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

NCT06002360 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Devin McKissic · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-12-31
Completion
2024-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002360 on ClinicalTrials.gov