- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07624292
An Online Intervention to Reduce E-cigarette Use and Cigarette Smoking Risk in Adolescents
An Online Intervention to Reduce E-cigarette Use and Potential for Cigarette Smoking in Adolescents
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Denise Tran, Ph.D.
- Phone Number: 17145487785
- Email: denise.tran@med.usc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- currently receiving nicotine cessation services
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Digital vaping intervention
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.
|
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.
|
|
No Intervention: Waitlist control
Those in the control arm will be waitlisted and given the option to access VIBE (the intervention) at the end of study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days vaped in the past 7 days
Time Frame: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
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
Time Frame: Past 7 day vaping measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
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
Time Frame: Past 7 day smoking susceptibility measured at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks post-randomization.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vaping Quit Attempts
Time Frame: Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Quit attempts will be measured with questions asking for the number of quit attempts lasting at least 1 day since the last assessment.
|
Vaping quit attempts in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Vaping Descriptive Normative Perceptions
Time Frame: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Participants will report their beliefs regarding the percentage of teens who vaped, number of days individuals their age vaped, the number of times others their age picked up their vaping device per day in the past 30 days,
|
Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Vaping Injunctive Normative Perceptions
Time Frame: Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Participants will report how much they believe others their age approve (or disapprove) of vaping using a 5-point Likert scale (responses options: Strongly disapprove to Strongly approve).
|
Vaping normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Smoking Descriptive Normative Perceptions
Time Frame: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Participants will report their beliefs about the percentage of teens who have smoked, the number of days others their age smoked in the past 30 days, and the quantity of cigarettes others their age smoked per day in the past 30 days.
|
Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Smoking Injunctive Normative Perceptions
Time Frame: Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Participants will report how much they believe others their age approve (or disapprove) of cigarette smoking using a 5-point Likert scale (responses options: Strongly disapprove to Strongly approve).
|
Smoking normative perceptions assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Quitting vaping self-efficacy
Time Frame: Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Self-efficacy will be assessed by 2 adapted items that originally assessed self-efficacy to quit smoking.
Participants rate their confidence about quitting vaping "someday" and "in the next 6 months."
|
Self-efficacy in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
|
Motivation to Quit Vaping
Time Frame: Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Motivation will be assessed by asking participants whether they were seriously thinking about quitting vaping with responses ranging from 1 = No, I am not thinking about quitting to 5 = Yes, I want to quit during the next 30 days.
|
Motivation to quit in the past 7 days assessed at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks.
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- T35IP9813
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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