Effect of a youth-led early childhood care and education programme on children's development and learning in rural Sindh, Pakistan (LEAPS): a stepped-wedge cluster-randomised implementation trial

In low-income and middle-income countries, an estimated 181·9 million (74·6%) preschool-aged children do not receive adequate nurturing care in health, nutrition, protection, learning, and responsive care, thus jeopardising their healthy development across the life course. Working alongside the health sector, multisectoral actions including social protection and education are necessary to achieve child health and development outcomes. Innovations are needed to expand access to high-quality early childhood care and education (ECCE) for young children and opportunities for youth development. Youth Leaders for Early Childhood Assuring Children are Prepared for School (LEAPS) is a two-generation programme that trains female youth aged 18–24 years to deliver ECCE. We evaluated the effectiveness of LEAPS to improve children's school readiness when delivered at scale in rural Pakistan. We implemented a stepped-wedge cluster-randomised trial with three steps from Dec 3, 2018, to June 30, 2021. 99 villages (clusters) in four districts in rural Sindh, Pakistan, were randomly assigned (1:1:1) to introduce LEAPS across three steps. Eligible clusters were those that had a feeder primary school run by the National Commission for Human Development, a department of the Ministry of Federal Education and Professional Training; were safe; had space for a LEAPS preschool; could identify a female youth to deliver the ECCE service; and had not previously participated in the pilot study. Government partners trained female youth, aged 18–24 years, to provide community-based ECCE, enrolling up to 20 children, aged 3·5–5·0 years, per class. Population-based cross-sectional surveys were conducted at baseline and after each step for children who were eligible if they resided in the cluster, were aged 4·5–5·5 years at the time of the survey, and without any severe clinical health conditions or disability. The primary outcome was children's school readiness using the International Development and Early Learning Assessment (IDELA) composite score comprising emergent numeracy, emergent literacy, socio-emotional development, and motor skills. An intention-to-treat analysis was conducted, using linear mixed models accounting for clustering and the stepped-wedge design. The trial is registered with ClinicalTrials.gov (NCT03764436). LEAPS was implemented in 91 of 99 villages. In eight clusters, a LEAPS preschool could not be set up. For the intervention programme, the average enrolment of ch