Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-29 @ 10:23 AM
Study NCT ID:
NCT00782028
Status:
UNKNOWN
Last Update Posted:
2008-10-29
First Post:
2008-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-10-28', 'studyFirstSubmitDate': '2008-10-28', 'studyFirstSubmitQcDate': '2008-10-28', 'lastUpdatePostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved maternal and child health behaviors will be measured using a computer assisted interview.', 'timeFrame': 'Interviews will be given at 2 weeks, 6 and 12 months of age.'}], 'secondaryOutcomes': [{'measure': 'Better health care utilization for babies will be measured using Medical records review.', 'timeFrame': '1 year'}, {'measure': 'Better psychosocial outcomes for mothers, fathers and babies will be measured using a computer assisted interview.', 'timeFrame': '2 weeks, 6 months and 12 months of age'}, {'measure': 'Improved parenting skills will be assessed using a computer assisted inteview.', 'timeFrame': '2 weeks, 6 months ad 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['primary care, high-risk families, maternal depression'], 'conditions': ['Primary Care']}, 'descriptionModule': {'briefSummary': 'We hypothesize that relative to families who receive standard individual postpartum and pediatric care, families that receive group care will be more likely to have:\n\n* Improved maternal and child health behaviors: i.e increased breastfeeding, exercise, child safety measures in the home and decreased smoking.\n* Better health care use for babies: i.e. attend more care visits, on-time and complete immunizations and decreased emergency services use.\n* Better psychosocial outcomes for the families: i.e. decreased stress and depression, and increased social support.\n* Improved parenting skills: i.e. improved knowledge of child development, involvement in developmentally appropriate activities, and parental sense of competence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postpartum woman with baby in her care\n* Receive well-woman care, well-child care and interviews in English\n* Willingness to receive care in a group setting\n* Woman planning to receive care at the Yale Women's Center for herself and the Primary Care Center for her baby\n\nExclusion Criteria:\n\n* severe medical problem requiring individualized care for mother or baby\n* Baby born at less than 37 weeks gestation\n* Baby remaining in hospital when mother getting discharged for any other reason except hyperbilirubinemia\n* Baby with severe cardiac, respiratory, neuro-developmental or surgical problems"}, 'identificationModule': {'nctId': 'NCT00782028', 'briefTitle': 'Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness', 'organization': {'class': 'NIH', 'fullName': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}, 'officialTitle': 'Integrating Well-Woman and Well-Baby Care to Improve Parenting and Family Wellness', 'orgStudyIdInfo': {'id': 'R21 HDJ2810-01A1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'No intervention consists of routine well child care', 'interventionNames': ['Other: Standard Care']}, {'type': 'OTHER', 'label': 'Centering parenting/Group well child care', 'interventionNames': ['Other: Centering parenting/Group well child care']}], 'interventions': [{'name': 'Centering parenting/Group well child care', 'type': 'OTHER', 'description': "Intervention families will receive well child care in a group format for the first 12 month of the child's life.", 'armGroupLabels': ['Centering parenting/Group well child care']}, {'name': 'Standard Care', 'type': 'OTHER', 'armGroupLabels': ['Standard Care']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'John M. Leventhal, MD', 'oldOrganization': 'Department of Pediatrics'}}}}