PSYCHOSOCIAL STIMULATIONS AND TREATMENT OUTCOME OF SEVERE ACUTE MALNOURISHED CHILDREN

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorUniversiti Putra Malaysia

About this trial

A playroom and a playground are already part of the stabilization unit and are furnished with basic facilities for engaging the SAM children in play-based motor, language, and personal-social activities. The severely acute malnourished children in the intervention group will be sent to a development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational therapist, and a physiotherapist will also be available for sessions.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All children aged 6m to 59 months admitted to stabilization centre fulfilling criteria of severe acute malnutrition will be included in study.

Disqualifiers

Children with chronic diseases like cystic fibrosis, cerebral palsy, celiac disease, chronic kidney disease, chronic liver failure, congenital heart disease, inborn error of metabolism, cleft lip and palate will be excluded from study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psychosocial stimulations

    Behavioral

    The psychosocial stimulation will be offered in two phases: in-patient (at stabilization unit) and after discharge patient will be referred to out-patient (at outpatient therapeutic centre) and developmental out-patient. The sessions with development paediatrician and team will be held every week lasting for about 20-40 min in the presence of the caregiver. The intervention includes auditory, tactile and visual stimulation, hand-eye coordination, and different types of sensory-motor training that included fine and gross motor activities. The guiding principle will be to enhance a child's holistic development-cognitive, language, physical, and social-in an integrated manner by using age-appropriate play materials, cultural tools, and resources.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Developmental performance

Developmental performance in terms of gross motor, fine motor, language and personal-social by using Denver II developmental screening test. The number of test items that a child has successfully performed (passed) is described as the performance score. A child is delayed if he fails to perform what 90% of children of that age can perform. Caution is raised if a child is not able to perform a task that 75% to 90% of children can perform.

Time frame
6- months from baseline

Secondary outcomes

1

Child growth

Growth in terms of z-scores (improved from \< -- 3 to \< --1 z-score) and MUAC ( improved from \< 11.5 cm to \> 12.5 cm).

Time frame
6- months from baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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