The Effectiveness of MInding the Baby in a Danish Community Sample

NCT03495895 | Completed

• 1 other identifier: VIVE
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Family; Pregnancy, High Risk

Keywords

Disadvantaged families; Pregnancy; Intervention; Minding the Baby

Outcome Measures

Primary Outcomes (1)

• Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

  Maternal sensitivity

  at child age 24 months

Secondary Outcomes (17)

• Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

  Child age 12 months

• Coding interactive bahavior (CIB)

  child age 12 and 24 months

• Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)

  3, 12 and 24 months

• Edinburgh Postnatal depression Scale (EPDS)

  3, 12 , 24 months

• Warwick-Edinburgh Mental Well-being Scale

  Baseline, 3, 12 , 24 months

Study Arms (2)

Minding the Baby

EXPERIMENTAL

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

Control

OTHER

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

Interventions

Minding the Baby BEHAVIORAL

Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.

Minding the Baby

Usual Care BEHAVIORAL

Usual care condition

Control

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Pregnant vulnerable women

You may not qualify if:

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

Sponsors & Collaborators

• VIVE - The Danish Center for Social Science Research: lead
• Yale University: collaborator
• Metodecentret - Center for Effective Innovation in Social Services: collaborator

Study Sites (1)

VIVE - The Danish Centre of Applied Social Science

Copenhagen, 1052, Denmark

Location

Related Publications (2)

• 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: 40717494 DERIVED

• 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.

  PMID: 35751089 DERIVED

Study Officials

• Maiken Pontoppidan, Ph.D.

  VIVE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As the intervention is a home visiting intervention participants and care providers cannot be blinded. Outcome assessor and data analyst will be blinded.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: April 12, 2018
• Study Start: June 10, 2018
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)