Effect of a Youth Led Early Childhood Care and Education Programme on Children's Development and Learning: A Stepped-Wedge Cluster-Randomised Implementation Trial in Rural Sindh, Pakistan

Background: 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 training female youth to deliver ECCE. We evaluated the effectiveness of LEAPS to improve children’s school readiness when delivered at scale in rural Pakistan.Methods: We implemented a stepped-wedge cluster-randomised trial with three steps from December 3, 2018-June 30, 2021. Ninety-nine villages were randomly assigned to introduce LEAPS across three steps (1:1:1 ratio). 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 aged 4·5-5·5 years. The primary outcome was children’s school readiness using the International Development and Early Learning Assessment (IDELA) composite score. Secondary outcomes were IDELA sub-domains and executive functioning skills. An intent-to-treat analysis was conducted, using linear mixed models accounting for clustering and the stepped-wedge design. The trial was registered at ClinicalTrials.gov, NCT03764436.Findings: LEAPS was implemented in 91 of 99 villages. IDELA assessments were available for 3,852 children. LEAPS increased school readiness (standardised mean difference (SMD): 0·30, 95% CI 0·20-0·40). Effect sizes for IDELA sub-domains ranged from SMD=0·06 (95% CI -0·03-0·14) for motor skills to SMD=0·32 (95% CI 0·22-0·41) for numeracy. No impact was found on executive functioning, except for cognitive flexibility (SMD=0·24, 95% CI 0·14-0·35). Programme effectiveness was attenuated during the period of COVID-19-related school closures. The estimated cost-per-child for one year of LEAPS was USD $96.Interpretation: LEAPS offers a scalable solution to expand access to high-quality ECCE and promote children’s school readiness while providing employment for female youth in rural Pakistan.Trial Registration Details: The trial was registered at ClinicalTrials.gov, NCT03764436.Funding Information: Dubai Cares; Saving Brains, Grand Challenges Canada. Declaration of Interests: We declare no competing interests.Ethics Approval Statement: Adult caregivers provided both written and oral informed consent, and children were asked to verbally assent. Ethical approval was obtained from the Aga Khan University Ethics Review Committee, the Pakistan National Bioethics Committee, and the Harvard T.H. Chan School of Public Health Institutional Review Board.