Follow Up of Severely Malnourished Children (FUSAM) (FUSAM)
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|ClinicalTrials.gov Identifier: NCT02672982|
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Severe Malnutrition||Other: NUTPSY treatment Other: NUT treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||427 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Follow Up of Severely Malnourished Children (FUSAM): Effectiveness of a Combined Nutrition Psychosocial Intervention on Health and Development.|
|Actual Study Start Date :||December 8, 2014|
|Actual Primary Completion Date :||January 31, 2017|
|Actual Study Completion Date :||January 31, 2017|
Experimental: new combined NUTPSY treatment
2-month combined nutrition and psychosocial intervention
Other: NUTPSY 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.
Active Comparator: standard NUT treatment
2-month of standard nutritional treatment only
Other: NUT treatment
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 [ 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
- Child Care Practices [ 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.
- Mother-child interaction [ 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.
- Child stimulation [ 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
- Maternal perinatal mental health [ 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.
- Perceived Social Support [ 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.
- Maternal self-esteem [ Time Frame: Up to 11 months after inclusion ]The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.
- Maternal mental health [ 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.
- Child growth (height) [ Time Frame: Up to 11 months after inclusion ]Child growth measures change in height
- Child nutritional status defined by Mid-Upper Arm Circumference (MUAC) [ Time Frame: Up to 11 months after inclusion ]Comparison of the mean MUAC adjusted to age, sex and height
- Child nutritional status defined by Weight-For-Height Z-score [ Time Frame: Up to 11 months after inclusion ]Comparison of the mean Weight-For-Height Z-score
- Child nutritional status defined by height-for-Age Z score [ Time Frame: Up to 11 months after inclusion ]Comparison of the mean height-for-Age Z score
- Child health status (morbidity rate) [ Time Frame: Up to 11 months after inclusion ]Follow-up of morbidity rate
- Child death (mortality rate) [ Time Frame: Up to 11 months after inclusion ]Follow-up of mortality rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672982
|Principal Investigator:||Cecile Bizouerne, PhD||Action Contre la Faim|