Newborn Nursery Reach Out and Read

Duke University

Status: Completed

Conditions: Literacy

Treatments: Behavioral: Early Literacy Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04147429

Pro00102414

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Usual care

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Early Literacy Intervention