Evidence map›Paper›PMID 35073975›Full record

ArticleTrials2022

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

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03659721 (The Effects of Family Clinic and Municipality), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03659721 nacompletednot on this map

The Effects of Family Clinic and Municipality (FACAM)

TypeinterventionalSponsorVIVE - The Danish Center for Social Science ResearchRan2018 to 2023Enrolled332ConditionsAt-risk Pregnant WomenArmsFACAM, Care as Usual, COS-P
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Maiken PontoppidanVIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 1052, Copenhagen, Denmark. mpo@vive.dk.ORCID http://orcid.org/0000-0002-9491-3665
Lene NygaardUniversity of Canberra and ACT Health, Bruce, Australia.
Mette ThorsagerVIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 1052, Copenhagen, Denmark.
Mette Friis-HansenVIVE - The Danish Centre for Social Science Research, Herluf Trolles Gade 11, 1052, Copenhagen, Denmark.
Deborah DavisUniversity of Canberra and ACT Health, Bruce, Australia.
Ellen Aagaard NohrResearch Unit for Gynecology and Obstetrics, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
VIVE - The Danish Center for Social Science Research · DKUniversity of Southern Denmark · DKUniversity of Canberra · AU

Funding

A.P. Møllerske Støttefond 11678Odense Universitetshospital project 10212330
6 · The paper itself

Abstract

backgroundInequality 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.

methodsThe 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 registrationClinicalTrials.gov NCT03659721 . Registered on September 6, 2018.

Indexed as

Mother-Child RelationsMothersFemaleHumansInfantInfant, NewbornMental HealthParentsPregnancyProspective StudiesRandomized Controlled Trials as TopicDisadvantaged populationsEarly interventionHigh riskMental healthMotherMultidisciplinaryParentPovertyPregnantQualitativeRandomized controlled trialSubstance useSupportVulnerable families

Identifiers

PMID35073975
PMCPMC8785506
OpenAlexW4207071882

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.