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Forced Displacement and Mental Health
Initial registration date
April 09, 2020
April 10, 2020 11:46 AM EDT
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Technical University of Munich
Other Primary Investigator(s)
University of Newcastle
Additional Trial Information
This document lays out the research design and analysis plan for evaluating the impact of a program that aims to improve the mental health of forcibly displaced women and their children under 2 years. Through a home-based counseling program, Rohingya refugee women, residing in refugee camps in Bangladesh, are counseled weekly on mental health and child-rearing issues. The primary aim is to help them and their children overcome conflict and displacement induced trauma and depression. We evaluate the effect of this program using a cluster randomized control trial. The intervention began in early November 2019 and is scheduled to run for 60 weeks.
Counselings Rohingya refugee mothers (with 0-2-year-old children) weekly, in small groups, on issues related to mental health and childcare.
Intervention Start Date
Intervention End Date
Primary Outcomes (end points)
Trauma and depression of mothers and children.
Primary Outcomes (explanation)
The primary symptoms of psychological trauma are fear that is usually caused by re-experiencing traumatic memories and unusual emotional outbursts. Survey questions on trauma symptoms are asked on a 5-point scale (never (=0); less often (=1); sometimes (=2); very often (=3); always (=4)). We will construct a simplistic trauma index for each mother and child using survey questions on trauma symptoms. This index weights each question equally and, hence, would simply be the average of the responses satisfying 0<=Index<=1. Therefore, a higher value of the index means a mother/child has severe trauma.
We will construct the depression indices of mothers and children in the same manner as described above. The analysis plan describes these indices more in detail.
Secondary Outcomes (end points)
Secondary outcomes of mothers: happiness, aspiration, belongingness.
Secondary outcomes of 0-2-year-old children: physical health (underweight and stunting), motor skills (gross and fine), communication skills, problem-solving skills, and personal-social skills.
General secondary outcome: mother-child relationship.
Secondary Outcomes (explanation)
Mothers: Similar to indices explained in 'Primary Outcomes', indices on 'Happiness', 'Aspiration' and 'Belongingness' will also be created using survey questions (with answers on a 5-point scale). These indices weights each question equally and, hence, would simply be the average of the responses satisfying 0<=Index<=1. Therefore, a higher value of the index means a mother is better-off in that category.
Children: Motor (gross and fine), communication, problem-solving, and personal-social skills development questions from the survey (which are age-specific) will be used to create 4 different indices. For each age-group (i.e., below 2 months, 4 months, 6 months, etc., until 24 months), questions vary in order to match with the concerned age-group. These questions are answered on a 3-point scale. We will put equal weights on each question to work out the index, so that we have the average of the responses satisfying 0<=Index<=1. For 'Physical Health', we will explore the height-for-age and weight-for-age z-scores of children to explore stunting and underweightness respectively. We will also create a 'Parent-Child Relationship' index that will use 6 survey questions on children's behavior with their mother. These questions are also answered on a 3-point scale and will be constructed in the same way as the 'Skills' indices. The analysis plan (attached) describes these indices more in detail.
Through a home-based counseling program developed by BRAC, Rohingya refugee women, residing in refugee camps in Bangladesh, are counseled weekly on mental health and child-rearing issues. The primary aim is to help them and their children overcome conflict and displacement induced trauma and depression. We evaluate the effect of this program using a cluster randomized control trial.
Experimental Design Details
Randomization was done by a computer (using STATA).
A refugee camp consists of many blocks. Our unit of randomization is at the block level.
Was the treatment clustered?
Sample size: planned number of clusters
Sample size: planned number of observations
Between 5 and 10 mother-child pairs attend each session. A total of 3,621 mother-child pairs enrolled for the program.
Sample size (or number of clusters) by treatment arms
137 blocks are in the treatment and 114 blocks are in the control arm.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We computed the number of blocks required in each arm with an improvement in mental health by 0.05 units (on a mental health index scale between 0 and 1) at 5% significance level for a cluster-RCT study with 80% power. With the average number of observations in each cluster being 14 with cluster sizes varying by 2 observations, intra-cluster correlation of 0.4, and a within-cluster variation of 0.2, we found that a minimum of 112 blocks with 1,568 mother-child pairs are required in each arm to satisfy this requirement.
INSTITUTIONAL REVIEW BOARDS (IRBs)
BRAC James P Grant School of Public Health, BRAC University
IRB Approval Date
IRB Approval Number