A large trial will test whether a group support programme for parents of young children with intellectual disability improves their mental wellbeing. Parents of children with intellectual disability face higher rates of stress, anxiety, and depression than other parents, yet few evidence-based support programmes exist specifically for them. The Early Positive Approaches to Support (E-PAtS) programme was co-designed with families and tested in a smaller feasibility study. This trial will randomise 458 families (around 594 parents or carers) to either receive E-PAtS plus usual care, or usual care alone, and measure wellbeing after 12 months. If E-PAtS proves effective and cost-effective, it could give the NHS and local authorities a practical, scalable intervention to offer families during the critical early years. The programme is delivered in community settings, not hospitals, and requires only that parents attend five of eight group sessions. Success would mean better mental health for carers, improved outcomes for children, and reduced strain on health and social care services. The trial also includes a health economic evaluation and interviews with 70 participants to understand what works and why.
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Aim: Examine effectiveness and cost-effectiveness of the Early Positive Approaches to Support (E-PAtS) programme for family carers (FCs) (e.g., parents) of young children with Intellectual Disability (ID). Research Questions: (1) Does E-PAtS plus usual practice (UP) lead to higher wellbeing compared to UP plus wait-list control for FCs of young children with ID? (2) What is the impact of E-PAtS on other psychological, emotional, behavioural and support outcomes for FCs, their child and family? (3) What is the cost-effectiveness of E-PAtS? (4) What are the experiences of facilitators and families accessing E-PAtS? Background: FCs of children with ID are at risk of psychological problems, linked to problems for their child. E-PAtS is a co-produced and co-facilitated group programme specifically for FCs of children with ID and the subject of a feasibility RCT[39]. Design: Two-arm cluster randomised wait-list controlled trial of E-PAtS plus UP compared to UP plus wait-list control for FC wellbeing with measures at baseline, 4m and 12m post-randomisation. Experimental intervention: E-PAtS in accordance with programme manuals delivered in non-NHS community settings to groups of 8 families (on average). Adherence as attendance of 5/8 sessions. Fidelity assessed via facilitator checklists. Population: FCs of children with ID. Inclusion: family has child with likely ID (for which we will screen[46]) 1.5-5 years; FC can attend sessions and has English language ability (spoken); informed consent. Exclusions: Child in 24hr placement; FC in parenting programme at baseline; family in crisis (as per screening[47]). Sample: 458 families (229 per arm), to include approximately 594 FCs (297 per arm) (90% power; two-sided Type I error rate of 5%). Outcomes: Primary outcome of Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)[45] at 12m post-randomisation. Secondary outcomes are parenting, child with ID behaviour/emotions, family impacts, support for family and health economic measures. Recruitment and Retention: PPI informed strategies across all UK countries coordinated by 3 research sites. Participant choice of data collection via online or paper completion, with/without interviewer support. Data collected from 2 FCs per family by researchers blind to study arm allocation. Randomisation: Families cluster randomised on a 1:1 ratio stratified by study site in batches of 6 families. Internal Pilot: Months 6-14 of study with defined progression criteria for recruitment, retention, and adherence. Analysis: Primary analysis mean WEMWBS scores between arms at 12m post-randomisation (baseline WEMWBS covaried). Secondary outcomes analysed similarly. Routinely Collected Data: Consent to be sought in England and Wales with respect to Education and Health data. A Health Economic Evaluation will utilise parent health-related quality of life (EQ-5D-5L[56] and a modified Client Service Receipt Inventory (CSRI)[57]. Process Evaluation: Facilitator/participant interviews (total N=70): barriers/facilitators, adherence, therapeutic relationship, change mechanisms, group processes, daily life impact of E-PAtS; with analysis informed by MRC guidance[70]. Timeline: Set-up (m1-5); randomisation (m6-22); 4m data (m10-26); 12m data (m18-34); analysis/writeup (m35-39). Dissemination: Academic articles, co-produced resources, presentations, network activities. Impact: Increased effective wellbeing support for FCs of children with ID.
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