ATI-V Program for Preventing Adolescent Vaping

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Non-English speaking

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

Compensation: Varies

Number of Visits: 16

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on finding effective ways to prevent adolescents from starting or continuing to use electronic vaping products (EVPs). The study tests an intervention called Above the Influence-Vaping (ATI-V), where 8th and 9th-grade students train as peer leaders to conduct school-wide campaigns against vaping, with adult guidance. The trial aims to determine if these peer-led campaigns can successfully reduce vaping among teenagers. Eligible participants include 8th-grade students who speak English and attend a participating school. As an unphased trial, this study offers a unique opportunity to contribute to important research that could help peers make healthier choices.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this intervention is safe for adolescents?

Research shows that the "Above the Influence-Vaping" (ATI-V) program aims to prevent vaping among teens by training peer leaders to share anti-vaping messages in schools. However, specific safety data for the ATI-V program itself is not available.

The ATI-V program is a school-based educational effort and does not involve medical treatments or drugs. Therefore, it lacks typical safety concerns like side effects associated with medications. The program focuses on teaching students to support each other in avoiding vaping through communication and encouragement.

Since this is not a medical treatment, the primary focus is on its effectiveness in reducing vaping among teens. Safety concerns, as seen with new drugs, do not apply here. Instead, the goal is to evaluate how well the program prevents kids from starting to vape. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ATI-V program because it aims to tackle adolescent vaping by proactively educating students before habits form. Unlike traditional approaches that often focus on cessation after vaping begins, ATI-V integrates prevention into the school curriculum, engaging students over two school years. This early intervention strategy is designed to provide lasting prevention by embedding anti-vaping messages and skills at a critical developmental stage.

What evidence suggests that the ATI-V program is effective for preventing adolescent vaping?

Research has shown that the Above the Influence-Vaping (ATI-V) program might help reduce vaping among teenagers. In early tests, student leaders encouraged their classmates not to vape. These leaders shared anti-vaping messages, fostering a supportive environment against vaping. Although some studies have shown mixed results for school-based vaping prevention, the ATI-V program's focus on peer influence is unique and promising. In this trial, participants will receive either the Immediate ATI-V Intervention or the Delayed ATI-V Intervention. Overall, the ATI-V approach could effectively lower vaping rates among young people. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for current 8th grade students in a participating school, regardless of race, color, national origin, sexual orientation, sex, gender identity, age or ability. Non-English speaking students cannot participate.

Inclusion Criteria

I understand I cannot be excluded based on my race, gender, age, or abilities.

I am currently an 8th grader at the study school.

Exclusion Criteria

You do not speak English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Intervention

School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years.

18 months

Surveys at baseline, 8 months, 20 months, 28 months

Delayed Intervention

ATI-V prevention program training after 4th assessment, following a wait-list period.

28 months

Surveys at baseline, 8 months, 20 months, 28 months

Follow-up

Participants are monitored for changes in vaping behavior and attitudes after intervention

4 months

What Are the Treatments Tested in This Trial?

Interventions

• Above the Influence-Vaping (ATI-V)

Trial Overview The study tests the 'Above the Influence-Vaping' (ATI-V) program where trained student peer leaders run anti-vaping campaigns with adult guidance to see if it can reduce vaping among adolescents.

How Is the Trial Designed?

Group I: Immediate Above the Influence-Vaping Intervention Experimental Treatment 1 Intervention

School receives Above the Influence-Vaping (ATI-V) prevention program training after baseline assessment. Training and intervention continue over two school years (approximately 18 months). Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade).

Group II: Delayed Above the Influence-Vaping Intervention Active Control 1 Intervention

Surveys at baseline, 8 months (end 8th grade), 20 mo (end 9th grade), 28 mo (mid-10th grade). ATI-V prevention program training after 4th assessment - after 28 months.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Penn State University

Collaborator

Trials

380

Recruited

131,000+

Claremont Graduate University

Collaborator

Trials

10

Recruited

13,200+

Texas Tech University

Collaborator

Trials

89

Recruited

10,300+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

In a study of 494 adolescents aged 12 to 23, 20% were identified as frequent users of electronic vapor products (EVPs), while 80% were either nonusers or experimenters, highlighting a significant prevalence of EVP use among young people.

Frequent EVP users reported a range of negative symptoms in the past 6 months, including headaches, cough, sleep disturbances, and racing heart, suggesting potential health risks associated with regular vaping and supporting the need for preventive measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk Factors and Medical Symptoms Associated With Electronic Vapor Product Use Among Adolescents and Young Adults. Benyo, SE., Bruinsma, TJ., Drda, E., et al.[2021]

A study of 32 adolescents and young adults receiving medication treatment for opioid use disorder revealed a high prevalence of nicotine use, with 97% having tried combustible cigarettes and 90% having tried e-cigarettes, indicating early initiation of nicotine use.

Most participants (71%) reported daily use of combustible cigarettes, highlighting a significant concern for this population, and suggesting the need for targeted interventions like universal nicotine screening and tailored cessation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns and perceptions of nicotine use among U.S. adolescents and young adults receiving medication treatment for opioid use disorder. Watson, ML., McKnight, ER., Groner, JA., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0306460320308236

Peer leader influence and diffusion of a network-informed ... We pilot tested the peer-led Above the Influence of Vaping (ATI-V) and examined diffusion through 8th grade networks in three schools.

2. withpower.com withpower.com/trial/phase-8-2020-88958

ATI-V Program for Preventing Adolescent Vaping This study leverages a state-supported prevention initiative to test the effectiveness of a promising intervention that trains 8th-9th grade student peer ...

3. ajpmonline.org ajpmonline.org/article/S0749-3797(23)00389-6/fulltext

Interventions for Preventing E-Cigarette Use Among ... This systematic review summarized the evidence on the effectiveness of vaping prevention interventions among children and youth delivered at the ...

4. researchgate.net researchgate.net/figure/Peer-Led-Above-the-Influence-of-Vaping-Social-Network-Model-for-EVP-Prevention_fig1_346143358

Peer-Led Above the Influence of Vaping: Social Network ... We pilot tested the peer-led Above the Influence of Vaping (ATI-V) and examined diffusion through 8th grade networks in three schools.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295513/

Vaping Education: A Two-Year Study Examining Health ... These results suggest that vaping prevention education outcomes among youths are mixed. Keywords: vaping prevention, school-based program, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0749379723003896

Interventions for Preventing E-Cigarette Use Among ... A meta-analysis in 2017 reported that youth who had ever vaped were over 3 times more likely to initiate combustible cigarette smoking than those who never ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33069108/

Peer leader influence and diffusion of a network-informed ... We pilot tested the peer-led Above the Influence of Vaping (ATI-V) and examined diffusion through 8th grade networks in three schools.

8. library.samhsa.gov library.samhsa.gov/sites/default/files/pep20-06-01-003.pdf

Reducing Vaping Among Youth and Young Adults In fact, research has found that adolescents who reported never smoking but tried e-cigarettes were more likely to try cigarettes in the future.

9. ajpmonline.org ajpmonline.org/article/S0749-3797(23)00389-6/pdf

Interventions for Preventing E-Cigarette Use Among ... The primary outcome was the difference in inci- dence or prevalence of vaping initiation among children or youth exposed to an intervention compared to a con-.