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Abstract Background Most children with developmental disabilities (DD) live in low- and middle-income countries, but access to services is limited, impacting their ability to thrive. Pilot study findings of the World Health Organization’s Caregiver Skills Training (WHO CST) intervention, which equips caregivers with strategies to facilitate learning and adaptive behaviours in children with DD, are promising but evidence from an appropriately powered trial delivered by non-specialist facilitators is lacking. This study will investigate the effectiveness and the resource impacts and costs and consequences of the WHO CST intervention in four sites in rural and urban Kenya and Ethiopia. Methods This is a 2-arm multi-site hybrid type-1 effectiveness implementation cluster randomised controlled superiority trial. After baseline assessments (T0) are completed by participants in clusters comprising 7 to 10 caregiver-child dyads, the clusters will be randomised to either the WHO CST intervention arm or a waitlist enhanced care as usual control arm. Further assessments will be completed at endpoint (T1, 18 ± 2 weeks after randomisation) and follow-up (T2, 44 ± 2 weeks after randomisation). The intervention comprises three individualised home visits and nine group sessions with trained non-specialist facilitators. Participants in the control arm will receive the intervention after completing follow-up assessments. We aim to recruit 544 child-caregiver dyads, evenly distributed across the two arms and countries. The co-primary outcomes are the child-focused Child Behavior Checklist (assessing emotional and behavioural problems) and the caregiver-focused Pediatric Quality of Life Inventory (assessing caregiver quality of life), both assessed at endpoint. Secondary outcome measures comprise the two co-primary outcomes at follow-up and ten additional outcome measures at endpoint, assessing stigma-based experiences, depressive symptoms, household food insecurity, child disciplinary strategies and beliefs, CST knowledge and skill competencies, caregiver and child quality of life, social support, and children’s communication modes and functions. After quantitative follow-up assessments are completed, a mixed-methods evaluation approach will be used to investigate implementation processes and acceptability, feasibility, and potential sustainability of the intervention. Discussion The study’s findings will provide evidence of the effectiveness and resource impacts and costs and consequences of a non-specialist-delivered intervention in under-resourced contexts in one low-income and one middle-income country in East Africa. Findings will inform future research, intervention, and policy efforts to support children with DD and their families in under-resourced majority world contexts. Trial registration Pan African Clinical Trial Registry PACTR202310908063134. Registered on October 16, 2023.

Abstract Background 98% of people with surgical conditions living in low- and middle-income countries (LMICs) do not receive safe, timely and affordable surgical and anesthesia care. Research exploring barriers to receiving care has tended to be narrow in focus, often facility-based and ignoring the community beliefs, experiences and behaviours that will be an essential component of closing the gap in surgical care. Using qualitative methods, we captured diverse community perspectives in rural Ethiopia: exploring beliefs, perceptions, knowledge and experiences related to surgical conditions, with the overall aim of (re)constructing explanatory models. Methods Our study was nested within a community-based survey of surgical conditions conducted in the Butajira Health and Demographic Surveillance Site, southern Ethiopia, and a follow-up study of people accessing surgical care in two local hospitals. We carried out 24 semi-structured interviews. Participants were community members who needed but did/did not access surgical care, community-based healthcare workers and traditional bone-setters. Interviews were conducted in Amharic, audio-recorded, transcribed, and translated into English. We initially carried out thematic analysis and we recognized that emerging themes were aligned with Kleinman’s explanatory models framework and decided to use this to guide the final stages of analysis. Results We found that community members primarily understood surgical conditions according to severity. We identified two categories: conditions you could live with and those which required urgent care, with the latter indicating a clear and direct path to surgical care whilst the former was associated with a longer, more complex and experimental pattern of help-seeking. Fear of surgery and poverty disrupted help-seeking, whilst community narratives based on individual experiences fed into the body of knowledge people used to inform decisions about care. Conclusions We found explanatory models to be flexible, responsive to new evidence about what might work best in the context of limited community resources. Our findings have important implications for future research and policy, suggesting that community-level barriers have the potential to be responsive to carefully designed interventions which take account of local knowledge and beliefs.