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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002360
• Other study ID #: STUDY00015592
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: University of Washington
• Contact: Devin McKissic
• Phone: (206) 300-1239
• Email: devinam[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Literacy
• Parent-Child Relations

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington Medical Center NICU	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.		At enrollment