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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04147429
Enrollment
50
Registered
2019-11-01
Start date
2019-10-30
Completion date
2020-04-18
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Literacy

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.

Interventions

BEHAVIORALEarly 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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Program feasibility assessed by determining the cost of books required for the intervention1 month
Program feasibility assessed by the time required to complete enrollment1 month
Program feasibility assessed by the time required to complete the intervention1 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 completion1 month
Program acceptability as measured by survey data1 monthSurvey data will be analyzed using grounded theory.
Program acceptability as measured by structured interviews1 monthThe structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.

Secondary

MeasureTime frameDescription
Family's home literacy environment as measured by the READ subscale of the StimQ2-Infant.1 monthAge 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026