Child Pedestrian Safety
Conditions
Brief summary
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
Interventions
BEHAVIORALpedestrian safety training in pedestrian virtual environment
pedestrian safety training
Sponsors
National Institutes of Health (NIH)
Drexel University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* children ages 7-8 and their families * one sibling per family, randomly chosen if multiple siblings are eligible * children and parent speak English
Exclusion criteria
* disabilities that prohibit participants from valid understanding of or participation in the experimental protocol * families that plan to move more than 50 miles away over the next year * families unable to commit to frequent visits required in the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risky Crossings | 3.5 months after baseline (about 1 week after completion of all training) | risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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 | 254 |
| 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 | 225 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-related closure | 6 | 2 |
| Overall Study | failed to attend appointments | 47 | 34 |
| Overall Study | motion sickness in virtual reality | 2 | 0 |
| Overall Study | sibling discovered to be in study so participant ineligible | 1 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 10 |
Baseline characteristics
| Characteristic | Google Cardboard Virtual Environment | Total | Semi-immersive Virtual Environment |
|---|---|---|---|
| Age, Continuous | 7.5 years STANDARD_DEVIATION 0.5 | 7.5 years STANDARD_DEVIATION 0.5 | 7.4 years STANDARD_DEVIATION 0.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 18 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 243 Participants | 458 Participants | 215 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 23 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 132 Participants | 244 Participants | 112 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) White | 99 Participants | 194 Participants | 95 Participants |
| Region of Enrollment United States | 254 participants | 479 participants | 225 participants |
| Sex: Female, Male Female | 139 Participants | 257 Participants | 118 Participants |
| Sex: Female, Male Male | 115 Participants | 222 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 254 | 0 / 225 |
| other Total, other adverse events | 1 / 254 | 0 / 225 |
| serious Total, serious adverse events | 0 / 254 | 0 / 225 |
Outcome results
Primary
Risky Crossings
risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street
Time frame: 3.5 months after baseline (about 1 week after completion of all training)
Population: Participants who completed study protocol, as described in participant flow section
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Google Cardboard Virtual Environment | Risky Crossings | .20 count of risky crossings | Standard Deviation 0.11 |
| Semi-immersive Virtual Environment | Risky Crossings | .13 count of risky crossings | Standard Deviation 0.091 |