Newborn Nursery Reach Out and Read

NCT04147429 | Completed

• 1 other identifier: Pro00102414
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Program acceptability as measured by survey data

  Survey data will be analyzed using grounded theory.

  1 month

• Program acceptability as measured by structured interviews

  The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.

  1 month

• Program feasibility assessed by determining the cost of books required for the intervention

  1 month

• Program feasibility assessed by the time required to complete enrollment

  1 month

• Program feasibility assessed by the time required to complete the intervention

  1 month

• Program feasibility assessed by the number of eligible families enrolled in the study.

  1 month

• Program feasibility assessed by the percentage of families who are followed through to study completion

  1 month

Secondary Outcomes (1)

• Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.

  1 month

Study Arms (2)

Usual care

NO INTERVENTION

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

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.

Behavioral: Early Literacy Intervention

Interventions

Early Literacy Intervention 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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Elizabeth Erickson, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: October 30, 2019
• Primary Completion: April 18, 2020
• Study Completion: April 18, 2020
• Last Updated: July 27, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)