TY - JOUR

T1 - Family wellbeing in general practice

T2 - a study protocol for a cluster-randomised trial of the web-based resilience programme on early child development

AU - Overbeck, Gritt

AU - Kragstrup, Jakob

AU - Gørtz, Mette

AU - Rasmussen, Ida Scheel

AU - Graungaard, Anette Hauskov

AU - Siersma, Volkert

AU - de Voss, Sarah

AU - Ertmann, Ruth Kirk

AU - Shahrzad, Sinead

AU - Appel, Clara Lundmark

AU - Wilson, Philip

N1 - © 2022. The Author(s).

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Infant

KW - Humans

KW - Female

KW - Child, Preschool

KW - Pregnancy

KW - Child Development

KW - Mothers/psychology

KW - Parents

KW - General Practice

KW - Internet

KW - Randomized Controlled Trials as Topic

KW - Faculty of Health and Medical Sciences

KW - Complex Intervention

KW - Psychosocial wellbeing

U2 - 10.1186/s13063-022-07045-7

DO - 10.1186/s13063-022-07045-7

M3 - Journal article

C2 - 36597136

VL - 24

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 7

ER -