Clinical trial NCT06002360: Reach Out and Read (ROR) in the Neonatal Intensive Care Unit (NICU) Study
Official title: The Effect of Reach Out and Read on Home Literacy Scores, Parental Stress, and Parent-Infant Bonding in the Neonatal ICU
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Parent-Child Relations
Literacy
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 60
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the effects of the ROR intervention on the home literacy environment by comparing home literacy scores
timeFrame: Between enrollment and 3 months corrected gestational age for infant
measure: To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
timeFrame: Between enrollment and 3 months corrected gestational age for infant
measure: To evaluate the effects of the ROR intervention on parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
timeFrame: Between enrollment and 3 months corrected gestational age for infant
measure: To complete a needs assessment for literacy interventions in the NICU population through evaluating baseline home literacy scores.
timeFrame: At enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center NICU
state: Washington
Study officials:
affiliation: University of Washington
name: Devin McKissic
role: PRINCIPAL_INVESTIGATOR
References: