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

The Effect of Reach Out and Read on Home Literacy Scores, Parental Stress, and Parent-Infant Bonding in the Neonatal ICU

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Parent-Child Relations; Literacy
• Intervention / Treatment: Behavioral: Reach Out and Read

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Devin McKissic; Phone Number: (206) 300-1239; Email: devinam@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington Medical Center NICU
      • Contact: Devin McKissic, MD; Email: devinam@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reach Out and Read; Families assigned to this group will receive Reach Out and Read education every two weeks between enrollment and when their infant reaches 36 weeks gestation.	Behavioral: Reach Out and Read; Families will be provided with a book and ROR programming from trained study team members (either the principal investigator or a research assistant, both of whom are ROR trained). ROR programming will include discussion of current reading practices, anticipatory guidance on the importance and benefits of reading, modeling of active reading, discussion of how to incorporate reading into a daily routine and answering any questions parents/caregivers may have.
No Intervention: Control; Standard neonatal care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores	Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)	Between enrollment and 3 months corrected gestational age for infant
To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)	Between enrollment and 3 months corrected gestational age for infant
To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.	At enrollment

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Devin McKissic, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00015592

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No