Skip to content

Evaluating a programme of early assessment, care and support for children at risk of developmental disabilities and their caregivers in Rwanda: the PDC/Baby Ubuntu trial

Impact evaluation of the Pediatric Development Clinic/Baby Ubuntu programme of early assessment, care and support for children at risk of developmental disabilities in Rwanda: a cluster randomised-controlled trial, economic evaluation and process evaluation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17523514
Enrollment
1400
Registered
2024-07-24
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

Children with or at risk of developmental disabilities Other

Interventions

After the baseline survey is complete, clusters will be randomised to the intervention or control arm using a 1:1 allocation ratio. Randomisation will be stratified by district. Depending on the heter

Sponsors

London School of Hygiene & Tropical Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Months to 5 Years

Inclusion criteria

Inclusion criteria: Eligible participants will be children at risk of developmental disability aged 0-5 years, and their caregivers where ‘at risk’ is defined as: 1. History of a newborn condition that is a recognised risk factor for developmental disability: prematurity, neonatal infection, neonatal encephalopathy (‘birth asphyxia’), severe jaundice, cerebral malaria, suspected genetic and chromosomal conditions, and seizures. 2. Not meeting age-specific developmental milestones as identified through routine child health services 3. Positive screening for developmental disability assessment on caregiver report Inclusion criteria: 1. Children (0-59 months) meeting the definition of ‘at risk’ and their caregivers as above 2. Living within the catchment area of one of the health centres in a study cluster 3. Caregiver willing and able to give written informed consent to take part in the evaluation 4. Caregiver is either 18 years of age or older, or, if the caregiver is younger than 18 years and the biological parent of the child, they are considered emancipated youth and eligible for participation

Exclusion criteria

Exclusion criteria: Children requiring hospital treatment at the time of the baseline assessment and those in institutional care

Design outcomes

Primary

MeasureTime frame
Co-primary effectiveness outcome measures: 1. Child participation measured using the Young Children’s Participation and Environment Measure at baseline and endline 2. Family impact quality of life measured using the Pediatric Quality of Life, Family Impact Module at baseline and endline

Secondary

MeasureTime frame
Secondary effectiveness outcome measures: 1. Child mortality measured using Severe Adverse Event forms, Electronic Health Records, Caregiver report at baseline and endline 2. Childhood illnesses, such as pneumonia and seizures, measured by parental report and electronic health records at baseline and endline 3. Child development (children without disability) or function (children with disability) measured using the Malawi Developmental Assessment Tool, the Global Scales of Early Development or the Pediatric Evaluation of Disability Inventory Computer Adaptive Test at baseline and endline 4. Child growth and nutritional status measured using weight-for-age, height-for-age, weight-for-height malnutrition at baseline and endline 5. Caregiver skills in caring for a child with developmental disability measured using pre- and post-Parent Skills Training Test for Caregivers at baseline and endline 6. Caregiver mental health measured using self-report questionnaire at baseline and endline 7. Caregiver experiences of stigma measured using the Affiliate Stigma Scale at baseline and endline 8. Caregiver livelihood and economic activity measured using Time-use survey from Living Standards Measurement Survey at baseline and endline Other exploratory outcome measures: 1. Child supervision and child discipline measured using the relevant module from the UNICEF-supported Multiple Indicator Cluster Survey (MICS) at baseline and endline 2. Family support for their child's need and experience of early intervention will be measured using the Family Outcomes Survey (Revised) at baseline and endline 3. Access to disability-related goods and services will be measured using caregiver report at baseline and endline

Countries

Rwanda

Contacts

Public ContactCally;Erick Tann;Baganizi

;

cally.tann@lshtm.ac.uk;ebaganizi@pih.org+44 (0)20 7636 8636;+250 (0)788 308 289

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026