Skip to main content
Clinical Trials/NCT06002360
NCT06002360
Recruiting
N/A

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

University of Washington1 site in 1 country60 target enrollmentNovember 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Washington
Enrollment
60
Locations
1
Primary Endpoint
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2022
End Date
June 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Devin McKissic

Fellow, Neonatology

University of Washington

Eligibility Criteria

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

Outcomes

Primary Outcomes

To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores

Time Frame: 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)

Time Frame: 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)

Time Frame: 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.

Time Frame: At enrollment

Study Sites (1)

Loading locations...

Similar Trials