Effectiveness-implementation hybrid type 1 trial evaluating the WHO caregiver skills training for families of children with developmental disabilities in Ethiopia and Kenya: implementation study protocol

Africa continues to witness a growing number of children with developmental disabilities or delays (DD), estimated at over 14.4 million (1,2). Existing interventions for children with DDs, including autism and intellectual disabilities, are largely western-oriented, require specialists, and are resource-intensive to implement. The World Health Organization (WHO) in 2016 launched the Caregiver Skills Training (CST), a caregiver-mediated intervention delivered by non-specialists, to bridge the gap in mental health services in low-resourced settings, where there are limited specialists in primary healthcare settings (3). A key CST feature is the task-sharing approach, where trained and supervised non-specialists such as nurses, teachers, social workers, and experienced caregivers/parents deliver the intervention. Until recently, small-scale and pilot studies have documented early experiences with the CST implementation, particularly evaluating its acceptability and feasibility in high and low-income settings across the globe (4-13). These studies suggest CST has positive effect on caregiver wellbeing and improvements in children’s developmental outcomes, especially social and communication functions. To date, the CST has been offered in a variety of formats (in-person sessions, self-directed eLearning, and virtually). Most of the previous evaluations [e.g. (5, 6, 8, 14)], used specialist facilitators to deliver CST; one study used both specialists and non-specialists (9). A small number of studies have tested the feasibility of using non-specialist facilitators (4,10,13). However, there is a dearth of evidence examining this task-sharing approach and effects on CST implementation in real-world contexts, especially on a larger scale and implemented across different contexts. The aim of the study is to assess the implementation of the WHO caregiver skills training (CST) by non-specialist facilitators in the context of three clinical trial sites in Ethiopia and Kenya, facilitating an understanding of how divergent contexts influenced the implementation of the CST. This will be achieved through mixed methods approaches to understand how context influenced mechanisms that in turn influenced implementation and clinical outcomes. Ultimately, this will enable the development of an implementation blueprint to facilitate future implementation in Ethiopia and Kenya, and inform adaptation and implementation in other settings. The study will address the following implementation questions from the perspectives of the intervention stakeholders [including caregivers of children with developmental disorders/disabilities (DD), CST delivery team, stakeholders in health, education, and community systems]. 1. To what extent is the CST acceptable, appropriate, and feasible to implement in Ethiopian and Kenyan contexts? 2. To what extent was the CST delivered as intended (fidelity of delivery)? 3. To what extent was the CST received as intended (fidelity of receipt)? 4. What are stakeholders’ perspectives on the sustainability of implementing the CST in the longer term? 5. What are the contextual enablers and barriers associated with the implementation of the CST at different study sites, and how does this influence the mechanisms? 6. Were there any unintended consequences of the intervention i.e. with regards to how the CST was delivered and its potential impact on recipients and the implementation context? 7. How do the divergent contexts at the different study sites, influence the delivery of the intervention on implementation and clinical outcomes? 8. What mechanisms (mediators) influence the effectiveness of the intervention?