Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2026-01-31 @ 9:40 AM
Study NCT ID:
NCT02544035
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2015-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Determining Age Appropriateness of Children's Products and Toys
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'putnickd@mail.nih.gov', 'phone': '301-496-6291', 'title': 'Dr. Diane Putnick', 'organization': 'National Institute of Child Health and Human Development'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year 11 months', 'description': 'Adverse events were defined consistent with the clinicaltrials.gov definitions.', 'eventGroups': [{'id': 'EG000', 'title': '12-18 Month-old Toy Type', 'description': '12-18 month-olds (1-1.5 year olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '19-35 Month-old Toy Type', 'description': '19-35 month-olds (1.5-2 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '36-71 Month-old Toy Type', 'description': '36-71 month-olds (3-5 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '72-107 Month-old Toy Type', 'description': '72-107 month-olds (6-8 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '12-18 Month-old Play Partner', 'description': '12-18 month-olds (1-1.5 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '19-35 Month-old Play Partner', 'description': '19-35 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 0, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '36-71 Month-old Play Partner', 'description': '36-71 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '72-107 Month-old Play Partner', 'description': '72-107 month-olds (6-8 year-olds)\n\nPlay Partner: Each child will first play alone then play with parent.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Utilization of Toy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '12-18 Month-old Toy Type', 'description': '12-18 month-olds (1-1.5 year olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG001', 'title': '19-35 Month-old Toy Type', 'description': '19-35 month-olds (1.5-2 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG002', 'title': '36-71 Month-old Toy Type', 'description': '36-71 month-olds (3-5 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG003', 'title': '72-107 Month-old Toy Type', 'description': '72-107 month-olds (6-8 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG004', 'title': '12-18 Month-old Play Partner', 'description': '12-18 month-olds (1-1.5 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'OG005', 'title': '19-35 Month-old Play Partner', 'description': '19-35 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'OG006', 'title': '36-71 Month-old Play Partner', 'description': '36-71 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'OG007', 'title': '72-107 Month-old Play Partner', 'description': '72-107 month-olds (6-8 year-olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}], 'classes': [{'categories': [{'measurements': [{'value': '.45', 'groupId': 'OG000'}, {'value': '.49', 'groupId': 'OG001'}, {'value': '.50', 'groupId': 'OG002'}, {'value': '.53', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour play session', 'description': "Children's play with each of the toys was categorized as fully utilized (1) or not fully utilized (0) according to the intended use of each toy", 'unitOfMeasure': 'Proportion', 'reportingStatus': 'POSTED', 'populationDescription': 'Child age by toy age appropriateness'}, {'type': 'SECONDARY', 'title': 'Played With Toy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '12-18 Month-old Toy Type', 'description': '12-18 month-olds (1-1.5 year olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG001', 'title': '19-35 Month-old Toy Type', 'description': '19-35 month-olds (1.5-2 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG002', 'title': '36-71 Month-old Toy Type', 'description': '36-71 month-olds (3-5 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'OG003', 'title': '72-107 Month-old Toy Type', 'description': '72-107 month-olds (6-8 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}], 'classes': [{'categories': [{'measurements': [{'value': '.67', 'groupId': 'OG000'}, {'value': '.61', 'groupId': 'OG001'}, {'value': '.62', 'groupId': 'OG002'}, {'value': '.65', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 hour play session', 'description': 'We constructed a variable to indicate whether the child played with the toy (1) or did not play with the toy (0).', 'unitOfMeasure': 'Proportion', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Toy Play', 'timeFrame': '1 hour play session', 'description': 'Duration of time child plays with each toy', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Preference for the Toy - Child-report', 'timeFrame': '1 hour play session', 'description': 'Child preference for the toys based on child-report', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Solicits to Parent Involvement', 'timeFrame': '1 hour play session', 'description': 'Number of times child solicits parent involvement', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12-18 Month-old Toy Type', 'description': '12-18 month-olds (1-1.5 year olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'FG001', 'title': '19-35 Month-old Toy Type', 'description': '19-35 month-olds (1.5-2 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'FG002', 'title': '36-71 Month-old Toy Type', 'description': '36-71 month-olds (3-5 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'FG003', 'title': '72-107 Month-old Toy Type', 'description': '72-107 month-olds (6-8 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'FG004', 'title': '12-18 Month-old Play Partner', 'description': '12-18 month-olds (1-1.5 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'FG005', 