Newborn Nursery Reach Out and Read

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.

Study Overview

• Status: Completed
• Conditions: Literacy
• Intervention / Treatment: Behavioral: Early Literacy Intervention

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.	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.	1 month

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Elizabeth Erickson, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): April 18, 2020
• Study Completion (Actual): April 18, 2020

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): July 27, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00102414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No