Clinical trial NCT05202106: Digital Support Systems to Improve Child Health and Development in Peru
Official title: Digital Support Systems to Improve Child Health and Development in Peru - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Development
Keywords: child development
stimulation
mobile phones
digital interventions
Lead sponsor: Swiss Tropical & Public Health Institute
Sponsor class: OTHER
Collaborators: name: Harvard University
name: ETH Zurich (Switzerland)
name: Universidad Peruana Cayetano Heredia
First posted: 2022-01-21
Enrollment: 2400
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as an open-label, 3-arm parallel trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Development at age 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Caregiver mental health and stress
timeFrame: 2 years after enrollment (child age 2)
measure: Caregiver self-efficacy
timeFrame: 2 years after enrollment
measure: Home stimulation
timeFrame: Endline - 2 years after enrollment
measure: Caregiver screen time
timeFrame: Endline - 2 years after enrollment
Other outcomes:
Locations:
city: Lima
country: Peru
facility: Cayetano Heredia University
city: Basel
country: Switzerland
facility: Swiss Tropical and Public Health Institute
state: BS
Study officials:
References: