Anxiety & Depression Association of America

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

Purpose

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

Eligibility

Eligible Ages: Under 14 Days
Eligible Genders: All
Accepts 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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.	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.
No Intervention Control	Standard neonatal care

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Washington

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.