A Good Start to Life - an Early Cross-sectorial Intervention

NCT03190707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2020-06-01

No results posted yet for this study

Summary

The aim of the project is to develop and evaluate an interdisciplinary and cross-sectorial intervention targeting pregnant women with psychosocial vulnerabilities. The objective is to 1) detect depression, anxiety and personality disorders in the pregnant women, 2) to increase knowledge sharing across the health care sectors and 3) strengthen the parents' parenting skills and thereby support a secure attachment between parents and child and thus promoting the child's well-being.

The overriding hypothesis is that an early multi-stringed, interdisciplinary and cross-sectorial intervention, with a long-term perspective from the early pregnancy throughout the child's first years of life, can effectively prevent disorders in the parent-child relation. The approach is to detect and treat depression, anxiety and personality disorders in the mother and strengthen the parents' parenting skills in families with maternal psychosocial vulnerabilities. The hypothesis indicates that the over-all intervention will result in improved interaction between child and parents which will make it possible to detect higher maternal sensitivity and a higher level of well-being among both children and parents in the intervention group compared to the control group.

The projects' specific hypotheses are;

* A systematic screening for anxiety, depression and personality disorders in the midwifery consultation will imply more pregnant women with symptoms of anxiety, depression and personality disorders being detected and offered treatment in the intervention group compared to the control group.
* Knowledge sharing across health care sectors will improve by the implementation of a joint consultation involving the vulnerable pregnant woman/families, the midwife and the health visitor and by a systematic transmission of information when the woman leaves the post-natal ward and is transferred to the health visitor.
* Parental skills in psychosocial vulnerable pregnant women and their partners can be strengthened by a parental training program and by education and dialogue about perceived challenges and breast-feeding. Parents in the intervention group will therefore gain greater knowledge on what it takes to make breast-feeding work successfully, be able to interact more appropriate with their children, and improve their mentalization skills and experience less stress compared to parents in the control group.

Conditions

Interventions

BEHAVIORAL

Intervention

1. Detection of ill-being: An extended consultation with the midwife. The midwife will screen the women for symptoms of anxiety, depression and personality disorders. 2. Knowledge sharing: An additional midwife consultation accompanied by the health visitor. The aim of is sharing knowledge and transmission of information between the two sectors responsible for making a shared plan for the course of the process for the pregnant woman. 3. Strengthen parenting skills through: * Two visits by the health visitor before birth and eight after. The visits are based on the parent training program The Circle of Security, aiming at promoting a secure attachment between child and carer. * Teaching the woman/couple on the importance of breast-feeding and how to succeed.

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER
  • Intersectoral Research Unit for Health Services

    lead OTHER_GOV

Principal Investigators

  • Michaela ML Schiøtz · Intersectoral Research Unit for Health Services

  • Anne Kristine AK Aarestrup · Intersectoral Research Unit for Health Services

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190707 on ClinicalTrials.gov