Using Virtual Reality to Train Children in Pedestrian Safety

Pedestrian Safety Clinical Trial

Official title:

Using Virtual Reality to Train Children in Pedestrian Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850759
• Other study ID #: F080715010
• Secondary ID: R01HD058573-01A1
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2009
• Last updated: December 1, 2014
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: December 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 2014
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pedestrian Safety
• Street-crossing Ability

Intervention

Device:
• virtual pedestrian environment
a computer-driven virtual pedestrian environment
• computer and video
various computer-based and video-based programs such as Otto the Auto and WalkSafe

Behavioral:
• streetside training
one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills

Locations

Country	Name	City	State
United States	UAB Youth Safety Lab, University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2011 Jun 17. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Street-crossing Ability	average count of hits/close calls per participant in virtual environment, out of 30 crossings	post-training and again 6 months later	Yes