xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05988996</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00025682</org_study_id>
      <nct_id>NCT05988996</nct_id>
    </id_info>
    <brief_title>Peer Support Groups for Families With an Infant in the NICU</brief_title>
    <official_title>Peer Support for Black and Latino Families With an Infant in the NICU</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Oregon Health and Science University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Legacy Health System</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Providence Health &amp; Services</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Oregon Health and Science University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn the impact of race, ethnicity, and language&#xD;
        matched peer support groups on parental stress, anxiety, and sense of belonging for families&#xD;
        who have or have had an infant hospitalized in the Neonatal Intensive Care Unit (NICU). The&#xD;
        main questions aim to answer: Do race, ethnicity, and language matched peer support groups&#xD;
        decrease parental stress and anxiety and improve sense of belonging of parents while their&#xD;
        baby is hospitalized in the NICU? And, are there any changes that should be made to the&#xD;
        format of the peer support group sessions?&#xD;
  &#xD;
        Participants will be invited to attend a peer support group that is matched for race,&#xD;
        ethnicity, and language. Participants will have the option of filling out a survey on stress,&#xD;
        anxiety, and sense of belonging before and after the peer group session. Additionally,&#xD;
        participants will have the option of filling out a satisfaction survey after the peer group&#xD;
        session.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be observational research wherein participants who want to attend a peer&#xD;
        support group, will have the option of filling out surveys before and after peer support&#xD;
        group attendance. Surveys are voluntary and the only way of assessing the behavioral outcome&#xD;
        (impact on parental stress, anxiety, and sense of belonging); families can attend the peer&#xD;
        support groups even if the family member does not want to participate in the survey.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 4, 2023</start_date>
    <completion_date type="Anticipated">March 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Parental stress</measure>
      <time_frame>1 week prior to 2 days after peer group session</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Parental sense of belonging</measure>
      <time_frame>2 days after peer group session</time_frame>
      <description>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 &quot;Not Applicable&quot;. The minimum and maximum score are 3 and 15 respectively, with higher scores indicating greater sense of belonging.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Anxiety</condition>
    <condition>Stress</condition>
    <arm_group>
      <arm_group_label>African American and Black</arm_group_label>
      <description>One cohort includes families that identify as Black, African American, or African attending the racially concordant peer group sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Latino English Preferred</arm_group_label>
      <description>One cohort includes families that identify as Latino, Hispanic, Chicano and language preference of English attending the ethnically concordant peer group sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Latino Spanish preferred</arm_group_label>
      <description>One cohort includes families that identify as Latino, Hispanic, Chicano and language preference of Spanish attending the ethnically and linguistically concordant peer group sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Participant guided peer support gathering</intervention_name>
      <description>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.</description>
      <arm_group_label>African American and Black</arm_group_label>
      <arm_group_label>Latino English Preferred</arm_group_label>
      <arm_group_label>Latino Spanish preferred</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Study participants will be selected from the population of people who are attending the&#xD;
          peer support group sessions.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Parental or guardian self-identified as Black, African American, African, Latino,&#xD;
               Hispanic, Chicano&#xD;
  &#xD;
            -  Parent or guardian of infant that was or is admitted to Oregon Health &amp; Science&#xD;
               University, Randall Children's Hospital, or Providence Health NICU in Portland, OR&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Parent or guardian age less than 18 years old&#xD;
  &#xD;
            -  Preferred language other than English or Spanish (including if preferred communication&#xD;
               is sign language)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Devlynne S Ondusko, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Oregon Health and Science University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Devlynne S Ondusko, MD</last_name>
      <phone>5034948122</phone>
      <email>ondusko@ohsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zayna Bakizada, MD</last_name>
      <phone>5034948211</phone>
      <email>bakizada@ohsu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
      <investigator_full_name>Sasha Ondusko</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Parental stress</keyword>
    <keyword>Parental anxiety</keyword>
    <keyword>NICU</keyword>
    <keyword>Peer support</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>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.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05988996
  org study id: STUDY00025682
  nct id: NCT05988996
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Parental stress
  time frame: 1 week prior to 2 days after peer group session
  description: 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.
  measure: Parental sense of belonging
  time frame: 2 days after peer group session
  description: 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.
  arm group label: African American and Black
  description: One cohort includes families that identify as Black, African American, or African attending the racially concordant peer group sessions.
  arm group label: Latino English Preferred
  description: One cohort includes families that identify as Latino, Hispanic, Chicano and language preference of English attending the ethnically concordant peer group sessions.
  arm group label: Latino Spanish preferred
  description: One cohort includes families that identify as Latino, Hispanic, Chicano and language preference of Spanish attending the ethnically and linguistically concordant peer group sessions.
  intervention type: Behavioral
  intervention name: Participant guided peer support gathering
  description: 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.
  arm group label: African American and Black
  arm group label: Latino English Preferred
  arm group label: Latino Spanish preferred
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Devlynne S Ondusko, MD
  role: Principal Investigator
  affiliation: Oregon Health and Science University
  last name: Devlynne S Ondusko, MD
  phone: 5034948122
  email: ondusko@ohsu.edu
  last name: Zayna Bakizada, MD
  phone: 5034948211
  email: bakizada@ohsu.edu
  responsible party type: Principal Investigator
  investigator affiliation: Oregon Health and Science University
  investigator full name: Sasha Ondusko
  investigator title: Principal Investigator
  sharing ipd: No
  ipd description: 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.