking in the long ...
Rationale, design, and methods for the development of a ...The Y-BTI is based on the Brief Tobacco Intervention (BTI) that has demonstrated efficacy in helping 18–20-year-olds reduce their tobacco use in a randomized ...
Effectiveness of family-based behavioral intervention for ...Parents receiving family-based behavioral interventions showed greater reductions in daily cigarette consumption, increased quit attempts, ...
Protecting Children and Adolescents From Tobacco and ...It should be noted that the evidence supports the safety of nicotine replacement therapy (NRT) in adolescents. Only 3 studies in the USPSTF ...
Percentage of current tobacco smoking students receiving ...More than half of current tobacco smoking students received help or advice to quit from either a program or professional, friend, or family member.
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