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Vaping Prevention and Vaping in Youth (Vapechat)

Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06003439
Acronym
Vapechat
Enrollment
119
Registered
2023-08-22
Start date
2024-04-04
Completion date
2024-06-07
Last updated
2024-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaping, Smoking Cessation

Keywords

Virtual reality (VR), High School Students

Brief summary

Many youth are addicted to nicotine due to increased nicotine vaping (e.g., e-cigarettes). Unfortunately, there are no effective interventions to help teens quit vaping. In addition, existing vaping prevention programs have limited effectiveness because teens have reported that existing available interventions are out of touch with teen's culture and are not appealing to the intended audience. Therefore, to be effective, a vaping intervention must be acceptable, appealing, and engaging to teens, and most importantly, it should be designed to be channeled into an existing infrastructure such as the school setting. The investigators' research group has designed a vaping prevention and cessation intervention that is implemented as a VR game for high school teens. The overall objective of this research is to assess the acceptability, feasibility, and preliminary efficacy of the VR experience among high school students in two high schools in Boston.

Detailed description

The investigators will conduct a randomized trial of high school students (freshman to seniors) in the Boston area to determine feasibility, satisfaction, and preliminary efficacy of the VR-based vaping cessation and prevention game. Students will be randomized by class to either receive the Virtual Reality (VR) program (experimental condition) or control condition (questionnaire assessment only). There will be three VR sessions played at school during a health class. Participants in the VR condition will also engage in a gamified home-based component on their smartphone, in order to reinforce skills learned in the school-based VR experience. Seven high school classes across two high schools will be randomized to VR intervention or assessment only. Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator. Participants will be enrolled in the study for approximately 6 weeks. In the first 3 weeks, participants will engage in the VR game experience once per week during their classes. In the fourth and fifth week, participants may make up any VR game session that they missed because of absence (e.g., illness). At week 6, participants will complete the follow-up questionnaire assessments.

Interventions

Behavioral: Virtual Reality Program The VR Program will be pre-installed on Meta Quest 2 headsets, which will be donned by students as a class to experience the intervention for approximately the length of one school class period (approximately 30-40 minutes). Each participant will experience the program once a week for 3 weeks. Participants who missed a week will complete the program by the 4th or 5th week.

BEHAVIORALVR Program

VR program participants will be able to download a mobile app that complements and reinforces the school-based VR session.

Sponsors

American Heart Association
CollaboratorOTHER
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator.

Eligibility

Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

* Students enrolled at Everett and Quincy High Schools (freshmen, sophomores, juniors, and seniors). * Students in Health class * Child assents

Exclusion criteria

* Teacher indicates that participation is not appropriate for the student (e.g., severe mental illness; visual or auditory disability; medical issue) * Parent(s)/guardian(s) opt student out of the study. * Prone to motion sickness or seizures. * Visual impairments that would preclude playing VR or otherwise unable to use VR device.

Design outcomes

Primary

MeasureTime frameDescription
Engagement with the VR program5 weeksExperimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome
Satisfaction with the VR game5 weeksExperimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome
Awareness of vaping5 weeksExperimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Knowledge of vaping5 weeksExperimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Attitudes towards vaping5 weeksExperimental condition arm. Self-report attitudes towards vaping adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Intention to change5 weeksExperimental condition arm. Self-report intention to change vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Help seeking5 weeksExperimental condition arm. Self-report help seeking for vaping behaviors adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome
Gameplay experience and satisfaction5 weeksExperimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome

Secondary

MeasureTime frameDescription
Self-efficacy to resist vaping5 weeksScores on the adapted smoking abstinence self-efficacy questionnaire for adolescents. Scores range 0-24 , higher values mean a better outcome
Resilience5 weeksScores on a brief resilience scale. Scores range 0-3 , higher values mean a worse outcome
Positive affect5 weeksScores on the Pediatric Positive Affect (PROMIS) scale. Scores range 8-40, higher values mean a better outcome
Negative affect5 weeksScores on the Negative Affect for Children scale Scores range 10-50, higher values mean a worse outcome
Quit vaping attempts5 weeksProportion of participants who have made one or more attempts to quit vaping for at least 24 hours
Intention to connect with vaping cessation resources5 weeksScores on a single item assessing intentions to connect with vaping cessation resources. Scores range 1-10, higher values mean a better outcome
Emotion Regulation and Coping5 weeksScores on the Adolescent-Coping Orientation for Problem Experience (A-COPE). Scores range 6-30, higher values mean a better outcome
Connection with vaping cessation resources5 weeksProportion of participants who have made contact with any vaping cessation resources during the study
Tolerability of the VR game5 weeksExperimental condition arm Scores on the VR sickness questionnaire. Scores range 1-4, higher values mean a worse outcome
Past 30-days vaping frequency5 weeksProportion of participants who have vaped '0', or '1-2', or '3-5', or '6-9', or '10-19', or '20-30' days in the past 30-days
Past 7-days vaping frequency5 weeksProportion of participants who have vaped '0', or '1-2', or '3-4', or '5-6', or '7' days in the past 7-days
Frequency of current vaping5 weeksProportion of participants who currently vape 'not at all', or 'some days', or 'most days', or 'every day'
Motivation to quit (or avoid) vaping within the next 30-days5 weeksProportion of participants who are seriously thinking about quitting (or avoid) vaping within the next 30-days
Motivation to quit (or avoid) vaping5 weeksScores on a scale assessing motivation to quit (or avoid) vaping. Score range 1 - 10; higher values mean a better outcome
Intention to try vaping (or quit vaping)5 weeksProportion of participants who are 'probably not' or 'definitely not' thinking of vaping in the next 30- days
Confidence in avoiding vaping5 weeksScores on a single item assessing confidence in avoiding vaping within 30-days. Scores range 1-10, higher values mean a better outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026