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      Using Stakeholder Involvement, Expert Knowledge and Naturalistic Implementation to Co-Design a Complex Intervention to Support Children’s Inclusion and Participation in Schools: The CIRCLE Framework

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          Abstract

          Whist inclusion is recommended for most children most of the time it remains difficult to implement. In this paper, we present the process undertaken to review and redesign a pre-existing complex intervention (The CIRCLE Framework) which was designed to enhance teachers confidence and competence in provision of universal first level supports for 5–12 year old children with additional support needs. The approach presented draws on the Medical Research Council guidance for the development of complex interventions. A series of ten co-design workshops with 70 stakeholders was completed, applying interactive and participatory methods. Analysing outputs of each workshop revealed recurring design ideas that became the main aspects of the new framework and associated manuals. Intervention content, theoretical frameworks, manuals to support use in practice and implementation strategies were developed. On completion, the updated intervention was extended up to 18 years of age and redistributed to all teachers in the participating local authority. We present the main conclusions and interpretations around the design and naturalistic implementation of the framework, and reflections on use in practice, including a detailed list of recommendations for implementation across schools and staff.

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          Most cited references 56

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          Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

          Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.
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            Guidance on how to develop complex interventions to improve health and healthcare

            Objective To provide researchers with guidance on actions to take during intervention development. Summary of key points Based on a consensus exercise informed by reviews and qualitative interviews, we present key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving stakeholders, reviewing published research evidence, drawing on existing theories, articulating programme theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real world and designing and refining an intervention using iterative cycles of development with stakeholder input throughout. Conclusion Researchers should consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.
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              Prevalence and Trends of Developmental Disabilities among Children in the United States: 2009–2017

              To study the national prevalence of ten developmental disabilities in US children aged 3–17 years and explore changes over time by associated demographic and socioeconomic characteristics using the 2009–2017 National Health Interview Survey (NHIS). Data come from the NHIS, a nationally-representative survey of the civilian noninstitutionalized population. Parents reported physician or other health care professional diagnoses of attention-deficit/hyperactivity disorder (ADHD); autism spectrum disorder (ASD); blindness; cerebral palsy; moderate to profound hearing loss; learning disability (LD); intellectual disability (ID); seizures; stuttering or stammering; and other developmental delays. Weighted percentages for each of the selected developmental disabilities and any developmental disability were calculated between 2009–2017 and stratified by selected demographic/socioeconomic characteristics. From 2009–2011 to 2015–2017, there were overall significant increases in the prevalence of any developmental disability (16.2% to 17.8%, p<.001), ADHD (8.5% to 9.5%, p <.01), ASD (1.1% to 2.5%, p <.001), and ID (0.9% to 1.2%, p <.05), but a significant decrease for any other developmental delay (4.7% to 4.1% , p <.05). The prevalence of any developmental disability increased among boys, children ages 12–17, non-Hispanic white and Hispanic children, children with private insurance only, and children with birthweights ≥2,500 grams. An increase in prevalence of any developmental disability was also seen for children living in urban areas and with less educated mothers. The prevalence of developmental disability among US children aged 3–17 years increased between 2009–2017. Changes by demographic and socioeconomic subgroups may be related to improvements in awareness and access to health care. From the 2009–2017 NHIS, there was a 9.5% increase in the prevalence of developmental disabilities among children aged 3–17.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                Children (Basel)
                Children (Basel)
                children
                Children
                MDPI
                2227-9067
                11 March 2021
                March 2021
                : 8
                : 3
                Affiliations
                [1 ]School of Health Sciences, Queen Margaret University, Edinburgh EH21 6UU, UK; chunter@ 123456qmu.ac.uk (C.H.); LJohnston2@ 123456qmu.ac.uk (L.J.); kforsyth@ 123456qmu.ac.uk (K.F.)
                [2 ]Additional Support for Learning Service, Communities and Families, City of Edinburgh Council, Edinburgh EH8 8BG, UK
                Author notes
                [* ]Correspondence: dmaciver@ 123456qmu.ac.uk
                Article
                children-08-00217
                10.3390/children8030217
                8001448
                17dedf00-2c47-434d-a097-7089b35c0314
                © 2021 by the authors.

                Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license ( http://creativecommons.org/licenses/by/4.0/).

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