AnxietyNCT05988996
Peer Support Groups for Families With an Infant in the NICU
An observational study of Anxiety and Stress, run by Oregon Health and Science University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Participant guided peer support gathering
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be selected from the population of people who are attending the peer support group sessions.
Who may be able to join
- 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
Who cannot join
- Parent or guardian age less than 18 years old
- Preferred language other than English or Spanish (including if preferred communication is sign language)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the detailed description
The study will be observational research wherein participants who want to attend a peer support group, will have the option of filling out surveys before and after peer support group attendance. Surveys are voluntary and the only way of assessing the behavioral outcome (impact on parental stress, anxiety, and sense of belonging); families can attend the peer support groups even if the family member does not want to participate in the survey.
- Being tested
- Participant guided peer support gathering
- Keywords
- Parental stress, Parental anxiety, NICU, Peer support
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant guided peer support gatheringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| African American and Black | One cohort includes families that identify as Black, African American, or African attending the racially concordant peer group sessions. Receives: 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. Receives: 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. Receives: Behavioral: Participant guided peer support gathering |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week prior to 2 days after peer group session
Secondary outcomes (1)
Parental sense of belonging
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.
Measured: 2 days after peer group session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Legacy Health System, Providence Health & Services
- Responsible party
- Principal investigator, Sasha Ondusko, Oregon Health and Science University
- Investigators
- Devlynne S Ondusko, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988996
- Sponsor's protocol ID
- STUDY00025682
- Status last verified
- Apr 2025
- First submitted
- 3 Aug 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support for Black and Latino Families With an Infant in the NICU
- ClinicalTrials.gov ID
- NCT05988996
- Acronym / sponsor ID
- STUDY00025682
- Keywords
- Parental stress, Parental anxiety, NICU, Peer support
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Legacy Health System, Providence Health & Services
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will be observational research wherein participants who want to attend a peer support group, will have the option of filling out surveys before and after peer support group attendance. Surveys are voluntary and the only way of assessing the behavioral outcome (impact on parental stress, anxiety, and sense of belonging); families can attend the peer support groups even if the family member does not want to participate in the survey.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| African American and Black | – | Behavioral: Participant guided peer support gatheringOne cohort includes families that identify as Black, African American, or African attending the racially concordant peer group sessions. |
| Latino English Preferred | – | Behavioral: Participant guided peer support gatheringOne cohort includes families that identify as Latino, Hispanic, Chicano and language preference of English attending the ethnically concordant peer group sessions. |
| Latino Spanish preferred | – | Behavioral: Participant guided peer support gatheringOne cohort includes families that identify as Latino, Hispanic, Chicano and language preference of Spanish attending the ethnically and linguistically concordant peer group sessions. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from the population of people who are attending the peer support group sessions.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Parent or guardian age less than 18 years old
- Preferred language other than English or Spanish (including if preferred communication is sign language)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participant guided peer support gatheringThis 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. | Behavioural | African American and Black, Latino English Preferred, Latino Spanish preferred |
Primary outcome
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 secondary outcome
Parental sense of belonging
Time frame: 2 days after peer group session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devlynne S Ondusko, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and Stress, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental stress (time frame: 1 week prior to 2 days after peer group session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.