Baby Item Learning and Development Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Miami
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
Study Overview
Brief Summary
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Baby Bouncer Group
Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth.
Intervention: Baby Bouncer (Other)
Baby Bouncer Group with Infant T-Shirt with LENA
A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.
Intervention: Baby Bouncer (Other)
Baby Bouncer Group with Infant T-Shirt with LENA
A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders.
Intervention: Infant t-shirts with Language Environment Analysis (LENA) audio recorders (Other)
Baby Carrier Group
Participants in the group will be receiving a baby carrier for use from infant's birth up to 8 months after birth.
Intervention: Baby Carrier (Other)
Baby Carrier Group with Infant T-Shirt with LENA
A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders.
Intervention: Infant t-shirts with Language Environment Analysis (LENA) audio recorders (Other)
Baby Carrier Group with Infant T-Shirt with LENA
A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders.
Intervention: Baby Carrier (Other)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Elizabeth Simpson
Assistant Professor
University of Miami