Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-01-06 @ 4:24 AM
Study NCT ID:
NCT01907412
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2013-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Transition to Parenthood Program for Couples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2013-07-22', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cardiovascular disease risk', 'timeFrame': '8 years from baseline', 'description': 'We assessed parent and child cardiovascular disease risk via inflammatory (C-reactive protein, Interleukin-6) and metabolic (total cholesterol, glycated hemoglobin, body mass index, blood pressure) outcomes previously linked to cardiovascular disease risk (e.g., Danesh et al., 2004; Goran et al., 2003; Ortega et al., 2016; Fuchs et al., 2020).'}], 'primaryOutcomes': [{'measure': 'Coparenting Quality', 'timeFrame': 'Up to 2.5 years from baseline', 'description': 'We assessed coparenting relationship quality with the 31-item Coparenting Scale, which was created based on prior work (e.g., Abidin \\& Brunner, 1995; Cordova, 2001; Frank, Olmstead, Wagner,\\& Laub, 1991; Margolin et al., 2001; McHale, 1997). The overall score represents an average of items covering theoretically important domains: coparental agreement, support,undermining, and exposure of the child to conflict.'}], 'secondaryOutcomes': [{'measure': 'Aggressive Parenting', 'timeFrame': 'Up to 2.5 years after baseline', 'description': 'Aggressive parenting was measured using Parent-Child Conflict Tactics Scales (Straus et al., 1998).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['First time parents', 'Coparenting', 'Family Foundations'], 'conditions': ['Parent-Child Relations']}, 'referencesModule': {'references': [{'pmid': '41325157', 'type': 'DERIVED', 'citation': 'Aytuglu A, Graham-Engeland JE, Feinberg ME, Murray-Perdue SA, Conway CA, Schreier HMC. Longitudinal associations between father- and mother-child interactions, coparenting, and child cardiometabolic health. Health Psychol. 2025 Dec 1:10.1037/hea0001567. doi: 10.1037/hea0001567. Online ahead of print.'}, {'pmid': '39818869', 'type': 'DERIVED', 'citation': "Aytuglu A, Graham-Engeland JE, Feinberg ME, Jones DE, Schreier HMC. Child sleep problems mediate prospective associations between fathers' parenting stress and child blood glucose levels. J Fam Psychol. 2025 Mar;39(2):277-283. doi: 10.1037/fam0001306. Epub 2025 Jan 16."}, {'pmid': '38408496', 'type': 'DERIVED', 'citation': "Schreier HMC, Feinberg ME, Jones DE, Ganguli A, Givens C, Graham-Engeland J. Children's empathy moderates the association between perceived interparental conflict and child health. Brain Behav Immun. 2024 May;118:128-135. doi: 10.1016/j.bbi.2024.02.022. Epub 2024 Feb 24."}, {'pmid': '37625684', 'type': 'DERIVED', 'citation': 'Jones EJ, Feinberg ME, Graham-Engeland JE, Jones DE, Schreier HMC. A perinatal coparenting intervention: Effects of a randomized trial on parent cardiometabolic risk and self-reported health. Biol Psychol. 2023 Oct;183:108664. doi: 10.1016/j.biopsycho.2023.108664. Epub 2023 Aug 23.'}, {'pmid': '26194453', 'type': 'DERIVED', 'citation': 'Feinberg ME, Jones DE, Roettger ME, Hostetler ML, Sakuma KL, Paul IM, Ehrenthal DB. Preventive Effects on Birth Outcomes: Buffering Impact of Maternal Stress, Depression, and Anxiety. Matern Child Health J. 2016 Jan;20(1):56-65. doi: 10.1007/s10995-015-1801-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a research study to evaluate the effectiveness of the Family Foundations program and to better understand how families cope with having a new baby. The research questions include: What is the effectiveness of the Family Foundations program? How do families cope with having a new baby?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expecting first child\n* Couple living together and planning to raise child together\n* 18 years or older\n\nExclusion Criteria:\n\n* not first child'}, 'identificationModule': {'nctId': 'NCT01907412', 'acronym': 'FF2', 'briefTitle': 'Trial of Transition to Parenthood Program for Couples', 'organization': {'class': 'OTHER', 'fullName': 'Penn State University'}, 'officialTitle': 'Trial of Transition to Parenthood Program for Couples', 'orgStudyIdInfo': {'id': 'R01HD058529-02', 'link': 'https://reporter.nih.gov/quickSearch/R01HD058529-02', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Couples in the Control group did not receive the Family Foundations Coparenting Program.'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Couples randomly assigned to the Intervention Group received the Family Foundations Coparenting Program.', 'interventionNames': ['Behavioral: Family Foundations Coparenting Program']}], 'interventions': [{'name': 'Family Foundations Coparenting Program', 'type': 'BEHAVIORAL', 'description': "Family Foundations, a program for adult couples expecting their first child, is designed to help them establish positive parenting skills and adjust to the physical, social, and emotional challenges of parenthood. Program topics include coping with postpartum depression and stress, creating a caring environment, and developing the child's social and emotional competence.\n\nFamily Foundations is delivered to groups of couples through four prenatal and four postnatal classes of 2 hours each. Prenatal classes are started during the fifth or sixth month of pregnancy, and the postnatal classes end when the children are 6 months old.\n\nFamily Foundations is delivered in a community setting by childbirth educators who have received 3 days of training from Family Foundations staff.", 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16802', 'city': 'University Park', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University, Prevention Research Center', 'geoPoint': {'lat': 40.80201, 'lon': -77.85639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Penn State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research professor', 'investigatorFullName': 'Mark Feinberg', 'investigatorAffiliation': 'Penn State University'}}}}