Effectiveness of an integrated care package for Refugee mothers and children: protocol for a cluster randomised controlled trial

Background:

Thousands of Rohingya refugee mothers at the world’s largest refugee camp located in Bangladesh are at risk of poor mental health. Their children are vulnerable to delayed cognitive and physical development.

Objective:

This study aims to evaluate an integrated care package’s effectiveness in reducing the prevalence of developmental delays among children aged one year and improving their mothers’ mental health status.

Methods:

This is a parallel, two-arms, single-blind, cluster randomized controlled trial (cRCT). A total of 704 mother-child dyads residing at the Kutupalong refugee camp in Cox’s Bazar, Bangladesh, will be recruited from 22 clusters, with 32 mother-child dyads per cluster. In the intervention arm, an integrated early childhood development (ECD) and maternal mental health (MMH) package will be delivered every quarter to mothers of newborns by trained community health workers (CHWs) until the child is one year old. Our primary outcome is a reduction in the prevalence of two or more childhood developmental delays of infants aged one year, compared to the usual treatment. The secondary outcomes include reduced stunting among children and the prevalence of maternal depression. We will also assess the cost-effectiveness of the integrated intervention and explore the intervention’s acceptability and feasibility.

Results:

The study is currently at the stage of end-point assessment. The data analysis will start in December 2020, and the result of the study is expected to be published during the first quarter of 2021.

Conclusions:

The study will address the burden of childhood developmental delays and poor maternal mental health in a low resource setting. If proven effective, the delivery of the intervention through CHWs will ensure the proposed intervention’s sustainability. Clinical Trial: The trial has been registered with the Current Controlled Trials ISRCTN10892553.

URL: https://preprints.jmir.org/preprint/25047/accepted