Infant DevelopmentNCT06195358
Mobile Health Intervention for Infants in Guatemala (18-m Intervention)
A study testing Mobile Health (Smartphone) Application and Printed Caregiving Materials in people with Infant Development, run by Children's Hospital Los Angeles at 1 site in Guatemala.
Trial summary
Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers'… Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Mobile Health (Smartphone) Application and Printed Caregiving Materials
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGuatemala
- Study dates
- 25 Jan 2024to 21 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- first-time caregivers with an infant in the eligible age range (0-4 weeks)
- infant from singleton birth
- infant from full-term (> 37 weeks gestation) birth
Who cannot join
- Presence of acute malnutrition/wasting or severe medical illness (heart disease, kidney disease, congenital abnormality) in the infant
- medical need for supplementation of breastfeeding
- caregiver not literate
Trial locations and contacts
1 site in 1 country.
Guatemala1 site
Wuqu' Kawoq/ Maya Health Alliance
Chimaltenango, Departamento de Chimaltenango
About this study
Official title: Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.
Read the detailed description
Rationale: According to recent estimates, nore than 40% of children under age 5 residing in low- and middle-income countries (LMICs)-250 million children in total-are at risk of not reaching their developmental potential due to living in environments with malnutrition, poverty, and lack of early stimulation. Mobile health (mHealth) technology represents an efficient strategy for scaling interventions to promote infant development.
Intervention: Individually-randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 18 months.
Objectives and purpose: We will test the effectiveness of a smartphone application that will directly engage caregivers in providing nurturing care to at-risk infants. We will assess effectiveness of the mHealth application compared to paper caregiving materials by comparing group differences in Bayley scores after 18 months (primary outcome = language composite score).
Study population: first-time parents of newborn infants, newborn infants.
- Conditions
- Infant Development
- Being tested
- Mobile Health (Smartphone) Application, Printed Caregiving Materials
- Keywords
- early childhood development, LMIC, Guatemala, mHealth, smartphone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health (Smartphone) ApplicationDevice
The intervention arm will receive the smartphone application, which has been designed to engage primary caregivers directly in the active monitoring of their infants' development, and to provide tailored feedback and support for the provision of nurturing care. Study staff will make an initial home visit (less than an hour) to install the application on the caregiver phone and demonstrate use and collect baseline data. Subsequently, in the intervention arm, staff will make visits every 3 months (approximately 15 minutes duration) to assess functionality of the smartphone and answer questions/reinforce use.
Printed Caregiving MaterialsOther
The control arm will receive printed caregiving materials. In the control arm, staff will make visits every 3 months (approximately 15 minutes duration) to ask if there are questions about the printed caregiving materials.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | The control arm will receive printed caregiving materials. Receives: Other: Printed Caregiving Materials |
| Intervention Arm | Experimental | The intervention arm will receive the smartphone application. Receives: Device: Mobile Health (Smartphone) Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between study arms in Composite Language Score
Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153
Measured: 18 months
Secondary outcomes (4)
Difference between study arms in Composite Cognitive Score
Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 55-145
Measured: 18 months
Difference between study arms in Composite Motor Score
Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 46-154
Measured: 18 months
Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score
Raw score range 0-45, higher scores better
Measured: Change from 0 to 18 months
Change in the Nursing Child Assessment Satellite Training (NCAST) Feeding Scale Total Score
Raw score, higher scores better
Measured: Change from 0 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start25 Jan 2024
- Primary completion21 Aug 2026
- Study completion21 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Beth Smith, Children's Hospital Los Angeles
- Investigators
- Beth Smith, PT, DPT, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06195358
- Sponsor's protocol ID
- CHLA-21-00168_18-month
- Other IDs
- R33HD107983
- Status last verified
- Sep 2026
- First submitted
- 22 Dec 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results will be deposited in a publicly accessible data repository.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Intervention to Promote Positive Infant Health Outcomes in Guatemala
- ClinicalTrials.gov ID
- NCT06195358
- Acronym / sponsor ID
- CHLA-21-00168_18-month
- Conditions
- Infant Development
- Keywords
- early childhood development, LMIC, Guatemala, mHealth, smartphone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 21 Aug 2026 (actual)
- Study completion
- 21 Aug 2026 (actual)
- First posted
- 8 Jan 2024 (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.
