Integrated Early Childhood Development in Cambodia: Protocol of a Cluster Stepped-Wedge Trial.

Abstract

Limited evidence is available on mechanisms linking integrated, multisector interventions with early childhood development. The Integrated Early Childhood Development program aims to improve children's development by promoting targeted caregiving behaviors beginning prenatally through age 5 years, in partnership with the Royal Government of Cambodia. This cluster stepped-wedge trial is being conducted in Cambodia among 3 cohorts, encompassing 339 villages and 1790 caregivers who are pregnant or caring for a child aged <5 years. The 12- to 15-month intervention is delivered to each cohort using a staggered stepped-wedge design. Among all cohorts, enrollment evaluations will be followed by 3 data collection waves. Targeted caregiving interventions are provided through community, group, and home-visiting platforms. Child development is measured using the Caregiver Reported Early Development Instrument and the Early Childhood Development Index 2030. The evaluation assesses mediation through targeted caregiving behaviors: responsive caregiving, nutrition, health and hygiene, and household stability and support; moderation by household wealth, caregiver education, and child birth weight; and sustainability after the intervention concludes. This protocol article describes the plans for a cluster randomized controlled trial to measure the impact of an integrated, multisector intervention on children's development. By partnering with the Royal Government of Cambodia and addressing intervention pathways and moderators, this trial will provide guidance for policies and programs to promote early childhood development using principles of implementation science and equity, including increased investment for vulnerable families.