A Virtual Reality Videogame for E-cigarette Prevention in Teens

NCT ID: NCT04054765

Last Updated: 2021-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-17
• Study Completion Date: 2020-06-05

Brief Summary

The use of the Invite Only VR, with the aim to prevent the initiation of e-cigarette use in teens by increasing their knowledge, decreasing their intentions to use e-cigarettes, influencing their harm perceptions and attitudes associated with e-cigarettes, and increasing self-efficacy associated with refusing peers involving e-cigarettes.

Detailed Description

Specific Aim #1: DEVELOPMENT: The researcher will update our current VR prototype into a polished videogame intervention using input from 4 focus groups of 5 adolescents each (n = 20), aged 12-17 and the extant literature. These focus groups will inform the development of the VR videogame intervention, Invite Only VR, for e-cigarette prevention among teens.

Specific Aim #2: EVALUATION: Conduct a pilot non-randomized cluster trial with 295 teens ages 11-14 comparing the Invite Only VR intervention vs. an attention/control non-health-related VR videogame, collecting assessment data at baseline, post-gameplay, three months and six months to determine:

1. the preliminary impact of the intervention on e-cigarette use behaviors, knowledge, nicotine addiction knowledge, perceived addictiveness of e-cigarettes, perceived likelihood of using e-cigarettes, perceptions of harm, self-efficacy to refuse, social approval of e-cigarettes, and e-cigarette social perceptions

2. the intervention's acceptability and feasibility by collecting quantitative and qualitative data on teens' satisfaction and gameplay experience of the intervention.

3. preliminary evidence of the impact of Invite Only VR on players' perception and experience of social pressure and social norm development

Conditions

E-Cig Use; Vaping

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Teens in the Invite Only VR videogame

155 adolescents playing the Invite Only VR intervention

Group Type: EXPERIMENTAL

videogame

Intervention Type: DEVICE

Invite Only VR videogame

Teens receive treatment as usual

132 adolescents receive treatment as usual, which includes regular instruction in health class regarding the dangers of e-cigarettes

Group Type: OTHER

treatment as usual

Intervention Type: OTHER

treatment as usual

Interventions

videogame

Invite Only VR videogame

Intervention Type: DEVICE

treatment as usual

treatment as usual

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Willing to wear a VR headset and play a video game for 45-60 minutes for 2-3 sessions and answer questions before and after playing the videogame.
• Be enrolled in Milford Middle School District

Exclusion Criteria

• If subject does not fit the criteria above

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kimberly Hieftje, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Milford School District

Milford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2000025177

Identifier Type: -

Identifier Source: org_study_id