Child Pedestrian SafetyNCT02948400
Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety
A study testing pedestrian safety training in pedestrian virtual environment in people with Child Pedestrian Safety, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Pedestrian Safety
- What is being tested?
- pedestrian safety training in pedestrian virtual environment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children ages 7-8 and their families
- one sibling per family, randomly chosen if multiple siblings are eligible
- children and parent speak English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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
- Conditions
- Child Pedestrian Safety
- Being tested
- pedestrian safety training in pedestrian virtual environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedestrian safety training in pedestrian virtual environmentBehavioural
pedestrian safety training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: pedestrian safety training in pedestrian virtual environment |
| 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. Receives: Behavioral: pedestrian safety training in pedestrian virtual environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risky Crossings
risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street
Measured: 3.5 months after baseline (about 1 week after completion of all training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Pedestrian SafetyStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Drexel University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948400
- Sponsor's protocol ID
- R01HD088415-01
- Other IDs
- R01HD088415
- Status last verified
- Jan 2024
- First submitted
- 24 Oct 2016
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will share with qualified investigators upon their individual request
Publications
Morgan CH, Stager LM, Smith CH, McClure LA, Davis AR, Johnston A, Shen J, Wang Y, Schwebel DC. An Evaluation of Parent and Child Perceptions About Pediatric Pedestrian Safety Skills. Child Youth Care Forum. 2026 Aug 12:10.1007/s10566-026-09971-y. doi: 10.1007/s10566-026-09971-y. Online ahead of print.
PubMed 42699685
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety
- ClinicalTrials.gov ID
- NCT02948400
- Acronym / sponsor ID
- R01HD088415-01
- Conditions
- Child Pedestrian Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Drexel University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Dec 2016 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Google Cardboard virtual environment | Experimental | Behavioral: pedestrian safety training in pedestrian virtual environmentpedestrian 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. |
| semi-immersive virtual environment | Active comparator | Behavioral: pedestrian safety training in pedestrian virtual environmentpedestrian 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. |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children ages 7-8 and their families
- one sibling per family, randomly chosen if multiple siblings are eligible
- children and parent speak English
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pedestrian safety training in pedestrian virtual environmentpedestrian safety training | Behavioural | Google Cardboard virtual environment, semi-immersive virtual environment |
Primary outcome
Risky Crossings
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42699685Morgan CH, Stager LM, Smith CH, McClure LA, Davis AR, Johnston A, Shen J, Wang Y, Schwebel DC. An Evaluation of Parent and Child Perceptions About Pediatric Pedestrian Safety Skills. Child Youth Care Forum. 2026 Aug 12:10.1007/s10566-026-09971-y. doi: 10.1007/s10566-026-09971-y. Online ahead of print.
- Individual participant dataSharing planned: Yes. will share with qualified investigators upon their individual request
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pedestrian safety training in pedestrian virtual environment in people with Child Pedestrian Safety, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risky Crossings (time frame: 3.5 months after baseline (about 1 week after completion of all training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02948400, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.