Peer Support Groups for Families With an Infant in the NICU

Anxiety Clinical Trial

Official title:

Peer Support for Black and Latino Families With an Infant in the NICU

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05988996
• Other study ID #: STUDY00025682
• Status: Enrolling by invitation
• Start date: August 1, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: November 2023
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety
• Stress

Intervention

Behavioral:
• Participant guided peer support gathering
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.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Legacy Health System, Providence Health & Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	2 days after peer group session