ACF, Nepal
Kathmandu, Nepal
NCT Number: NCT02672982
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.
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Notify Me6 month–23 month
All sexes
Interventional
Not applicable
Kathmandu, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.
Time frame: up to 11 months after inclusion
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
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
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
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
The Edinburgh Post-natal Depression Scale (Cox et al, 1987) is a valuable and efficient way of identifying mothers at risk for "perinatal" depression.
Time frame: Up to 11 months after inclusion
The Multidimensional Scale of Perceived Social Support (Zimet et al, 1988) measures perceived support from 3 sources: family, friends and significant others.
Time frame: Up to 11 months after inclusion
The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.
Time frame: Up to 11 months after inclusion
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.
Time frame: Up to 11 months after inclusion
Child growth measures change in height
Time frame: Up to 11 months after inclusion
Comparison of the mean MUAC adjusted to age, sex and height
Time frame: Up to 11 months after inclusion
Comparison of the mean Weight-For-Height Z-score
Time frame: Up to 11 months after inclusion
Comparison of the mean height-for-Age Z score
Time frame: Up to 11 months after inclusion
Follow-up of morbidity rate
Time frame: Up to 11 months after inclusion
Follow-up of mortality rate
Action Contre la Faim
Other
Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.
Acronym: FUSAM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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