Actively Recruiting

Phase Not Applicable
Age: 3Months - 9Months
All Genders
NCT05202106

Digital Support Systems to Improve Child Health and Development in Peru

Led by Swiss Tropical & Public Health Institute · Updated on 2025-05-18

2400

Participants Needed

2

Research Sites

251 weeks

Total Duration

On this page

Sponsors

S

Swiss Tropical & Public Health Institute

Lead Sponsor

H

Harvard University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Digital Support Systems to Improve Child Health and Development in Peru

Who Can Participate

Age: 3Months - 9Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Child resides in the study area
Not Eligible

You will not qualify if you...

  • Child has disabilities
  • Family plans to leave the study area
  • Family is participating in the national Cuna Mas program

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Cayetano Heredia University

Lima, Peru

Actively Recruiting

2

Swiss Tropical and Public Health Institute

Basel, Canton of Basel-City, Switzerland, 4051

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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