Follow Up of Severely Malnourished Children (FUSAM)

Study Overview
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Brief Summary
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The overall objective of the research is to assess the long-term and cost-effectiveness of a combined nutrition psychosocial intervention to a stand-alone nutritional treatment of children with Severe Acute Malnutrition (SAM) aged 6 to 24 months in the Saptari District of Nepal.

Detailed Description
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In Nepal, the majority of SAM children are treated with therapeutic food in community/home-based care, and little is known about the long-term sustainability of the nutritional and health benefits of treatment after rehabilitation. The two treatments will be compared in terms of costs of treatment and convened health benefits (child nutritional status and development, cured rate and relapse, maternal mental health, and family care practices) at both short and long-term periods after admission. The proposed complementary psychosocial intervention focuses directly on the key underlying determinants of acute malnutrition within children's early years, such as child care practices and stimulation, parent-child relationships and maternal mental health. It includes the mother/caregiver as patient of psychosocial support, but also empowers her as the key ally in the treatment of the undernourished child. Adding a brief psychosocial component to the standard medico-nutritional treatment is expected to pay off in terms of sustainable recovery, health, and development outcomes of children.

Official Title
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Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.

Conditions
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Severe Acute Malnutrition

Intervention / Treatment
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* Other: NUTPSY treatment
* Other: NUT treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 6-23 months 2 sexes Diagnosis: uncomplicated severe acute malnutrition requiring follow-up outpatient therapeutic feeding unit (OTPs), supported by Action Contre la Faim in Saptari district Weight-for-height (WH) <-3 Standard Deviation compared to the WHO reference and/or MUAC <115 mm And / or nutritional oedema moderate (+ or + +) And successful test of appetite And no medical complications New cases Presence of mother / father or legal guardian aged > 18 years. Understanding of the consent and information letter Follow-up possible Exclusion Criteria: Age <6 months or> 24 months Moderate Acute Malnutrition Severe Acute Malnutrition complicated Weight for height <-3 Standard Deviation compared to the WHO reference and / or MUAC <115mm but failure to test appetite OR medical complications OR severe oedema + + + OR kwashiorkor, marasmus (malnutrition with the same criteria, with oedema mild or severe). Relapse or if already registered in the past two months; Any child with developmental anomalies, known chronic illnesses like epilepsy, twins and multiple births, parents not consenting,

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 23 Months

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new combined NUTPSY treatment<br>2-month combined nutrition and psychosocial intervention | Other: NUTPSY treatment<br>* The psychosocial component of the new combined treatment involves seven weekly counselling sessions with mothers focused on feeding, emotional attachment, stages of child development, stimulation, emotional responsiveness and interaction, and on concerns/strategies of child care and parenting.<br>|
| Active Comparator: standard NUT treatment<br>2-month of standard nutritional treatment only | Other: NUT treatment<br>* Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire | The Ages and Stages Questionnaire (Squires et al, 1999), is a low-cost, easily administered, parent-report screening test of development in communication, motor, problem-solving and personal-social domains. The questionnaire has been adapted and used in low- and middle-income countries in Africa, Asia and Latin America, where it has demonstrated sensitivity to child nutritional status and psychosocial stimulation. While it is not a diagnostic test, it offers an opportunity to systematically obtain information about children's development with an instrument that does not require extensive training | up to 11 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Care Practices | The quality of care practices is measured by assessing the level of knowledge and the practices. It comprises sub-thematics: care for women, pregnancy and delivery, care for the newborn, breastfeeding and feeding, access to resources for care, as well as child development and psychosocial care. The Child Care Knowledge & Practices Questionnaire has been developped by Action Contre la Faim. | Up to 11 months after inclusion | 
| Mother-child interaction | Action Contre la Faim's Mother-Child Interaction Grid will be used for assessing the quality of mother-child interactions and interpersonal sensitivity and responsiveness. | Up to 11 months after inclusion | 
| Child stimulation | Family Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation | Up to 11 months after inclusion | 
| Maternal perinatal mental health | The Edinburgh Post-natal Depression Scale (Cox et al, 1987) is a valuable and efficient way of identifying mothers at risk for perinatal depression. | Up to 11 months after inclusion | 
| Perceived Social Support | The Multidimensional Scale of Perceived Social Support (Zimet et al, 1988) measures perceived support from 3 sources: family, friends and significant others. | Up to 11 months after inclusion | 
| Maternal self-esteem | The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem. | Up to 11 months after inclusion | 
| Maternal mental health | The WHO Self Reporting Questionnaire (SRQ-20) (WHO, 1994) assesses the frequency of depressive symptoms, anxiety, and psychosomatic complaints in the past month. The measure has been shown to be an accurate predictor of common mental disorder and has been successfully used in several studies in developing countries. | Up to 11 months after inclusion | 
| Child growth (height) | Child growth measures change in height | Up to 11 months after inclusion | 
| Child nutritional status defined by Mid-Upper Arm Circumference (MUAC) | Comparison of the mean MUAC adjusted to age, sex and height | Up to 11 months after inclusion | 
| Child nutritional status defined by Weight-For-Height Z-score | Comparison of the mean Weight-For-Height Z-score | Up to 11 months after inclusion | 
| Child nutritional status defined by height-for-Age Z score | Comparison of the mean height-for-Age Z score | Up to 11 months after inclusion | 
| Child health status (morbidity rate) | Follow-up of morbidity rate | Up to 11 months after inclusion | 
| Child death (mortality rate) | Follow-up of mortality rate | Up to 11 months after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Severe acute malnutrition, Psychosocial intervention, Child, Stimulation, CMAM, Nepal