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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD088415 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Drexel University | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The investigators will conduct a non-inferiority clinical trial to evaluate whether children trained in pedestrian safety amidst a Google Cardboard virtual environment achieve equivalent levels of pedestrian safety to children trained in a full semi-immersive virtual pedestrian environment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Google Cardboard virtual environment | Experimental | pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms. |
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| semi-immersive virtual environment | Active Comparator | pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pedestrian safety training in pedestrian virtual environment | Behavioral | pedestrian safety training |
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| Measure | Description | Time Frame |
|---|---|---|
| Risky Crossings | risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street | 3.5 months after baseline (about 1 week after completion of all training) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Youth Safety Lab, University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
will share with qualified investigators upon their individual request
Data available after all primary analyses are completed, for undetermined amount of time
Data can be accessed by qualified investigators upon contacting the PI or study biostatitician
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21 participants were excluded prior to randomization, for the following reasons: COVID-related research closure: 2 Child discovered to be wrong age (ineligible): 5 Child unable to understand protocol: 1 Sibling discovered to be in study previously (ineligible): 3 Motion sickness in virtual reality: 1 Participant withdrew for unknown reasons: 9
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| ID | Title | Description |
|---|---|---|
| FG000 | Google Cardboard Virtual Environment | pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training |
| FG001 | Semi-immersive Virtual Environment | pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Google Cardboard Virtual Environment | pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Risky Crossings | risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street | Participants who completed study protocol, as described in participant flow section | Posted | Mean | Standard Deviation | count of risky crossings | 3.5 months after baseline (about 1 week after completion of all training) |
|
During participation in the study, about 6 months for each participant.
The definition matches that in clinicaltrials.gov and requirements of our university IRB.
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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 | Google Cardboard Virtual Environment | pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| motion sickness | Nervous system disorders | Systematic Assessment | participant experienced possible fainting episode due to motion sickness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Schwebel | University of Alabama at Birmingham | 205-934-8745 | schwebel@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2023 | Jan 3, 2024 | Prot_SAP_000.pdf |
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| COVID-related closure |
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| sibling discovered to be in study so participant ineligible |
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| motion sickness in virtual reality |
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| BG001 | Semi-immersive Virtual Environment | pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Semi-immersive Virtual Environment | pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training |
|
|
| 0 |
| 254 |
| 0 |
| 254 |
| 1 |
| 254 |
| EG001 | Semi-immersive Virtual Environment | pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms. pedestrian safety training in pedestrian virtual environment: pedestrian safety training | 0 | 225 | 0 | 225 | 0 | 225 |
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