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OpenTrials
Completed

NCT Number: NCT04147429

Newborn Nursery Reach Out and Read

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Literacy Intervention

Behavioral

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.

Primary outcomes

  1. Program acceptability as measured by survey data

    Time frame: 1 month

    Survey data will be analyzed using grounded theory.

  2. Program acceptability as measured by structured interviews

    Time frame: 1 month

    The structured interviews will be evaluated and themes and subthemes will be identified using NVivo software.

  3. Program feasibility assessed by determining the cost of books required for the intervention

    Time frame: 1 month

  4. Program feasibility assessed by the time required to complete enrollment

    Time frame: 1 month

  5. Program feasibility assessed by the time required to complete the intervention

    Time frame: 1 month

  6. Program feasibility assessed by the number of eligible families enrolled in the study.

    Time frame: 1 month

  7. Program feasibility assessed by the percentage of families who are followed through to study completion

    Time frame: 1 month

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2019
Registry last updated
Jul 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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