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

Williams-Thomas, Rhys, Coulman, Elinor, Bradshaw, Jill, Austin, Debbie, Bradshaw, Cameron, Gianatsi, Myrsini, Gillespie, David ORCID: https://orcid.org/0000-0002-6934-2928, Grant, Gemma, Hastings, Richard P, Kim, Sungwook, May, Richard, McNamara, Rachel ORCID: https://orcid.org/0000-0002-7280-1611, Mulhall, Peter, Penrose, Lydia, Petrou, Stavros, Rose, Sophie, Segrott, Jeremy ORCID: https://orcid.org/0000-0001-6215-0870, Sweeney, Joanne, Taggart, Laurence, Tomlinson, Serena, Totsika, Vasiliki, Williams, Caitlin and Gore, Nick 2026. E-PAtS trial: a protocol for a cluster randomised controlled trial of Early Positive Approaches to Support (E-PAtS) for families of young children with intellectual disabilities. BMJ Open 16 , e112783. 10.1136/bmjopen-2025-112783

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Abstract

Introduction Approximately 2%–3% of children globally have intellectual disabilities, with around 300 000 in England. These children face cognitive, social and educational challenges, and their parents often experience high stress and reduced mental health. Early interventions are vital to support both child development and family well-being. The parent–child relationship in early years (ages 3–5) and parental well-being both play a key role in shaping later child outcomes. However, current interventions often focus on either child development or parental well-being, not both. There is a gap in group programmes tailored for families of young children with intellectual disabilities, especially those that include peer support and co-production. The Early Positive Approaches to Support (E-PAtS) programme was developed to address these gaps, showing promise in a feasibility trial. Methods and analysis We are conducting a randomised controlled trial of the E-PAtS intervention. Trial design and delivery have been co-produced with family carers, following on from a successful feasibility trial. A recruitment period of 29 months will commence on 1 September 2023. After completing baseline assessments, families are randomised on a 1:1 basis either to the E-PAtS intervention or continue with usual care. Control group families will have access to the intervention following 12-month assessments. The intervention comprises an 8-week manualised group programme for the family carers of children with an intellectual disability. At 4 months and 12 months, participants are invited to complete repeat outcome assessments. The primary objective is to assess whether the E-PAtS intervention has a positive effect on parents/carers’ mental well-being at the 12-month time point, assessed by Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The primary treatment effect at 12 months will be estimated using a partially clustered linear mixed model of repeated WEMWBS measurements, adjusting for baseline score and site, with random effects for participants, families and intervention-arm E-PAtS groups. Secondary objectives include further exploration of mental health outcomes in both parent and child as well as health-related quality of life and an economic analysis. Ethics and dissemination The Sponsors of this study are the University of Birmingham and University of Kent. This protocol received approval from Humanities and Social Sciences Ethics Committee, University of Birmingham (13/08/2025, Ref: ERN_3848-Jul2025), following initial approval from the Tizard Centre University of Kent Ethics Committee (16/08/2023, Ref: 0897) Study results will be disseminated through peer reviewed literature, academic conferences, ISRCTN registry, directly to participants and stakeholders and through dissemination events. Processes will be determined through partnership working with our Public and Patient Involvement and Engagement group.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Schools > Medicine Research Institutes & Centres > Centre for Trials Research (CNTRR)
Publisher:	BMJ Publishing Group
ISSN:	2044-6055
Date of First Compliant Deposit:	3 November 2026
Date of Acceptance:	29 September 2026
Last Modified:	03 Nov 2026 11:30
URI:	https://orca.cardiff.ac.uk/id/eprint/190624

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