NCT00850759

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

November 20, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

February 24, 2009

Results QC Date

June 17, 2013

Last Update Submit

December 1, 2014

Conditions

Keywords

pedestrian safetystreet-crossing abilityroad-crossingchildreninjury prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

virtual reality

EXPERIMENTAL

street-crossing training in a virtual pedestrian environment

Device: virtual pedestrian environment

computer and video

ACTIVE COMPARATOR

exposure to training in pedestrian safety via computer software, internet games, and television videos

Device: computer and video

streetside training

ACTIVE COMPARATOR

one-on-one training in street-crossing skills by an adult, at a streetside location

Behavioral: streetside training

no-contact control

NO INTERVENTION

no-contact control group.

Interventions

a computer-driven virtual pedestrian environment

virtual reality

various computer-based and video-based programs such as Otto the Auto and WalkSafe

computer and video

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

streetside training

Eligibility Criteria

Age7 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • and 8 year old children living in Birmingham, Alabama, area

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Youth Safety Lab, University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (2)

  • 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.

    PMID: 20179024BACKGROUND
  • 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.

    PMID: 23066380BACKGROUND

Results Point of Contact

Title
David Schwebel
Organization
UAB

Study Officials

  • David C Schwebel, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology and Associate Dean for Research in the Sciences

Study Record Dates

First Submitted

February 24, 2009

First Posted

February 25, 2009

Study Start

October 1, 2009

Primary Completion

May 1, 2012

Study Completion

March 1, 2014

Last Updated

December 16, 2014

Results First Posted

November 20, 2013

Record last verified: 2014-12

Locations