Trial Outcomes & Findings for Using Virtual Reality to Train Children in Pedestrian Safety (NCT NCT00850759)

NCT ID: NCT00850759

Last Updated: 2014-12-16

Results Overview

average count of hits/close calls per participant in virtual environment, out of 30 crossings

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 240 participants
• Primary outcome timeframe: post-training and again 6 months later
• Results posted on: 2014-12-16

Participant Flow

recruitment from a variety of community sources between October 2009 and September 2011

9 excluded prior to group assignment, for these reasons: Not meeting inclusion criteria; child of incorrect age (n = 3) Not meeting inclusion criteria; child unable to understand protocol (n = 3) Did not complete baseline assessment (n = 3)

Participant milestones

Measure	Virtual Reality street-crossing training in a virtual pedestrian environment	Computer and Video exposure to training in pedestrian safety via computer software, internet games, and television videos	Streetside Training one-on-one training in street-crossing skills by an adult, at a streetside location	No-contact Control no-contact control group.
Overall Study STARTED	59	57	57	58
Overall Study COMPLETED	52	52	52	55
Overall Study NOT COMPLETED	7	5	5	3

Reasons for withdrawal

Measure	Virtual Reality street-crossing training in a virtual pedestrian environment	Computer and Video exposure to training in pedestrian safety via computer software, internet games, and television videos	Streetside Training one-on-one training in street-crossing skills by an adult, at a streetside location	No-contact Control no-contact control group.
Overall Study Lost to Follow-up	7	5	5	3

Baseline Characteristics

Using Virtual Reality to Train Children in Pedestrian Safety

Baseline characteristics by cohort

Measure	Virtual Reality n=59 Participants street-crossing training in a virtual pedestrian environment	Computer and Video n=57 Participants exposure to training in pedestrian safety via computer software, internet games, and television videos	Streetside Training n=57 Participants one-on-one training in street-crossing skills by an adult, at a streetside location	No-contact Control n=58 Participants no-contact control group.	Total n=231 Participants Total of all reporting groups
Age, Categorical <=18 years	59 Participants n=5 Participants	57 Participants n=7 Participants	57 Participants n=5 Participants	58 Participants n=4 Participants	231 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	7.9 years STANDARD_DEVIATION 0.67 • n=5 Participants	8.1 years STANDARD_DEVIATION 0.63 • n=7 Participants	7.9 years STANDARD_DEVIATION 0.68 • n=5 Participants	8.1 years STANDARD_DEVIATION 0.63 • n=4 Participants	8.0 years STANDARD_DEVIATION 0.65 • n=21 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	35 Participants n=7 Participants	35 Participants n=5 Participants	30 Participants n=4 Participants	132 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	28 Participants n=4 Participants	99 Participants n=21 Participants
Region of Enrollment United States	59 participants n=5 Participants	57 participants n=7 Participants	57 participants n=5 Participants	58 participants n=4 Participants	231 participants n=21 Participants

PRIMARY outcome

Timeframe: post-training and again 6 months later

average count of hits/close calls per participant in virtual environment, out of 30 crossings

Outcome measures

Measure	Virtual Reality n=52 Participants street-crossing training in a virtual pedestrian environment	Streetside Training n=52 Participants one-on-one training in street-crossing skills by an adult, at a streetside location	Computer and Video n=52 Participants exposure to training in pedestrian safety via computer software, internet games, and television videos	No-contact Control n=55 Participants no-contact control group.
Street-crossing Ability post-intervention hits/close calls in VR	2.7 number of hits/close calls Standard Deviation 1.6	2.3 number of hits/close calls Standard Deviation 1.2	2.6 number of hits/close calls Standard Deviation 1.6	3.0 number of hits/close calls Standard Deviation 1.6
Street-crossing Ability 6 month follow-up hits/close calls in VR	2.1 number of hits/close calls Standard Deviation 1.4	1.7 number of hits/close calls Standard Deviation 1.1	2.3 number of hits/close calls Standard Deviation 1.5	2.6 number of hits/close calls Standard Deviation 1.6

Adverse Events

Virtual Reality

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Computer and Video

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Streetside Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No-contact Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Schwebel

UAB

Phone: 205-934-8745

Email: schwebel@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place