Early Positive Approaches to Support (E-PAtS) for families of young children with intellectual disability: a feasibility randomised controlled trial

Coulman, E. et al. (2021) Early Positive Approaches to Support (E-PAtS) for families of young children with intellectual disability: a feasibility randomised controlled trial. Frontiers in Psychiatry, 12, 729129. (doi: 10.3389/fpsyt.2021.729129) (PMID:34992552) (PMCID:PMC8725992)

Abstract

Background: 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. Methods: 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. Results: 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. Conclusions: 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. Clinical Trial Registration: https://www.isrctn.com, identifier: ISRCTN70419473.

• Item Type: Articles
• Additional Information: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme (PHR/15/126/11).
• Keywords: Psychiatry, intellectual disability, developmental disability, developmental delay, randomised controlled trial, parenting, Early Positive Approaches to Support (E-PAtS), mental well-being, support.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Jahoda, Professor Andrew
• Authors: 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., and Hastings, R. P.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Mental Health and Wellbeing
• Journal Name: Frontiers in Psychiatry
• Publisher: Frontiers Media
• ISSN: 1664-0640
• ISSN (Online): 1664-0640
• Copyright Holders: Copyright © 2021 Coulman, Gore, Moody, Wright, Segrott, Gillespie, Petrou, Lugg-Widger, Kim, Bradshaw, McNamara, Jahoda, Lindsay, Shurlock, Totsika, Stanford, Flynn, Carter, Barlow and Hastings
• First Published: First published in Frontiers in Psychiatry 12: 729129
• Publisher Policy: Reproduced under a Creative Commons License