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

NCT ID: NCT06002360

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Reach Out and Read

Intervention Type: 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.

Control

Standard neonatal care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Devin McKissic

Fellow, Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Devin McKissic

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington Medical Center NICU

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Devin McKissic

Role: CONTACT

devinam@uw.edu

(206) 300-1239

Facility Contacts

Devin McKissic, MD

Role: primary

devinam@uw.edu

Other Identifiers

STUDY00015592

Identifier Type: -

Identifier Source: org_study_id