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

Primary Purpose

Nicotine Vaping, Nicotine Use Disorder

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
quitSTART Mobile Application
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nicotine Vaping focused on measuring vaping, mobile app intervention, youth, young adults, chatbot, nicotine, social media

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control Group

    Experimental Group A: Mobile App Intervention

    Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature

    Arm Description

    Nationwide resource referral and intervention waitlist

    quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults

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

    Outcomes

    Primary Outcome Measures

    Vaping cessation
    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

    Nicotine dependence
    Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).
    Risk perception related to vaping
    Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020.
    Intervention engagement
    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).

    Full Information

    First Posted
    August 8, 2023
    Last Updated
    August 8, 2023
    Sponsor
    Washington University School of Medicine
    Collaborators
    The University of Texas Health Science Center, Houston, University of South Carolina, National Institute on Drug Abuse (NIDA)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05994209
    Brief Title
    Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
    Official Title
    Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2024 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    March 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    The University of Texas Health Science Center, Houston, University of South Carolina, National Institute on Drug Abuse (NIDA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nicotine Vaping, Nicotine Use Disorder
    Keywords
    vaping, mobile app intervention, youth, young adults, chatbot, nicotine, social media

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    189 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    Nationwide resource referral and intervention waitlist
    Arm Title
    Experimental Group A: Mobile App Intervention
    Arm Type
    Experimental
    Arm Description
    quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults
    Arm Title
    Experimental Group B: Mobile App Intervention with Embedded Chatbot Feature
    Arm Type
    Experimental
    Arm Description
    quitSTART Mobile Application Adapted for Vaping Cessation Among Young Adults Including Embedded Chatbot Feature
    Intervention Type
    Device
    Intervention Name(s)
    quitSTART Mobile Application
    Intervention Description
    Mobile application with educational content, motivational messages, self-monitoring, and tips for managing cravings to support vaping cessation among young adults.
    Primary Outcome Measure Information:
    Title
    Vaping cessation
    Description
    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.
    Time Frame
    Baseline, 6 weeks, 3 months
    Secondary Outcome Measure Information:
    Title
    Nicotine dependence
    Description
    Nicotine dependence will be assessed using the 4-item Patient-Reported Outcomes Measurement Information System (PROMIS).
    Time Frame
    Baseline, 6 weeks, 3 months
    Title
    Risk perception related to vaping
    Description
    Perceived risks of vaping, both general and conditional, will be assessed with two items adapted from Wackowski et al., 2020.
    Time Frame
    Baseline, 6 weeks, 3 months
    Title
    Intervention engagement
    Description
    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).
    Time Frame
    Baseline, 6 weeks, 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patricia Cavazos-Rehg, PhD
    Phone
    314-362-2152
    Email
    pcavazos@wust.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Erin Kasson, MSW
    Phone
    314-362-9003
    Email
    erinmkasson@wustl.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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