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Completed

NCT Number: NCT03495895

The Effectiveness of MInding the Baby in a Danish Community Sample

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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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

VIVE - The Danish Centre of Applied Social Science

Copenhagen, 1052, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Usual Care

Behavioral

Usual care condition

Primary outcomes

  1. Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

    Time frame: at child age 24 months

    Maternal sensitivity

Secondary outcomes

  1. Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

    Time frame: Child age 12 months

    Maternal sensitivity

  2. Coding interactive bahavior (CIB)

    Time frame: child age 12 and 24 months

    Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states

  3. 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.

  4. Edinburgh Postnatal depression Scale (EPDS)

    Time frame: 3, 12 , 24 months

    Depression Total score range 0-30. Low score is better

  5. 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.

  6. 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

  7. 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)

  8. 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.

  9. Parental Stress Scale (PSS)

    Time frame: 12 ,24 months

    Parental stress Total score range 18-90 low score is better

  10. Ages and Stages Questionnaire 3 (ASQ:3)

    Time frame: 3 months

    Child development

  11. Acitvities with child

    Time frame: 12 and 24 months

    Singing and reading Total score range 0-70. High score is better.

  12. SEAM Family profile

    Time frame: 12 months

    Family profile

  13. Parent behavior Inventory (PBI)

    Time frame: 12 and 24 months

    Parent Behavior. Two subscales Supportive/Engaged and Hostile/Coercive.

  14. Being a Mother (BAM-13)

    Time frame: 3 months

    Maternal confidence. Total score range 0-39. Low score is better

  15. 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)

  16. PTSD-8

    Time frame: Baseline, 12 and 24 months

    A Short PTSD Inventory. Total score range 8-32, low score is better

  17. 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)

Sponsors and collaborators

Lead sponsor

VIVE - The Danish Center for Social Science Research

Other

Collaborators

  • Metodecentret - Center for Effective Innovation in Social Services
  • Yale University

Registry information

Acronym: MTB

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Apr 12, 2018
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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