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NCT Number: NCT05202106

Digital Support Systems to Improve Child Health and Development in Peru

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.

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Key information

Conditions

Child Development

Age range

3 month–9 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cayetano Heredia University, Lima, Peru

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Child Development at age 2 years

    Time frame: 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.

Secondary outcomes

  1. Caregiver mental health and stress

    Time frame: 2 years after enrollment (child age 2)

    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. Caregiver self-efficacy

    Time frame: 2 years after enrollment

    Caregiver self-efficacy will be assessed at endline - when child turn 2 years. Higher scores on this scale indicate better outcomes.

  3. Home stimulation

    Time frame: Endline - 2 years after enrollment

    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).

  4. Caregiver screen time

    Time frame: Endline - 2 years after enrollment

    Caregiver screen time will be collected at endline through a (self-reported) question to caregivers.

Sponsors and collaborators

Lead sponsor

Swiss Tropical & Public Health Institute

Other

Collaborators

  • ETH Zurich (Switzerland)
  • Harvard University
  • Universidad Peruana Cayetano Heredia

Registry information

Official study title

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

Acronym: DigitalECD

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jan 21, 2022
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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