Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-04 @ 5:56 PM
Study NCT ID:
NCT04936269
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002658', 'term': 'Developmental Disabilities'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Young children's participation and environment measure (YC- PEM)", 'timeFrame': 'two years', 'description': "Young children's participation and environment measure (YC- PEM) is developed for assessing the activity and participation levels and effects of environmental factors on functional abilities in children with neurodevelopmental disabilities or typically development under five years."}], 'secondaryOutcomes': [{'measure': 'Pediatric Evaluation of Disability Inventory (PEDI)', 'timeFrame': 'two years', 'description': 'Pediatric Evaluation of Disability Inventory (PEDI) for assessing the activity and participation levels and effects of environmental factors on functional abilities in children with neurodevelopmental disabilities or typically development under seven years.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'Activity', 'Participaiton', 'Environment'], 'conditions': ['Child Development Disorder', 'Activity, Motor']}, 'descriptionModule': {'briefSummary': "The Young Children's Participation and Environment Measure (YC-PEM) is a parent/caregiver reported outcome measure that evaluates the participation status and environmental factors of children under five years old. The aim of this study is to translate the Young Children's Participation and Environment Measure (YC-PEM) into the Turkish language and to investigate the psychometric properties of the Turkish version of YC-PEM in children with typical development and neurodevelopmental disabilities under five years old.", 'detailedDescription': 'Cross-cultural adaptation Rest-retest reliability Discriminant validity Concurrent validity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '12 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with typical development and children with neurodevelopmental disabilities (Cerebral palsy, obstetric brachial plexus palsy, autism spectrum disorders or developmental coordination disorders etc.)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children under five years\n* children with neurodevelopmental disabilities\n\nExclusion Criteria:\n\n* parents who refused to participate in the study'}, 'identificationModule': {'nctId': 'NCT04936269', 'briefTitle': "Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure", 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': "Psychometric Properties of the Turkish Version of Young Children's Participation and Environment Measure (YC-PEM) in Young Children With Typical Development and Neurodevelopmental Disorders", 'orgStudyIdInfo': {'id': 'GO 21/430 2021/07-44'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Children under five years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'state': 'Sıhhıye', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Kübra S BIYIK, Dr', 'role': 'CONTACT', 'email': 'kubra.seyhan@yahoo.com', 'phone': '00903123051576'}, {'name': 'Mintaze KEREM GÜNEL, Prof.', 'role': 'CONTACT', 'email': 'mintaze@yahoo.com', 'phone': '00903123051576'}], 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Kübra S Bıyık', 'role': 'CONTACT', 'email': 'kubra.seyhan@yahoo.com', 'phone': '+903123051576'}], 'overallOfficials': [{'name': 'Kübra S Bıyık', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr.Pt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.Pt', 'investigatorFullName': 'Kübra Seyhan', 'investigatorAffiliation': 'Hacettepe University'}}}}