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Clinical Trials/NCT03495895
NCT03495895
Completed
Not Applicable

The Effectiveness of MInding the Baby in a Danish Community Sample

VIVE - The Danish Center for Social Science Research1 site in 1 country256 target enrollmentJune 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Family
Sponsor
VIVE - The Danish Center for Social Science Research
Enrollment
256
Locations
1
Primary Endpoint
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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. The 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.

Registry
clinicaltrials.gov
Start Date
June 10, 2018
End Date
August 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Sequential
Sex
Female

Investigators

Sponsor
VIVE - The Danish Center for Social Science Research
Responsible Party
Principal Investigator
Principal Investigator

Maiken Pontoppidan

Researcher

VIVE - The Danish Center for Social Science Research

Eligibility Criteria

Inclusion Criteria

  • Pregnant vulnerable women

Exclusion Criteria

  • Current severe substance abuse
  • Severe psychotic illness
  • Profound or severe learning disabilities
  • Life-threatening illness in parent or child
  • Non-Danish speaking

Outcomes

Primary Outcomes

Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

Time Frame: at child age 24 months

Maternal sensitivity

Secondary Outcomes

  • Coding interactive bahavior (CIB)(child age 12 and 24 months)
  • Maternal sensitivity measured by the CIB (Coding Interactive Behavior)(Child age 12 months)
  • Parental Stress Scale (PSS)(12 ,24 months)
  • SEAM Family profile(12 months)
  • Parent behavior Inventory (PBI)(12 and 24 months)
  • Edinburgh Postnatal depression Scale (EPDS)(3, 12 , 24 months)
  • Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)(3, 12 and 24 months)
  • Parental reflective functioning questionnaire (PRFQ-1)(12 and 24 months)
  • Hospital Anxiety and Depression Scale (HADS)(Baseline, 3, 12,24 months)
  • Being a Mother (BAM-13)(3 months)
  • Warwick-Edinburgh Mental Well-being Scale(Baseline, 3, 12 , 24 months)
  • 2-5(24 months)
  • Prenatal Parental reflective functioning questionnaire (P-PRFQ)(Baseline)
  • Ages and Stages Questionnaire 3 (ASQ:3)(3 months)
  • Acitvities with child(12 and 24 months)
  • PTSD-8(Baseline, 12 and 24 months)
  • Experiences in Close Relationship Scale-Short Form (ECR-S)(Baseline, 12, 24 months)

Study Sites (1)

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