MedPath

Vaping Prevention and Vaping in Youth (Vapechat)

Not Applicable
Completed
Conditions
Vaping
Smoking Cessation
Interventions
Behavioral: Virtual Reality Program
Behavioral: VR Program
Registration Number
NCT06003439
Lead Sponsor
Boston University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
119
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Virtual Reality ProgramVR ProgramStudents in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program.
Virtual Reality ProgramVirtual Reality ProgramStudents in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program.
Primary Outcome Measures
NameTimeMethod
Engagement with the VR program5 weeks

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

Awareness of vaping5 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

Gameplay experience and satisfaction5 weeks

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

Satisfaction with the VR game5 weeks

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

Knowledge of vaping5 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

Attitudes towards vaping5 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

Help seeking5 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

Intention to change5 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

Secondary Outcome Measures
NameTimeMethod
Confidence in avoiding vaping5 weeks

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

Motivation to quit (or avoid) vaping within the next 30-days5 weeks

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

Past 7-days vaping frequency5 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

Positive affect5 weeks

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

Intention to connect with vaping cessation resources5 weeks

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

Frequency of current vaping5 weeks

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

Motivation to quit (or avoid) vaping5 weeks

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

Intention to try vaping (or quit vaping)5 weeks

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

Negative affect5 weeks

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

Quit vaping attempts5 weeks

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

Past 30-days vaping frequency5 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

Self-efficacy to resist vaping5 weeks

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

Resilience5 weeks

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

Tolerability of the VR game5 weeks

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

Emotion Regulation and Coping5 weeks

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

Connection with vaping cessation resources5 weeks

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

Trial Locations

Locations (1)

Boston University, Goldman School of Dental Medicine

🇺🇸

Boston, Massachusetts, United States

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