Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors

Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05994209
Collaborator
The University of Texas Health Science Center, Houston (Other), University of South Carolina (Other), National Institute on Drug Abuse (NIDA) (NIH)
189
3
14

Study Details

Study Description

Brief Summary

Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults. With limited information on the long-term effects of vaping products, health information about vaping has been somewhat unclear in regards to associated health risks. Teens and young adults may be reluctant to disclose their use of vaping products to parents or health providers and instead turn to social media to share and seek out information regarding vaping risks and cessation supports. Thus, our current proposal outlines the use of social media to identify teens and young adults socially networking about vaping, the use of an online chatbot screen to evaluate individual cessation support needs, and the use of a digital intervention system to support vaping cessation. The mobile intervention used in this study is based on a widely-used evidence-based mobile intervention for combustible smoking (i.e., quitSTART) and has been adapted for vaping and young adults to include an in-app chatbot to guide users to tailored content and to motivate and encourage their cessation efforts. We aim to integrate our social media recruitment and online screening approach to connect individuals with this mobile app intervention, and will conduct a randomized controlled trial to evaluate user engagement with and preliminary efficacy of the digital intervention on reducing vaping behaviors among teens and young adults.

Condition or Disease Intervention/Treatment Phase
  • Device: quitSTART Mobile Application
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
189 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

Nationwide resource referral and intervention waitlist

Experimental: Experimental Group A: Mobile App Intervention

quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults

Device: quitSTART Mobile Application
Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.

Experimental: Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature

quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature

Device: quitSTART Mobile Application
Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.

Outcome Measures

Primary Outcome Measures

  1. Vaping cessation [Baseline, 6 weeks, 3 months]

    Vaping cessation as assessed by 7 day self-reported vaping abstinence at follow-up. Timeline follow back procedures will be used to establish abstinence or if participants lapsed (their first instance of vaping post quit) or relapsed (vaped on 7 consecutive days) at each follow up time point.

Secondary Outcome Measures

  1. Nicotine dependence [Baseline, 6 weeks, 3 months]

    Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).

  2. Risk perception related to vaping [Baseline, 6 weeks, 3 months]

    Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020.

  3. Intervention engagement [Baseline, 6 weeks, 3 months]

    Data automatically captured within the chatbot, and app platform will be used to calculate a composite measure of engagement for those randomized to each of these intervention components and will be examined as a predictor of outcomes. We will use a modified version of an app Engagement Index (EI).

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • US Resident

  • English Speaking

  • Have daily access to a smartphone

  • Current vaping product user (P30D)

  • Identified as socially networking about a desire to quit vaping and/or experiencing negative health outcomes due to vaping

  • Vaping product user only (i.e., not using vaping as a means to support combustible smoking cessation)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Washington University School of Medicine
  • The University of Texas Health Science Center, Houston
  • University of South Carolina
  • National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05994209
Other Study ID Numbers:
  • 1R34DA054725-01A1
  • R34DA054725
First Posted:
Aug 16, 2023
Last Update Posted:
Aug 16, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Washington University School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2023