An interventional study of NUTPSY treatment and NUT treatment in Severe Acute Malnutrition, sponsored by Action Contre la Faim. Completed at 1 site in Nepal. Open to participants aged 6 Months to 23 Months. Per ClinicalTrials.gov, last updated 2022-03-25.
Sponsored by Action Contre la Faim · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Severe Acute Malnutrition; 13 are open to participants now.
This study's enrollment of 427 is close to the median of 400 across 69 interventional studies indexed under Severe Acute Malnutrition.
Browse Severe Acute Malnutrition studies →Action Contre la Faim is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
2-month combined nutrition and psychosocial intervention
Other: NUTPSY treatment
2-month of standard nutritional treatment only
Other: NUT treatment
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.
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
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.
Time frame: 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.
Time frame: Up to 11 months after inclusion
Maternal self-esteem
The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.
Time frame: 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.
Time frame: Up to 11 months after inclusion
Child growth (height)
Child growth measures change in height
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 11 months after inclusion
Child health status (morbidity rate)
Follow-up of morbidity rate
Time frame: Up to 11 months after inclusion
Child death (mortality rate)
Follow-up of mortality rate
Time frame: Up to 11 months after inclusion
Plan to share: No
Ran from Dec 2014 to primary completion in Jan 2017, 25 months.
Of 32 non-industry interventional studies with no phase under Severe Acute Malnutrition, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 28. This study's 25 months is above that.
Counting every sponsor, half of 32 studies reached it within 19 months; a quarter within 11 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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