Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03495895
Study type Interventional
Source VIVE - The Danish Centre of Applied Social Science
Contact Maiken Pontoppidan, Ph.D.
Phone +4533697720
Email mpo@vive.dk
Status Recruiting
Phase N/A
Start date June 10, 2018
Completion date December 2023

See also
  Status Clinical Trial Phase
Completed NCT01269086 - Family Preventive Visits to Detect Risk Factors in the Family N/A
Completed NCT03721770 - Psychological Impact in a Relative, Following the Announcement of the Death of a Loved One After Cardiac Arrest and the Early Request for Organ Donation
Not yet recruiting NCT03429322 - Medical and Resource Facilitation Intervention After Traumatic Brain Injury N/A
Active, not recruiting NCT02307734 - A Family-Focused Intervention for Asian American Male Smokers N/A
Completed NCT01883375 - Dignity Talk: Helping Palliative Care Patients and Families Have Important Conversations N/A
Recruiting NCT00418912 - Family Study in Schizophrenia N/A
Not yet recruiting NCT03602391 - The Senior Companion Program Plus N/A
Completed NCT03571165 - Feasibility Study of "My Tools 4 Care-In Care" for Family Caregivers of Residential-Living Older Persons With Dementia N/A
Completed NCT02303561 - The Childhood Health and Asthma Management Program N/A
Recruiting NCT02866773 - A Community-based Family Holistic Health Promotion Project in Hong Kong: A Cluster Randomized Controlled Trial (cRCT) N/A
Completed NCT02643472 - GPS (Giving Parents Support): Parent Navigation After NICU Discharge N/A
Completed NCT02844244 - Training Workshop for Promoting Family Well-being Through a Community-based "Learning Families" Campaign N/A
Completed NCT02428387 - Evaluation of "My Tools 4 Care" for Family Caregivers of Persons With Dementia N/A
Not yet recruiting NCT01729377 - The Meaning of Suicidality for Older Persons With Suicidal Tendencies and Their Families N/A