Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:07 AM
Study NCT ID:
NCT07376369
Status:
RECRUITING
Last Update Posted:
2026-02-03
First Post:
2026-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association of Spousal Support With Parenting Self-Confidence and Depression in Primipar Mothers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 193}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-22', 'studyFirstSubmitQcDate': '2026-01-22', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Introduction Information Forum', 'timeFrame': 'At enrollment', 'description': 'This form was developed by the researchers based on the relevant literature and consists of 29 items designed to assess the sociodemographic, obstetric, and early postpartum experiences of primiparous women. The form includes variables related to partner support, sources of social support, childbirth experience, initiation of breastfeeding, and maternal emotional status. The items were constructed using core variables commonly employed in the assessment of psychosocial status during the postpartum period.'}, {'measure': 'Parenting Self-Confidence (Karitane Parenting Confidence Scale)', 'timeFrame': 'At enrollment', 'description': 'Parenting self-confidence assessed using the Karitane Parenting Confidence Scale (KPCS). The scale consists of 15 items scored on a 4-point Likert scale, with total scores ranging from 0 to 42. Higher scores indicate greater parenting self-confidence.'}, {'measure': 'Perceived Spousal Support measured by the Early Postpartum Perceived Spousal Support Scale', 'timeFrame': 'At enrollment', 'description': "The Early Postpartum Perceived Spousal Support Scale (ELSKAEDÖ) is a structured self-report questionnaire developed to assess women's perceived spousal support during the early postpartum period. The scale consists of 16 items and includes three subdomains: emotional support (7 items), social support (6 items), and physical support (3 items).\n\nItems are rated on a 5-point Likert scale. Positively worded items are scored from 1 (strongly disagree) to 5 (strongly agree), while negatively worded items are reverse-coded before calculating the total score.\n\nThe total score ranges from 16 to 80, with higher scores indicating greater perceived spousal support and better psychosocial outcomes, and lower scores indicating insufficient perceived support."}, {'measure': 'Postpartum Depression (Edinburgh Postnatal Depression Scale)', 'timeFrame': 'At enrollment', 'description': 'Depressive symptoms assessed using the Edinburgh Postnatal Depression Scale (EPDS). The scale includes 10 items scored on a 4-point Likert scale, with total scores ranging from 0 to 30. Higher scores indicate greater risk of postpartum depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum Period', 'Support', 'Parenting', 'Primipar'], 'conditions': ['Support', 'Postpartum Period', 'Parenting']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Warren, P. L. (2005). First-time mothers: Social support and confidence in infant care. Journal of Advanced Nursing, 50(5), 479-488.'}, {'type': 'BACKGROUND', 'citation': 'Yılmaz, B., & Oskay, Ü. (2021). Karitane Parent Self-Confidence Scale: Turkish validity and reliability study. Cukurova Medical Journal, 46(2), 801-813.'}]}, 'descriptionModule': {'briefSummary': "The transition to motherhood, particularly for first-time (primiparous) women, is a critical life period requiring substantial psychological and social adjustment. Hormonal changes, increased caregiving responsibilities, sleep disturbances, and potential social isolation during pregnancy and the postpartum period may increase vulnerability to stress, anxiety, and depressive symptoms. Postpartum depression (PPD) is a common mental health concern that adversely affects maternal well-being, mother-infant interaction, and infant development, with insufficient social support identified as one of its most significant risk factors.\n\nMaternal self-efficacy, defined as a mother's perceived competence in caring for and responding to her infant's needs, is a key indicator of successful adaptation to the parenting role. Evidence suggests that maternal self-efficacy develops primarily within the first months after childbirth and tends to be lower in primiparous women. Low parenting self-efficacy has been associated with increased depressive symptoms, higher parenting stress, impaired mother-infant bonding, and negative developmental outcomes for the infant.\n\nAmong social support sources, partner support plays a particularly protective role during the transition to parenthood. Emotional, informational, and practical support provided by the partner has been shown to enhance maternal self-efficacy, reduce psychological distress, improve marital adjustment, and lower the risk of postpartum depression. Conversely, low perceived partner support and relationship difficulties are associated with an increased risk of PPD in primiparous mothers.\n\nThe aim of this study is to examine the relationship between perceived partner support and postpartum parenting self-efficacy and depressive symptoms in primiparous women. Additionally, the study seeks to evaluate the explanatory and protective role of partner support on maternal self-efficacy and postpartum depression during the early postpartum period."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of primiparous mothers aged 18 years and older who are between 0 and 12 months postpartum and living with their spouse or partner. Participants will be recruited online via social media and similar digital platforms and will complete self-report questionnaires.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusionsd Criteria:\n\n* Aged 18 years or older\n* Primiparous mothers (first childbirth)\n* Between 0 and 12 months postpartum\n* Living with spouse or partner\n* Able to read and write Turkish\n* Having access to the internet\n* Voluntarily agreeing to participate in the study\n\nExclusion Criteria:\n\n* Diagnosed neurological disorder\n* Diagnosed psychiatric disorder\n* Visual impairment preventing completion of questionnaires\n* Cognitive impairment preventing completion of questionnaires'}, 'identificationModule': {'nctId': 'NCT07376369', 'briefTitle': 'Association of Spousal Support With Parenting Self-Confidence and Depression in Primipar Mothers', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University - Cerrahpasa'}, 'officialTitle': 'Primipar Annelerde Eş Desteğinin Doğum Sonu Ebeveynlik Özgüveni ve Depresyon Düzeyleri Üzerindeki Etkisi: Kesitsel Bir Çalışma', 'orgStudyIdInfo': {'id': '2025-20/738'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primipar mothers', 'description': 'Primipar mothers aged 18 years and older, who are in the postpartum period (0-12 months), living with their spouse/partner, and participating voluntarily in this observational study.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Eslem Altıntaş, MSc', 'role': 'CONTACT', 'email': 'eslem.altintas@acibadem.edu.tr', 'phone': 'Investigator'}], 'facility': 'Online study', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Eslem Altıntaş, MSc', 'role': 'CONTACT', 'email': 'eslem.altintas@acibadem.edu.tr', 'phone': '+90 541 610 54 12'}], 'overallOfficials': [{'name': 'Merve Coşkun, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Acibadem University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University - Cerrahpasa', 'class': 'OTHER'}, 'collaborators': [{'name': 'Acibadem University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Eslem Altıntaş', 'investigatorAffiliation': 'Acibadem University'}}}}