Mobile Health Intervention for Infants in Guatemala (18-m Intervention)

NCT06195358 | Recruiting

• 2 other identifiers: CHLA-21-00168_18-monthR33HD107983
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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' 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.

Conditions

Infant Development

Keywords

early childhood development; LMIC; Guatemala; mHealth; smartphone

Outcome Measures

Primary Outcomes (3)

• 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

  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

  18 months

• 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

  18 months

Secondary Outcomes (1)

• Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score

  Change from 0 to 18 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

The control arm will receive printed caregiving materials.

Other: Printed Caregiving Materials

Intervention Arm

EXPERIMENTAL

The intervention arm will receive the smartphone application.

Device: Mobile Health (Smartphone) Application

Interventions

Mobile Health (Smartphone) Application DEVICE

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 monthly visits (approximately 15 minutes duration) to assess functionality of the smartphone and answer questions/reinforce use.

Intervention Arm

Printed Caregiving Materials OTHER

The control arm will receive printed caregiving materials. In the control arm, staff will make monthly visits (approximately 15 minutes duration) to ask if there are questions about the printed caregiving materials.

Control Arm

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Children's Hospital Los Angeles: lead

Study Sites (1)

Wuqu' Kawoq/ Maya Health Alliance

Chimaltenango, Departamento de Chimaltenango, Guatemala

RECRUITING

Study Officials

• Beth Smith, PT, DPT, PhD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beth Smith, PT, DPT, PhD

CONTACT

323-361-4670; bsmith@chla.usc.edu

Dana Fine

CONTACT

323-356-5293; dafine@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics (USC Faculty/Non Physician CWR)

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 25, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: data will become available upon completion of the study and publication of primary paper and will remain available indefinitely.
• Access Criteria: per NICHD DASH procedures

Locations

GU (1)