Clinical trial NCT06003439: Vaping Prevention and Vaping in Youth (Vapechat)
Official title: Virtual Reality for the Prevention and Cessation of Nicotine Vaping in Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Smoking Cessation
Keywords: Virtual reality (VR)
High School Students
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2023-08-22
Enrollment: 119
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Health classes in each high school will be randomly assigned using a 1:3 threshold probability using a random digit generator.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Engagement with the VR program
timeFrame: 5 weeks
measure: Satisfaction with the VR game
timeFrame: 5 weeks
measure: Awareness of vaping
timeFrame: 5 weeks
measure: Knowledge of vaping
timeFrame: 5 weeks
measure: Attitudes towards vaping
timeFrame: 5 weeks
measure: Intention to change
timeFrame: 5 weeks
measure: Help seeking
timeFrame: 5 weeks
measure: Gameplay experience and satisfaction
timeFrame: 5 weeks
Secondary outcomes:
measure: Quit vaping attempts
timeFrame: 5 weeks
measure: Past 30-days vaping frequency
timeFrame: 5 weeks
measure: Past 7-days vaping frequency
timeFrame: 5 weeks
measure: Frequency of current vaping
timeFrame: 5 weeks
measure: Motivation to quit (or avoid) vaping within the next 30-days
timeFrame: 5 weeks
measure: Motivation to quit (or avoid) vaping
timeFrame: 5 weeks
measure: Intention to try vaping (or quit vaping)
timeFrame: 5 weeks
measure: Confidence in avoiding vaping
timeFrame: 5 weeks
measure: Self-efficacy to resist vaping
timeFrame: 5 weeks
measure: Resilience
timeFrame: 5 weeks
measure: Positive affect
timeFrame: 5 weeks
measure: Negative affect
timeFrame: 5 weeks
measure: Tolerability of the VR game
timeFrame: 5 weeks
measure: Intention to connect with vaping cessation resources
timeFrame: 5 weeks
measure: Emotion Regulation and Coping
timeFrame: 5 weeks
measure: Connection with vaping cessation resources
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University, Goldman School of Dental Medicine
state: Massachusetts
Study officials:
affiliation: Boston University, Goldman School of Dental Medicine, Center for Behavioral Science Research
name: Belinda Borrelli, PhD
role: PRINCIPAL_INVESTIGATOR
References: