Vaping Prevention and Vaping in Youth (Vapechat) (Vapechat)

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Vaping
• Intervention / Treatment: Behavioral: Virtual Reality Program; Behavioral: VR Program

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.

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston University, Goldman School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Program; Students in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program.	Behavioral: Virtual Reality Program; 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; Behavioral: VR Program; VR program participants will be able to download a mobile app that complements and reinforces the school-based VR session.
No Intervention: Assessment Only; Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement with the VR program	Experimental condition arm. Playing time in minutes objectively measured by the program software; higher values mean a better outcome	5 weeks
Satisfaction with the VR game	Experimental condition arm. Self-report star rating of the VR game (1 to 5 stars); higher values mean a better outcome	5 weeks
Awareness of vaping	Experimental condition arm. Self-report awareness adapted from the Mobile App Rating Scale (MARS). Score range 1 - 5; higher values mean a better outcome	5 weeks
Knowledge of vaping	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 weeks
Attitudes towards vaping	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	5 weeks
Intention to change	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	5 weeks
Help seeking	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	5 weeks
Gameplay experience and satisfaction	Experimental condition arm. Scores on a scale assessing the gameplay experience. Score range 1 - 4; higher values mean a better outcome	5 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: American Heart Association
• Investigators: Principal Investigator: Belinda Borrelli, PhD, Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Actual): June 7, 2024
• Study Completion (Actual): June 7, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: High School Students; Virtual reality (VR)
• Other Study ID Numbers: H-43102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No