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PSYCHOSOCIAL STIMULATIONS and TREATMENT OUTCOME of SEVERE ACUTE MALNOURISHED CHILDREN

EFFECT of PSYCHOSOCIAL STIMULATIONS on TREATMENT OUTCOME of SEVERE ACUTE MALNOURISHED CHILDREN

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06653790
Enrollment
800
Registered
2024-10-22
Start date
2024-11-10
Completion date
2025-04-10
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition Severe

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALPsychosocial stimulations

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.

Sponsors

Universiti Putra Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Investigator)

Masking description

The care provider and investigators will be blided

Intervention model description

The severely acute malnourished children in intervention group will be sent to development pediatrician who will do a developmental assessment of the child and stimulation. A sensory therapist, an occupational and a physiotherapist will also be available for sessions. The psychosocial stimulation will be offered in two phases: in-patient (at stabilization unit) and after discharge, patient will be referred to outpatient (at outpatient therapeutic center) and developmental outpatient. The sessions with development pediatrician 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 include 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 t

Eligibility

Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Developmental performance6- months from baselineDevelopmental 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

MeasureTime frameDescription
Child growth6- months from baselineGrowth in terms of z-scores (improved from \< -- 3 to \< --1 z-score) and MUAC ( improved from \< 11.5 cm to \> 12.5 cm).

Contacts

Primary ContactNabeela Mushtaq, MBBS, FCPS
70145501@student.uol.edu.pk00923324292532
Backup ContactMuhammad Arshed, MBBS, MPH,PhD
drarshedchaudhary@gmail.com00923337474464

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026