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

Gritt Overbeck* (Corresponding Author), Jakob Kragstrup, Mette Gørtz, Ida Scheel Rasmussen, Anette Hauskov Graungaard, Volkert Siersma , Sarah Strøyer de Voss, Ruth Kirk Ertmann, Sinead Shahrzad, Clara Lundmark Appel , Philip Wilson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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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.

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).

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.

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 NCT04129359. Registered on Oct 16 2019.
Original languageEnglish
Article number7
Number of pages12
Publication statusPublished - 4 Jan 2023

Bibliographical note

Funding: The TRYG Foundation l. Grant number: 125227

The Quality and Educational Committee (KEU; Kvalitet og Efterudannelsesudvalget) Capital Region of Denmark. Grant number: 19035774 The funders have no role nor authority in the design of the study and collection, analysis, and interpretation of data dissemination of the project.

Data Availability Statement

After our primary publication of the trial results, a version of the data will be shared on a public platform and made available for research in accordance with Danish law about the protection of personal data.


  • child development
  • Internet-based intervention
  • general practice
  • psychosocial factors
  • mentalisation


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