RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-11-01
Study Completion:2024-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06002360

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 14 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Families of subjects born between 24w0d and 33w6d gestation
  2. * Primary language is English or Spanish
  1. * Severe clinical instability such that the principal investigators do not think the infant will survive to 36 weeks gestation

Contacts and Locations

Study Contact

Devin McKissic
CONTACT
(206) 300-1239
devinam@uw.edu

Principal Investigator

Devin McKissic
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

University of Washington Medical Center NICU
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Devin McKissic, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01
Study Completion Date2024-06

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2024-06

Terms related to this study

Additional Relevant MeSH Terms

  • Anxiety
  • Parent-Child Relations
  • Literacy