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
- Conditions
- Children with or at risk of developmental disabilitiesNot Applicable
- Registration Number
- ISRCTN17523514
- Lead Sponsor
- ondon School of Hygiene & Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 1400
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
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
Children requiring hospital treatment at the time of the baseline assessment and those in institutional care
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Co-primary effectiveness outcome measures:<br>1. Child participation measured using the Young Children’s Participation and Environment Measure at baseline and endline<br>2. Family impact quality of life measured using the Pediatric Quality of Life, Family Impact Module at baseline and endline
- Secondary Outcome Measures
Name Time Method