Follow Up of Severely Malnourished Children (FUSAM)

Action Contre la Faim427 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

427

Conditions

Severe Acute Malnutrition

Interventions

NUTPSY treatmentOTHER

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.

NUT treatmentOTHER

Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 23 Months

Medical Language ↔ Plain English

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,

Locations (1)

ACF, Nepal

Kathmandu, Nepal

Outcomes

Primary Outcomes

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

Time frame: up to 11 months after inclusion

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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