Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-06 @ 7:19 PM
Study NCT ID:
NCT03495895
Status:
COMPLETED
Last Update Posted:
2024-11-13
First Post:
2018-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of MInding the Baby in a Danish Community Sample
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'], 'maskingDescription': 'As the intervention is a home visiting intervention participants and care providers cannot be blinded. Outcome assessor and data analyst will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal sensitivity measured by the CIB (Coding Interactive Behavior)', 'timeFrame': 'at child age 24 months', 'description': 'Maternal sensitivity'}], 'secondaryOutcomes': [{'measure': 'Maternal sensitivity measured by the CIB (Coding Interactive Behavior)', 'timeFrame': 'Child age 12 months', 'description': 'Maternal sensitivity'}, {'measure': 'Coding interactive bahavior (CIB)', 'timeFrame': 'child age 12 and 24 months', 'description': 'Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states'}, {'measure': 'Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)', 'timeFrame': '3, 12 and 24 months', 'description': 'Child social-emotional Development Total score range 0-150 ( 3 months 15 items), 0-260 (12 months 26 items), 0-300 (24 months 30 items). Low score is better.'}, {'measure': 'Edinburgh Postnatal depression Scale (EPDS)', 'timeFrame': '3, 12 , 24 months', 'description': 'Depression Total score range 0-30. Low score is better'}, {'measure': 'Warwick-Edinburgh Mental Well-being Scale', 'timeFrame': 'Baseline, 3, 12 , 24 months', 'description': 'Maternal mental Health 7 items. A total score i calculated by summing the 7 items and converting the raw score according to a published conversion table. Raw score range 7- 35. Converted score range 7-35. High is better outcome.'}, {'measure': '2-5', 'timeFrame': '24 months', 'description': 'The name of the measure is 2-5 and measures child Development. Subscales included: Perception (7 items) low score is better, Language (10 items) low score is better'}, {'measure': 'Prenatal Parental reflective functioning questionnaire (P-PRFQ)', 'timeFrame': 'Baseline', 'description': 'Parental reflective functioning for pregnant women. Total score range 14-98. Higher score is better. Three subscales: Opacity of mental states (4 items), reflecting on the fetus-baby (3 items) and Dynamic of mental states (5 items)'}, {'measure': 'Parental reflective functioning questionnaire (PRFQ-1)', 'timeFrame': '12 and 24 months', 'description': 'Parental reflective functioning Three subscales score range 6-42: Pre-Mentalizing Modes (PRFQ-PM) 6 items. low score is better. Certainty about Mental States (PRFQ-CMS) 6 items high score is better. Interest and curiosity in mental states PRFQ-IC 6 items high score is better.'}, {'measure': 'Parental Stress Scale (PSS)', 'timeFrame': '12 ,24 months', 'description': 'Parental stress Total score range 18-90 low score is better'}, {'measure': 'Ages and Stages Questionnaire 3 (ASQ:3)', 'timeFrame': '3 months', 'description': 'Child development'}, {'measure': 'Acitvities with child', 'timeFrame': '12 and 24 months', 'description': 'Singing and reading Total score range 0-70. High score is better.'}, {'measure': 'SEAM Family profile', 'timeFrame': '12 months', 'description': 'Family profile'}, {'measure': 'Parent behavior Inventory (PBI)', 'timeFrame': '12 and 24 months', 'description': 'Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.'}, {'measure': 'Being a Mother (BAM-13)', 'timeFrame': '3 months', 'description': 'Maternal confidence. Total score range 0-39. Low score is better'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline, 3, 12,24 months', 'description': 'Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)'}, {'measure': 'PTSD-8', 'timeFrame': 'Baseline, 12 and 24 months', 'description': 'A Short PTSD Inventory. Total score range 8-32, low score is better'}, {'measure': 'Experiences in Close Relationship Scale-Short Form (ECR-S)', 'timeFrame': 'Baseline, 12, 24 months', 'description': 'Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disadvantaged families', 'Pregnancy', 'Intervention', 'Minding the Baby'], 'conditions': ['Family', 'Pregnancy, High Risk']}, 'referencesModule': {'references': [{'pmid': '40717494', 'type': 'DERIVED', 'citation': 'Pontoppidan M, Hirani JC, Friis-Hansen M. Minding the Baby versus usual care: effects on parental sensitivity and parent-child interaction in a cluster quasi-randomized trial. Attach Hum Dev. 2025 Aug;27(4):567-590. doi: 10.1080/14616734.2025.2534608. Epub 2025 Jul 28.'