Reach Out and Read From Cradle to Clinic: A Novel Reach Out and Read Intervention in the Newborn Nursery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Program feasibility assessed by the percentage of families who are followed through to study completion
研究概览
简要总结
The purpose of this research study is to learn new things about how parents and others who care for babies think about sharing books with their baby and how they might respond to guidance from their doctors. The study involves participants filling out a survey with questions about a newborn baby and thoughts about the baby's development. The study should not take more than an hour and fifteen minutes during the delivery hospital stay and another 20 minutes at the baby's one month well child visit by phone or emailed survey link. Participants may also be interviewed and asked some questions about these topics. The conversation will be audio recorded, and should last no more than 30 minutes. The survey should take no more than 15 minutes to complete. The participant and their child will be randomized, like flipping a coin, to either receive the study intervention book, Cluck and Moo, along with standard or care or solely standard of care at your time of hospital discharge. The greatest risks to this study would be feeling uncomfortable about answering some of the questions and potential risk of loss of confidentiality.
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
- •Child delivered at Duke Hospital Birthing Center
- •Families who can read and write in English
- •Families with children born at >36 weeks gestation
- •Families who plan to continue primary pediatric care with Duke Children's Primary Care
排除标准
- •Parent with severe medical or mental health condition limiting ability to attend appointments
- •Newborn with severe medical condition
- •Families who plan to move out of state in the next 6 months
结局指标
主要结局
Program feasibility assessed by the percentage of families who are followed through to study completion
时间窗: 1 month
Program acceptability as measured by survey data
时间窗: 1 month
Survey data will be analyzed using grounded theory.
Program feasibility assessed by the time required to complete the intervention
时间窗: 1 month
Program acceptability as measured by structured interviews
时间窗: 1 month
The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.
Program feasibility assessed by the time required to complete enrollment
时间窗: 1 month
Program feasibility assessed by the number of eligible families enrolled in the study.
时间窗: 1 month
Program feasibility assessed by determining the cost of books required for the intervention
时间窗: 1 month
次要结局
- Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.(1 month)