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Reach Out and Read for Parent-Child Relationship in NICU

N/A
Recruiting
Led By Devin McKissic
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between enrollment and 3 months corrected gestational age for infant
Awards & highlights

Study Summary

This trial will study the effect of Reach Out and Read on NICU infants and their families, such as literacy skills, parental stress, and bonding.

Who is the study for?
This trial is for families with infants born prematurely (between 24 and nearly 34 weeks of gestation) who speak English or Spanish. It's not suitable for those whose babies are severely unstable and unlikely to survive until they're about 8 weeks old.Check my eligibility
What is being tested?
The study examines the Reach Out and Read program in the NICU, assessing its impact on home literacy, parental stress using the STAI-6 questionnaire, parent-infant bonding via PBQ scores, at enrollment, when baby reaches a certain age, and again at three months.See study design
What are the potential side effects?
Since this intervention involves education rather than medication or medical procedures, traditional side effects aren't expected. However, there may be emotional impacts related to changes in literacy practices or family dynamics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between enrollment and 3 months corrected gestational age for infant
This trial's timeline: 3 weeks for screening, Varies for treatment, and between enrollment and 3 months corrected gestational age for infant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 parent-infant bonding by comparing scores on the 25-item Postpartum Bonding Questionnaire (PBQ)
To evaluate the effects of the ROR intervention on parental stress levels as assessed by the 6-question State-Trait Anxiety Index (STAI-6)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reach Out and ReadExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Standard neonatal care

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Who is running the clinical trial?

University of WashingtonLead Sponsor
1,752 Previous Clinical Trials
1,840,437 Total Patients Enrolled
17 Trials studying Anxiety
64,360 Patients Enrolled for Anxiety
Devin McKissicPrincipal InvestigatorUniversity of Washington
~23 spots leftby Jun 2025
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