Prevention of developmental delays among children at public healthcare facilities of Pakistan: protocol for a cluster Randomized Controlled Trial

Objectives: This cluster Randomized Controlled Trial (cRCT) aims to evaluate the effectiveness of an integrated ECD package in preventing developmental delays among children aged two years, in public health care centers, as compared to a control arm. Methods: This is a parallel, two-arm, cluster randomized controlled trial. 768 mother-child pairs ('dyads') attending any of the 24-public health centers in two districts of Pakistan will be recruited. with an average of 32 participants per cluster. In the intervention arm, ECD based counselling sessions will be delivered to mother-child dyads by trained staff at public health care centers. Our primary outcome is reduction in prevalence of two or more developmental delays among children, from 38% to 23% in the intervention arm. Unit of randomization will be public health care center. 24 eligible clusters recruited will be randomized into intervention and control arms, using 1:1 allocation. Discussion: The integrated model of child care into primary health care has the potential to provide a feasible and sustainable model for improving child developmental scale.