Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05202106 |
| Other study ID # |
DigitalECD |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Swiss Tropical & Public Health Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
About 250 million children under age five are at risk of not reaching their developmental
potential due to continued exposure to ill health, malnutrition and lack of appropriate
learning environments. A large number of initiatives have been launched in recent years to
support early childhood development, with home visiting programs increasingly being
recognized as a key strategy for improving child wellbeing. However, the most effective ways
to reach families in low income settings remain unclear due to the large expense associated
with personal family visits. This project assesses the effectiveness and equity of a newly
developed digital platform designed to deliver evidence-based, individualized parenting
support through automated services. The Afinidata platform uses state-of-the art machine
learning algorithms to allow caregivers to get answers to questions about child health and
development, while also identifying and promoting age- and development-appropriate activities
for parents to support their children. The goal of this study is to rigorously assess the
reach, impact and cost effectiveness of this digital platform in a poor rural population
through a randomized controlled trial. The study is designed as mixed-methods evaluation
approach with repeated feedback into the Afinidata system. A total of 2400 newborns will be
enrolled in a randomized controlled trial in San Marcos, Peru, and followed up for two years.
The primary study outcome will be children's healthy development at 24 months of age assessed
through the Bayley Scales of Infant and Toddler Development (BSID-III). Secondary outcomes
will be systems utilization, program coverage and cost-effectiveness, as well as caregiver
satisfaction. If proven effective, this innovative digital platform may increase global
access to low-cost parental support -a widely recognized key strategy for improving child
well-being.
Description:
Children in low and middle income countries continue to be exposed to large amount of
adversity, undermining their health and early development. While a large number of programs
have been launched recently to support children in their home environment, the best ways to
reach families in low income settings remain unclear.
In this study we will assess the impact of a newly developed virtual platform designed to
support parents of young children in low resource settings. The Afinidata platform was
launched in 2017 to support caregivers online via social media messengers that are now almost
universally used in low and middle income countries. The Afinidata platform allows caregivers
to get answers to questions about child health and development, while also identifying and
promoting age- and development-appropriate activities for parents to support their children.
The main objective of this study is to assess the reach, impact, cost-effectiveness and
scalability of the Afinidata platform for improving early childhood health and development.
The primary study outcomes will be children's overall development at age 2, assessed through
Global Scales for Early Development (GSED) long form. Secondary outcomes will include
parental engagement as well as children's motor, cognitive, language and socio-emotional
development.
A total of 164 communities in San Marcos, Cajabamba and Cajamarca provinces will be
identified for the trial, and divided into 3 groups: a control group (72 community clusters,
1080 caregiver-child dyads) a home visiting group (20 community clusters, 300 caregiver-child
dyads), and an online intervention group using the Afinidata platform (72 community clusters,
1080 caregiver-child dyads).
All 2400 caregivers in the trials, as well as 240 children participating in the national Cuna
Mas program (external reference group) will be visited in their homes for a baseline
interview at the beginning and an end-line interview at the end of the study.
Caregivers in the home visiting group will receive a home visit by a trained agent every two
weeks following the guidelines of the nationally developed CUNA MAS program starting from six
months of age until the child turns 2.
Caregivers in the Afinidata group will be visited once in the beginning of the study and
introduced to the online system. After this initial visit, caregivers will be supported
through the Afinidata platform. A randomly selected subgroup of Afinidata users (20 clusters)
will also receive small biweekly or monthly data transfers of about USD 2 to support access
to Afini's data systems.
