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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Home visits
BehavioralHome 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 interventionAfini 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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)
Caregiver self-efficacy
Caregiver self-efficacy will be assessed at endline - when child turn 2 years. Higher scores on this scale indicate better outcomes.
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).
Caregiver screen time
Caregiver screen time will be collected at endline through a (self-reported) question to caregivers.
Sponsors and contacts
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Swiss Tropical & Public Health Institute
Lead sponsor
Harvard University
Collaborator
ETH Zurich (Switzerland)
Collaborator
Universidad Peruana Cayetano Heredia
Collaborator