NCT05988996

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Aug 2023Jun 2026

Study Start

First participant enrolled

August 1, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

July 31, 2025

Status Verified

April 1, 2025

Enrollment Period

2.9 years

First QC Date

August 3, 2023

Last Update Submit

July 29, 2025

Conditions

Keywords

Parental stressParental anxietyNICUPeer support

Outcome Measures

Primary Outcomes (1)

  • Parental stress

    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 Outcomes (1)

  • Parental sense of belonging

    2 days after peer group session

Study Arms (3)

African American and Black

One cohort includes families that identify as Black, African American, or African attending the racially concordant peer group sessions.

Behavioral: Participant guided peer support gathering

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.

Behavioral: Participant guided peer support gathering

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.

Behavioral: Participant guided peer support gathering

Interventions

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.

African American and BlackLatino English PreferredLatino Spanish preferred

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be selected from the population of people who are attending the peer support group sessions.

You may qualify if:

  • 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

You may not qualify if:

  • Parent or guardian age less than 18 years old
  • Preferred language other than English or Spanish (including if preferred communication is sign language)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Devlynne S Ondusko, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

August 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

July 31, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

IPD will only be shared with institutionally IRB approved study team members for data analysis. All other IPD will only be shared in publication in a de-identified, aggregated manner.

Locations