The FACAM study: protocol for a randomized controlled study of an early interdisciplinary intervention to support women in vulnerable positions through pregnancy and the first 5 years of motherhood

Maiken Pontoppidan*, Lene Nygaard, Mette Thorsager, Mette Friis-Hansen, Deborah Davis, Ellen Aagaard Nohr

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Abstract

Background: Inequality in health can have profound short- and long-term effects on a child’s life. Infants develop in a responsive environment, and the relationship between mother and infant begins to develop during pregnancy. The mother’s ability to bond with the fetus and newborn child may be challenged by mental health issues which can cause impaired functioning and poorer health outcomes. Families with complex problems need interdisciplinary interventions starting in early pregnancy to be prepared for motherhood and to ensure healthy child development. This study aims to examine the effects of an early and coordinated intervention (the Family Clinic and Municipality (FACAM) intervention) offered to vulnerable pregnant women during pregnancy and the child’s first year of life on the mother-child relationship, maternal social functioning, mental health, reflective functioning, well-being, parental stress, and the development and well-being of the child. Methods: The study is a prospective randomized controlled trial where we will randomize 320 pregnant women enrolled to receive antenatal care at the family clinic at Odense University Hospital, to either FACAM intervention or usual care. The FACAM intervention consists of extra support by a health nurse or family therapist during pregnancy and until the child starts school. The intervention is most intensive in the first 12 months and also includes attachment-based support provided either individually or in groups. The participants are assessed at baseline, and when the infant is 3 and 12 months old. The primary outcome is maternal sensitivity measured by the Coding Interactive Behavior (CIB) instrument. Secondary outcomes include prenatal parental reflective functioning, mental well-being, depressive symptoms, breastfeeding duration, maternal satisfaction, child development, parent competence, parental stress, and activities with the child. Discussion: The trial is expected to contribute knowledge about the effect of early coordinated support in antenatal and postnatal care for vulnerable pregnant women and their families. Trial registration: ClinicalTrials.gov NCT03659721. Registered on September 6, 2018

OriginalsprogEngelsk
Artikelnummer73
TidsskriftTrials
Vol/bind23
Antal sider14
ISSN1745-6215
DOI
StatusUdgivet - 24. jan. 2022

Bibliografisk note

Funding Information:
The authors would like to acknowledge and thank all the families who are participating in the trial, the staff at the family clinic at Odense University Hospital for recruiting the participants, and the staff at Odense Municipality who are delivering the intervention. We would also like to thank the project team Ida Bohn Tarbuck, N?nne Maal? Larsen, and Sonja Seerup at Odense Municipality, and Ulla Rudbeck at the family clinic at Odense University Hospital who have worked closely with the research team during the trial. A special thanks to Inge Olga Ibsen who originally came up with the idea for the trial. Also, a special thanks to N?nne Maal? Larsen and Sidsel Frida Andersen whose hard work with the recruitment and data collection has been invaluable. Thank you to Anders Bo Bojesen who acted as trial statistician until the end of 2019. Finally, the authors would like to thank and acknowledge OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark, who has provided data management through REDCap, OPEN randomize, and OPEN storage (www.sdu.dk/ki/open).

Funding Information:
We gratefully acknowledge the funding provided by Odense Municipality, by the Odense University Hospital Ph.D. Fund project number 10212330, and especially by the A. P. Møller Relief Foundation (den A. P. Møllerske Støttefond) donation number 11678. The funding body did not help with the design, data collection, analysis, or interpretation of the data and did not help in the writing of the manuscript or in the decision to submit the manuscript for publication.

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