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| ID | Type | Description | Link |
|---|---|---|---|
| R33HD107983 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
Study population: first-time parents of newborn infants, newborn infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Active Comparator | The control arm will receive printed caregiving materials. |
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| Intervention Arm | Experimental | The intervention arm will receive the smartphone application. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Home Observation for Measurement of the Environment Scale (HOME) Raw Score | Raw score range 0-45, higher scores better | Change from 0 to 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth Smith, PT, DPT, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuqu' Kawoq/ Maya Health Alliance | Chimaltenango | Departamento de Chimaltenango | Guatemala |
de-identified data will be shared via NICHD DASH
data will become available upon completion of the study and publication of primary paper and will remain available indefinitely.
per NICHD DASH procedures
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| 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. |
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