Digital Support Systems to Improve Child Health and Development in Peru - a Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 9 months
Healthy Volunteers: f
View:

• children residing in the study area

Locations
Other Locations
Peru
Cayetano Heredia University
RECRUITING
Lima
Switzerland
Swiss Tropical and Public Health Institute
RECRUITING
Basel
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 2400
Treatments
No_intervention: Control
Families in the control group will not receive any interventions and will simply complete baseline and endline surveys.
Experimental: Home visits
Families in the home visiting arm will receive visits by trained child development agents every two weeks between enrollment and 2 years of age.
Experimental: Afini
Families in the Afini arm will be introduced to the Afini app on Messenger and encouraged to use this platform throughout the study.
Related Therapeutic Areas
Sponsors
Collaborators: ETH Zurich (Switzerland), Universidad Peruana Cayetano Heredia, Harvard University
Leads: Swiss Tropical & Public Health Institute

This content was sourced from clinicaltrials.gov