Study Design
A pragmatic, parallel, cluster randomized controlled trial (cRCT) was conducted to evaluate the effectiveness of an integrated ECD care package at public health facilities in Punjab, Pakistan. The unit of randomization was a public health facility at a 1:1 allocation ratio. Cluster design was used to prevent the risk of contamination as it was not viable to expect the provider to effectively give or withhold the components of the intervention based on the client's individual allocation. The reporting adhered to the CONSORT extension for randomized trials (The CONSORT 2010 Checklist).