Virtual Reality by Mobile Phone: Improving Child Pedestrian Safety

The investigators will conduct a non-inferiority clinical trial to evaluate whether children trained in pedestrian safety amidst a Google Cardboard virtual environment achieve equivalent levels of pedestrian safety to children trained in a full semi-immersive virtual pedestrian environment

Study Overview

• Status: Completed
• Conditions: Child Pedestrian Safety
• Intervention / Treatment: Behavioral: pedestrian safety training in pedestrian virtual environment

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Youth Safety Lab, University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• children ages 7-8 and their families
• one sibling per family, randomly chosen if multiple siblings are eligible
• children and parent speak English

Exclusion Criteria:

• disabilities that prohibit participants from valid understanding of or participation in the experimental protocol
• families that plan to move more than 50 miles away over the next year
• families unable to commit to frequent visits required in the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Google Cardboard virtual environment; pedestrian safety training using the Google Cardboard device and delivery of a pedestrian virtual environment by mobile smartphone. Note that children in this arm will be trained using an immersive virtual environment delivered by smartphone, which is different from the other arm that is trained using a semi-immersive virtual environment delivered in a kiosk. The intervention is pedestrian safety training for both arms.	Behavioral: pedestrian safety training in pedestrian virtual environment; pedestrian safety training
Active Comparator: semi-immersive virtual environment; pedestrian safety training using a semi-immersive virtual pedestrian environment kiosk. Note that children in this arm will be trained using a semi-immersive virtual environment delivered in a kiosk, which is different from the other arm that is trained using an immersive virtual environment delivered by smartphone. The intervention is pedestrian safety training for both arms.	Behavioral: pedestrian safety training in pedestrian virtual environment; pedestrian safety training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risky Crossings	risky crossings in virtual environment setting, indicated by hits/close calls while crossing virtual street	3.5 months after baseline (about 1 week after completion of all training)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); Drexel University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: October 24, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimated): October 28, 2016

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: R01HD088415-01 (U.S. NIH Grant/Contract); R01HD088415 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: will share with qualified investigators upon their individual request
• IPD Sharing Time Frame: Data available after all primary analyses are completed, for undetermined amount of time
• IPD Sharing Access Criteria: Data can be accessed by qualified investigators upon contacting the PI or study biostatitician
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No