Promoting optimal development for children at risk in low- and middle-income countries (LMICs) is an important global health priority. Supporting caregivers to provide nurturing care is an evidence-based strategy, however feasibility of scaling-up this supporting is limited by competing demands on health workers' time. For infant development, mHealth technologies have the potential to solve this problem by providing tailored content directly to caregivers, involving and empowering them to promote infant development, promoting and facilitating interactions with health workers when areas of concern are identified and, therefore, expanding the reach of healthcare systems. Following a pilot feasibility study, this current study will examine the effectiveness of a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala and support early childhood development.
Detailed description
Rationale: According to recent estimates, nore than 40% of children under age 5 residing in low- and middle-income countries (LMICs)-250 million children in total-are at risk of not reaching their developmental potential due to living in environments with malnutrition, poverty, and lack of early stimulation. Mobile health (mHealth) technology represents an efficient strategy for scaling interventions to promote infant development.
Intervention: Individually-randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 18 months.
Objectives and purpose: We will test the effectiveness of a smartphone application that will directly engage caregivers in providing nurturing care to at-risk infants. We will assess effectiveness of the mHealth application compared to paper caregiving materials by comparing group differences in Bayley scores after 18 months (primary outcome = language composite score).
Study population: first-time parents of newborn infants, newborn infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Printed Caregiving MaterialsThe control arm will receive printed caregiving materials. |
| Intervention Arm | Experimental | Device: Mobile Health (Smartphone) ApplicationThe intervention arm will receive the smartphone application. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- first-time caregivers with an infant in the eligible age range (0-4 weeks)
- infant from singleton birth
- infant from full-term (> 37 weeks gestation) birth
Key exclusion criteria (3 listed)
- Presence of acute malnutrition/wasting or severe medical illness (heart disease, kidney disease, congenital abnormality) in the infant
- medical need for supplementation of breastfeeding
- caregiver not literate
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 |
|---|---|---|
| Mobile Health (Smartphone) ApplicationThe intervention arm will receive the smartphone application, which has been designed to engage primary caregivers directly in the active monitoring of their infants' development, and to provide tailored feedback and support for the provision of nurturing care. Study staff will make an initial home visit (less than an hour) to install the application on the caregiver phone and demonstrate use and collect baseline data. Subsequently, in the intervention arm, staff will make visits every 3 months (approximately 15 minutes duration) to assess functionality of the smartphone and answer questions/reinforce use. | Device | Intervention Arm |
| Printed Caregiving MaterialsThe control arm will receive printed caregiving materials. In the control arm, staff will make visits every 3 months (approximately 15 minutes duration) to ask if there are questions about the printed caregiving materials. | Other | Control Arm |
Primary outcome
Difference between study arms in Composite Language Score
Time frame: 18 months
Using the Bayley Scales of Infant Development, 4th Edition (BSID4), higher scores better, scale range 47-153
4 secondary outcomes
Difference between study arms in Composite Cognitive Score
Time frame: 18 months
Difference between study arms in Composite Motor Score
Time frame: 18 months
Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score
Time frame: Change from 0 to 18 months
Change in the Nursing Child Assessment Satellite Training (NCAST) Feeding Scale Total Score
Time frame: Change from 0 to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be deposited in a publicly accessible data repository.
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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. This study is not recruiting at the moment.
Beth Smith, PT, DPT, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health (Smartphone) Application and Printed Caregiving Materials in people with Infant Development, run by Children's Hospital Los Angeles at 1 site in Guatemala.
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 3 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Guatemala. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between study arms in Composite Language Score (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.