Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial

<br><strong>Background: </strong>Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and profes...

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المؤلفون الرئيسيون: Coulman, E, Gore, N, Moody, G, Wright, M, Segrott, J, Gillespie, D, Petrou, S, Lugg-Widger, F, Kim, S, Bradshaw, J, McNamara, R, Jahoda, A, Lindsay, G, Shurlock, J, Totsika, V, Stanford, C, Flynn, S, Carter, A, Barlow, C, Hastings, RP
التنسيق: Journal article
اللغة:English
منشور في: Frontiers Media 2021
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author Coulman, E
Gore, N
Moody, G
Wright, M
Segrott, J
Gillespie, D
Petrou, S
Lugg-Widger, F
Kim, S
Bradshaw, J
McNamara, R
Jahoda, A
Lindsay, G
Shurlock, J
Totsika, V
Stanford, C
Flynn, S
Carter, A
Barlow, C
Hastings, RP
author_facet Coulman, E
Gore, N
Moody, G
Wright, M
Segrott, J
Gillespie, D
Petrou, S
Lugg-Widger, F
Kim, S
Bradshaw, J
McNamara, R
Jahoda, A
Lindsay, G
Shurlock, J
Totsika, V
Stanford, C
Flynn, S
Carter, A
Barlow, C
Hastings, RP
author_sort Coulman, E
collection OXFORD
description <br><strong>Background: </strong>Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS. <br><strong> Methods:</strong> This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures. <br><strong> Results: </strong>Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial. <br><strong> Conclusions: </strong>The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers. <br><strong> Clinical Trial Registration: </strong>https://www.isrctn.com, identifier: ISRCTN70419473.
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spelling oxford-uuid:888d6a1d-cd3d-4b76-bc64-b451e26cfe9f2022-03-26T22:18:08ZEarly positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:888d6a1d-cd3d-4b76-bc64-b451e26cfe9fEnglishSymplectic ElementsFrontiers Media2021Coulman, EGore, NMoody, GWright, MSegrott, JGillespie, DPetrou, SLugg-Widger, FKim, SBradshaw, JMcNamara, RJahoda, ALindsay, GShurlock, JTotsika, VStanford, CFlynn, SCarter, ABarlow, CHastings, RP<br><strong>Background: </strong>Parents of children with intellectual disabilities are likely to experience poorer mental well-being and face challenges accessing support. Early Positive Approaches to Support (E-PAtS) is a group-based programme, co-produced with parents and professionals, based on existing research evidence and a developmental systems approach to support parental mental well-being. The aim of this study was to assess the feasibility of community service provider organisations delivering E-PAtS to parents/family caregivers of young children with intellectual disability, to inform a potential definitive randomised controlled trial of the effectiveness and cost-effectiveness of E-PAtS. <br><strong> Methods:</strong> This study was a feasibility cluster randomised controlled trial, with embedded process evaluation. Up to two parents/family caregivers of a child (18 months to <6 years old) with intellectual disability were recruited at research sites and allocated to intervention (E-PAtS and usual practise) or control (usual practise) on a 1:1 basis at cluster (family) level. Data were collected at baseline and 3 and 12 months' post-randomisation. The following feasibility outcomes were assessed: participant recruitment rates and effectiveness of recruitment pathways; retention rates; intervention adherence and fidelity; service provider recruitment rates and willingness to participate in a future trial; barriers and facilitating factors for recruitment, engagement, and intervention delivery; and feasibility of collecting outcome measures. <br><strong> Results: </strong>Seventy-four families were randomised to intervention or control (n = 37). Retention rates were 72% at 12 months post-randomisation, and completion of the proposed primary outcome measure (WEMWBS) was 51%. Recruitment of service provider organisations and facilitators was feasible and intervention implementation acceptable. Adherence to the intervention was 76% and the intervention was well-received by participants; exploratory analyses suggest that adherence and attendance may be associated with improved well-being. Health economic outcome measures were collected successfully and evidence indicates that linkage with routine data would be feasible in a future trial. <br><strong> Conclusions: </strong>The E-PAtS Feasibility RCT has demonstrated that the research design and methods of intervention implementation are generally feasible. Consideration of the limitations of this feasibility trial and any barriers to conducting a future definitive trial, do however, need to be considered by researchers. <br><strong> Clinical Trial Registration: </strong>https://www.isrctn.com, identifier: ISRCTN70419473.
spellingShingle Coulman, E
Gore, N
Moody, G
Wright, M
Segrott, J
Gillespie, D
Petrou, S
Lugg-Widger, F
Kim, S
Bradshaw, J
McNamara, R
Jahoda, A
Lindsay, G
Shurlock, J
Totsika, V
Stanford, C
Flynn, S
Carter, A
Barlow, C
Hastings, RP
Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial
title Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial
title_full Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial
title_fullStr Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial
title_full_unstemmed Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial
title_short Early positive approaches to support (E-PAts) for families of young children with intellectual disability: a feasibility randomised controlled trial
title_sort early positive approaches to support e pats for families of young children with intellectual disability a feasibility randomised controlled trial
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