Baby Item Learning and Development Study

Study Overview
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Brief Summary
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The goal of this study is to experimentally test whether baby items can promote healthy infant development.

Official Title
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Baby Item Learning and Development Study

Conditions
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Infant Development

Intervention / Treatment
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* Other: Baby Bouncer
* Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders
* Other: Baby Carrier


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Baby Bouncer Group<br>Participants in the group will be receiving a baby bouncer for use from infant's birth up to 8 months after birth. | Other: Baby Bouncer<br>* Fischer Price baby bouncer.<br>|
| Other: Baby Bouncer Group with Infant T-Shirt with LENA<br>A subsample of the participants in the baby bouncer group will also receive infant t-shirts with wearable audio recorders. | Other: Baby Bouncer<br>* Fischer Price baby bouncer.<br>Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders<br>* Infant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking.<br>|
| Other: Baby Carrier Group<br>Participants in the group will be receiving a baby carrier for use from infant's birth up to 8 months after birth. | Other: Baby Carrier<br>* Ergobaby Baby carrier.<br>|
| Other: Baby Carrier Group with Infant T-Shirt with LENA<br>A subsample of the participants in the baby carrier group will also receive infant t-shirts with wearable audio recorders. | Other: Infant t-shirts with Language Environment Analysis (LENA) audio recorders<br>* Infant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking.<br>Other: Baby Carrier<br>* Ergobaby Baby carrier.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive skill as assessed via eye tracking | Cognitive skill is reported as the percentage of accuracy of eye gaze as evaluated via the eye tracking procedure. | 8 months | 
| Parental Engagement | 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. | 8 months | 
| Infant Reactivity (Crying) assessed by the Face to Face/Still Face Procedure | 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. | 8 months | 
| Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure | 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. | 8 months | 
| Oxytocin levels | Mother and infant oxytocin levels will be measured via saliva sample. | 8 months | 
| Percentage of infant and adult vocalizations time | Assessed via 2-8 hours audio recordings on LENA. | Up to 8 hours | 
| Percentage of infant and adult turn taking | Assessed via 2-8 hours audio recordings on LENA. Turn taking is defined as the verbal exchange by adult and infant. | Up to 8 hours | 
| Percentage of Infant crying time | Percentage of infant crying time will be assessed via 2-8 hours audio recordings on LENA. | Up to 8 hours |