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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06002360
Enrollment
60
Registered
2023-08-21
Start date
2022-11-01
Completion date
2024-06-30
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Literacy, Parent-Child Relations

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.

Interventions

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.

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scoresBetween 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 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 complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.At enrollment

Countries

United States

Contacts

Primary ContactDevin McKissic
devinam@uw.edu(206) 300-1239

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026