- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988996
Peer Support Groups for Families With an Infant in the NICU
Peer Support for Black and Latino Families With an Infant in the NICU
The goal of this observational study is to learn the impact of race, ethnicity, and language matched peer support groups on parental stress, anxiety, and sense of belonging for families who have or have had an infant hospitalized in the Neonatal Intensive Care Unit (NICU). The main questions aim to answer: Do race, ethnicity, and language matched peer support groups decrease parental stress and anxiety and improve sense of belonging of parents while their baby is hospitalized in the NICU? And, are there any changes that should be made to the format of the peer support group sessions?
Participants will be invited to attend a peer support group that is matched for race, ethnicity, and language. Participants will have the option of filling out a survey on stress, anxiety, and sense of belonging before and after the peer group session. Additionally, participants will have the option of filling out a satisfaction survey after the peer group session.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Parental or guardian self-identified as Black, African American, African, Latino, Hispanic, Chicano
- Parent or guardian of infant that was or is admitted to Oregon Health & Science University, Randall Children's Hospital, or Providence Health NICU in Portland, OR
Exclusion Criteria:
- Parent or guardian age less than 18 years old
- Preferred language other than English or Spanish (including if preferred communication is sign language)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
African American and Black
One cohort includes families that identify as Black, African American, or African attending the racially concordant peer group sessions.
|
This prospective observational cohort study will be assessing parental stress, anxiety, and sense of belonging before and after participant attendance at the culturally concordant peer group session.
|
|
Latino English Preferred
One cohort includes families that identify as Latino, Hispanic, Chicano and language preference of English attending the ethnically concordant peer group sessions.
|
This prospective observational cohort study will be assessing parental stress, anxiety, and sense of belonging before and after participant attendance at the culturally concordant peer group session.
|
|
Latino Spanish preferred
One cohort includes families that identify as Latino, Hispanic, Chicano and language preference of Spanish attending the ethnically and linguistically concordant peer group sessions.
|
This prospective observational cohort study will be assessing parental stress, anxiety, and sense of belonging before and after participant attendance at the culturally concordant peer group session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental stress
Time Frame: 1 week prior to 2 days after peer group session
|
The degree of parental stress in the NICU will be assessed using the Parental Stressor Scale: Neonatal Intensive Care Unit validated tool.
The minimum and maximum values are 26 and 130 respectively, with higher scores indicating higher parental stress.
|
1 week prior to 2 days after peer group session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parental sense of belonging
Time Frame: 2 days after peer group session
|
Sense of belonging will be assessed with three non-validated questions about community and within NICU sense of belonging questions.
The scoring system is a 5-point Likert scale with an option for "Not Applicable".
The minimum and maximum score are 3 and 15 respectively, with higher scores indicating greater sense of belonging.
|
2 days after peer group session
|
Collaborators and Investigators
Investigators
- Principal Investigator: Devlynne S Ondusko, MD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- STUDY00025682
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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