'title': '19-35 Month-old Play Partner', 'description': '19-35 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'FG006', 'title': '36-71 Month-old Play Partner', 'description': '36-71 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'FG007', 'title': '72-107 Month-old Play Partner', 'description': '72-107 month-olds (6-8 year-olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '61'}, {'groupId': 'FG006', 'numSubjects': '62'}, {'groupId': 'FG007', 'numSubjects': '60'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '60'}, {'groupId': 'FG005', 'numSubjects': '61'}, {'groupId': 'FG006', 'numSubjects': '62'}, {'groupId': 'FG007', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '486', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '12-18 Month-old Toy Type', 'description': '12-18 month-olds (1-1.5 year olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'BG001', 'title': '19-35 Month-old Toy Type', 'description': '19-35 month-olds (1.5-2 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'BG002', 'title': '36-71 Month-old Toy Type', 'description': '36-71 month-olds (3-5 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'BG003', 'title': '72-107 Month-old Toy Type', 'description': '72-107 month-olds (6-8 year-olds)\n\nType of Toy: Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;'}, {'id': 'BG004', 'title': '12-18 Month-old Play Partner', 'description': '12-18 month-olds (1-1.5 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'BG005', 'title': '19-35 Month-old Play Partner', 'description': '19-35 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'BG006', 'title': '36-71 Month-old Play Partner', 'description': '36-71 month-olds (1.5-2 year olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'BG007', 'title': '72-107 Month-old Play Partner', 'description': '72-107 month-olds (6-8 year-olds)\n\nPlay Partner: Each child will first play alone then play with parent.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '15.34', 'spread': '2.02', 'groupId': 'BG000'}, {'value': '26.88', 'spread': '4.96', 'groupId': 'BG001'}, {'value': '54.16', 'spread': '10.77', 'groupId': 'BG002'}, {'value': '89.52', 'spread': '11.42', 'groupId': 'BG003'}, {'value': '15.34', 'spread': '2.02', 'groupId': 'BG004'}, {'value': '26.88', 'spread': '4.96', 'groupId': 'BG005'}, {'value': '54.16', 'spread': '10.77', 'groupId': 'BG006'}, {'value': '89.52', 'spread': '11.42', 'groupId': 'BG007'}, {'value': '46.46', 'spread': '29.66', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '28', 'groupId': 'BG007'}, {'value': '236', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '28', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '32', 'groupId': 'BG007'}, {'value': '250', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '44', 'groupId': 'BG008'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '56', 'groupId': 'BG006'}, {'value': '52', 'groupId': 'BG007'}, {'value': '442', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '42', 'groupId': 'BG008'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '40', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '42', 'groupId': 'BG006'}, {'value': '36', 'groupId': 'BG007'}, {'value': '318', 'groupId': 'BG008'}]}, {'title': 'More than one race', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '12', 'groupId': 'BG007'}, {'value': '86', 'groupId': 'BG008'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '60', 'groupId': 'BG007'}, {'value': '486', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Children aged 6-11 months were dropped from inclusion because they were not reliably able to play with toys in pilot testing.\n\nChildren aged 108-144 months were dropped from inclusion because few toys were identified as age appropriate for this group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-15', 'size': 750117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-15T17:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04-30', 'completionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2015-09-05', 'resultsFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2015-09-05', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-16', 'studyFirstPostDateStruct': {'date': '2015-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Utilization of Toy', 'timeFrame': '1 hour play session', 'description': "Children's play with each of the toys was categorized as fully utilized (1) or not fully utilized (0) according to the intended use of each toy"}], 'secondaryOutcomes': [{'measure': 'Played With Toy', 'timeFrame': '1 hour play session', 'description': 'We constructed a variable to indicate whether the child played with the toy (1) or did not play with the toy (0).'}, {'measure': 'Duration of Toy Play', 'timeFrame': '1 hour play session', 'description': 'Duration of time child plays with each toy'}, {'measure': 'Preference for the Toy - Child-report', 'timeFrame': '1 hour play session', 'description': 'Child preference for the toys based on child-report'}, {'measure': 'Solicits to Parent Involvement', 'timeFrame': '1 hour play session', 'description': 'Number of times child solicits parent involvement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Childhood Growth and Development', 'Development'], 'conditions': ['Healthy Volunteers Only']}, 'referencesModule': {'references': [{'pmid': '9071765', 'type': 'BACKGROUND', 'citation': "Bornstein MH, Haynes OM, O'Reilly AW, Painter KM. Solitary and collaborative pretense play in early childhood: sources of individual variation in the development of representational competence. Child Dev. 1996 Dec;67(6):2910-29."}, {'pmid': '35110960', 'type': 'RESULT', 'citation': "Richards MN, Putnick DL, Bradley LP, Lang KM, Little TD, Suwalsky JTD, Bornstein MH. Children's Utilization of Toys is Moderated by Age-Appropriateness, Toy Category, and Child Age. Appl Dev Sci. 2022;26(1):192-205. doi: 10.1080/10888691.2020.1760868. Epub 2020 May 19."