Mental and Behavioural Disorders Nutritional, Metabolic, Endocrine Paediatrics
Conditions
Interventions
Tri Modal Play Therapy
Standard SAM Inpatient Care
Sponsors
Evas Juliet Tibagonzeka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children aged 6–59 months (i.e., 6 months to under 5 years) Diagnosed with Severe Acute Malnutrition (SAM) using WHO criteria: Weight-for-height/length < -3 Z-scores, or MUAC <11.5 cm, or Presence of nutritional edema Admitted to the Inpatient Therapeutic Care (ITC) unit at Mwanamugimu or selected regional referral hospitals Medically stable and eligible for Phase 2 (rehabilitation/play) according to SAM treatment protocols Consent obtained from the parent or legal guardian Willingness of caregiver to engage in at least one play session per day
Exclusion criteria
Exclusion criteria: Children with known neurodevelopmental disorders or severe congenital anomalies Children with co-morbidities requiring intensive care (e.g., severe pneumonia, sepsis not yet stabilized) Children with physical disabilities that preclude participation in structured play sessions (unless adapted play is available) Children with severe mental distress or trauma needing specialized psychosocial care Children already enrolled in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome type: Primary Outcome: Mean weight gain (g/kg/day) Time point(s) at which outcome measured: Baseline (admission), Day 7, Day 14, At discharge Outcome type: Primary Outcome: MUAC (cm) change from baseline Time point(s) at which outcome measured: Baseline, Day 7, Day 14, At discharge, 4 weeks post-discharge Outcome type: Primary Outcome: Psychomotor development score (MDAT total z-score) Time point(s) at which outcome measured: Baseline when clinically stable, At discharge, 4 weeks post-discharge, 3 months post-discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome type: Secondary Outcome: Weight-for-length/height z-score (WHZ) change from baseline Time point(s) at which outcome measured: Baseline, Day 14, At discharge, 3 months post-discharge Outcome type: Secondary Outcome: Length of hospital stay (days) Time point(s) at which outcome measured: At discharge Outcome type: Secondary Outcome: Readmission within 30 days post-discharge (yes/no) Time point(s) at which outcome measured: 30 days post-discharge Outcome type: Secondary Outcome: Caregiver–child interaction quality (HOME/OMCI score) Time point(s) at which outcome measured: Baseline (stable), At discharge, 3 months post-discharge Outcome type: Secondary Outcome: Child socio-emotional functioning (e.g., ASQ:SE-2 score) Time point(s) at which outcome measured: Baseline (stable), At discharge, 3 months post-discharge Outcome type: Secondary Outcome: Intervention fidelity (% of planned play sessions delivered; adherence checklist score) Time point(s) at which outcome measured: Daily during admission; summarized at discharge Outcome type: Secondary Outcome: Adverse events related to intervention (e.g., falls, distress requiring termination of session) Time point(s) at which outcome measured: Continuously during admission; summarized at discharge Outcome type: Secondary Outcome: Caregiver stress (Perceived Stress Scale short form) Time point(s) at which outcome measured: Baseline (stable), At discharge Outcome type: Secondary Outcome: Dietary intake adequacy during admission (% RUTF/RUFT target achieved per protocol) Time point(s) at which outcome measured: Daily during admission; summarized at discharge | — |
Countries
Uganda
Contacts
Public ContactSabrina Kitaka
Supervisor
Outcome results
None listed