Newborn Nursery Reach Out and Read
2020年7月24日 更新者：Duke University
Reach Out and Read From Cradle to Clinic: A Novel Reach Out and Read Intervention in the Newborn Nursery
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.
研究概览
研究类型
介入性
注册 (实际的)
50
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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North Carolina
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Durham、North Carolina、美国、27705
- Duke University Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：Usual care
Newborns randomized to the usual care group will receive standard education about safe sleep practices, measuring temperatures and newborn feeding needs.
This information will be accompanied by printed instructions that will be added to the family's discharge instructions.
This reflects current practice in the Duke Hospital Newborn Nursery.
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实验性的：Intervention
In addition to usual care, families randomized to the intervention group will receive an early literacy intervention, delivered by a trained research assistant.
To ensure intervention and delivery fidelity, the PI will meet with research assistants at bi-weekly intervals to review procedures and perform structured observations of intervention delivery.
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Similar to the standard Reach out and Read model, parents will be given a high-contrast board book, Cluck and Moo, and education about the importance of and how to engage with newborns in early shared reading behaviors.
This will include instructive information for families about using books to stimulate newborns through pictures and spoken words.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Program acceptability as measured by survey data
大体时间：1 month
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Survey data will be analyzed using grounded theory.
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1 month
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Program acceptability as measured by structured interviews
大体时间：1 month
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The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.
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1 month
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Program feasibility assessed by determining the cost of books required for the intervention
大体时间：1 month
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1 month
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Program feasibility assessed by the time required to complete enrollment
大体时间：1 month
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1 month
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Program feasibility assessed by the time required to complete the intervention
大体时间：1 month
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1 month
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Program feasibility assessed by the number of eligible families enrolled in the study.
大体时间：1 month
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1 month
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Program feasibility assessed by the percentage of families who are followed through to study completion
大体时间：1 month
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1 month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.
大体时间：1 month
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Age appropriate items will be pulled from the StimQ2-Infant READ subscale.
The StimQ2-Infant READ subscale measures a family's shared reading behaviors in the home.
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1 month
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elizabeth Erickson, MD、Duke University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年10月30日
初级完成 (实际的)
2020年4月18日
研究完成 (实际的)
2020年4月18日
研究注册日期
首次提交
2019年10月30日
首先提交符合 QC 标准的
2019年10月30日
首次发布 (实际的)
2019年11月1日
研究记录更新
最后更新发布 (实际的)
2020年7月27日
上次提交的符合 QC 标准的更新
2020年7月24日
最后验证
2020年2月1日
更多信息
与本研究相关的术语
其他研究编号
- Pro00102414
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Early Literacy Intervention的临床试验
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Saranas, Inc.Cardiovascular Research Foundation, New York; Proxima Clinical Research, Inc.完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人