Using Virtual Reality to Train Children in Pedestrian Safety
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| First Received Date ICMJE | February 24, 2009 | ||||
| Last Updated Date | March 7, 2013 | ||||
| Start Date ICMJE | October 2009 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
street-crossing ability [ Time Frame: post-training and again 6 months later ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00850759 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Using Virtual Reality to Train Children in Pedestrian Safety | ||||
| Official Title ICMJE | Using Virtual Reality to Train Children in Pedestrian Safety | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 240 | ||||
| Estimated Completion Date | August 2014 | ||||
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 7 Years to 8 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00850759 | ||||
| Other Study ID Numbers ICMJE | F080715010, R01HD058573-01A1 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | David Schwebel, University of Alabama at Birmingham | ||||
| Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of Alabama at Birmingham | ||||
| Verification Date | March 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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