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The Early Positive Approaches to Support (E-PAtS) study : study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability
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Coulman, Elinor, Hastings, Richard P., Gore, Nick, Gillespie, David, McNamara, Rachel, Petrou, Stavros, Segrott, Jeremy, Bradshaw, Jill, Hood, Kerry, Jahoda, Andrew, Lindsay, Geoff, Lugg-Widger, Fiona, Robling, Michael, Shurlock, Jacqui and Totsika, Vaso (2020) The Early Positive Approaches to Support (E-PAtS) study : study protocol for a feasibility cluster randomised controlled trial of a group programme (E-PAtS) for family caregivers of young children with intellectual disability. Pilot and Feasibility Studies, 6 (1). 147. doi:10.1186/s40814-020-00689-9
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Official URL: https://doi.org/10.1186/s40814-020-00689-9
Abstract
Background: Children with intellectual disability have an IQ < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems. In addition, parents of children with intellectual disability are likely to report high levels of mental health and other psychological problems. The Early Positive Approaches to Support (E-PAtS) programme for family caregivers of young children (5 years and under) with intellectual and developmental disabilities is a group-based intervention which aims to enhance parental psychosocial wellbeing and service access and support positive development for children. The aim of this study is to assess the feasibility of delivering E-PAtS to family caregivers of children with intellectual disability by community parenting support service provider organisations. The study will inform a potential, definitive RCT of the effectiveness and cost-effectiveness of E-PAtS. Methods: This study is a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to 2 family caregivers will be recruited from 64 families with a child (18 months to 5 years) with intellectual disability at research sites in the UK. Participating families will be allocated to intervention: control on a 1:1 basis; intervention families will be offered the E-PAtS programme immediately, continuing to receive usual practice, and control participants will be offered the opportunity to attend the E-PAtS programme at the end of the follow-up period and will continue to receive usual practice. Data will be collected at baseline, 3 months post-randomisation and 12 months post-randomisation. The primary aim is to assess feasibility via the assessment of: recruitment of service provider organisations; participant recruitment; randomisation; retention; intervention adherence; intervention fidelity and the views of participants, intervention facilitators and service provider organisations regarding intervention delivery and study processes. The secondary aim is preliminary evaluation of a range of established outcome measures for individual family members, subsystem relationships and overall family functioning, plus additional health economic outcomes for inclusion in a future definitive trial. Discussion: The results of this study will inform a potential future definitive trial, to evaluate the effectiveness and cost-effectiveness of the E-PAtS intervention to improve parental psychosocial wellbeing. Such a trial would have significant scientific impact internationally in the intellectual disability field. Trial registration: ISRCTN70419473
| Item Type: | Journal Article | ||||||
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| Subjects: | H Social Sciences > HQ The family. Marriage. Woman H Social Sciences > HV Social pathology. Social and public welfare L Education > LC Special aspects of education R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine R Medicine > RJ Pediatrics |
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| Divisions: | Faculty of Social Sciences > Centre for Education Studies (2013- ) | ||||||
| SWORD Depositor: | Library Publications Router | ||||||
| Library of Congress Subject Headings (LCSH): | Intellectual disability, Learning disabled children, Self-care, Health, Mental health promotion, Parents of children with mental disabilities, Parents of children with mental disabilities -- Services for, Parents of children with mental disabilities -- Psychological aspects | ||||||
| Journal or Publication Title: | Pilot and Feasibility Studies | ||||||
| Publisher: | BioMed Central | ||||||
| ISSN: | 2055-5784 | ||||||
| Official Date: | 2 October 2020 | ||||||
| Dates: |
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| Volume: | 6 | ||||||
| Number: | 1 | ||||||
| Article Number: | 147 | ||||||
| DOI: | 10.1186/s40814-020-00689-9 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Publisher Statement: | ** From Springer Nature via Jisc Publications Router ** History: received 14-06-2019; registration 21-09-2020; accepted 21-09-2020; epub 02-10-2020; online 02-10-2020; collection 12-2020. ** Licence for this article: https://creativecommons.org/licenses/by/4.0/ | ||||||
| Access rights to Published version: | Open Access | ||||||
| RIOXX Funder/Project Grant: |
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