}, {'pmid': '35751089', 'type': 'DERIVED', 'citation': 'Pontoppidan M, Thorsager M, Friis-Hansen M, Slade A, Sadler LS. Minding the Baby versus usual care: study protocol for a quasi-cluster-randomized controlled study in Denmark of an early interdisciplinary home-visiting intervention for families at increased risk for adversity. Trials. 2022 Jun 24;23(1):529. doi: 10.1186/s13063-022-06434-2.'}]}, 'descriptionModule': {'briefSummary': 'Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Families are assessed before they give birth and when their child is three months, one and two years old with a range of assessments including maternal sensitivity, parent mental Health, child development, and health related register data. The aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child relations and the mental health of parents and children.', 'detailedDescription': 'Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. In the proposed Randomised Control Trial (RCT) the investigators will study the efficacy of this innovative intervention across ten Danish sites. Site staff will be trained at two sessions one year apart. Sites are randomized to training at time 1 or 2. All sites will recruit treatment as usual control families before they receive the training and start offering the intervention to all families. Potential participants will be approached by a local front staff member (e.g. midwife, helath visitor or social worker) who will inform mothers of the project in the early pregnancy. Consenting eligible participants will be assessed before they give birth and when their child is three months, one and two years old.\n\nThe effectiveness of the MTB programme will be evaluated by assessing a range of maternal and infant outcomes, including maternal sensitivity, parent mental Health, child development, and register data on e.g. infant maltreatment and neglect, hospitalization, income, immunization. By combining parent report, observational and register data researchers will get a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in Denmark.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pregnant vulnerable women\n\nExclusion Criteria:\n\n* Current severe substance abuse\n* Severe psychotic illness\n* Profound or severe learning disabilities\n* Life-threatening illness in parent or child\n* Non-Danish speaking'}, 'identificationModule': {'nctId': 'NCT03495895', 'acronym': 'MTB', 'briefTitle': 'The Effectiveness of MInding the Baby in a Danish Community Sample', 'organization': {'class': 'OTHER', 'fullName': 'VIVE - The Danish Center for Social Science Research'}, 'officialTitle': 'The Effectiveness of MInding the Baby in a Danish Community Sample', 'orgStudyIdInfo': {'id': 'VIVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Minding the Baby', 'description': "Families are visited weekly beginning in the mother's third trimester of pregnancy up through the child's first birthday, at which point visits take place biweekly up through the child's second birthday.", 'interventionNames': ['Behavioral: Minding the Baby']}, {'type': 'OTHER', 'label': 'Control', 'description': 'Usual care control condition. Families in the control Group receive the usual care that is offered to families in the target group', 'interventionNames': ['Behavioral: Usual Care']}], 'interventions': [{'name': 'Minding the Baby', 'type': 'BEHAVIORAL', 'description': 'Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.', 'armGroupLabels': ['Minding the Baby']}, {'name': 'Usual Care', 'type': 'BEHAVIORAL', 'description': 'Usual care condition', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1052', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'VIVE - The Danish Centre of Applied Social Science', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Maiken Pontoppidan, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VIVE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There will be few participants from each local authority and data can therefore not be made publicly available due to protect participant privacy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIVE - The Danish Center for Social Science Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yale University', 'class': 'OTHER'}, {'name': 'Metodecentret - Center for Effective Innovation in Social Services', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Maiken Pontoppidan', 'investigatorAffiliation': 'VIVE - The Danish Center for Social Science Research'}}}}