The Effectiveness of MInding the Baby in a Danish Community Sample (MTB)

November 12, 2024 updated by: Maiken Pontoppidan, VIVE - The Danish Center for Social Science Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

256

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1052
        • VIVE - The Danish Centre of Applied Social Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Minding the Baby
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.
Behavioral: Minding the Baby
Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.
Other: Control
Usual care control condition. Families in the control Group receive the usual care that is offered to families in the target group
Behavioral: Usual Care
Usual care condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
Time Frame: at child age 24 months
Maternal sensitivity
at child age 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
Time Frame: Child age 12 months
Maternal sensitivity
Child age 12 months
Coding interactive bahavior (CIB)
Time Frame: child age 12 and 24 months
Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states
child age 12 and 24 months
Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)
Time Frame: 3, 12 and 24 months
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.
3, 12 and 24 months
Edinburgh Postnatal depression Scale (EPDS)
Time Frame: 3, 12 , 24 months
Depression Total score range 0-30. Low score is better
3, 12 , 24 months
Warwick-Edinburgh Mental Well-being Scale
Time Frame: Baseline, 3, 12 , 24 months
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.
Baseline, 3, 12 , 24 months
2-5
Time Frame: 24 months
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
24 months
Prenatal Parental reflective functioning questionnaire (P-PRFQ)
Time Frame: Baseline
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)
Baseline
Parental reflective functioning questionnaire (PRFQ-1)
Time Frame: 12 and 24 months
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.
12 and 24 months
Parental Stress Scale (PSS)
Time Frame: 12 ,24 months
Parental stress Total score range 18-90 low score is better
12 ,24 months
Ages and Stages Questionnaire 3 (ASQ:3)
Time Frame: 3 months
Child development
3 months
Acitvities with child
Time Frame: 12 and 24 months
Singing and reading Total score range 0-70. High score is better.
12 and 24 months
SEAM Family profile
Time Frame: 12 months
Family profile
12 months
Parent behavior Inventory (PBI)
Time Frame: 12 and 24 months
Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.
12 and 24 months
Being a Mother (BAM-13)
Time Frame: 3 months
Maternal confidence. Total score range 0-39. Low score is better
3 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Baseline, 3, 12,24 months
Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)
Baseline, 3, 12,24 months
PTSD-8
Time Frame: Baseline, 12 and 24 months
A Short PTSD Inventory. Total score range 8-32, low score is better
Baseline, 12 and 24 months
Experiences in Close Relationship Scale-Short Form (ECR-S)
Time Frame: Baseline, 12, 24 months
Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)
Baseline, 12, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVE - The Danish Center for Social Science Research

Collaborators

Yale University
Metodecentret - Center for Effective Innovation in Social Services

Investigators

  • Principal Investigator: Maiken Pontoppidan, Ph.D., VIVE

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2018

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

January 30, 2018

First Submitted That Met QC Criteria

April 11, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

November 13, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VIVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There will be few participants from each local authority and data can therefore not be made publicly available due to protect participant privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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