Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509484532555 Date of Registration: 11/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Play to Thrive: Testing a Culturally Adapted Play Therapy Framework to Improve Recovery of Malnourished Children in Ugandan Hospitals
Official scientific title A Randomized Controlled Trial of a Culturally Adapted Play Therapy Intervention to Enhance Nutritional, Psychological, and Physical Recovery of Children with Severe Acute Malnutrition in Ugandan Referral Hospitals
Brief summary describing the background and objectives of the trial Children with Severe Acute Malnutrition (SAM) face not only life-threatening nutritional deficits but also significant developmental and psychological risks. While the World Health Organization (WHO) and UNICEF recommend daily play and caregiver interaction as an essential component of SAM management, this aspect is rarely implemented in Ugandan hospitals. This trial evaluates the effectiveness of a culturally adapted, tri-modal play therapy framework—which integrates (1) free play through child-centered play therapy (CCPT), (2) structured play activities, and (3) caregiver–child interactive play—using locally available and UNICEF-supported tools, including the “Project Play” approach with RUTF carton-based toys. The objectives are to determine the feasibility, fidelity, and impact of the tri-modal play therapy intervention on the nutritional (weight gain velocity, MUAC, length of stay), psychological (caregiver–child interaction, emotional regulation), and physical (motor milestones, activity levels) recovery outcomes of children with SAM when integrated into routine inpatient treatment at four Ugandan referral hospitals.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Play to Thrive RCT
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Nutritional, Metabolic, Endocrine,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 05/01/2026
Actual trial start date
Anticipated date of last follow up 30/06/2027
Actual Last follow-up date 05/07/2027
Anticipated target sample size (number of participants) 400
Actual target sample size (number of participants) 378
Recruitment status Not yet recruiting
Publication URL To be got after peer review
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Tri Modal Play Therapy 15–30 minutes daily, 5–7 days/week during inpatient stay From randomisation until discharge (typically 7–21 days; up to 28 days if admission is prolonged) A culturally adapted tri‑modal package delivered by trained ward staff with active caregiver involvement: Free Play (Child‑Centered Play Therapy/CCPT) – child‑led play to support autonomy and emotional regulation; Structured Play – brief, goal‑oriented activities (gross/fine motor, language, problem‑solving) using locally available materials and UNICEF Project Play tools (e.g., RUTF carton‑based toys); Caregiver–Child Play – coached co‑engagement to strengthen responsive caregiving and carryover to home. Sessions follow a standard checklist (orient → select developmentally appropriate activity → model caregiver involvement → scaffold → close with a simple home‑practice tip). Fidelity is monitored (adherence, dose, quality, responsiveness, differentiation). The intervention is in addition to standard inpatient SAM care per national/WHO guidance. 189
Control Group Standard SAM Inpatient Care Per hospital protocol (feeding, medical management, counselling) From admission until discharge Participants receive standard inpatient management of Severe Acute Malnutrition according to WHO and Uganda IMAM guidelines (medical stabilization, therapeutic feeding, routine medications, caregiver counselling). No structured/tri-modal play therapy sessions are delivered. Informal play that occurs as part of routine ward life is not restricted but is not scheduled or coached. 189 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 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 Infant: 0 Month(s)-12 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 30/09/2025 Makerere University School of Public Health Higher Degrees Research and Ethics Committee MakSPH HDREC
Ethics Committee Address
Street address City Postal code Country
Mulago Hill Road, New Mulago Complex, School of Public Health Building Kampala 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 0,7,14, discharge days,4 weeks,3 months post discharge
Secondary Outcome 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 0,7,14,discharge,1,3 months post discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mwanamugimu Nutrition Unit Mulago National Referral Hospital Mulago Hill Road, within Mulago Hospital Complex Kampala 7051 Uganda
Mbale Regional Referral Hospital Along Pallisa Road Mbale 22 Uganda
Gulu Regional Referral Hospital Hospital Road, Pece Division Gulu 160 Uganda
Mbarara Regional Referral Hospital Bananuka Drive, Off Ruharo Road Mbarara 40 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Evas Juliet Tibagonzeka Makerere Hill Road Kampala 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Evas Juliet Tibagonzeka Makerere Hill Road Kampala Uganda Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Christopher Garimoi Orach cgorach@musph.ac.ug 0772511444 Makerere Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Supervisor
Role Name Email Phone Street address
Scientific Enquiries Edward Buzigi ebuzigi@musph.ac.ug 0772867437 Makerere Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Supervisor
Role Name Email Phone Street address
Public Enquiries Sabrina Kitaka sabrinakitaka@gmail.com 0772401790 Makerere Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda Supervisor
Role Name Email Phone Street address
