Child DevelopmentDigitalECDNCT05202106
Digital Support Systems to Improve Child Health and Development in Peru
A study testing Home visits and Afini App in people with Child Development, run by Swiss Tropical & Public Health Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 months
- Conditions the study is for
- Child Development
- What is being tested?
- Home visits and Afini App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2021to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children residing in the study area
Who cannot join
- children with disabilities
- families planning to leave study area
- families participating in national Cuna Mas program
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Peru1 site, 1 recruiting
- Recruiting
Cayetano Heredia University
Lima
Stella Hartinger, PhD, +51 13190000, stella.hartinger.p@upch.pe
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Tropical and Public Health Institute
Basel, Canton of Basel-City, 4051
Günther Fink, PhD, +4161284-0, guenther.fink@swisstph.ch
Daniel Mäusezahl, PhD, +4161284-0, daniel.maeusezahl@swisstph.ch
About this study
Official title: Digital Support Systems to Improve Child Health and Development in Peru - a Randomized Controlled 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.
Read the 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.
- Conditions
- Child Development
- Being tested
- Home visits, Afini App
- Keywords
- child development, stimulation, mobile phones, digital interventions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitsBehavioural
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 AppOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Afini App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (4)
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)
Measured: 2 years after enrollment (child age 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.
Measured: 2 years after enrollment
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).
Measured: Endline - 2 years after enrollment
Caregiver screen time
Caregiver screen time will be collected at endline through a (self-reported) question to caregivers.
Measured: Endline - 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start1 Sep 2021
- Primary completion30 Apr 2025
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as an open-label, 3-arm parallel trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, ETH Zurich (Switzerland), Universidad Peruana Cayetano Heredia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202106
- Sponsor's protocol ID
- DigitalECD
- Acronym
- DigitalECD
- Status last verified
- May 2025
- First submitted
- 7 Jan 2022
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The trial data will be made publicly available after publication of the study.
Publications
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.
PubMed 38096020
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Support Systems to Improve Child Health and Development in Peru - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05202106
- Acronym / sponsor ID
- DigitalECD / DigitalECD
- Conditions
- Child Development
- Keywords
- child development, stimulation, mobile phones, digital interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Harvard University, ETH Zurich (Switzerland), Universidad Peruana Cayetano Heredia
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is designed as an open-label, 3-arm parallel trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Families in the control group will not receive any interventions and will simply complete baseline and endline surveys. |
| Home visits | Experimental | Behavioral: Home visitsFamilies in the home visiting arm will receive visits by trained child development agents every two weeks between enrollment and 2 years of age. |
| Afini | Experimental | Other: Afini AppFamilies in the Afini arm will be introduced to the Afini app on Messenger and encouraged to use this platform throughout the study. |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children residing in the study area
Key exclusion criteria (3 listed)
- children with disabilities
- families planning to leave study area
- families participating in national Cuna Mas program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visitsHome 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. | Behavioural | Home visits |
| Afini AppAfini 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. | Other | Afini |
Primary outcome
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.
4 secondary outcomes
Caregiver mental health and stress
Time frame: 2 years after enrollment (child age 2)
Caregiver self-efficacy
Time frame: 2 years after enrollment
Home stimulation
Time frame: Endline - 2 years after enrollment
Caregiver screen time
Time frame: Endline - 2 years after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Derived from this study: PubMed 38096020Hartinger 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.
- Individual participant dataSharing planned: Yes. The trial data will be made publicly available after publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visits and Afini App in people with Child Development, run by Swiss Tropical & Public Health Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Peru, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Development at age 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05202106, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.