About this trial
The goal of this quasi-experimental study is to test if a smartphone app can help adolescents aged 14-20 quit e-cigarettes. The main questions it aims to answer are:
* Can the app help adolescents manage cravings and increase their readiness to quit? * Does the personalized and real-time support provided by the app improve their success in quitting e-cigarettes?
Researchers will compare two groups: an immediate-intervention group that starts using the app right away and a delayed-intervention group that begins after three months, to see if the timing of app access influences outcomes in e-cigarette cessation.
Participants will:
* Set personal goals and track their daily progress within the app. * Use a real-time "urge" feature that provides immediate support during cravings. * Engage with a chatbot for quick answers and motivational support around quitting.
This study aims to create an accessible, personalized tool to help adolescents reduce or quit e-cigarette use, exploring its feasibility as a broader intervention model.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents who are 14 to 20 years old
Currently use nicotine-containing e-cigarettes (those responding "Yes" to: Have you used an electronic vaping product such as PuffBar, ElfBar, Lost Mary, JUUL, Vuse, e-cigarettes, vapes, vape pens, e-cigars, e-hookahs, hookah pens, or mods at least 1 day in the last 30 days? [CDC, 2020])
Interested in participating in an e-cigarette use cessation program
Owners of an iPhone or Android smartphone who use their phone daily
Disqualifiers
Individuals who fall outside the age range of 14 to 20 years
Those who have not used a nicotine-containing e-cigarette in the past 30 days
Individuals not interested in participating in an e-cigarette cessation program
Adolescents who do not own or regularly use an iPhone or Android smartphone
Trial design
Parallel
Treatments tested in this trial
AI-enhanced smartphone app
BehavioralA smartphone app has been developed and is in keeping with guideline recommendations for the treatment of e-cigarette products. This app has a user-friendly Graphic User Interface (GUI) to allow users to build their own accounts and individualized contents conveniently, based on the input the users initially provide including e-cigarette use patterns, readiness to quit e-cigarette, beliefs about e-cigarette, nicotine addiction, self-efficacy, other substance use status, and parental or peer e-cigarette use status. The proposed AI model in this app will learn information from the input data, including progress toward e-cigarette cessation (e,g, changes of readiness of quitting, quit attempts), and additional data including emotional status, stress level, feedback to the previous learning modules, and then predict the result on the fly. Based on the predicted result, the app will send in-time motivational messages and mindfulness training modules.
AI-enhanced smartphone app, but with delayed access
BehavioralParticipants in the control group will be placed on a three-month waitlist. After this period, they will receive access to the same app-based intervention as the immediate intervention group, allowing a comparison between immediate and delayed access.
Treatment groups
Trial outcomes
Primary outcomes
Usability
The usability of the intervention will be assessed using the mHealth App Usability Questionnaire, a 21-item instrument designed for interactive mobile health apps. It measures three domains: ease of use and satisfaction, system information arrangement, and usefulness. Each item is rated on a 5-point Likert scale, yielding a total score range of 21 to 105, with higher scores indicating better usability. An open-ended question will also be included at the end of the survey to gather suggestions for app improvement.
Secondary outcomes
Engagement - Frequency of App Use
Automatically recorded log data from the app will track each login event by a participant.
Engagement - Minutes of App Use
Cumulative minutes of app usage will be captured via app log data.
E-cigarette Use
Self-reported number of days participants used e-cigarettes in the past 30 days. Responses range from 0 to 30 days.
Quit attempts
Self-reported number of quit attempts in the past 30 days, along with the longest duration of abstinence.
Sponsors and contacts
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State University of New York at Buffalo
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Advanced Bionics
Collaborator
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