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

Elinor Coulman,Fiona Lugg-Widger,Andrew Jahoda,Jill Bradshaw,Nick Gore,Richard Hastings,Stavros Petrou,Michael Robling,Kerry Hood,Vaso Totsika,Jacqui Shurlock,David Gillespie,Geoff Lindsay,Jeremy Segrott,Rachel Mcnamara

doi:10.1186/s40814-020-00689-9

Abstract

BackgroundChildren 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.MethodsThis 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.DiscussionThe 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 registrationISRCTN70419473

Highlights

Children with intellectual disability have an Intelligence quotient (IQ) < 70, associated deficits in adaptive skills and are at increased risk of having clinically concerning levels of behaviour problems
Just over 2% of children in England have been identified by local authorities/schools as having intellectual disability (ID), according to data by the UK Learning Disability Observatory [1], and prevalence varies slightly with socio-economic factors, it appears broadly similar across the UK
UK population-based data have shown that children with ID are 4–5 times more likely to have a diagnosable mental health disorder [2] compared to other UK children

Summary

Introduction

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. 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. High proportions (60–80%) of children with ID in population-based samples have clinically concerning levels of behaviour problems (including hyperactivity and conduct problems) [3]. These health inequalities for children with ID emerge by the time the child with ID is 3–5 years of age at the latest [4]

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