Newborn Nursery Reach Out and Read

Not Applicable

Completed

• Conditions: Literacy
• Interventions: Behavioral: Early Literacy Intervention

• Registration Number: NCT04147429
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-30
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Status Verified: 2020-02
• Primary Completion: 2020-04-18
• Study Completion: 2020-04-18
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Early Literacy 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.

Primary Outcome Measures

Name	Time	Method
Program feasibility assessed by the percentage of families who are followed through to study completion	1 month
Program acceptability as measured by survey data	1 month	Survey data will be analyzed using grounded theory.
Program feasibility assessed by the time required to complete the intervention	1 month
Program acceptability as measured by structured interviews	1 month	The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.
Program feasibility assessed by the time required to complete enrollment	1 month
Program feasibility assessed by the number of eligible families enrolled in the study.	1 month
Program feasibility assessed by determining the cost of books required for the intervention	1 month

Secondary Outcome Measures

Name	Time	Method
Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.	1 month	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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States