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

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          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.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13063-022-07045-7.

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          Most cited references65

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          Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support.

          Research electronic data capture (REDCap) is a novel workflow methodology and software solution designed for rapid development and deployment of electronic data capture tools to support clinical and translational research. We present: (1) a brief description of the REDCap metadata-driven software toolset; (2) detail concerning the capture and use of study-related metadata from scientific research teams; (3) measures of impact for REDCap; (4) details concerning a consortium network of domestic and international institutions collaborating on the project; and (5) strengths and limitations of the REDCap system. REDCap is currently supporting 286 translational research projects in a growing collaborative network including 27 active partner institutions.
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            The hospital anxiety and depression scale.

            A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
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              Developing and evaluating complex interventions: the new Medical Research Council guidance

              Evaluating complex interventions is complicated. The Medical Research Council's evaluation framework (2000) brought welcome clarity to the task. Now the council has updated its guidance
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                Author and article information

                Contributors
                grio@sund.ku.dk
                jakr@sund.ku.dk
                mette.gortz@econ.ku.dk
                idra@sund.ku.dk
                angra@sund.ku.dk
                siersma@sund.ku.dk
                svo@sund.ku.dk
                ruth@sund.ku.dk
                sinead@sund.ku.dk
                c.appel@sund.ku.dk
                p.wilson@sund.ku.dk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                4 January 2023
                4 January 2023
                2023
                : 24
                : 7
                Affiliations
                [1 ]GRID grid.5254.6, ISNI 0000 0001 0674 042X, University of Copenhagen, Department of Public Health, Centre for General Practice, , University of Copenhagen, ; Copenhagen, Denmark
                [2 ]GRID grid.5254.6, ISNI 0000 0001 0674 042X, Department of Economics and Center for Economic Behavior and Inequality (CEBI), , University of Copenhagen, ; Copenhagen, Denmark
                [3 ]GRID grid.7107.1, ISNI 0000 0004 1936 7291, Institute of Applied Health Sciences, , University of Aberdeen, ; Aberdeen, Scotland
                Author information
                http://orcid.org/0000-0002-1740-1148
                http://orcid.org/0000-0002-9346-0625
                http://orcid.org/0000-0002-7242-7324
                http://orcid.org/0000-0003-1941-2681
                http://orcid.org/0000-0002-9018-9534
                http://orcid.org/0000-0003-4629-3518
                http://orcid.org/0000-0002-4123-8248
                Article
                7045
                10.1186/s13063-022-07045-7
                9810520
                36597136
                ca799508-3cbb-49e2-bad6-7b67f472d366
                © The Author(s) 2022

                Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

                History
                : 7 November 2022
                : 20 December 2022
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100007437, TrygFonden;
                Award ID: 125227
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2023

                Medicine
                child development,internet-based intervention,general practice,psychosocial factors,mentalisation

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