Digital Support Systems to Improve Child Health and Development in Peru (DigitalECD)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Child Development
• Intervention / Treatment: Behavioral: Home visits; Other: Afini App

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 2400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru
    • Recruiting
    • Cayetano Heredia University
    • Contact: Stella Hartinger, PhD; Phone Number: +51 13190000; Email: stella.hartinger.p@upch.pe
• Switzerland
  • BS
    • Basel, BS, Switzerland, 4051
      • Recruiting
      • Swiss Tropical and Public Health Institute
      • Contact: Günther Fink, PhD; Phone Number: +4161284-0; Email: guenther.fink@swisstph.ch
      • Contact: Daniel Mäusezahl, PhD; Phone Number: +4161284-0; Email: daniel.maeusezahl@swisstph.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 9 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• children residing in the study area

Exclusion Criteria:

• children with disabilities
• families planning to leave study area
• families participating in national Cuna Mas program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Home visits; Home visits entail a visit a children's home every two weeks. During this visit, trained child development agents will engage parents in activities with the child and provide basic toys and learning materials.
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.	Other: Afini App; Afini is an app designed to help parents provide nurturing environments and stimulation to their young children. Most caregivers currently connect to the platform via Facebook Messenger; once they sign up, the platforms start engaging the caregiver by recommending age-specific health- and development-promoting activities. Rather than just hoping that caregivers will later engage in these activities, the virtual assistant directly observes whether caregivers access the materials for the recommended activity, and asks caregivers to provide feedback on each task.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Development at age 2 years	The primary study outcome will be overall child development as measured by the Global Scales for Early Development (GSED). Total scores on the GSED scales will be converted to z-scores for the analysis. Higher scores indicate better outcomes.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver mental health and stress	Caregiver mental health and stress scores will be assessed using the Depression, Anxiety and Stress Scales (DASS). The scale contains three subscores for depression, stress and anxiety - higher scores on these scales indicate mental health problems (worse outcomes)	2 years after enrollment (child age 2)
Caregiver self-efficacy	Caregiver self-efficacy will be assessed at endline - when child turn 2 years. Higher scores on this scale indicate better outcomes.	2 years after enrollment
Home stimulation	Home stimulation measures caregiver engagement with children. We will measure this using the MICS home stimulation questionnaire. This scale ranges from 0-6 - higher scores imply more home stimulation (better outcomes).	Endline - 2 years after enrollment
Caregiver screen time	Caregiver screen time will be collected at endline through a (self-reported) question to caregivers.	Endline - 2 years after enrollment

Collaborators and Investigators

• Sponsor: Swiss Tropical & Public Health Institute
• Collaborators: Harvard University; Universidad Peruana Cayetano Heredia; ETH Zurich (Switzerland)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: stimulation; child development; mobile phones; digital interventions
• Other Study ID Numbers: DigitalECD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The trial data will be made publicly available after publication of the study.
• IPD Sharing Time Frame: After publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No