- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00850759
Using Virtual Reality to Train Children in Pedestrian Safety
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294
- UAB Youth Safety Lab, University of Alabama at Birmingham
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 7 and 8 year old children living in Birmingham, Alabama, area
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: virtual reality
street-crossing training in a virtual pedestrian environment
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a computer-driven virtual pedestrian environment
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Active Comparator: computer and video
exposure to training in pedestrian safety via computer software, internet games, and television videos
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various computer-based and video-based programs such as Otto the Auto and WalkSafe
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Active Comparator: streetside training
one-on-one training in street-crossing skills by an adult, at a streetside location
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one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills
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No Intervention: no-contact control
no-contact control group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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post-training and again 6 months later
|
Collaborators and Investigators
Collaborators
Publications and helpful links
General 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.
- Schwebel 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- F080715010
- R01HD058573-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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