Effectiveness of an Integrated Care Package for Refugee Mothers and Children: Protocol for a Cluster Randomized Controlled Trial.
Bangladesh
Rohingya
community health care
community health worker
early childhood development
mental health
refugee health
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
04 May 2021
04 May 2021
Historique:
received:
15
10
2020
accepted:
09
03
2021
revised:
26
02
2021
entrez:
4
5
2021
pubmed:
5
5
2021
medline:
5
5
2021
Statut:
epublish
Résumé
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. 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. 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. 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. 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. ISRCTN Registry ISRCTN10892553; https://www.isrctn.com/ISRCTN10892553. DERR1-10.2196/25047.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ISRCTN Registry ISRCTN10892553; https://www.isrctn.com/ISRCTN10892553.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/25047.
Identifiants
pubmed: 33944793
pii: v10i5e25047
doi: 10.2196/25047
pmc: PMC8132976
doi:
Types de publication
Journal Article
Langues
eng
Pagination
e25047Informations de copyright
©Zunayed Al Azdi, Khaleda Islam, Muhammad Amir Khan, Nida Khan, Amna Ejaz, Muhammad Ahmar Khan, Azza Warraitch, Ishrat Jahan, Rumana Huque. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 04.05.2021.
Références
Lancet Glob Health. 2015 Aug;3(8):e426-e427
pubmed: 26144388
BJGP Open. 2018 Jun 27;2(2):bjgpopen18X101593
pubmed: 30564726
BMJ. 2004 Apr 3;328(7443):820-3
pubmed: 15070641
Lancet Psychiatry. 2018 Feb;5(2):95-97
pubmed: 29413140
Int J Infect Dis. 2018 Mar;68:39-43
pubmed: 29329951
Lancet. 2014 Oct 4;384(9950):1282-93
pubmed: 24947106
BMJ. 2015 Mar 19;350:h1258
pubmed: 25791983
Dev Med Child Neurol. 2019 Apr;61(4):431-443
pubmed: 29926467
Health Policy. 2019 Sep;123(9):851-863
pubmed: 30850148
J Glob Health. 2018 Dec;8(2):020309
pubmed: 30410735
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
BMJ. 2004 Mar 20;328(7441):702-8
pubmed: 15031246
Early Hum Dev. 2013 Dec;89(12):1011-5
pubmed: 24041814
Early Hum Dev. 2013 Aug;89(8):561-76
pubmed: 23507472