Early childhood intervention for children at risk of developmental disabilities and their caregivers in Rwanda: study protocol for the PDC/Baby Ubuntu cluster randomised trial

Abstract Background Early childhood intervention strategies have the potential to promote health, participation and quality of life for young children at risk of developmental disabilities and their caregivers, however evidence on the impact of integrated care strategies in sub-Saharan Africa is lacking. Access to early intervention is crucial for affected children and families, particularly in resource-constrained settings with limited access to specialised services. This trial aims to evaluate the effectiveness and implementation of a bundle of early identification, care and support, integrated into government health systems in Rwanda: the Pediatric Development Clinic (PDC)/Baby Ubuntu programme. Methods The study is a single-blind, effectiveness implementation-hybrid (type II) cluster randomised controlled trial with two arms (1:1 ratio). At cluster level, all community health centres in the three trial districts will be eligible for inclusion. At the participant level, at risk children aged ≤ 59 months will be eligible where ‘at risk’ is defined as being a survivor of a newborn condition that is a recognised risk factor for developmental disability (neonatal encephalopathy, prematurity, meningitis, severe jaundice, cerebral malaria, suspected genetic and chromosomal conditions and seizures), and/or not meeting age-specific developmental milestones. Those receiving inpatient hospital treatment or in institutional care will not be eligible. Primary outcomes will be family health-related quality of life (PedsQL) and child participation (Young Child Participation & Environment Measure) assessed 12 months after enrolment and randomisation. Secondary outcomes include caregiver knowledge and confidence (scored structured assessments), psychological distress (Self-Report Questionnaire), experience of disability-affiliated stigma (Affiliate Stigma Scale), and economic activity (time-use survey), in addition to child mortality, illness and hospitalisation, child development/function (Global Scales of Early Development, Malawi Developmental Assessment Tool, PEDI-CAT), and nutritional status (weight-for-age, height-for-age). Analysis will be by intention-to-treat, consisting of all randomised subjects analysed according to assigned study arm. Cluster-level analyses will assess intervention effect. Discussion The trial utilises best practice methodology and frameworks to conduct rigorous and comprehensive impact, process and economic evaluation of the intervention implemented and is guided by a multi-disciplinary team and steering committee. Trial registration ISRCTN, ISRCTN17523514. Retrospectively registered 24 July 2024, https://doi.org/10.1186/ISRCTN17523514