Clinical trial NCT03495895: The Effectiveness of MInding the Baby in a Danish Community Sample
Official title: The Effectiveness of MInding the Baby in a Danish Community Sample
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family
Pregnancy, High Risk
Keywords: Disadvantaged families
Pregnancy
Intervention
Minding the Baby
Lead sponsor: VIVE - The Danish Center for Social Science Research
Sponsor class: OTHER
Collaborators: name: Yale University
name: Metodecentret - Center for Effective Innovation in Social Services
First posted: 2018-04-12
Enrollment: 256
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
timeFrame: at child age 24 months
Secondary outcomes:
measure: Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
timeFrame: Child age 12 months
measure: Coding interactive bahavior (CIB)
timeFrame: child age 12 and 24 months
measure: Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)
timeFrame: 3, 12 and 24 months
measure: Edinburgh Postnatal depression Scale (EPDS)
timeFrame: 3, 12 , 24 months
measure: Warwick-Edinburgh Mental Well-being Scale
timeFrame: Baseline, 3, 12 , 24 months
measure: 2-5
timeFrame: 24 months
measure: Prenatal Parental reflective functioning questionnaire (P-PRFQ)
timeFrame: Baseline
measure: Parental reflective functioning questionnaire (PRFQ-1)
timeFrame: 12 and 24 months
measure: Parental Stress Scale (PSS)
timeFrame: 12 ,24 months
measure: Ages and Stages Questionnaire 3 (ASQ:3)
timeFrame: 3 months
measure: Acitvities with child
timeFrame: 12 and 24 months
measure: SEAM Family profile
timeFrame: 12 months
measure: Parent behavior Inventory (PBI)
timeFrame: 12 and 24 months
measure: Being a Mother (BAM-13)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 3, 12,24 months
measure: PTSD-8
timeFrame: Baseline, 12 and 24 months
measure: Experiences in Close Relationship Scale-Short Form (ECR-S)
timeFrame: Baseline, 12, 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: VIVE - The Danish Centre of Applied Social Science
Study officials:
affiliation: VIVE
name: Maiken Pontoppidan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.