Digital Support Systems to Improve Child Health and Development in Peru

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorSwiss Tropical & Public Health Institute

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

children residing in the study area

Disqualifiers

children with disabilities

families planning to leave study area

families participating in national Cuna Mas program

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

2,400 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: Home visitsExperimental treatment 1 intervention
Group C: AfiniExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 years

Secondary outcomes

1

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)

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

Time frame
2 years after enrollment
3

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).

Time frame
Endline - 2 years after enrollment
4

Caregiver screen time

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

Time frame
Endline - 2 years after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Swiss Tropical & Public Health Institute

Lead sponsor

Harvard University

Collaborator

ETH Zurich (Switzerland)

Collaborator

Universidad Peruana Cayetano Heredia

Collaborator