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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Child Malnutrition

Intervention / Treatment
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* Behavioral: Counseling Intervention Package
* Behavioral: Standard of Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>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. | Behavioral: Standard of Care<br>* 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.<br>|
| Experimental: Counseling Intervention Package<br>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. | Behavioral: Counseling Intervention Package<br>* 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.<br>* Other names: Kusamala Program;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Malawi Developmental Assessment Tool Score | Gross motor, fine motor, language, and social development | 6 months post-discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status based on: mid-upper arm circumference (MUAC) | MUAC in millimeters | 6 months post-discharge from hospital | 
| Nutritional status based on: World Health Organization (WHO) z-scores | Weight-for-length or -height z-scores and height-for-age z-scores | 6 months post-discharge from hospital | 
| Nutritional status based on: nutritionally-induced bilateral pitting oedema | Bilateral pitting oedema | 6 months post-discharge from hospital | 
| Duration of hospital stay | Number of days that hospital treatment is required | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) | 
| Appetite | Number of days that nasogastric tube is required | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) | 
| Clinical deterioration | Number of clinical danger signs | During hospitalization; up to three days before enrollment until discharge from hospital (e.g., up to 30 days) | 
| Readmission | Requiring inpatient treatment | Within 6 months post-discharge from hospital | 
| Mortality | Inpatient or post-discharge mortality | Within 6 months post-discharge from hospital | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child malnutrition, child development, counseling