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NCT Number: NCT06653790

PSYCHOSOCIAL STIMULATIONS AND TREATMENT OUTCOME OF SEVERE ACUTE MALNOURISHED CHILDREN

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.

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Key information

Conditions

Malnutrition Severe

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

The World Health Organisation (WHO) also suggests including psychological stimulation in the treatment of severe acute malnutrition. However, there is limited evidence that these interventions are beneficial for SAM children, especially when there are severe food shortages and a lack of a balanced diet.

There is limited available research in Pakistan examining the impact of psychosocial stimulation on severely malnourished children and a significant gap in its implementation. It is obvious that current implementation research is needed to understand how to improve brain development in children with SAM who require inpatient care in a practical and pragmatic approach.

The purpose of this study is to present data on the efficacy of these therapies, which may help shape future SAM treatment plans and policies. Mitigating the physical and mental dimensions of malnourishment can result in more enduring and significant consequences, ultimately enhancing the standard of living for millions of children around the globe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

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.

Primary outcomes

Developmental performance

Time frame: 6- months from baseline

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.

Secondary outcomes

Child growth

Time frame: 6- months from baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad Arshed, MBBS, MPH,PhD

CONTACT

[email protected]

00923337474464

Nabeela Mushtaq, MBBS, FCPS

CONTACT

[email protected]

00923324292532

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

EFFECT OF PSYCHOSOCIAL STIMULATIONS ON TREATMENT OUTCOME OF SEVERE ACUTE MALNOURISHED CHILDREN

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 22, 2024
Registry last updated: Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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