Short summary

The first 1000 days of a child's can bee seen as a window of opportunity to create a base of a healthy psycho-social growths. General Practicioners see pregnant women and young children frequently and  can provide an increased focus on early child mental well being . In the context of standardised antenatal and child development assessments focussed on parental emotional wellbeing and family relationships, does a web-based mentalisation resource, the Resilience Programme 'FamilieTrivsel', improve parental mental health, parent-child relationships and child socio-emotional and language development?

Rationale

Early childhood social, emotional and behavioural problems are associated with increased risk of a wide range of poor outcomes. Parental mentalisation skills (ability to understand the child's and one owns mental states) is crucial in the development of the child's socio-emotional resilience. Mentalisation skills can be trained. 

The Resilience Programme (RP) is an internet-based intervention programme developed in Denmark during the last 10 years. Resilience is here defined as successful adaptation to adversity, including successful recovery from adverse life events and sustainability in relation to life challenges, individually and at group- and community-level. Danish general practice is unique in having a central role in preventive care during pregnancy and in providing the nationally mandated child development assessments described below. Increasingly, practices employ nurses and midwives to provide preventive antenatal and child health services. 

The GP (and in some practices the practice-attached nursing and midwifery staff) plays a key role in antenatal care and sees women for antenatal examinations at gestational ages of 6-10, 25 and 32 weeks as well as at 8 weeks postpartum. At these assessments the focus is mainly on identifying physical risk to the mother and fetus as well as addressing established pregnancy complications. This biomedical focus is supported by the national pregnancy health record, and as a result there is a minor focus on the woman's mental well-being.

 We propose a cluster randomised trial in which GPs are trained and supported to offer RP interventions at all first antenatal consultations and subsequently when needs become apparent during pregnancy and later among families with young children.  The trial explicitly involves opportunities arising during scheduled assessments to offer intervention flexibly on the basis of objectively-assessed need.

The main research question is: Do families supported by GPs trained to offer RP interventions to mothers at antenatal and postnatal assessments and at unscheduled clinical contacts benefit in terms of improved social, emotional and language development of their children at 30 months and parental mental wellbeing?

Description of the cohort

100 General practices in the Capital Region, Region Zealand and The Region of Southern Denmark will be invited to participate. Eligible practices willing to participate will be assigned at random to the intervention or control groups.  Participating practices will need to express a commitment to personal clinical continuity of care - in other words pregnant women and their offspring would normally expect to attend scheduled appointments with the same one or two clinicians. Each practice will be asked to recruit 10 consecutive participants at their first pregnancy assessment over the course of one year. Main patient exclusion criteria at time of recruitment is inability to complete questionnaires or participate in the intervention because of very limited Danish language comprehension. 

Data and biological material

Data from GPs: Clinical records Copies of  first pregnancy consultation  record from the GP and data from a systematic child record, developed by the researchers. 

Data from patients: Questionnaies and 

Data from registers.

Collaborating researchers and departments

Research Unit of General Practice, Department of Public Health, University of Southern Denmark

• Professor Frans Boch Waldorff, PhD

The Research Unit and Section of General Practice, Institute of Public Health, University of Copenhagen

• Project Manager Gritt Overbeck