Principal Investigator Evas Juliet Tibagonzeka evasgoshens@gmail.com 0788135124 Makerere Hill Road
City Postal code Country Position/Affiliation
Kampala 7072 Uganda PhD Student
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) collected during the trial, including demographic information, anthropometric measurements (e.g., weight, MUAC, height), psychomotor and socio-emotional development scores, nutritional intake data, length of stay, and intervention adherence metrics. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD and associated documents will be available 12 months after primary publication and for a period of 5 years thereafter. Access to IPD will be granted to qualified researchers whose proposed use of the data has been approved by an independent review committee ("data access committee"). Requestors must submit a data access proposal, including intended use, analysis plan, and data protection safeguards. A data sharing agreement will be required to ensure privacy and ethical use.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/09/2025 The actual sample size for the experimental arm is n = 189, which represents half of the total sample size of 378 participants. For the structured play therapy sessions, the 189 children will be organized into approximately 38 smaller, manageable groups, each consisting of five children. Experimental Group, Tri Modal Play Therapy, 15–30 minutes daily, 5–7 days/week during inpatient stay, From randomisation until discharge (typically 7–21 days; up to 28 days if admission is prolonged), A culturally adapted tri‑modal package delivered by trained ward staff with active caregiver involvement: Free Play (Child‑Centered Play Therapy/CCPT) – child‑led play to support autonomy and emotional regulation; Structured Play – brief, goal‑oriented activities (gross/fine motor, language, problem‑solving) using locally available materials and UNICEF Project Play tools (e.g., RUTF carton‑based toys); Caregiver–Child Play – coached co‑engagement to strengthen responsive caregiving and carryover to home. Sessions follow a standard checklist (orient → select developmentally appropriate activity → model caregiver involvement → scaffold → close with a simple home‑practice tip). Fidelity is monitored (adherence, dose, quality, responsiveness, differentiation). The intervention is in addition to standard inpatient SAM care per national/WHO guidance., 5, Experimental Group, Tri Modal Play Therapy, 15–30 minutes daily, 5–7 days/week during inpatient stay, From randomisation until discharge (typically 7–21 days; up to 28 days if admission is prolonged), A culturally adapted tri‑modal package delivered by trained ward staff with active caregiver involvement: Free Play (Child‑Centered Play Therapy/CCPT) – child‑led play to support autonomy and emotional regulation; Structured Play – brief, goal‑oriented activities (gross/fine motor, language, problem‑solving) using locally available materials and UNICEF Project Play tools (e.g., RUTF carton‑based toys); Caregiver–Child Play – coached co‑engagement to strengthen responsive caregiving and carryover to home. Sessions follow a standard checklist (orient → select developmentally appropriate activity → model caregiver involvement → scaffold → close with a simple home‑practice tip). Fidelity is monitored (adherence, dose, quality, responsiveness, differentiation). The intervention is in addition to standard inpatient SAM care per national/WHO guidance., 189,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 01/09/2025 Initially, the control group size was mistakenly recorded as 1 based on the individual nature of standard care delivery, where each child receives treatment independently and not within a group setting. However, this figure did not reflect the actual sample size allocated to the control arm. Upon final review of the study design, it has been corrected that the control group will comprise 189 children, consistent with the 1:1 allocation ratio in this parallel randomized controlled trial. While these participants will not be grouped for intervention purposes—as they will receive routine inpatient therapeutic care for Severe Acute Malnutrition (SAM)—their total number matches that of the experimental arm to ensure statistical balance and comparability of outcomes. Control Group, Standard SAM Inpatient Care, Per hospital protocol (feeding, medical management, counselling), From admission until discharge, Participants receive standard inpatient management of Severe Acute Malnutrition according to WHO and Uganda IMAM guidelines (medical stabilization, therapeutic feeding, routine medications, caregiver counselling). No structured/tri-modal play therapy sessions are delivered. Informal play that occurs as part of routine ward life is not restricted but is not scheduled or coached., 1, Active-Treatment of Control Group Control Group, Standard SAM Inpatient Care, Per hospital protocol (feeding, medical management, counselling), From admission until discharge, Participants receive standard inpatient management of Severe Acute Malnutrition according to WHO and Uganda IMAM guidelines (medical stabilization, therapeutic feeding, routine medications, caregiver counselling). No structured/tri-modal play therapy sessions are delivered. Informal play that occurs as part of routine ward life is not restricted but is not scheduled or coached., 189, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 06/09/2025 The change is from Self to Evas Juliet Tibagonzeka. The reason for change is because this part needs an actual Name Self, Makerere Hill Road, Kampala, 7072, Uganda, Self Funded, Evas Juliet Tibagonzeka, Makerere Hill Road, Kampala, 7072, Uganda, Self Funded,