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
9 affiliations
- 1Centre for Trials Research, Cardiff University, Cardiff, UK
- 2Intellectual Disabilities Research Institute, University of Birmingham, Birmingham, UK
- 3The Challenging Behaviour Foundation, Chatham, UK
- 4Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
- 5University of South Wales, Pontypridd, UK
- 6Queen�s University Belfast, Belfast, UK
- 7DECIPHer Centre, Cardiff School of Social Sciences, Cardiff University, Cardiff, UK
- 8University of Kent, Canterbury, England, UK
- 9Division of Psychiatry, University College London, London, UK
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.
Trial registration number: ISRCTN11192967
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BibTeX
@article{williamsthomas2026epats,
title = {{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}},
author = {Rhys Williams-Thomas and Elinor Coulman and Jill Bradshaw and Debbie Austin and Cameron Bradshaw and Myrsini Gianatsi and David Gillespie and Gemma Grant and Richard P Hastings and Sungwook Kim and Richard May and Rachel McNamara and Peter Mulhall and Lydia Penrose and Stavros Petrou and Sophie Rose and Jeremy Segrott and Joanne Sweeney and Laurence Taggart and Serena Tomlinson and Vasiliki Totsika and Caitlin Williams and Nick Gore},
journal = {BMJ Open},
year = {2026},
month = oct,
doi = {10.1136/bmjopen-2025-112783},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-112783},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Rhys Williams-Thomas
AU - Elinor Coulman
AU - Jill Bradshaw
AU - Debbie Austin
AU - Cameron Bradshaw
AU - Myrsini Gianatsi
AU - David Gillespie
AU - Gemma Grant
AU - Richard P Hastings
AU - Sungwook Kim
AU - Richard May
AU - Rachel McNamara
AU - Peter Mulhall
AU - Lydia Penrose
AU - Stavros Petrou
AU - Sophie Rose
AU - Jeremy Segrott
AU - Joanne Sweeney
AU - Laurence Taggart
AU - Serena Tomlinson
AU - Vasiliki Totsika
AU - Caitlin Williams
AU - Nick Gore
PY - 2026
DA - 2026/10/27
JO - BMJ Open
DO - 10.1136/bmjopen-2025-112783
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2025-112783
AB - 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. Trial registration number: ISRCTN11192967
SN - 2044-6055
SN - 2044-6055
ER -