Vaping Cessation for Youth

Study Overview
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Brief Summary
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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 they 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 high school in Boston.

Detailed Description
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The investigators will conduct a randomized trial (N=150) 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 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. For every 4 - 5 classes enrolled in the VR condition, two will be enrolled in the control condition. Participants will be enrolled in the study for approximately 5 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 5, participants will complete the follow-up questionnaire assessments.

Official Title
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Virtual Reality Intervention to Promote Cessation of Nicotine Vaping in Youth

Conditions
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Vaping, Smoking Cessation

Intervention / Treatment
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* Behavioral: Virtual Reality Program
* Behavioral: Augmented Reality Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students enrolled at Public High Schools (freshmen, sophomores, juniors, and seniors). Must be able to speak and understand English. Child assents Exclusion Criteria: Teacher indicates that participation is not appropriate for the student (e.g., severe mental illness; visual or auditory disability) Parent(s)/guardian(s) opt student out of the study. Prone to motion sickness or seizures. Blind or otherwise unable to use VR device.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality Program<br>Students in classrooms randomized to this group will receive the Virtual Reality vaping cessation and prevention program. | Behavioral: Virtual Reality Program<br>* 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 45 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.<br>* Other names: VR Program;Behavioral: Augmented Reality Program<br>* VR program participants will be able to download an optional mobile app that complements and reinforces the school-based VR session.<br>|
| No Intervention: Assessment Only<br>Students in classrooms randomized to this group will not receive the VR intervention but will complete questionnaire assessment only. | |

What is the study measuring?
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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 | 
| Self-efficacy to resist vaping | Scores on the adapted self-efficacy scale for adolescents. Scores range 0-90, higher values mean a better outcome | 5 weeks | 
| Self-efficacy to refuse e-cigarettes | Scores on an adapted self-efficacy scale for youth. Scores range 1-5, higher values mean a better outcome | 5 weeks | 
| Resilience | Scores on a brief resilience scale. Scores range 0-18, higher values mean a better outcome | 5 weeks | 
| Positive affect | Scores on the 'positive affect subscale' of the Positive and Negative Affect Schedule (PANAS). Scores range 10-50, higher values mean a better outcome | 5 weeks | 
| Negative affect | Scores on the 'negative affect subscale' of the Positive and Negative Affect Schedule (PANAS). Scores range 10-50, higher values mean a worse 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 | 
| Psychological stress experience | Scores on a scale assessing stress experiences. Scores range 0-32, higher values mean a worse 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality (VR), Augmented reality (AR), High School Students