Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-28 @ 8:34 PM
Study NCT ID:
NCT05066295
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation and Reliability of the Parents Assessment of Protective Factors Survey
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turkish Validation of The Parents Assessment of Protective Factors (PAPF) Survey', 'timeFrame': 'Baseline', 'description': 'Parents Assessment of Protective Factors (PAPF) Survey will be validated'}, {'measure': 'Turkish Reliability of The Parents Assessment of Protective Factors (PAPF) Survey', 'timeFrame': 'Baseline', 'description': 'Parents Assessment of Protective Factors (PAPF) Survey will be tested for reliability'}, {'measure': 'Turkish Reliability of The Parents Assessment of Protective Factors (PAPF) Survey', 'timeFrame': 'at 6 months', 'description': 'Parents Assessment of Protective Factors (PAPF) Survey will be tested for reliability'}], 'secondaryOutcomes': [{'measure': 'Subscale scores for each protective factors', 'timeFrame': 'Baseline', 'description': 'Parents Assessment of Protective Factors (PAPF) Survey subscale scores will be computed. Higher scores indicate greater protective factors.'}, {'measure': 'Protective Factors Index (PFI)', 'timeFrame': 'Baseline', 'description': 'Parents Assessment of Protective Factors (PAPF) Survey total scores will be summed'}, {'measure': 'Adverse Childhood Events', 'timeFrame': 'Baseline', 'description': 'Adverse Childhood Events will be measured with Adverse Childhood Events Questionnaire.\n\nHigher scores indicate increased exposure to trauma, which have been associated with a greater risk of negative consequences.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["parents' assessment", 'protective factors', 'child abuse', 'prevention', 'validity'], 'conditions': ['Family']}, 'descriptionModule': {'briefSummary': 'Neglect and abuse, which have a devastating effect on children, can be prevented with community-based education programs aimed at strengthening families. The study aimed to validate and determine reliability of the "Parents Assessment of Protective Factors (PAPF) survey" and to develop a culturally appropriate program and educational design for strengthening families.', 'detailedDescription': 'The American Center for Social Policy Studies (CSSP) Center for Quality Improvement in Early Childhood (QIC\\_EC) defined protective factors that will form the basis of programs designed to prevent neglect and abuse, with community-based approaches. Community-based programs for primary prevention should be developed to prevent neglect and abuse, before it occurs. Existing studies in our country show that there is rarely a focus on preventing adverse childhood experiences with primary preventive approaches. Most of the studies are school-based, and aimed at increasing awareness of children and families about abuse.\n\nThis study aimed to evaluate the Turkish translation of the PAPF survey for validity and reliability and to adapt a culturally appropriate program and educational design for strengthening families, with a multidisciplinary team.\n\nIn the first step of the study, Turkish validity and reliability of the Parents Assessment of Protective Factors (PAPF) survey, will be conducted and applied to parents to determinate the protective factors. Turkish version of Adverse Childhood Experience Questionnaire (ACE), will be applied simultaneously with the PAPF survey, to identify adverse childhood experiences of parents that might affect parental resilience, parenting characteristics, and family dynamics.\n\nIn the second phase of the study, community-based family education programs that are currently being implemented in different countries will be reviewed by a multidisciplinary team (healthcare professionals, social workers and non-governmental organizations). A culturally appropriate educational primary prevention program for child neglect and abuse will be developed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Parents of children aged between 0 to 8 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of children aged between 0 to 8 years\n* Ability to read and complete the self-assessment questionnaires\n\nExclusion Criteria:\n\n* Parents who do not give consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT05066295', 'briefTitle': 'Validation and Reliability of the Parents Assessment of Protective Factors Survey', 'organization': {'class': 'OTHER', 'fullName': 'Marmara University'}, 'officialTitle': 'Strengthening Families to Prevent Child Neglect and Abuse With Community Based Protective Approaches: Culturally Appropriate Program Development and Educational Design', 'orgStudyIdInfo': {'id': '09.2021.848'}}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Marmara University School of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Requests for wider sharing of data (for example in response to publications about the study and willingness to share), will be addressed on a case-by-case basis. Any data sharing request will be made to investigators through a pre-defined data requisition form. This form will contain information about the applicant, institution, purpose of data request, study objectives, ethical clearance of the study, etc. Once a request has been made the data governance body will discuss if that request was appropriate; data will be released following signing of the data sharing agreement. The data will be stored on the Marmara University servers and not be deposited in any 'community' database."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marmara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Perran Boran', 'investigatorAffiliation': 'Marmara University'}}}}