Clinical trial NCT04054765: A Virtual Reality Videogame for E-cigarette Prevention in Teens
Official title: A Virtual Reality Videogame for E-cigarette Prevention in Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: E-Cig Use
Vaping
Keywords: prevention
intervention
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 287
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-equivalent control groups design with 285 teens ages 12-15 comparing the Invite Only VR intervention vs. treatment as usual
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Percent of Participants Who Report E-cigarette Use at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Attitudes Towards E-cigarettes Pre-test
timeFrame: baseline
measure: Attitudes Towards E-cigarettes Post-test
timeFrame: immediately after gameplay is completed
measure: Attitudes Towards E-cigarettes Post-test
timeFrame: 3 months after gameplay is completed
measure: Attitudes Towards E-cigarettes Post-test
timeFrame: 6 months after gameplay is completed
measure: Knowledge of E-cigarettes Pre-test
timeFrame: baseline
measure: Knowledge of E-cigarettes Post-test
timeFrame: immediately after gameplay
measure: Knowledge of E-cigarettes Post-test
timeFrame: 3 months after gameplay
measure: Knowledge of E-cigarettes Post-test
timeFrame: 6 months after gameplay
measure: Intentions of E-cigarettes Pre-test
timeFrame: baseline
measure: Intentions of E-cigarettes Post-test
timeFrame: immediately after gameplay
measure: Intentions of E-cigarettes Post-test
timeFrame: 3 months after gameplay
measure: Intentions of E-cigarettes Post-test
timeFrame: 6 months after gameplay
measure: Perceptions Involving E-cigarettes Pretest
timeFrame: baseline
measure: Perceptions Involving E-cigarettes Post-test
timeFrame: immediately after gameplay is completed
measure: Perceptions Involving E-cigarettes Post-test
timeFrame: 3 months after gameplay is completed
measure: Perceptions Involving E-cigarettes Post-test
timeFrame: 6 months after gameplay is completed
measure: Refuse E-cigarettes Pre-test
timeFrame: baseline
measure: Refuse E-cigarettes Post-test
timeFrame: immediately after gameplay
measure: Refuse E-cigarettes Post-test
timeFrame: 3 months after gameplay
measure: Refuse E-cigarettes Post-test
timeFrame: 6 months after gameplay
Other outcomes:
measure: Satisfaction With Gameplay Experience - Experimental Only
timeFrame: immediately after gameplay
Locations:
city: Milford
country: United States
facility: Milford School District
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly Hieftje, PhD
role: PRINCIPAL_INVESTIGATOR
References: