Family wellbeing in general practice: a study protocol for a cluster-randomised trial of the web-based resilience programme on early child development

Abstract

Background Social, emotional and behavioural problems in early childhood are associated with increased risk for a wide range of poor outcomes associated with substantial cost and impact on society as a whole. Some of these problems are rooted in the early mother-infant relationship and might be prevented. In Denmark, primary health care has a central role in preventive care during pregnancy and the first years of the child’s life and general practice provides opportunities to promote a healthy mother-infant relationship in early parenthood. Objective In the context of standardised antenatal and child development assessments focused on psychosocial wellbeing, we examine the impact of a complex intervention designed to improve maternal mentalisation skills, involving training of general practice clinicians and signposting towards a web-based resource. Joint main outcomes are child socio-emotional and language development at age 30 months measured by parentally reported questionnaires (Communicative Development Inventory and Strengths and Difficulties Questionnaire). Methods The study is a cluster-randomised controlled trial based in general practices in the Capital Region and the Zealand Region of Denmark. Seventy practices were included. Practices were randomised by a computer algorithm in a ratio of 1:1 to intervention or control groups. Each practice was asked to recruit up to 30 women consecutively at their first scheduled antenatal assessment. Clinicians in both groups received one day of training in preventive antenatal and child development consultations with added focus on parental psychosocial well-being, social support, and parent–child interaction. These preventive consultations delivered in both trial arms require enhanced data recording about psychosocial factors. In intervention clinics, clinicians were asked to signpost a web page at three scheduled antenatal consultations and at four scheduled consultations when the child is 5 weeks, 5 months, 1 and 2 years. Discussion We hypothesise that the intervention will increase mothers’ ability to be sensitive to their child’s mental state to an extent that improves the child’s language and mental state at 30 months of age measured by parent-reported questionnaires. Trial registration ClinicalTrials.gov NCT04129359. Registered on Oct 16 2019.

Increasing the psychosocial focus in child developmental assessments: a qualitative study

“…The research was nested in the Family Wellbeing trial mentioned above. Further details are reported elsewhere [ 28 , 29 ]. Only control group clinics were included in this study to avoid bias from the web-intervention currently being examined in the Family Wellbeing trial.…”

“…Pregnant women were offered to participate in the Family Wellbeing trial consecutively at their first antenatal assessment if they understood Danish and if they intended to continue as patients in the practice [ 28 , 29 ]. The present study took place in 12 general practices; three from Region Zealand and nine from the Capital Region.…”

“…A cluster randomised trial, FamilieTrivsel (‘Family Wellbeing’) [ 28 , 29 ] is investigating the use of a web-based intervention focusing on parental mentalization skills and mental wellbeing and examines its impact on the child’s language and social development. The Family Wellbeing trial has implemented standardised child records with an enhanced focus on psychosocial aspects in both study arms with the aim of increasing the scope of the scheduled developmental assessments.…”

Increased family psychosocial focus during children’s developmental assessments: a study of parents’ views

“…This interview study was nested in Project Family Wellbeing, a cluster-randomised trial testing the effect of a web-based mentalization program on children’s social skills and language development [ 34 ]. The project involves 650 families from pregnancy to child age 31 months.…”

“…The sample was drawn from families participating in Project Family Wellbeing [ 34 ]. The starting point of the interview was the experience of a specific developmental assessment that the parent(s) had attended with their child.…”