Vaping Prevention and Vaping in Youth (Vapechat)

NCT ID: NCT06003439

Last Updated: 2024-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2024-06-07

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.

Conditions

Vaping; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Virtual Reality Program

Students in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program.

Group Type: EXPERIMENTAL

Virtual Reality Program

Intervention Type: 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.

VR Program

Intervention Type: BEHAVIORAL

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

Assessment Only

Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

VR Program

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

Intervention Type: BEHAVIORAL

Other Intervention Names

VR Program

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Belinda Borrelli, PhD

Role: PRINCIPAL_INVESTIGATOR

Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research

Locations

Boston University, Goldman School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

References

Borrelli B, Weinstein D, Endrighi R, Ling N, Koval K, Quintiliani LM, Konieczny K. Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youths: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 15;14:e71961. doi: 10.2196/71961.

Reference Type: DERIVED

PMID: 40278000 (View on PubMed)

Other Identifiers

H-43102

Identifier Type: -

Identifier Source: org_study_id