Street-crossing AbilityPhase 3NCT00850759
Using Virtual Reality to Train Children in Pedestrian Safety
A Phase 3 study testing virtual pedestrian environment, computer and video and streetside training in people with Street-crossing Ability and Pedestrian Safety, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Pedestrian injuries are among the leading causes of morbidity and mortality in American children ages 7-8, but existing behavior-oriented interventions achieve only modest success. Read more about this study
- Who is it for?
- Ages 7 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Street-crossing Ability, Pedestrian Safety
- What is being tested?
- virtual pedestrian environment, computer and video and streetside training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2014
- Phase
- Phase 3
- 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
- 7 and 8 year old children living in Birmingham, Alabama, area
Who cannot join
- family plans to move within 6 months of recruitment
- visual or perceptual impairment (e.g., blindness) that are uncorrected and would prevent valid participation in protocol
- physical impairment (e.g., use of wheelchair) that would prevent valid participation in protocol
- cognitive impairment (e.g., moderate mental retardation) that would prevent valid participation in 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
Pedestrian injuries are among the leading causes of morbidity and mortality in American children ages 7-8, but existing behavior-oriented interventions achieve only modest success. One limitation to existing interventions is that they fail to provide children with the repeated practice needed to develop the complex perceptual and cognitive skills required for safe pedestrian activity.
Virtual reality (VR) offers a highly promising technique to train children in pedestrian safety skills. VR permits repeated unsupervised practice without risk of injury; automated feedback to children on success or failure in crossings; adjustment of traffic density and speed to match children's skill level; and an appealing and fun environment for training. The proposed research is designed to test the efficacy of virtual reality as a tool to train child pedestrians in safe street-crossing behavior.
A randomized controlled trial will be conducted with four equal-sized groups of children ages 7-8 (total N = 240). One group will receive training in an interactive and immersive virtual pedestrian environment. The virtual environment, already developed, has been demonstrated to have face, construct, and convergent validity. The second group will receive pedestrian safety training via video and computer strategies that are most widely used in American schools today. The third group will receive what is judged to be the most efficacious treatment currently available, individualized behavioral training at streetside locations. The fourth and final group will serve as a no-contact control group. All participants in all groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill during baseline and post-intervention visits, as well as during a six-month follow-up assessment. Primary analyses will be conducted through linear mixed models designed to test change over time in the four intervention groups. We hypothesize all children in active learning groups will increase pedestrian safety skills, but the largest increase will be among children in the virtual reality group.
- Conditions
- Street-crossing Ability, Pedestrian Safety
- Being tested
- virtual pedestrian environment, computer and video, streetside training
- Keywords
- pedestrian safety, street-crossing ability, road-crossing, children, injury prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual pedestrian environmentDevice
a computer-driven virtual pedestrian environment
computer and videoDevice
various computer-based and video-based programs such as Otto the Auto and WalkSafe
streetside trainingBehavioural
one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Experimental | street-crossing training in a virtual pedestrian environment Receives: Device: virtual pedestrian environment |
| computer and video | Active comparator | exposure to training in pedestrian safety via computer software, internet games, and television videos Receives: Device: computer and video |
| streetside training | Active comparator | one-on-one training in street-crossing skills by an adult, at a streetside location Receives: Behavioral: streetside training |
| no-contact control | No intervention | no-contact control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Street-crossing Ability
average count of hits/close calls per participant in virtual environment, out of 30 crossings
Measured: post-training and again 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startOct 2009
- Primary completionMay 2012
- Study completionMar 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Street-crossing AbilityStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
- Investigators
- David C Schwebel, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850759
- Sponsor's protocol ID
- F080715010
- Other IDs
- R01HD058573-01A1
- Status last verified
- Dec 2014
- First submitted
- 24 Feb 2009
- Last updated
- 16 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Schwebel DC, McClure LA. Using virtual reality to train children in safe street-crossing skills. Inj Prev. 2010 Feb;16(1):e1-5. doi: 10.1136/ip.2009.025288.
PubMed 20179024Schwebel DC, Davis AL, O'Neal EE. Child Pedestrian Injury: A Review of Behavioral Risks and Preventive Strategies. Am J Lifestyle Med. 2012 Jul;6(4):292-302. doi: 10.1177/0885066611404876. Epub 2011 Jun 17.
