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

NCT06002360 | Unknown

• 1 other identifier: STUDY00015592
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Reach Out and Read

EXPERIMENTAL

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

Control

NO INTERVENTION

Standard neonatal care

Interventions

Reach Out and Read BEHAVIORAL

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.

Reach Out and Read

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Medical Center NICU

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Literacy

Condition Hierarchy (Ancestors)

Mental Disorders; Communication; Behavior

Study Officials

• Devin McKissic

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devin McKissic

CONTACT

(206) 300-1239; devinam@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow, Neonatology

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: August 21, 2023
• Study Start: November 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)