The Effectiveness of MInding the Baby in a Danish Community Sample

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-10

Study Completion Date

2024-08-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Family Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

As the intervention is a home visiting intervention participants and care providers cannot be blinded. Outcome assessor and data analyst will be blinded.

Study Groups

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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.

Group Type EXPERIMENTAL

Minding the Baby

Intervention Type BEHAVIORAL

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

Control

Usual care control condition. Families in the control Group receive the usual care that is offered to families in the target group

Group Type OTHER

Usual Care

Intervention Type BEHAVIORAL

Usual care condition

Interventions

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Minding the Baby

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

Intervention Type BEHAVIORAL

Usual Care

Usual care condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No