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Completed

NCT Number: NCT06003439

Vaping Prevention and Vaping in Youth (Vapechat)

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.

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Key information

Conditions

Vaping Behavior Health Behavior Smoking Smoking Cessation

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University, Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality Program

Behavioral

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.

Other names: VR Program

VR Program

Behavioral

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

Primary outcomes

  1. Engagement with the VR program

    Time frame: 5 weeks

    Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome

  2. Satisfaction with the VR game

    Time frame: 5 weeks

    Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome

  3. Awareness of vaping

    Time frame: 5 weeks

    Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome

  4. Knowledge of vaping

    Time frame: 5 weeks

    Experimental condition arm Self-report knowledge adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome

  5. Attitudes towards vaping

    Time frame: 5 weeks

    Experimental 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

  6. Intention to change

    Time frame: 5 weeks

    Experimental 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

  7. Help seeking

    Time frame: 5 weeks

    Experimental 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

  8. Gameplay experience and satisfaction

    Time frame: 5 weeks

    Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome

Secondary outcomes

  1. Quit vaping attempts

    Time frame: 5 weeks

    Proportion of participants who have made one or more attempts to quit vaping for at least 24 hours

  2. Past 30-days vaping frequency

    Time frame: 5 weeks

    Proportion 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

  3. Past 7-days vaping frequency

    Time frame: 5 weeks

    Proportion of participants who have vaped '0', or '1-2', or '3-4', or '5-6', or '7' days in the past 7-days

  4. Frequency of current vaping

    Time frame: 5 weeks

    Proportion of participants who currently vape 'not at all', or 'some days', or 'most days', or 'every day'

  5. Motivation to quit (or avoid) vaping within the next 30-days

    Time frame: 5 weeks

    Proportion of participants who are seriously thinking about quitting (or avoid) vaping within the next 30-days

  6. Motivation to quit (or avoid) vaping

    Time frame: 5 weeks

    Scores on a scale assessing motivation to quit (or avoid) vaping. Score range 1 - 10; higher values mean a better outcome

  7. Intention to try vaping (or quit vaping)

    Time frame: 5 weeks

    Proportion of participants who are 'probably not' or 'definitely not' thinking of vaping in the next 30- days

  8. Confidence in avoiding vaping

    Time frame: 5 weeks

    Scores on a single item assessing confidence in avoiding vaping within 30-days. Scores range 1-10, higher values mean a better outcome

  9. Self-efficacy to resist vaping

    Time frame: 5 weeks

    Scores on the adapted smoking abstinence self-efficacy questionnaire for adolescents. Scores range 0-24 , higher values mean a better outcome

  10. Resilience

    Time frame: 5 weeks

    Scores on a brief resilience scale. Scores range 0-3 , higher values mean a worse outcome

  11. Positive affect

    Time frame: 5 weeks

    Scores on the Pediatric Positive Affect (PROMIS) scale. Scores range 8-40, higher values mean a better outcome

  12. Negative affect

    Time frame: 5 weeks

    Scores on the Negative Affect for Children scale Scores range 10-50, higher values mean a worse outcome

  13. Tolerability of the VR game

    Time frame: 5 weeks

    Experimental condition arm Scores on the VR sickness questionnaire. Scores range 1-4, higher values mean a worse outcome

  14. Intention to connect with vaping cessation resources

    Time frame: 5 weeks

    Scores on a single item assessing intentions to connect with vaping cessation resources. Scores range 1-10, higher values mean a better outcome

  15. Emotion Regulation and Coping

    Time frame: 5 weeks

    Scores on the Adolescent-Coping Orientation for Problem Experience (A-COPE). Scores range 6-30, higher values mean a better outcome

  16. Connection with vaping cessation resources

    Time frame: 5 weeks

    Proportion of participants who have made contact with any vaping cessation resources during the study

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: Vapechat

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2023
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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