}, {'pmid': '32405125', 'type': 'RESULT', 'citation': 'Richards MN, Putnick DL, Bornstein MH. Toy Buying Today: Considerations, Information Seeking, and Thoughts about Manufacturer Suggested Age. J Appl Dev Psychol. 2020 May-Jun;68:101134. doi: 10.1016/j.appdev.2020.101134. Epub 2020 Apr 8.'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nPlay during childhood is an important part of healthy development, and children can learn many things when they play. Much of the time that children spend playing is with toys. However, children at different ages need different types of toys to engage in healthy play.\n\nUnderstanding children s play with toys is important to the National Institute of Child Health and Human Development (NICHD), and to the U.S. Consumer Product Safety Commission (CPSC). The CPSC rates toys that are currently available in the United States for children for age appropriateness. NICHD will share the findings of this study with CPSC to aid in their toy rating process.\n\nObjective:\n\nTo categorize traditional and contemporary children s products and toys into age appropriate groups.\n\nEligibility:\n\nHealthy children 6 months to 12 years old.\n\nTheir parents.\n\nDesign:\n\nParticipants will be screened with a phone call with the parents.\n\nParticipants will complete surveys online or on paper, and by phone. These will ask about demographic facts, behavior, thoughts on parenting and toys, and child development.\n\nParticipants will have 1 study visit. The child will play with toys by himself or herself. Then they will play with their parent. A researcher will observe. The sessions will be videotaped.\n\nChildren will share their thoughts about the toys by pointing at a smiley face scale.\n\nParents will fill out a short survey. Then can choose to participate in a 1-hour focus group.', 'detailedDescription': 'The proposed project is the outcome of an interagency agreement (IAG; #CPSC-I-14-0016) between the Consumer Product Safety Commission (CPSC) of the United States and the Child and Family Research Section (CFRS) within NICHD DIR. At the CPSC, the Division of Human Factors (ESHF) examines products and toys for U.S. children and determines the appropriate age of their potential users based on a set of Guidelines last revised in 2002. Due to the outdated nature of the 2002 Guidelines, the CFRS is charged with revising this rulebook after conducting an empirical research project to inform these amendments. The goal of the current study is to categorize traditional and contemporary children s products and toys into age appropriate groups and use this information to rewrite the Guidelines for efficient CPSC use.\n\nParticipants will be 360 parent-child dyads from 6 months to 12 years of age. We will recruit equal numbers of boys and girls from each of the following six developmentally determined and CPSC approved age groups: 6-11 mos, 12-18 mos, 19-35 mos, 36-71 mos (3-5 years), 72-107 mos (6-8 years), and 108-144 mos (9-12 years). Participants will be tested at the CFRS once parental consent and child assent have been obtained.\n\nEach child will receive one of three counterbalanced children s products or toys that are targeted to their age group from 6 of the 9 following categories: (1) Building or Construction (e.g., blocks, interlocking building materials), (2) Exploratory (e.g., clay, sand toys), (3) Games \\& Puzzles, (4) Instructional Toys (e.g., books, science kits), (5) Sports, Recreation, \\& Outdoor, (6) Imaginative Play (e.g., puppets, dolls, dress up materials), (7) Small Wheeled Vehicles (e.g., car toys), (8) Arts and Crafts, and (9) Musical Toys (e.g., musical instruments). Children will also receive one of three (counterbalanced) children s products or toys from each of the categories aimed at the age group below their age as well as another from each of the categories aimed at the age group older than their age. Each child will first play alone and then play with a parent. Different sets of toys will be presented when children switch from playing alone to playing in a dyad.\n\nParents will provide information about their socioeconomic status and demographics. They will also complete the Vineland Adaptive Behavior Scales (i.e., an instrument assessing the child s socialization, motor, communication, and daily living skills) and an age-appropriate instrument that assesses the child s temperament. They will provide information about toys that are already in their home. Some parents may be invited to take part in a more in-depth qualitative focus group interview about children s toys. All play sessions will be video recorded and will be scored for relevant behaviors.\n\nWe will examine differences in play with toys from the three age groups that are chronologically adjacent (i.e., to determine differences in outcomes for a given age group with age-appropriate toys compared to toys of the same category from the next youngest and next oldest age groupings). Our outcome measures include the following: (1) Complexity of play, (2) Parts and features of toys used by the child, (3) Duration of time spent with each toy, (4) Preference for the toys, and (5) Number of times and duration the child solicits the parent s involvement during play.\n\nThis observational study of children fits well with the CFRS program of research and the mission of the NICHD DIR. We will investigate children s interactions with toys that surround children in their natural environment, as well as study how parents moderate child play behavior. Observing and quantifying behaviors during play will allow us to have a richer understanding of social and cognitive growth during different stages of child development in the context of toy play with parents and will form an empirical basis for revising the 2002 CPSC Guidelines in light of changes in the last decade and a half in the toy industry.