Newborn Nursery Reach Out and Read

NCT ID: NCT04147429

Last Updated: 2020-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2020-04-18

Brief Summary

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.

Conditions

Literacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Early Literacy Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Early Literacy Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Erickson, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00102414

Identifier Type: -

Identifier Source: org_study_id