Recruiting

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

Sponsor:

University of Washington

Code:

NCT06002360

Conditions

Anxiety

Parent-Child Relations

Literacy

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Reach Out and Read

Study Details

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 ID

NCT06002360

Start date

Nov 1, 2022

Status verified date

Aug, 2023

Completion date

Jun, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: Control

Standard neonatal care

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.

Primary outcome measure

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 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 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 complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores. [ Time Frame: At enrollment ]

Central Contacts and Locations

Central contacts

Devin McKissic

(206) 300-1239 devinam@uw.edu

Locations

University of Washington Medical Center NICU

Recruiting

Seattle, Washington, United States, 98195

Contacts

Devin McKissic, MD

devinam@uw.edu

More Information

Sponsor

University of Washington

Last update posted

Aug 21, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2023-08-21.