Condition category
Not Applicable
Date applied
25/01/2019
Date assigned
15/05/2019
Last edited
15/05/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The study is going to target the Rohangian refugee population currently placed in more than 20 medium-sized camps in Bangladesh. As per current estimates, around three quarters of a million refugees have already reached; and with continued influx the refugee number will soon reach one million or more. In Myanmar, like most developing countries, early child development is considered to be a grossly neglected area of public health importance. Even before migration (i.e. in their own homeland), most of these refugees have been living in relatively poor circumstances. In refugee camps they are facing circumstances that increase the risk of delayed child development and occurrence of mental health conditions in women. About 1.75% of the 0.75 million refugees are estimated to be less than one year old (i.e. 13,125 infants). As per gross estimates, in the refugee population at least one-third of the less than one-year-old children are suffering from delayed development, and about the same number of mothers of infants are suffering from depression. The delayed development of child milestones relates mainly to: a) chronic child malnutrition due to poor child feeding practices and recurrent infections; and b) low childcare ability of mothers due to lack of child development care skills (<10%) and poor mental health condition of mothers. The refugee population currently lacks access to care for early child development and maternal mental health. The community-based intervention, implemented through modestly educated and enabled refugee women, will cover nutrition and hygiene, child brain development, and maternal mental health.

Who can participate?
Children aged 6 weeks or less and their mothers, living in the participating refugee camps

What does the study involve?
The participating refugee camps are randomly allocated into the intervention group or the control group. The intervention group receive the designed intervention for early child development, nutrition and maternal depression. The intervention is delivered by mothers counseling through community-based care providers. The control group continue with the routine practice that is generally present in the camps.

What are the possible benefits and risks of participating?
The intervention is expected to reduce early child development delays and maternal depression. The control group will continue receiving routine care from the primary health outlets in the respective camps. There are no risks involved for the participants.

Where is the study run from?
Rohangian refugee camps (Bangladesh)

When is the study starting and how long is it expected to run for?
June 2018 to June 2020

Who is funding the study?
Grand Challenges Canada

Who is the main contact?
Dr Muhammad Amir Khan

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muhammad Amir Khan

ORCID ID

Contact details

Association for Social Development
Street# 48
House # 12
Sector F7/4
Islamabad
44210
Pakistan

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

SB-1810-19890

Study information

Scientific title

Delivering a contextualized package of care for child development (0 - 12 months) and maternal mental health in the Rohangian refugee camps in Bangladesh

Acronym

Study hypothesis

The main hypothesis to be tested is that the delivery of child development and maternal mental health care, by modestly educated community-based providers, is potentially effective and feasible in the refugee setting.

Ethics approval

Approved 24/10/2018, Bangladesh Medical Research Council (Bangladesh Medical Research Council, Mohakhali, Dhaka-1212, Bangladesh, Tel: 8819311, 8828396; Email: info@bmrcbd.org), ref: BMRC/NREC/2016-2019/843

Study design

Cluster randomized controlled trial with two arms

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format. Please use contact details to request a participant information sheet.

Condition

Early child development, maternal health, child nutrition

Intervention

The population of 10000 people per cluster was needed to get the required sample size. The average population per block in each block is almost 5-6 thousand. Hence 2 blocks were combined together to make one cluster to get the required population i.e. 10000. After organizing 22 clusters with population more than 10,000, these were arranged with given numbers. These were further allocated into intervention and control arm by simple randomization of selected clusters by drawing clusters from a hat.

Intervention arm
1. Adapted set of intervention materials for the community-based providers to deliver home-based care i.e. pictorial counseling tool and leaflet
2. Trained community-based care providers to visit and counsel each mother, on a quarterly basis, about child development and depression management care (using the intervention materials)
3. The key care contents will include: a) breastfeeding and weaning food; b) infant nurturing and child brain development; c) infection control e.g. food hygiene and hand washing; d) behaviour activation for maternal depression; and e) identify and refer for clinical care

Control arm
Community-based care providers will visit each registered mother-child pair on a quarterly basis. On each quarter the care provider will offer general health guidance, and also facilitate the mother's access to a primary health care facility as needed.
Field Coordinator to monitor every month the performance of each community-based care provider in the trial.

The duration of intervention and follow-up is almost one year with three quarterly follow-ups.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Reduction in two or more than two child development delays, measured by ASQ-3 questionnaire by a trained external assessor at endline

Secondary outcome measures

Measured at endline by a trained external assessor:
1. Maternal depression measured by PHQ-9 questionnaire
2. Height-weight for stunting measured using infantometer and infant weight machine

Overall trial start date

30/06/2018

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Children aged 6 weeks or less
2. Children resident of respective refugee camp

Participant type

Other

Age group

Mixed

Gender

Both

Target number of participants

This trial will have a total of 696 mother-child pairs in 22 clusters, randomly divided into equal number of intervention and control clusters.

Participant exclusion criteria

1. Children of more than 6 weeks
2. Child known to have congenital abnormality, history of delayed cry or seizures, cretinism

Recruitment start date

01/02/2019

Recruitment end date

01/05/2019

Locations

Countries of recruitment

Bangladesh

Trial participating centre

Ukhiya Refugee Camps (8)
Rohangian refugee camps Ukhiya
Kutupalong
4700
Bangladesh

Sponsor information

Organisation

Grand Challenges Canada

Sponsor details

MaRS Centre
South Tower
101 College Street
Suite 406
Toronto
M5G 1L7
Canada
+1 (0)41 673 6568
infor@grandchallenges.ca

Sponsor type

Government

Website

http://www.grandchallenges.ca/who-we-are/

Funders

Funder type

Government

Funder name

Grand Challenges Canada

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

The trialists have planned to publish papers related to the main trial and process evaluation in peer reviewed journals.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

30/09/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/04/2019: Trial's existence confirmed by ethics committee.