Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-28 @ 11:14 PM
Study NCT ID:
NCT00850759
Status:
COMPLETED
Last Update Posted:
2014-12-16
First Post:
2009-02-24
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using Virtual Reality to Train Children in Pedestrian Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'schwebel@uab.edu', 'phone': '205-934-8745', 'title': 'David Schwebel', 'organization': 'UAB'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'Both serious and other (non-serious) adverse events were collected and assessed, but non were observed.', 'eventGroups': [{'id': 'EG000', 'title': 'Virtual Reality', 'description': 'street-crossing training in a virtual pedestrian environment', 'otherNumAtRisk': 59, 'otherNumAffected': 0, 'seriousNumAtRisk': 59, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Computer and Video', 'description': 'exposure to training in pedestrian safety via computer software, internet games, and television videos', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Streetside Training', 'description': 'one-on-one training in street-crossing skills by an adult, at a streetside location', 'otherNumAtRisk': 57, 'otherNumAffected': 0, 'seriousNumAtRisk': 57, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'No-contact Control', 'description': 'no-contact control group.', 'otherNumAtRisk': 58, 'otherNumAffected': 0, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Street-crossing Ability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Virtual Reality', 'description': 'street-crossing training in a virtual pedestrian environment'}, {'id': 'OG001', 'title': 'Streetside Training', 'description': 'one-on-one training in street-crossing skills by an adult, at a streetside location'}, {'id': 'OG002', 'title': 'Computer and Video', 'description': 'exposure to training in pedestrian safety via computer software, internet games, and television videos'}, {'id': 'OG003', 'title': 'No-contact Control', 'description': 'no-contact control group.'}], 'classes': [{'title': 'post-intervention hits/close calls in VR', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.2', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '1.6', 'groupId': 'OG002'}, {'value': '3.0', 'spread': '1.6', 'groupId': 'OG003'}]}]}, {'title': '6 month follow-up hits/close calls in VR', 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '1.5', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '1.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'post-training and again 6 months later', 'description': 'average count of hits/close calls per participant in virtual environment, out of 30 crossings', 'unitOfMeasure': 'number of hits/close calls', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Virtual Reality', 'description': 'street-crossing training in a virtual pedestrian environment'}, {'id': 'FG001', 'title': 'Computer and Video', 'description': 'exposure to training in pedestrian safety via computer software, internet games, and television videos'}, {'id': 'FG002', 'title': 'Streetside Training', 'description': 'one-on-one training in street-crossing skills by an adult, at a streetside location'}, {'id': 'FG003', 'title': 'No-contact Control', 'description': 'no-contact control group.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'recruitment from a variety of community sources between October 2009 and September 2011', 'preAssignmentDetails': '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)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Virtual Reality', 'description': 'street-crossing training in a virtual pedestrian environment'}, {'id': 'BG001', 'title': 'Computer and Video', 'description': 'exposure to training in pedestrian safety via computer software, internet games, and television videos'}, {'id': 'BG002', 'title': 'Streetside Training', 'description': 'one-on-one training in street-crossing skills by an adult, at a streetside location'}, {'id': 'BG003', 'title': 'No-contact Control', 'description': 'no-contact control group.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '7.9', 'spread': '0.67', 'groupId': 'BG000'}, {'value': '8.1', 'spread': '0.63', 'groupId': 'BG001'}, {'value': '7.9', 'spread': '0.68', 'groupId': 'BG002'}, {'value': '8.1', 'spread': '0.63', 'groupId': 'BG003'}, {'value': '8.0', 'spread': '0.65', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '99', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '231', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 240}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2009-02-24', 'resultsFirstSubmitDate': '2013-06-17', 'studyFirstSubmitQcDate': '2009-02-24', 'lastUpdatePostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-10-28', 'studyFirstPostDateStruct': {'date': '2009-02-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Street-crossing Ability', 'timeFrame': 'post-training and again 6 months later', 'description': 'average count of hits/close calls per participant in virtual environment, out of 30 crossings'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pedestrian safety', 'street-crossing ability', 'road-crossing', 'children', 'injury prevention'], 'conditions': ['Street-crossing Ability', 'Pedestrian Safety']}, 'referencesModule': {'references': [{'pmid': '20179024', 'type': 'BACKGROUND', '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.'}, {'pmid': '23066380', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nVirtual 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.\n\nA 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7 and 8 year old children living in Birmingham, Alabama, area\n\nExclusion Criteria:\n\n* family plans to move within 6 months of recruitment\n* visual or perceptual impairment (e.g., blindness) that are uncorrected and would prevent valid participation in protocol\n* physical impairment (e.g., use of wheelchair) that would prevent valid participation in protocol\n* cognitive impairment (e.g., moderate mental retardation) that would prevent valid participation in protocol'}, 'identificationModule': {'nctId': 'NCT00850759', 'briefTitle': 'Using Virtual Reality to Train Children in Pedestrian Safety', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Using Virtual Reality to Train Children in Pedestrian Safety', 'orgStudyIdInfo': {'id': 'F080715010'}, 'secondaryIdInfos': [{'id': 'R01HD058573-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R01HD058573-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'virtual reality', 'description': 'street-crossing training in a virtual pedestrian environment', 'interventionNames': ['Device: virtual pedestrian environment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'computer and video', 'description': 'exposure to training in pedestrian safety via computer software, internet games, and television videos', 'interventionNames': ['Device: computer and video']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'streetside training', 'description': 'one-on-one training in street-crossing skills by an adult, at a streetside location', 'interventionNames': ['Behavioral: streetside training']}, {'type': 'NO_INTERVENTION', 'label': 'no-contact control', 'description': 'no-contact control group.'}], 'interventions': [{'name': 'virtual pedestrian environment', 'type': 'DEVICE', 'description': 'a computer-driven virtual pedestrian environment', 'armGroupLabels': ['virtual reality']}, {'name': 'computer and video', 'type': 'DEVICE', 'description': 'various computer-based and video-based programs such as Otto the Auto and WalkSafe', 'armGroupLabels': ['computer and video']}, {'name': 'streetside training', 'type': 'BEHAVIORAL', 'description': 'one-on-one training by an adult with the child at streetside locations, to teach children street-crossing skills', 'armGroupLabels': ['streetside training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAB Youth Safety Lab, University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'David C Schwebel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychology and Associate Dean for Research in the Sciences', 'investigatorFullName': 'David Schwebel', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}