Newborn Nursery Reach Out and Read

Literacy Clinical Trial

Official title:

Reach Out and Read From Cradle to Clinic: A Novel Reach Out and Read Intervention in the Newborn Nursery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147429
• Other study ID #: Pro00102414
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: April 18, 2020

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Literacy

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Program acceptability as measured by survey data	Survey data will be analyzed using grounded theory.	1 month
Primary	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
Primary	Program feasibility assessed by determining the cost of books required for the intervention		1 month
Primary	Program feasibility assessed by the time required to complete enrollment		1 month
Primary	Program feasibility assessed by the time required to complete the intervention		1 month
Primary	Program feasibility assessed by the number of eligible families enrolled in the study.		1 month
Primary	Program feasibility assessed by the percentage of families who are followed through to study completion		1 month
Secondary	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