An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents

NCT07624292 | Not Yet Recruiting DMC

• 1 other identifier: T35IP9813
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if a brief digital intervention can reduce e-cigarette use and prevent cigarette smoking initiation in teenagers ages 12-17. The main questions it aims to answer are:

• Compared to the control condition, does the intervention reduce e-cigarette use frequency in teenagers?
• Compared to the control condition, does the intervention reduce risk to start smoking cigarettes in teenagers? Researchers will compare the digital intervention to see if it leads to greater reductions in e-cigarette use and smoking risk than a waitlist control condition. Participants will complete 5 brief online surveys across 12 weeks, and some will be selected to do a post-intervention virtual interview. In this interview, participants will be asked to share their opinions about the intervention and identify areas that need refinement.

Conditions

E-cigarette Use; Cigarette Smoking Risk

Keywords

E-cigarette; Tobacco; Nicotine addiction; mHealth

Outcome Measures

Primary Outcomes (3)

• Days vaped in the past 7 days

  Participants will report the number of days they vaped in the past 7 days.

  Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.

• Times vape is picked up per day

  Participants will report the number of times they picked up their device to vape per day in the past 7 days.

  Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.

• Smoking Susceptibility

  Smoking susceptibility will be assessed with the 4-item Expanded Susceptibility to Smoking Index, with the following responses: Definitely not, Probably not, Probably yes, and Definitely yes. This is a binary outcome. If a respondent answers "definitely not" to all four questions, they are categorized as not susceptible. Any other response on any item flags the respondent as susceptible.

  Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.

Secondary Outcomes (7)

• Vaping Quit Attempts

  Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

• Vaping Descriptive Normative Perceptions

  Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

• Vaping Injunctive Normative Perceptions

  Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

• Smoking Descriptive Normative Perceptions

  Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

• Smoking Injunctive Normative Perceptions

  Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.

Study Arms (2)

Digital vaping intervention

EXPERIMENTAL

Virtual Intervention for Behavioral Empowerment (VIBE) is a one-time 30-minute online intervention that incorporates Personalized Normative Feedback (PNF) for vaping and smoking, motivational enhancement to encourage healthy behavior change, and vaping and smoking-related harms education. Lastly, strategies recommended for nicotine cessation are presented. This intervention can be completed in one sitting or split into multiple sessions and is delivered via an interactive website.

Other: Virtual Intervention for Behavioral Empowerment (VIBE)

Waitlist control

NO INTERVENTION

Those in the control arm will be waitlisted and given the option to access VIBE (the intervention) at the end of study.

Interventions

Virtual Intervention for Behavioral Empowerment (VIBE) OTHER

The intervention contains Personalized Normative Feedback (PNF), motivational interviewing (MI), and education about vaping and smoking harms. The program begins with the MI-based portion, which includes exploration of their experienced health and personal consequences of vaping and potential reasons for and motivation for shifting vaping behaviors (e.g., to save money, to be free from addiction). Second, the education portion involves presentation of the actual harms posed by e-cigarettes to clarify any misperceptions of the negative effects of vaping and nicotine exposure in teens. Next, users are presented with the PNF portion. In the PNF portion, participants receive feedback about their perceptions of peer vaping by presenting their typical behavior/attitude alongside their perceptions of others' behavior/attitude alongside the actual norm of the behavior/attitude. Lastly, strategies recommended for nicotine cessation are presented.

Digital vaping intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• be between the ages of 12 to 17
• be able to read English
• be a current resident of California
• report vaping at least one day per week in the past month
• report no history of cigarette use at screening and baseline
• have access to a computer or mobile device with internet access

You may not qualify if:

• currently receiving nicotine cessation services

Sponsors & Collaborators

• University of Southern California: lead
• Tobacco Related Disease Research Program: collaborator

MeSH Terms

Conditions

Vaping; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Smoking; Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Denise Tran, Ph.D.

CONTACT

17145487785; denise.tran@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be available beginning 9 months and ending 36 months following article publication upon approval.
• Access Criteria: De-identified individual participant data will be shared with external researchers who submit a scientifically meritorious research proposal and a comprehensive Statistical Analysis Plan (SAP). Data may be utilized for any secondary analysis or meta-analysis that contributes to public health knowledge. Requests will be evaluated directly by the Principal Investigator. Access is conditional upon the signing of a standard institutional Data Sharing Agreement. Data files will be securely shared via email attachment or secure cloud download.