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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06002360
Other study ID # STUDY00015592
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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