Behavior, Child, Childhood ALL, Healthy, Healthy Lifestyle
Conditions
Keywords
virtual reality, positive youth development, afterschool program
Brief summary
This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings.
Detailed description
This pilot study aims to leverage VR's capacity to easily replicate content and allow for multiple users to share the same space and engage in activities as if they're meeting in person. Integrating VR into afterschool programs will allow youth to receive more consistent programming content, even when they are unable to travel to the physical location for the in-person meetings. It will also empower youth to engage with the afterschool program at their own pace by providing a safe space to learn and practice their socioemotional skills. Implemented at scale, these benefits of a VR-integrated afterschool program will be able to address the issues of health inequity head on by expanding access to high quality afterschool content without incurring high operating costs. The results from this pilot study will provide a critical foundation to apply for an extramurally funded clinical trial to demonstrate the efficacy of a VR-integrated afterschool program on youth mental wellbeing.
Interventions
Rather than rely on mere exposure to devices, participants in the treatment group will receive a curriculum that integrates the devices into traditional content delivered through the after school program.
Children will be able to use the same devices but will not have access to a curriculum that integrates the devices with traditional content delivered through the after school program.
Sponsors
Study design
Masking description
Participants will be masked to which study condition they are assigned to.
Eligibility
Inclusion criteria
* Children enrolled in the Chess \& Community program * Between the ages of 9-17
Exclusion criteria
* Children who are unable to wear a VR headset will not be recruited
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability of VR System and Curriculum Content | One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system. | Based on the validated System Usability Scale (SUS), we created open ended questionnaires and scale items that inquired about user attitude and usability of the system. For scale items reported, all items were measured through a 5-point Likert scale, 1 = Strongly Disagree, 5 = Strongly Agree. Five of the items were adapted from the original scale to assess the usability of the system, with five other items being converted to an open-ended item for a mixed-methods approach and richer contextual information from participants regarding usability issues. |
| Attrition Rate Post Assent to the VR Treatment | One-time assessment post-treatment, following 4 weeks of exposure to treatment | Fraction of the children lost to follow up post assent to the intended treatment via the VR system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Step Count | To match the time frame of data collection between step count and heart rate, both measures were taken during a 2 hour observation window on the last day of the 4-week intervention. | Step count based on smart watch measurements. Average steps were calculated from data collected during the 2-hour observation period. Target variance metrics were decomposing the overall (SD), between (B-SD), and within child (W-SD) standard deviations to inform power computations for a large-scale behavioral trial. Step count analysis also indicated that while step counts may be similar in child cohorts/classrooms/after-school programs, there is substantial variability within-child that would indicate response heterogeneity to future behavioral activity interventions with children of this age group. Observation period was a 2 hour window post intervention. |
| Heart Rate | To match the time frame of data collection between step count and heart rate, both measures were taken during a 2 hour observation window on the last day of the 4-week intervention. | Heart rate (pulse) data from smart watch measurements. Target variance metrics were decomposing the overall (SD), between (B-SD), and within child (W-SD) standard deviations to inform power computations for a large-scale behavioral trial. |
| Engagement | 4 week observation period | Achieving 240 minutes total exposure VR wear time over four 60-minute sessions. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited in two waves, beginning September of 2023 and ending July of 2024.
Pre-assignment details
This was a single arm study and all participants were assigned to the same intervention/treatment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 12.46 Years STANDARD_DEVIATION 1.4 |
| Number of Participants with Prior Exposure to VR | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 23 Participants |
| Race/Ethnicity, Customized More than one race | 3 Participants |
| Race/Ethnicity, Customized Unknown | 5 Participants |
| Race/Ethnicity, Customized White | 1 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |