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

University of Washington

Status: Enrolling

Conditions: Literacy; Parent-Child Relations; Anxiety

Treatments: Behavioral: Reach Out and Read

Study type: Interventional

Funder types: Other

Identifiers

NCT06002360

STUDY00015592

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Reach Out and Read

Experimental group

Description:

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.

Treatment:

Behavioral: Reach Out and Read

Control

No Intervention group

Description:

Standard neonatal care