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. 2021 May 4;10(5):e25047.
doi: 10.2196/25047.

Effectiveness of an Integrated Care Package for Refugee Mothers and Children: Protocol for a Cluster Randomized Controlled Trial

Zunayed Al Azdi  1 , Khaleda Islam  1 , Muhammad Amir Khan  2 , Nida Khan  2 , Amna Ejaz  2 , Muhammad Ahmar Khan  2 , Azza Warraitch  2 , Ishrat Jahan  1 , Rumana Huque  1
Affiliations

Effectiveness of an Integrated Care Package for Refugee Mothers and Children: Protocol for a Cluster Randomized Controlled Trial

Zunayed Al Azdi et al. JMIR Res Protoc. .

Abstract

Background: Thousands of Rohingya refugee mothers at the world's largest refugee camp located in Bangladesh are at risk of poor mental health. Accordingly, their children are also vulnerable to delayed cognitive and physical development.

Objective: The aim of this study is to evaluate the effectiveness of an integrated care package in reducing the prevalence of developmental delays among children aged 1 year and improving their mothers' mental health status.

Methods: This is a parallel, two-arm, 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 and maternal mental health package will be delivered every quarter to mothers of newborns by trained community health workers until the child is 1 year old. Our primary outcome is a reduction in the prevalence of two or more childhood developmental delays of infants aged 1 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 will further explore the intervention's acceptability and feasibility.

Results: At the time of submission, the study was at the stage of endpoint assessment. The data analysis started in December 2020, and the results are expected to be published after the first quarter of 2021.

Conclusions: This 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 community health workers will ensure the proposed intervention's sustainability.

Trial registration: ISRCTN Registry ISRCTN10892553; https://www.isrctn.com/ISRCTN10892553.

International registered report identifier (irrid): DERR1-10.2196/25047.

Keywords: Bangladesh; Rohingya; community health care; community health worker; early childhood development; mental health; refugee health.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Logic model for intervention mechanism. CHW: community health worker; ECD: early childhood development; ASQ-3: Ages and Stages Questionnaire third edition; PHQ-9: Patient Health Questionnaire-9.
Figure 2
Figure 2
Trial flow. ECD: early childhood development; ASQ-3: Ages and Stages Questionnaire third edition; PHQ-9: Patient Health Questionnaire 9.
See this image and copyright information in PMC

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