Clinical trial NCT04147429: Newborn Nursery Reach Out and Read
Official title: Reach Out and Read From Cradle to Clinic: A Novel Reach Out and Read Intervention in the Newborn Nursery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Literacy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Program acceptability as measured by survey data
timeFrame: 1 month
measure: Program acceptability as measured by structured interviews
timeFrame: 1 month
measure: Program feasibility assessed by determining the cost of books required for the intervention
timeFrame: 1 month
measure: Program feasibility assessed by the time required to complete enrollment
timeFrame: 1 month
measure: Program feasibility assessed by the time required to complete the intervention
timeFrame: 1 month
measure: Program feasibility assessed by the number of eligible families enrolled in the study.
timeFrame: 1 month
measure: Program feasibility assessed by the percentage of families who are followed through to study completion
timeFrame: 1 month
Secondary outcomes:
measure: Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.
timeFrame: 1 month
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Elizabeth Erickson, MD
role: PRINCIPAL_INVESTIGATOR
References: