Clinical trial NCT06965296: AI-Enhanced App-based Intervention for Adolescent E-cigarette Cessation
Official title: AI-Enhanced App-based Intervention for Adolescent E-cigarette Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Dependence, Cigarettes
Keywords: Adolescent e-cigarette use
E-cigarette cessation
Smartphone app
Digital health intervention
Personalized health support
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Advanced Bionics
First posted: 2025-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involves two groups: an immediate-intervention group that starts using the app immediately and a delayed-intervention group that begins after three months.

Each group is assigned to its respective intervention timeline at the start and follows it independently of the other group, without switching or crossover.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: This quasi-experimental study aims to develop and evaluate an AI-enhanced smartphone app designed to support adolescents aged 14-20 in quitting e-cigarettes. Given the high prevalence of e-cigarette use among youth, this app-based intervention focuses on providing personalized, real-time support for cravings and motivation to quit. The app integrates interactive features to engage users and is designed for scalability, enabling wide-reaching impact in various settings such as schools, clinics, and communities.

Study Phases and Objectives

Phase 1: Development and Usability Testing Phase 1 focuses on refining an existing beta version of the app. In this formative stage, the app's design, content, and features will be adjusted based on adolescent feedback to ensure it is user-friendly and engaging. Participants will test the app and provide insights through usability surveys and interviews, which will inform necessary changes.

Key activities in this phase include:

* Gathering feedback on usability and design.
* Modifying app features to better meet the preferences and needs of adolescent users.
* Finalizing the app to meet high usability benchmarks for deployment in the next phase.

Phase 2: Clinical Feasibility Testing In Phase 2, the app's effectiveness will be tested using a quasi-randomized design with two groups: one group of participants will begin using the app immediately, while the second group will start after a three-month delay. This approach will help determine if earlier access to the intervention leads to improved outcomes in terms of e-cigarette cessation.

The study will assess how the app impacts participants' readiness to quit, actual quitting attempts, and ongoing motivation over time. Engagement levels with the app's features, such as real-time craving support and AI-driven educational modules, will also be tracked to evaluate the intervention's overall feasibility and appeal.

App Features and Personalization

The app's core features include:

1. Goal Setting and Progress Tracking: Users set personal quitting goals, track their progress, and access daily training modules to build skills for managing cravings and quitting.
2. Real-Time Craving Management: The "urge" feature provides immediate support during cravings, using mindfulness exercises and coping strategies tailored to each user's needs.
3. AI Chatbot Support: A chatbot offers 24/7 assistance, answering questions and providing motivation based on users' quitting status and individual characteristics.

These AI-driven tools are customized according to user data and interactions within the app, ensuring the intervention feels personal and responsive to each user's progress.

Data Collection and Analysis Data will be collected on app usage, engagement with specific features, and changes in e-cigarette use over time. Analysis will include both user feedback and statistical evaluation of the app's impact on participants' quitting success. Insights from this data will contribute to the ongoing refinement of the app and inform its potential for broader use as an adolescent-focused e-cigarette cessation tool.

Anticipated Impact This study aims to create a user-friendly, scalable app that leverages AI to support adolescents in quitting e-cigarettes effectively. If successful, this digital intervention could be a valuable resource for youth cessation programs and serve as a model for similar health-related app-based interventions.

Eligibility criteria: Inclusion Criteria

* 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
* Able to read English

Exclusion Criteria

* 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
* Non-English speakers

Primary outcomes:
measure: Usability
timeFrame: 30-Day Follow-up
Secondary outcomes:
measure: Engagement - Frequency of App Use
timeFrame: 30-Day and 3-Month Follow-up
measure: Engagement - Minutes of App Use
timeFrame: 30-Day and 3-Month Follow-up
measure: E-cigarette Use
timeFrame: 30-day and 3-month follow up
measure: Quit attempts
timeFrame: 30-Day and 3-Month Follow-up
measure: Readiness to Quit
timeFrame: 30-Day and 3-Month Follow-up
measure: Nicotine Dependence
timeFrame: 30-Day and 3-Month Follow-up
measure: Beliefs About E-Cigarettes
timeFrame: 30-Day and 3-Month Follow-up
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo, School of Nursing
state: New York
Study officials:
References:
citation: Hebert ET, Ra CK, Alexander AC, Helt A, Moisiuc R, Kendzor DE, Vidrine DJ, Funk-Lawler RK, Businelle MS. A Mobile Just-in-Time Adaptive Intervention for Smoking Cessation: Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Mar 9;22(3):e16907. doi: 10.2196/16907.
citation: Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.
citation: Bell ML, Whitehead AL, Julious SA. Guidance for using pilot studies to inform the design of intervention trials with continuous outcomes. Clin Epidemiol. 2018 Jan 18;10:153-157. doi: 10.2147/CLEP.S146397. eCollection 2018.
citation: Baskerville NB, Struik LL, Guindon GE, Norman CD, Whittaker R, Burns C, Hammond D, Dash D, Brown KS. Effect of a Mobile Phone Intervention on Quitting Smoking in a Young Adult Population of Smokers: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 23;6(10):e10893. doi: 10.2196/10893.
citation: Audrain-McGovern J, Rodriguez D, Pianin S, Alexander E. Initial e-cigarette flavoring and nicotine exposure and e-cigarette uptake among adolescents. Drug Alcohol Depend. 2019 Sep 1;202:149-155. doi: 10.1016/j.drugalcdep.2019.04.037. Epub 2019 Jul 19.