NCT07737080

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

7 months

First QC Date

July 27, 2026

Last Update Submit

July 27, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Percentage Of Participants Who Complete the Month 3 Assessment.

    The percentage will be calculated as the number of participants who complete the Month 3 assessment divided by the total number of enrolled participants.

    Month 3

  • Percentage Of Participants Who Are Satisfied With Their Assigned Intervention at 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.

    Month 3

  • Percentage Of Participants With Reduced Susceptibility To Future Vaping

    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.

    Baseline to Month 3

Study Arms (3)

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

Interventions

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.

Health Impacts of E-cigarettes

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.

Mind Matters: The Body's Response to Nicotine, Tobacco, and Vaping

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.

The Villainous Vape

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • A household member participating in the study
  • Living outside of Orleans County, New York

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Tobacco ProductsElectronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Smoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor - Department of Public Health Sciences (SMD)

Study Record Dates

First Submitted

July 27, 2026

First Posted

July 30, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 30, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations