Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-02 @ 4:54 PM
Study NCT ID:
NCT02934633
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2013-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parent Training in Child Safety Practices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C082263', 'term': 'tyrosyl-1,2,3,4-tetrahydro-3-isoquinolinecarbonyl-phenylalanyl-phenylalanine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 414}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2013-05-31', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in parent motivation to implement injury prevention strategies', 'timeFrame': '7 day and 30 day post intervention'}, {'measure': 'Change in parent knowledge of injury prevention practices', 'timeFrame': '7 and 30 day post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['injury', 'child', 'cars', 'pedestrians', 'child safety', 'interactive', 'computer', 'prevention', 'internet', 'CD-ROM'], 'conditions': ['Injury']}, 'descriptionModule': {'briefSummary': 'This project completed an intervention designed to teach parents of children aged 0-2 years of age how to prevent injuries to their child. The intervention consisted of a two DVD package with information on creating a safe home environment and correctly choosing and installing an appropriate car safety seat. The study hypothesis was that parents who used the intervention would score significantly higher on measures of knowledge, motivation, intention and self-efficacy in implementing injury prevention strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older\n* Parent whose oldest child is 0-24 months old\n* Speak and read English\n* Have internet access (online study only)\n\nExclusion Criteria:\n\n* Parents who do not have legal or physical custody\n* Subjects live in a household in which a family member had an overnight stay in the hospital as a result of an injury in the last 2 years'}, 'identificationModule': {'nctId': 'NCT02934633', 'acronym': 'BabySafety_2', 'briefTitle': 'Parent Training in Child Safety Practices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oregon Center for Applied Science, Inc.'}, 'officialTitle': 'Parent Training in Child Safety Practices', 'orgStudyIdInfo': {'id': 'SBIR 63-2'}, 'secondaryIdInfos': [{'id': 'R44HD044281', 'link': 'https://reporter.nih.gov/quickSearch/R44HD044281', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Keeping Baby Safe', 'description': "Keeping Baby Safe 2-DVD package, designed for parents of children from birth to 24 months. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits.", 'interventionNames': ['Behavioral: Keeping Baby Safe 2-DVD package']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AAP TIPP Sheets', 'description': 'American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets that parents would typically receive from their pediatrician or general practitioner at well-baby visits.', 'interventionNames': ['Behavioral: The Injury Prevention Program (TIPP) sheets']}], 'interventions': [{'name': 'Keeping Baby Safe 2-DVD package', 'type': 'BEHAVIORAL', 'description': "Keeping Baby Safe is a 2-DVD package that teaches childhood injury prevention skills to parents of children from birth to 24 months of age. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits.", 'armGroupLabels': ['Keeping Baby Safe']}, {'name': 'The Injury Prevention Program (TIPP) sheets', 'type': 'BEHAVIORAL', 'description': 'American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets parents would typically receive from their pediatrician or general practitioner at well-baby visits.', 'armGroupLabels': ['AAP TIPP Sheets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Center for Applied Science', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Lynne H Grilley Swartz, MPH, CHES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Center for Applied Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Center for Applied Science, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}