PubMed 23066380
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality to Train Children in Pedestrian Safety
- ClinicalTrials.gov ID
- NCT00850759
- Acronym / sponsor ID
- F080715010
- Conditions
- Street-crossing Ability, Pedestrian Safety
- Keywords
- pedestrian safety, street-crossing ability, road-crossing, children, injury prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Oct 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 20 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pedestrian injuries are among the leading causes of morbidity and mortality in American children ages 7-8, but existing behavior-oriented interventions achieve only modest success. One limitation to existing interventions is that they fail to provide children with the repeated practice needed to develop the complex perceptual and cognitive skills required for safe pedestrian activity.
Virtual reality (VR) offers a highly promising technique to train children in pedestrian safety skills. VR permits repeated unsupervised practice without risk of injury; automated feedback to children on success or failure in crossings; adjustment of traffic density and speed to match children's skill level; and an appealing and fun environment for training. The proposed research is designed to test the efficacy of virtual reality as a tool to train child pedestrians in safe street-crossing behavior.
A randomized controlled trial will be conducted with four equal-sized groups of children ages 7-8 (total N = 240). One group will receive training in an interactive and immersive virtual pedestrian environment. The virtual environment, already developed, has been demonstrated to have face, construct, and convergent validity. The second group will receive pedestrian safety training via video and computer strategies that are most widely used in American schools today. The third group will receive what is judged to be the most efficacious treatment currently available, individualized behavioral training at streetside locations. The fourth and final group will serve as a no-contact control group. All participants in all groups will be exposed to a range of field- and laboratory-based measures of pedestrian skill during baseline and post-intervention visits, as well as during a six-month follow-up assessment. Primary analyses will be conducted through linear mixed models designed to test change over time in the four intervention groups. We hypothesize all children in active learning groups will increase pedestrian safety skills, but the largest increase will be among children in the virtual reality group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Experimental | Device: virtual pedestrian environmentstreet-crossing training in a virtual pedestrian environment |
| computer and video | Active comparator | Device: computer and videoexposure to training in pedestrian safety via computer software, internet games, and television videos |
| streetside training | Active comparator | Behavioral: streetside trainingone-on-one training in street-crossing skills by an adult, at a streetside location |
| no-contact control | No intervention | –no-contact control group. |
Who may qualify
- Ages
- 7 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7 and 8 year old children living in Birmingham, Alabama, area
Key exclusion criteria (4 listed)
- family plans to move within 6 months of recruitment
- visual or perceptual impairment (e.g., blindness) that are uncorrected and would prevent valid participation in protocol
- physical impairment (e.g., use of wheelchair) that would prevent valid participation in protocol
- cognitive impairment (e.g., moderate mental retardation) that would prevent valid participation in 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 |
|---|---|---|
| virtual pedestrian environmenta computer-driven virtual pedestrian environment | Device | virtual reality |
| computer and videovarious computer-based and video-based programs such as Otto the Auto and WalkSafe | Device | computer and video |
| streetside trainingone-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills | Behavioural | streetside training |
Primary outcome
Street-crossing Ability
Time frame: post-training and again 6 months later
average count of hits/close calls per participant in virtual environment, out of 30 crossings
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20179024Schwebel DC, McClure LA. Using virtual reality to train children in safe street-crossing skills. Inj Prev. 2010 Feb;16(1):e1-5. doi: 10.1136/ip.2009.025288.
- Background: PubMed 23066380Schwebel DC, Davis AL, O'Neal EE. Child Pedestrian Injury: A Review of Behavioral Risks and Preventive Strategies. Am J Lifestyle Med. 2012 Jul;6(4):292-302. doi: 10.1177/0885066611404876. Epub 2011 Jun 17.
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.
David C Schwebel, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing virtual pedestrian environment, computer and video and streetside training in people with Street-crossing Ability and 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 1 inclusion and 4 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 16 Dec 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2013). 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?
Street-crossing Ability (time frame: post-training and again 6 months later). 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 NCT00850759, which also lists 2 linked publications.
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 16 Dec 2014.