Vaping Cessation for Youth

Smoking Cessation Clinical Trial

— Vapechat  

Official title:

Virtual Reality Intervention to Promote Cessation of Nicotine Vaping in Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003439
• Other study ID #: H-43102
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2024
• Est. completion date: September 2024

Study information

• Verified date: April 2024
• Source: Boston University
• Contact: Belinda Borrelli, PhD
• Phone: (617) 358-3358
• Email: belindab[@]bu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation
• Vaping

Intervention

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 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.
• Augmented Reality Program
VR program participants will be able to download an optional mobile app that complements and reinforces the school-based VR session.

Locations

Country	Name	City	State
United States	Boston University, Goldman School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Quit vaping attempts	Proportion of participants who have made one or more attempts to quit vaping for at least 24 hours	5 weeks
Secondary	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
Secondary	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
Secondary	Frequency of current vaping	Proportion of participants who currently vape 'not at all', or 'some days', or 'most days', or 'every day'	5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Resilience	Scores on a brief resilience scale. Scores range 0-18, higher values mean a better outcome	5 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Psychological stress experience	Scores on a scale assessing stress experiences. Scores range 0-32, higher values mean a worse outcome	5 weeks
Secondary	Connection with vaping cessation resources	Proportion of participants who have made contact with any vaping cessation resources during the study	5 weeks