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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21HD107983 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Wuqu' Kawoq, Maya Health Alliance | OTHER |
| 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. This overall study is designed to explore this idea, by designing a caregiver-directed smartphone application to directly engage first-time caregivers in rural Guatemala in providing nurturing care and, after design, to conduct a prospective implementation trial of its use followed by an adequately-powered efficacy study.
Rationale: According to recent estimates, 43% 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: Pilot randomized controlled trial of mHealth application compared to paper caregiving materials. Length of intervention = 6 months.
Objectives and purpose: We will test 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 establishing effect sizes of group differences in Bayley scores after 6 months.
Study population: newborn infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| smartphone application to promote nurturing care | Experimental | a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care |
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| printed caregiving materials | Active Comparator | caregivers will receive print materials on early childhood stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| smartphone application to promote nurturing care | Behavioral | see arm description |
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| Measure | Description | Time Frame |
|---|---|---|
| Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE | Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140. | 6 months |
| Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR | Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140. | 6 months |
| Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE | Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beth A Smith, PT, DPT, PhD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wuqu' Kawoq/ Maya Health Alliance | Chimaltenango | Guatemala |
de-identified data will be shared via NICHD DASH
data will become available upon completion of the study and will remain available indefinitely.
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Participants were infants. The Enrollment number and number of participants Started/Completed represents individual infants.
Participants were recruited from January 2023 to March 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Smartphone Application to Promote Nurturing Care | a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description |
| FG001 | Printed Caregiving Materials | caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Smartphone Application to Promote Nurturing Care | a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description |
| BG001 | Printed Caregiving Materials |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE | Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 months
The IRB's determined that the research involves no greater than minimal risk. Data were monitored on an ongoing basis by the PI.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smartphone Application to Promote Nurturing Care | a caregiver-directed smartphone application will directly engage first-time caregivers in providing nurturing care smartphone application to promote nurturing care: see arm description |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Beth A. Smith | Children's Hospital Los Angeles | 3233614670 | bsmith@chla.usc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 9, 2023 | Mar 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 26, 2022 | Mar 13, 2025 | ICF_001.pdf |
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| printed caregiving materials | Behavioral | see arm description |
|
caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description |
| BG002 | Total | Total of all reporting groups |
| days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Primary | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR | Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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|
|
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| Primary | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE | Bayley Scales of Infant and Toddler Development (4th edition). Composite scores are norm-referenced based on age. Higher scores are better. Minimum composite score value is 60 and maximum composite score value is 140. | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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|
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| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | Printed Caregiving Materials | caregivers will receive print materials on early childhood stimulation printed caregiving materials: see arm description | 0 | 21 | 0 | 21 | 0 | 21 |
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