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

Not Applicable

Recruiting

• Conditions: Parent-Child Relations; Anxiety; Literacy
• Interventions: Behavioral: Reach Out and Read

• Registration Number: NCT06002360
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-15
• Study First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Study First Posted: 2023-08-21
• Last Update Posted: 2023-08-21
• Primary Completion: 2023-12
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reach Out and Read	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.	At enrollment

Trial Locations

Locations (1)

University of Washington Medical Center NICU; 🇺🇸 Seattle, Washington, United States