\n\nThe cost impact for this project is minimal. All necessary testing facilities are already available at the CFRS. Funding for additional staff needed to work with participants, subject reimbursement, and supplies to carry out the project is allocated through the IAG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nAll children between the ages of 6 months to 12 years of age who are typically developing and born of a full term pregnancy if under 24 months of age, healthy, and English speaking are eligible for inclusion in the study. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. In addition, we will only enroll subjects if they are from a racial and ethnic group that is still needed to ensure the diversity and representative nature of our sample as set forth in the Planned Enrollment Form. These are the initial screening criteria that will be used.\n\nEXCLUSION CRITERIA:\n\n* Children outside of the 6 month-12 year age range: These years cover early life and are the ages of interest for children s play and are of central significance to the Consumer Product Safety Commission s goals.\n* Families not fluent in English: Fluency in English is essential for parents to be able to fill out surveys. Families also need to be fluent in English so that they can comprehend verbal directions given by the experimenter during the testing session. If we included people who were not fluent in English, we would need many additional staff members who speak the multitude of languages of the diverse population of the Washington, D.C metro area to work with participants during the testing session and code the videos after the testing session is complete.\n* Children who are sick, not typically developing, born premature (if they are under 24 months of age), blind, or deaf: We must recruit a healthy sample of typically developing children born in a full term pregnancy (if they are under 24 months of age) who are not blind or deaf for this project to remove any potential confounds that atypical conditions may have on children s play. Typically developing children would not have any diagnosed congenital conditions, developmental delay or disability, dyslexia, PDD, ADD, ADHD, or ASD. Including other populations such as deaf or blind children would require a different experimental set up, stimulus toys, and resources (i.e., someone who could convert our surveys to American Sign Language or Braille and could code the videos for the parent child behaviors during those sessions).\n* Children who are not adding to the ethnic and racial diversity of the sample: The goal of our study is to recruit a sample of subjects who are racially and ethnically diverse. By making this diverse sample a priority, we hope that our results will be applicable to the diverse populations residing within the United States. To keep with this goal of a diverse and representative sample of children, we may have to exclude some families if we have already reached the quota of families from that particular racial or ethnic group.'}, 'identificationModule': {'nctId': 'NCT02544035', 'briefTitle': "Determining Age Appropriateness of Children's Products and Toys", 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': "Determining Age Appropriateness of Children's Products and Toys: An Interagency Agreement With the Consumer Product Safety Commission", 'orgStudyIdInfo': {'id': '999915196'}, 'secondaryIdInfos': [{'id': '15-CH-N196', 'type': 'OTHER', 'domain': 'NIHCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '36-71 month-old Play Partner', 'description': '36-71 month-olds (1.5-2 year olds)', 'interventionNames': ['Other: Play Partner']}, {'type': 'EXPERIMENTAL', 'label': '72-107 month-old Play Partner', 'description': '72-107 month-olds (6-8 year-olds)', 'interventionNames': ['Other: Play Partner']}, {'type': 'EXPERIMENTAL', 'label': '12-18 month-old Toy Type', 'description': '12-18 month-olds (1-1.5 year olds)', 'interventionNames': ['Other: Type of Toy']}, {'type': 'EXPERIMENTAL', 'label': '19-35 month-old Toy Type', 'description': '19-35 month-olds (1.5-2 year-olds)', 'interventionNames': ['Other: Type of Toy']}, {'type': 'EXPERIMENTAL', 'label': '36-71 month-old Toy Type', 'description': '36-71 month-olds (3-5 year-olds)', 'interventionNames': ['Other: Type of Toy']}, {'type': 'EXPERIMENTAL', 'label': '72-107 month-old Toy Type', 'description': '72-107 month-olds (6-8 year-olds)', 'interventionNames': ['Other: Type of Toy']}, {'type': 'EXPERIMENTAL', 'label': '12-18 month-old Play Partner', 'description': '12-18 month-olds (1-1.5 year olds)', 'interventionNames': ['Other: Play Partner']}, {'type': 'EXPERIMENTAL', 'label': '19-35 month-old Play Partner', 'description': '19-35 month-olds (1.5-2 year olds)', 'interventionNames': ['Other: Play Partner']}], 'interventions': [{'name': 'Type of Toy', 'type': 'OTHER', 'description': 'Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;', 'armGroupLabels': ['12-18 month-old Toy Type', '19-35 month-old Toy Type', '36-71 month-old Toy Type', '72-107 month-old Toy Type']}, {'name': 'Play Partner', 'type': 'OTHER', 'description': 'Each child will first play alone then play with parent.', 'armGroupLabels': ['12-18 month-old Play Partner', '19-35 month-old Play Partner', '36-71 month-old Play Partner', '72-107 month-old Play Partner']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institute of Child Health and Human Development (NICHD)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Diane L Putnick, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}