Baby Item Learning and Development Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Development
- Sponsor
- University of Miami
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
Investigators
Elizabeth Simpson
Assistant Professor
University of Miami
Eligibility Criteria
Inclusion Criteria
- •Mothers and their infants must be healthy with no known birth complications
- •Infants must be born full term (at least 37 weeks gestation)
- •Mother must speak English
- •Mothers must be at least 28 weeks along in their pregnancy. Mothers with newborns who are less than 2 weeks will be included.
Exclusion Criteria
- •Participants who does not meet all the inclusion criteria.
Outcomes
Primary Outcomes
Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
Time Frame: 8 months
Infant emotions and social engagement is reported as the time noted when the infant was smiling during the 6 minute Face to Face/Still Face Procedure.
Parental Engagement
Time Frame: 8 months
Mother and infant will engage in a 15-minute unstructured free playtime. This engagement will be videotaped and assessed by the Investigator. Parental engagement is reported as the percentage of parental sensitivity and synchrony scored on a 0-100% scale with the higher score indicating increased sensitivity and synchrony.
Percentage of Infant crying time
Time Frame: Up to 8 hours
Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA.
Cognitive skill as assessed via eye tracking
Time Frame: 8 months
Cognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure.
Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure
Time Frame: 8 months
Infant emotions and social engagement is reported as the time noted when the infant was crying during the 6 minute Face to Face/Still Face Procedure.
Oxytocin levels
Time Frame: 8 months
Mother and infant oxytocin levels will be measured via saliva sample.
Percentage of infant and adult vocalizations time
Time Frame: Up to 8 hours
Assessed via 2-8 hours audio recordings on LENA.
Percentage of infant and adult turn taking
Time Frame: Up to 8 hours
Assessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant.