A Virtual Reality Videogame for E-cigarette Prevention in Teens

NCT04054765 | Completed Results

• 1 other identifier: 2000025177
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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.

Conditions

E-Cig Use; Vaping

Keywords

prevention; intervention

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Who Report E-cigarette Use at 6 Months

  The researcher will measure the percent of individuals who, after playing Invite Only VR, report the initiation of e-cigarette use in comparison to the control condition.

  6 months

Secondary Outcomes (20)

• Attitudes Towards E-cigarettes Pre-test

  baseline

• Attitudes Towards E-cigarettes Post-test

  immediately after gameplay is completed

• Attitudes Towards E-cigarettes Post-test

  3 months after gameplay is completed

• Attitudes Towards E-cigarettes Post-test

  6 months after gameplay is completed

• Knowledge of E-cigarettes Pre-test

  baseline

Other Outcomes (1)

• Satisfaction With Gameplay Experience - Experimental Only

  immediately after gameplay

Study Arms (2)

Teens in the Invite Only VR videogame

EXPERIMENTAL

155 adolescents playing the Invite Only VR intervention

Device: videogame

Teens receive treatment as usual

OTHER

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

Other: treatment as usual

Interventions

videogame DEVICE

Invite Only VR videogame

Teens in the Invite Only VR videogame

treatment as usual OTHER

treatment as usual

Teens receive treatment as usual

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• If subject does not fit the criteria above

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Milford School District

Milford, Connecticut, 06460, United States

Location

MeSH Terms

Conditions

Vaping

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Smoking; Behavior

Limitations and Caveats

It is possible that if we had followed the participants beyond 6 months, group differences might have emerged. It is also possible that because of the COVID-19 pandemic and subsequent lockdown, participants in both groups had reduced access to e-cigarettes.

Results Point of Contact

• Title: Dr. Kimberly Hieftje
• Organization: play4REAL XR Lab at the Yale School of Medicine

kimberly.hieftje@yale.edu

2037872402

Study Officials

• Kimberly Hieftje, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: non-equivalent control groups design with 285 teens ages 12-15 comparing the Invite Only VR intervention vs. treatment as usual

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 13, 2019
• Study Start: October 17, 2019
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: June 25, 2021
• Results First Posted: June 18, 2021

Record last verified: 2021-06

Locations

US (1)