Abstract
BackgroundSevere Acute Malnutrition (SAM) remains a major cause of child mortality. To improve the management and survival of children the World Health Organization (WHO) endorsed the protocol for the management of SAM. The protocol suggested the integration of psychosocial stimulation as part of the medico-nutritional care process to prevent the long-term adverse developmental impact of the SAM. However, there is little scientific evidence behind the recommended stimulation intervention.MethodA parallel-group cluster-randomized controlled trial will be conducted among 144 children with SAM age 6–59 months in Southern Ethiopia. The study will have two groups where: children with SAM admitted in the intervention health facilities will receive psychosocial stimulation in addition to the routine inpatient care and for 6 months after discharge. Children with SAM admitted in the SC of the control health facilities will receive the routine inpatient care without psychosocial stimulation and home-based follow up for 6 months after discharge. All mothers/ caregivers will also receive uniform health education on child health-related issues. The primary outcome of the study will be child development while the secondary outcomes will include child growth and treatment outcome. All outcomes will be assessed four times: at enrollment, upon discharge from the SC, at 3 and 6 months of follow up. The data will be analyzed using STATA Version 15 Statistical Software. The anthropometric Z-scores and percentile of the median will be calculated child using WHO Anthro Version 3.2.2 Statistical Software. To assess the overall effect of the intervention by controlling other potential contributing factors, a generalized linear mixed model will be used.DiscussionThe present study will have an important contribution in generating supplementary evidence regarding the effect of psychosocial stimulation interventions on the development and growth outcomes of children with SAM. The study will further address the impact of the intervention on treatment outcome indicators that are still under-researched areas requiring new scientific evidence.Trial registrationPan African Clinical Trials Registry -PACTR201901730324304. Registered 25 November 2018, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=5739
Highlights
Severe Acute Malnutrition (SAM) remains a major cause of child mortality
The present study will have an important contribution in generating supplementary evidence regarding the effect of psychosocial stimulation interventions on the development and growth outcomes of children with SAM
The study will further address the impact of the intervention on treatment outcome indicators that are still under-researched areas requiring new scientific evidence
Summary
Few studies were conducted to examine the effect of psychosocial stimulation interventions provided in conjunction with the routine nutritional care of children with SAM. The present study will have an important contribution in generating supplementary evidence regarding the effect of psychosocial stimulation interventions on the development and growth outcomes of children in resources poor public health facilities. The study will further address the impact of the intervention on treatment outcome indicators that are still under-researched areas requiring new scientific evidence. At the time of submission, the recruitment of study subjects is not yet started. The whole study will take an estimated 14 months. The recruitment, the intervention and follow up of the study subjects will take place for 8 months duration beginning from November 2019. The activities of the final phase of the study such as data analysis, report write up and manuscript preparation will take an estimated 3 months
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