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The Early Positive Approaches to Support (E-PAtS) study: study protocol for a feasibility cluster randomised
Elinor Coulman1, Richard Hastings2, Nick Gore3
1Centre for Trials Research, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS UK.
Insights
This study assessed the feasibility of the Early Positive Approaches to Support (E-PAtS) program for parents of children with intellectual disabilities. Findings will guide a future trial on E-PAtS effectiveness in improving parental well-being.
Area of Science:
- Developmental Psychology
- Clinical Psychology
- Public Health Interventions
Background:
- Children with intellectual disability (ID) face developmental and behavioral challenges.
- Parents of children with ID experience elevated psychological distress.
- The E-PAtS program aims to support parents and children with ID.
Purpose of the Study:
- To assess the feasibility of delivering the E-PAtS program by community organizations.
- To inform a definitive randomized controlled trial (RCT) on E-PAtS effectiveness and cost-effectiveness.
- To evaluate parental psychosocial well-being and child development.
Main Methods:
- Feasibility cluster randomized controlled trial with process evaluation.
- Recruitment of 64 families with children aged 18 months to 5 years with ID.
- Data collection at baseline, 3, and 12 months, assessing recruitment, retention, adherence, fidelity, and participant views.
Main Results:
- Feasibility of recruiting service providers and families was assessed.
- Participant recruitment, randomization, retention, adherence, and fidelity were evaluated.
- Preliminary outcomes for family members, relationships, and functioning were examined.
Conclusions:
- The study provides essential data for designing a definitive RCT of the E-PAtS intervention.
- Results will inform the effectiveness and cost-effectiveness evaluation of E-PAtS for parental well-being.
- This research has potential international impact in the intellectual disability field.
Background:
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. 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.
Methods:
This 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.
Discussion:
The 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 Registration:
ISRCTN70419473.
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