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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ between enrollment and 3 months corrected gestational age for infant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between enrollment and 3 months corrected gestational age for infant
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 moreTrial 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
1,741 Previous Clinical Trials
1,847,700 Total Patients Enrolled
17 Trials studying Anxiety
64,349 Patients Enrolled for Anxiety
Devin McKissicPrincipal InvestigatorUniversity of Washington
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial still open to participants?
"According to the information published on clinicaltrials.gov, this research is actively seeking participants. Its initial posting was made on November 1st 2022 and a recent update was applied on August 15th 2023."
Answered by AI
How many participants are currently involved in this experiment?
"Affirmative. According to the details provided on clinicaltrials.gov, this trial is actively sourcing patients from a single location upon its inception in November 1st 2022 and most recently updated on August 15th 2023. The study requires 60 individuals for participation."
Answered by AI
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