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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | In the treatment group, the child will receive the VR-based curriculum during the afterschool program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality curriculum | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of VR System and Curriculum Content | 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. | One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system. |
| Attrition Rate Post Assent to the VR Treatment | Fraction of the children lost to follow up post assent to the intended treatment via the VR system | One-time assessment post-treatment, following 4 weeks of exposure to treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Step Count | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Athens Chess & Community | Athens | Georgia | 30606 | United States |
De-identified data used in published analyses will be made available upon request to other researchers with a verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications. Intellectual property rights to all software applications and hardware products will be maintained by the University of Georgia.
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Verified scientific purpose, guarantee that they will store the data securely, not share the data further, not attempt to use the data to determine the identities of research participants, and reference the source of the data in any resulting publications
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This was a single arm study and all participants were assigned to the same intervention/treatment.
Participants were recruited in two waves, beginning September of 2023 and ending July of 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | In the treatment group, the child will receive the VR-based curriculum during the afterschool program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The study required participants to engage with the VR playground at least once a week for 4 weeks and use the smartwatch to track physical activity. Participants were required to wear their smartwatch during waking hours. We recruited and enrolled 32 adolescents (age range 9-17 years old, Mage = 12.46, SDage = 1.40).
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | In the treatment group, the child will receive the VR-based curriculum during the afterschool program. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Usability of VR System and Curriculum Content | 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. | Detailed open ended responses to the usability questions were obtained from diary measures and reported as a supplementary document in the Study Documents section. Although all participants wore wearables to track their movement and engagement with the VR system, 21 participants out of 32 participants completed the self-reported survey portion of the study. | Posted | Mean | Standard Deviation | Units on an ordinal scale | One-time assessment post-treatment, following 4 weeks of exposure to virtual reality system. |
|
Adverse events were monitored based on the study protocol during the 4 week intervention period, from enrollment to the end of the intervention.
The research team administered the intervention for one hour each week. Mild adverse events (e.g., cyber sickness from VR, skin irritation from wearables) were monitored by research staff. The IRB protocol outlines that these adverse events are mild and temporary. All-Cause Mortality and Serious Adverse Events were monitored/assessed but no events occurred.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | In the treatment group, the child will receive the VR-based curriculum during the afterschool program. |
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Based on the discussions and conversations with the community partner who participated in the clinical trial, initial plans for the feasibility study were changed due to shifts in their programmatic priorities and personnel changes. As a result, the duration of the intervention was reduced from 8 weeks to 4 weeks and the intended sample size changed from 100 to 32 children. This was due to the substantial reduction of the afterschool program size following budgetary changes in the program.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sun Joo Ahn | University of Georgia | 706-542-4791 | sjahn@uga.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 9, 2026 | Feb 10, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan | Feb 9, 2026 | Feb 10, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 24, 2024 | Oct 7, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Participants will be masked to which study condition they are assigned to.
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| No Virtual reality curriculum | Behavioral | 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. |
|
| 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 | 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. | 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. |
| Engagement | Achieving 240 minutes total exposure VR wear time over four 60-minute sessions. | 4 week observation period |
| Years |
|
| Sex: Female, Male | 2 of the participants sex is unknown | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of Participants with Prior Exposure to VR | Count of Participants | Participants |
|
| OG000 | Treatment | In the treatment group, the child will receive the VR-based curriculum during the afterschool program. |
|
|
| Primary | Attrition Rate Post Assent to the VR Treatment | Fraction of the children lost to follow up post assent to the intended treatment via the VR system | Children in an afterschool program were assented to use the VR system without involvement from the research team throughout the 4 week process. | Posted | Count of Participants | Participants | One-time assessment post-treatment, following 4 weeks of exposure to treatment |
|
|
|
| Secondary | Step Count | 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. | Step count was assessed from participants who wore their smart watch for at least one session of the VR experience during the 4 week intervention. Although all 32 participants wore a tracking monitor, data from 25 participants who had the full range of step count data during the 2 hour observation period were used. Seven participants were dropped due to incomplete data collection (e.g., left early). | Posted | Mean | Standard Deviation | Steps per minute | 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. |
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|
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| Secondary | Heart Rate | 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. | Heart rate was assessed from children who wore their pulse monitor throughout the 2-hour observation period. Due to incorrect wear and technical issues, particularly when young participants had small wrists, the sensor data was usable for 9 of the 32 participants. | Posted | Mean | Standard Deviation | Beats per minute | 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. |
|
|
|
| Secondary | Engagement | Achieving 240 minutes total exposure VR wear time over four 60-minute sessions. | All participants were subject to one hour per week of VR exposure across a 4 week program (240 minutes). | Posted | Count of Participants | Participants | 4 week observation period |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |