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

Maiken Pontoppidan, Mette Thorsager, Mette Friis-Hansen, Arietta Slade, Lois S Sadler, Maiken Pontoppidan, Mette Thorsager, Mette Friis-Hansen, Arietta Slade, Lois S Sadler

Abstract

Background: Inequality in health can have profound effects on a child's opportunities later in life. To prevent these downstream effects in families at increased risk of adversity, programs are needed to provide support and improve well-being across several domains. The present trial is aimed at assessing the effectiveness of the Minding the Baby® (MTB) home visiting intervention in improving the mother-child relationship, parental reflective functioning, well-being, and mental health, as well as child development and well-being in families at known risk of adverse health, relational, and developmental outcomes.

Methods: The study is a pragmatic, prospective, quasi-cluster-randomized controlled trial in which seven Danish municipalities were randomized to MTB training in either 2018 or 2019. A total of 250 pregnant women at increased risk of adversity will be recruited (75 care as usual families and 175 intervention families). Care as usual families will be recruited before and after the MTB training. The MTB intervention is an attachment-based, interdisciplinary home visiting intervention offered from the third trimester of pregnancy until the child is 2 years old. The participants are assessed at baseline, and when the infant is 3, 12, and 24 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior scale applied to video recordings of mother-infant interactions. Secondary outcomes include parent-child interaction, parental reflective functioning, parental mental health, maternal satisfaction, parental stress, and child development and well-being. The treatment effect is estimated as a fixed effect using a binary indicator of MTB treatment, and cluster-robust standard errors based on wild bootstrap are used for inference.

Discussion: This is the first trial of MTB in a Scandinavian context and will include the largest sample yet in a trial of MTB. The trial is expected to contribute to knowledge about the effect of early support for pregnant women, their infants, and their families at increased risk of adversity.

Trial registration: ClinicalTrials.gov NCT03495895 . The study was registered on April 12, 2018.

Keywords: At risk family; Cluster-randomized controlled trial; Disadvantaged population; Early intervention; Infant; Interdisciplinary; Mental health; Mother; Parent; Parental reflective functioning; Pregnant; Sensitivity.

Conflict of interest statement

Drs. Slade and Sadler at the Yale School of Nursing and Yale Child Study Center developed the program along with Dr. Linda Mayes in 2001. We have investigated the preliminary feasibility, effects, and efficacy of the intervention in our series of RCTs. We have provided training for interested clinicians and investigators and have overseen the implementation of the MTB model in multiple sites in the USA, the UK, and now in Denmark. All fees, grants, and contracts have been directed to the University to partially provide our salary support. We have advised on the Danish research and overseen implementation and fidelity in the Danish sites in collaboration with Chief Consultant Bjarke Nielsen, Ph.D. from Metodecentret, and Dr. Pontoppidan from VIVE.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Study flow chart
Fig. 2
Fig. 2
Schedule of enrolment, allocation, intervention, and assessments

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Source: PubMed

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