Digital Support Systems to Improve Child Health and Development in Peru

NCT05202106 | Recruiting

• 1 other identifier: DigitalECD
• Study Type: interventional
• Target: 2,400
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Child Development

Keywords

child development; stimulation; mobile phones; digital interventions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Caregiver mental health and stress

  2 years after enrollment (child age 2)

• Caregiver self-efficacy

  2 years after enrollment

• Home stimulation

  Endline - 2 years after enrollment

• Caregiver screen time

  Endline - 2 years after enrollment

Study Arms (3)

Control

NO INTERVENTION

Families in the control group will not receive any interventions and will simply complete baseline and endline surveys.

Home visits

EXPERIMENTAL

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

Afini

EXPERIMENTAL

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

Interventions

Home visits BEHAVIORAL

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.

Home visits

Afini App OTHER

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.

Afini

Eligibility Criteria

• Age: 3 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children residing in the study area

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Tropical & Public Health Institute: lead
• Harvard University: collaborator
• ETH Zurich (Switzerland): collaborator
• Universidad Peruana Cayetano Heredia: collaborator

Study Sites (2)

Cayetano Heredia University

Lima, Peru

RECRUITING

Swiss Tropical and Public Health Institute

Basel, Canton of Basel-City, 4051, Switzerland

RECRUITING

Related Publications (1)

• Hartinger Pena SM, Mausezahl D, Jaggi L, Aguilar L, Alvarado Llatance M, Castellanos A, Huaylinos Bustamante ML, Hinckley K, Charles McCoy D, Zhang C, Fink G. Digital Support Systems to Improve Child Health and Development in Peru: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Dec 14;12:e50371. doi: 10.2196/50371.

  PMID: 38096020 DERIVED

MeSH Terms

Interventions

House Calls

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to treatment, and final data analysis will be conducted using de-identified and blinded data.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is designed as an open-label, 3-arm parallel trial

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: September 1, 2021
• Primary Completion: April 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: After publication

Locations

PE (1); CH (1)