An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition

The Effect of an Intervention Program for Primary Caregivers on the Development of Children With Severe Malnutrition: A Cluster Randomized Controlled Clinical Trial

This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.

Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.

Comparison group will receive the current standard of care. Nurses are instructed to tell mothers about nutrition and water, sanitation and hygiene at any point prior to discharge from hospital. In addition, nurses will tell primary caregivers to play with their children even while they are receiving treatment in a play area with toys available.

Primary caregivers in the intervention group receive group education sessions involving psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene components during a total of four days.

Daily 45 minutes of group teaching for primary caregivers, followed by 45 minutes of supervised play and stimulation with their children for a total of four days. Teaching modules consist of psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene practices.

Nutrition and water sanitation and hygiene counseling at any point prior to discharge from hospital as per the local nutrition rehabilitation unit standard of care. In addition, primary caregivers will be stimulated to play with their children in a play area.

During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)

During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)

During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days)

Questionnaire with the following modules: hygiene and sanitation, nutrition and feeding with a 24-hour food recall of the child (follow-up only), and malnutrition knowledge and attitudes

Inclusion Criteria: Child 6-59 months of age with severe malnutrition Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications Primary caregiver (self-identified) present at hospital. Exclusion Criteria: Primary caregiver declined to give informed consent; Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months) Child requires a surgical procedure.

Daniel AI, Bwanali M, Tenthani JC, Gladstone M, Voskuijl W, Potani I, Ziwoya F, Chidzalo K, Mbale E, Heath A, Bourdon C, Njirammadzi J, van den Heuvel M, Bandsma RHJ. A Mixed-Methods Cluster-Randomized Controlled Trial of a Hospital-Based Psychosocial Stimulation and Counseling Program for Caregivers and Children with Severe Acute Malnutrition. Curr Dev Nutr. 2021 Jul 21;5(8):nzab100. doi: 10.1093/cdn/nzab100. eCollection 2021 Aug.

Daniel AI, van den Heuvel M, Gladstone M, Bwanali M, Voskuijl W, Bourdon C, Potani I, Fernandes S, Njirammadzi J, Bandsma RHJ. A mixed methods feasibility study of the Kusamala Program at a nutritional rehabilitation unit in Malawi. Pilot Feasibility Stud. 2018 Sep 24;4:151. doi: 10.1186/s40814-018-0347-8. eCollection 2018.

Daniel AI, van den Heuvel M, Voskuijl WP, Gladstone M, Bwanali M, Potani I, Bourdon C, Njirammadzi J, Bandsma RHJ. The Kusamala Program for primary caregivers of children 6-59 months of age hospitalized with severe acute malnutrition in Malawi: study protocol for a cluster-randomized controlled trial. Trials. 2017 Nov 17;18(1):550. doi: 10.1186/s13063-017-2299-3.