Reach Out and Read (ROR) in the Neonatal Intensive Care Unit (NICU) Study

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The goal of this clinical trial is to learn about the effects of the Reach Out and Read program on infants and their families in the neonatal ICU. The main goals of this study are: * To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores. * To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6) * To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ) * To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores Participants will complete three questionnaires that include demographic information, home literacy scores, the Postpartum Bonding Questionnaire and the State-Trait Anxiety Index; once at study enrollment, once at 36 weeks corrected gestational age, and once at 3 months corrected gestational age. Researchers will compare the control group (standard care) and a group that receives Reach Out and Read education to see whether exposure to Reach Out and Read affects literacy behaviors, parental anxiety, and parent-infant bonding.

Conditions:

Anxiety Parent-Child Relations Literacy

Study Start (Actual) 2022-11-01

Primary Completion (Estimated) 2023-12

Study Completion (Estimated) 2024-06

Enrollment (Estimated) 60

Study Type INTERVENTIONAL

Phase NA

Locations:

📍 Seattle, Washington, United States

Eligibility Criteria

Description

Inclusion Criteria:

* Families of subjects born between 24w0d and 33w6d gestation
* Primary language is English or Spanish

Exclusion Criteria:

* Severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation

Ages Eligible for Study: N/A to 14 Days (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted2023-08-15
First Submitted that Met QC Criteria2023-08-15
First Posted2023-08-21

Study Record Updates

Last Update Submitted that Met QC Criteria2023-08-15
Last Update Posted2023-08-21
Last Verified2023-08