Infant Development
Conditions
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. 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.
Detailed description
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.
Interventions
BEHAVIORALsmartphone application to promote nurturing care
see arm description
BEHAVIORALprinted caregiving materials
see arm description
Sponsors
Wuqu' Kawoq, Maya Health Alliance
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Children's Hospital Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE | 6 months | 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. |
| Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR | 6 months | 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. |
| Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE | 6 months | 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. |
Countries
Guatemala
Participant flow
Recruitment details
Participants were recruited from January 2023 to March 2023.
Pre-assignment details
Participants were infants. The Enrollment number and number of participants Started/Completed represents individual infants.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 19 |
| Printed Caregiving Materials caregivers will receive print materials on early childhood stimulation
printed caregiving materials: see arm description | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Printed Caregiving Materials | Total | Smartphone Application to Promote Nurturing Care |
|---|---|---|---|
| Age, Continuous | 14 days | 17 days | 20 days |
| Race/Ethnicity, Customized Maya ethnicity | 20 Participants | 38 Participants | 18 Participants |
| Region of Enrollment Guatemala | 21 participants | 40 participants | 19 participants |
| Sex: Female, Male Female | 13 Participants | 23 Participants | 10 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smartphone Application to Promote Nurturing Care | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE | 111 score on a scale | Standard Deviation 9 |
| Printed Caregiving Materials | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: COGNITIVE | 111 score on a scale | Standard Deviation 10 |
95% CI: [-7.4, 5.5]
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smartphone Application to Promote Nurturing Care | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE | 104 score on a scale | Standard Deviation 6 |
| Printed Caregiving Materials | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: LANGUAGE | 104 score on a scale | Standard Deviation 6 |
95% CI: [-5.6, 2.1]
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Smartphone Application to Promote Nurturing Care | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR | 105 score on a scale | Standard Deviation 9 |
| Printed Caregiving Materials | Bayley Composite Scores After 6 Months, Effect Size of Group Difference: MOTOR | 106 score on a scale | Standard Deviation 11 |
95% CI: [-8.3, 3.6]