ATI-V Program for Preventing Adolescent Vaping

Recruiting in Rochester (>99 mi)

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

3840 Participants Needed

Trial Summary

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 data supports the effectiveness of the ATI-V treatment for preventing adolescent vaping?

The Teen Vaping ECHO program showed that educating clinicians about vaping can increase their comfort in discussing and treating vaping with adolescents, suggesting that similar educational approaches like ATI-V could help reduce vaping among youth. ^{1 2 3 4 5}

What safety data exists for the ATI-V Program for Preventing Adolescent Vaping?

The research articles do not provide specific safety data for the ATI-V Program or similar treatments, but they highlight potential health issues associated with frequent vaping, such as headaches, cough, sleep disturbances, and chest pain. ^{3 6 7 8 9}

How is the ATI-V treatment different from other treatments for preventing adolescent vaping?

The ATI-V treatment is unique because it focuses on preventing adolescent vaping by addressing the influence of peer pressure and co-occurring substance use, such as cannabis and alcohol, which are often linked with vaping. This approach is different from other treatments that may not consider these social and behavioral factors. ^{3 4 9 10 11}

What is the purpose of this trial?

Rates of adolescent vaping are increasing rapidly. Current high school student use of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions are urgently needed to protect adolescents from initiating or continuing use of electronic vaping products (EVPs). This study leverages a state-supported prevention initiative to test the effectiveness of a promising intervention that trains 8th-9th grade student peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult mentoring. If study hypotheses are supported, the study will provide the first evidence of a school-based preventive intervention that reduces adolescent vaping behaviors, as well as insight into how peer communications can be harnessed to prevent vaping.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Examining the Efficacy of Project ECHO to Improve Clinicians' Knowledge and Preparedness to Treat Adolescent Vaping. [2023]

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

Treatment of Adolescent e-Cigarette Use: Limitations of Existing Nicotine Use Disorder Treatment and Future Directions for e-Cigarette Use Cessation. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adolescent Weight and Electronic Vapor Product Use: Comparing BMI-Based With Perceived Weight Status. [2019]

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

Nicotine and cannabis vaping among adolescents in treatment for substance use disorders. [2022]

5. United States 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. [2023]

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

Youth vaping beliefs and behaviors: evidence from New York. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

The national prevalence of adolescent nicotine use in 2017: Estimates taking into account student reports of substances vaped. [2022]

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

Risk Factors and Medical Symptoms Associated With Electronic Vapor Product Use Among Adolescents and Young Adults. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Nicotine Vaping and Co-occurring Substance Use Among Adolescents in the United States from 2017-2019. [2023]

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

Is susceptibility to E-cigarettes among youth associated with tobacco and other substance use behaviors one year later? Results from the PATH study. [2023]

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

D.A.R.E./keepin' it REAL elementary curriculum: Substance use outcomes. [2023]