NCT06003439

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 4, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

August 15, 2023

Last Update Submit

June 6, 2024

Conditions

Keywords

Virtual reality (VR)High School Students

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (16)

  • Quit vaping attempts

    5 weeks

  • Past 30-days vaping frequency

    5 weeks

  • Past 7-days vaping frequency

    5 weeks

  • Frequency of current vaping

    5 weeks

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

    5 weeks

  • +11 more secondary outcomes

Study Arms (2)

Virtual Reality Program

EXPERIMENTAL

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

Behavioral: Virtual Reality ProgramBehavioral: VR Program

Assessment Only

NO INTERVENTION

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

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.

Also known as: VR Program
Virtual Reality Program
VR ProgramBEHAVIORAL

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

Virtual Reality Program

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University, Goldman School of Dental Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

VapingSmoking Cessation

Condition Hierarchy (Ancestors)

SmokingBehaviorHealth Behavior

Study Officials

  • Belinda Borrelli, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

April 4, 2024

Primary Completion

June 7, 2024

Study Completion

June 7, 2024

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations