Al Azdi 2021.
| Study name | Effectiveness of an integrated care package for refugee mothers and children: protocol for a cluster randomized controlled trial |
| Methods |
Study design: cluster‐RCT Country: Bangladesh |
| Participants | Refugee mothers and their children Inclusion criteria (for mother‐child pairs): a. Child should be less than or equal to 6 weeks old, live with their biological mother, had a gestational period of at least 36 weeks, and weighed at least 2.5 kilograms at birth. Exclusion criteria: a. children with congenital abnormalities; b. mothers that have to move out of the area during the study period. Stated purpose: to evaluate the effectiveness of an integrated care package in reducing the prevalence of developmental delays amongst children aged 1 year and improving their mothers’ mental health status |
| Interventions |
Intervention: Integrated care package A total of four counselling sessions will be delivered to mother‐child dyads by CHWs in the intervention arm to promote early child development and maternal mental health. The counselling sessions will focus on the child’s cognitive and physical development, and the mother’s mental health based on a few key messages. The counselling contents are developed in consultation with technical experts, supported by a pictorial flip book that has been modified according to the local context and translated into Burmese to be consistent in delivering the messages. Each session will take at least 10‐15 minutes. Control: No intervention (the control arm will be strengthened by providing a 2‐day training to CHWs on recruitment of the mother‐child dyads, administration of outcome measures, record‐keeping, log maintenance, compliance, and communication. They will also be trained on taking anthropometric measurements to record the children’s height, weight, and mid‐upper arm circumference (MUAC) every quarter. These inputs will be the same for the control and intervention arms). |
| Outcomes |
Participants' outcomes of interest for this review
Economic outcomes Nil Time points: baseline, post‐intervention (endpoint) |
| Starting date | NA |
| Contact information | NA |
| Notes |
Source of funding: Grand Challenges Canada, Saving Brains (grant number SB‐1810‐19890) Prospective trial registration number: ISRCTN10892553 |