Baby Item Learning and Development Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
研究概览
简要总结
The goal of this study is to experimentally test whether baby items can promote healthy infant development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Participants who does not meet all the inclusion criteria.
研究组 & 干预措施
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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: 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.
干预措施: Baby Carrier (Other)
结局指标
主要结局
Infant Reactivity (Smiling) assessed by the Face to Face/Still Face Procedure
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 8 months
Mother and infant oxytocin levels will be measured via saliva sample.
Percentage of infant and adult vocalizations time
时间窗: Up to 8 hours
Assessed via 2-8 hours audio recordings on LENA.
Percentage of infant and adult turn taking
时间窗: 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.
次要结局
未报告次要终点
研究者
Elizabeth Simpson
Assistant Professor
University of Miami