| Registry | NCT07737080 |
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 90 (Estimated) |
| Sponsor | University of Rochester (Other) |
| Conditions | Vaping Behaviors |
| Interventions | Health Impacts of E-cigarettes, Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping, The Villainous Vape (Behavioral) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-03-31 (estimated), completion 2027-03-31 (estimated), first posted 2026-07-30, last updated 2026-07-30 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Vaping Behaviors All trials of Health Impacts of E-cigarettes All trials of Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping
-Summary
This is a randomized controlled trial to assess the feasibility, acceptability, and preliminary impact of The Villainous Vape, a vaping prevention comic book, among adolescents.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Health Impacts of E-cigarettes | Active comparator | Behavioral: Health Impacts of E-cigarettes | |
| Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping | Active comparator | Behavioral: Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping | |
| The Villainous Vape | Experimental | Behavioral: The Villainous Vape | |
- Health Impacts of E-cigarettes (Behavioral): Health Impacts of E-cigarettes is a one-page educational flyer that outlines the impact of using electronic cigarettes and what is being done to mitigate youth vaping. The flyer reviews the dangers of nicotine delivery devices, lung damage, and how to stay safe in the event of social exposure to vaping. Health Impacts of E-cigarettes was developed by the U.S. Food and Drug Administration.
- Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping (Behavioral): Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping is a five-page educational brochure that utilizes an illustrative approach to sharing basic information about nicotine and tobacco products. The brochure focuses on the physiological effect of these products, health effects, addiction, and key statistics. Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping was developed by the U.S. National Institute on Drug Abuse.
- The Villainous Vape (Behavioral): The Villainous Vape is an eleven-page comic book that follows Daniel, a high school student who gets addicted to vaping and is hospitalized in the intensive care unit because he develops a lung disease. Support from friends and family helps Daniel make the decision to quit vaping. Throughout the comic, readers are exposed to various vaping-related facts and statistics.
+Outcome measures
Primary outcomes
- Percentage Of Participants Who Complete the Month 3 Assessment. [Month 3]: The percentage will be calculated as the number of participants who complete the Month 3 assessment divided by the total number of enrolled participants.
- Percentage Of Participants Who Are Satisfied With Their Assigned Intervention at Month 3 [Month 3]: All participants will be asked the following question at Month 3: "How satisfied are you with the assigned intervention?" Responses will be collected using a 5-item Likert scale. The percentage of participants who are satisfied with their assigned intervention at Month 3 will be calculated as the number of participants who respond "satisfied" or "extremely satisfied," divided by the total number of participants in each group.
- Percentage Of Participants With Reduced Susceptibility To Future Vaping [Baseline to Month 3]: Susceptibility to future vaping will be assessed using the susceptibility to e-cigarettes scale. The scale consists of three questions: 1) Have you ever been curious about using e-cigarettes? 2) Do you think you will use e-cigarettes in the next year? 3) If one of your best friends were to offer you an e-cigarette, would you use it? The questions use a 4-point Likert scale ranging from not at all curious (1) to very curious (4) for question one and definitely not (1) to definitely yes (4) for questions two and three. Participants who provide a response other than "not all curious" or "definitely not" will be considered "susceptible". The percentage will be calculated as the number of participants who demonstrate a change from "susceptible" at baseline to "not susceptible" at Month 3, divided by the total number of participants in each group.
+Eligibility
Sex: All, ages: 12 Years to 17 Years, accepts healthy volunteers
Inclusion Criteria:
* Know how to read and speak English and/or Spanish
* Be at least 12 but no greater than 17 years old
* Be willing to complete three study visits over Zoom or a phone call
* Live in Orleans County, New York
Exclusion Criteria:
* A household member participating in the study
* Living outside of Orleans County, New York
+Locations (1)
| Facility | City | Country | Status |
|---|
| University of Rochester Medical Center | Rochester, New York | United States | |