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Follow Up of Severely Malnourished Children (FUSAM) (FUSAM)

Primary Purpose

Severe Acute Malnutrition

Status

Completed

Phase

Not Applicable

Locations

Nepal

Study Type

Interventional

Intervention

NUTPSY treatment

NUT treatment

About this trial

This is an interventional treatment trial for Severe Acute Malnutrition focused on measuring Severe acute malnutrition, Psychosocial intervention, Child, Stimulation, CMAM, Nepal

Eligibility Criteria

6 Months - 23 Months (Child)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

ACF, Nepal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

new combined NUTPSY treatment

standard NUT treatment

Arm Description

2-month combined nutrition and psychosocial intervention

2-month of standard nutritional treatment only

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

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.

Child stimulation

Family Care Indicators (FCI) (Frongillo et al, 2003) is used to assess the quality of child stimulation

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.

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.

Maternal self-esteem

The Rosenberg self-esteem scale (Rosenberg, 1965) assesses maternal self-esteem.

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.

Child growth (height)

Child growth measures change in height

Child nutritional status defined by Mid-Upper Arm Circumference (MUAC)

Comparison of the mean MUAC adjusted to age, sex and height

Child nutritional status defined by Weight-For-Height Z-score

Comparison of the mean Weight-For-Height Z-score

Child nutritional status defined by height-for-Age Z score

Comparison of the mean height-for-Age Z score

Child health status (morbidity rate)

Follow-up of morbidity rate

Child death (mortality rate)

Follow-up of mortality rate

Full Information

NCT ID

NCT02672982

First Posted

January 13, 2015

Last Updated

March 11, 2022

Sponsor

Action Contre la Faim

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

1. Study Identification

Unique Protocol Identification Number

NCT02672982

Brief Title

Follow Up of Severely Malnourished Children (FUSAM)

Acronym

FUSAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

December 8, 2014 (Actual)

Primary Completion Date

January 31, 2017 (Actual)

Study Completion Date

January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Action Contre la Faim

Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Severe Acute Malnutrition

Keywords

Severe acute malnutrition, Psychosocial intervention, Child, Stimulation, CMAM, Nepal

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

427 (Actual)

8. Arms, Groups, and Interventions

Arm Title

new combined NUTPSY treatment

Arm Type

Experimental

Arm Description

2-month combined nutrition and psychosocial intervention

Arm Title

standard NUT treatment

Arm Type

Active Comparator

Arm Description

2-month of standard nutritional treatment only

Intervention Type

Other

Intervention Name(s)

NUTPSY treatment

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

NUT treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Child motor, cognitive, emotional and social development assessed with Ages and Stages Questionnaire

Description

Time Frame

up to 11 months after inclusion

Secondary Outcome Measure Information:

Title

Child Care Practices

Description

Time Frame