<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/NCT03827109</url>
  </required_header>
  <id_info>
    <org_study_id>R01NR017533</org_study_id>
    <nct_id>NCT03827109</nct_id>
  </id_info>
  <brief_title>Peer Mentoring to Improve Self-management in Youth With IBD</brief_title>
  <official_title>Peer Mentoring to Improve Self-management in Youth With IBD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laura Mackner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nationwide Children's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is a multi-site randomized controlled clinical trial evaluating the efficacy of a&#xD;
      peer mentoring program for improving the self-management of youth with IBD. The primary&#xD;
      outcomes are youth QOL and functioning in typical life activities. Secondary outcomes are&#xD;
      disease outcomes, including disease severity and clinical outcomes (hospital admissions,&#xD;
      clinic appointments, missed appointments, procedures). Mentor and parent QOL will also be&#xD;
      assessed as secondary outcomes. Mechanisms that may contribute to the effects of the&#xD;
      Mentoring Program will be investigated: Parent and child self-efficacy, illness uncertainty,&#xD;
      coping, social support and child perceived stigma. Sex will be explored as a moderator.&#xD;
&#xD;
      A total of 200 youth and their parents and 100 mentors will be enrolled. Eligibility criteria&#xD;
      for youth include age 10-17 years, parent and child English fluency, and no documented&#xD;
      neurodevelopmental disorder or history of hospitalization for a psychiatric or behavioral&#xD;
      disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing their IBD&#xD;
      well. They will be rigorously screened via online application, interview, checks of&#xD;
      references, driving records, and social media, background check, and successful completion of&#xD;
      a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an&#xD;
      &quot;Educational Activity&quot; comparison group, with baseline assessments occurring prior to&#xD;
      randomization. Follow-up assessments will occur post-intervention and 6 months later.&#xD;
&#xD;
      The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group&#xD;
      educational activities, online educational information, and a parent support component.&#xD;
      Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person&#xD;
      contact 1 - 2 times per month.&#xD;
&#xD;
      Group activities target self-management skills through experiential opportunities, modeling,&#xD;
      and direct instruction. Educational topics include nutrition, stress, IBD and school, and&#xD;
      disease management, and are taught by experts in each content area. They also provide&#xD;
      opportunities to socialize with other mentors and mentees: lunch and games are provided&#xD;
      before or after the educational event.&#xD;
&#xD;
      The Educational Activity comparison group consists of separate educational group events on&#xD;
      the same topics (with no social time), educational information posted online, and monthly&#xD;
      encouragement to engage in activities in the community.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a multi-site randomized controlled clinical trial evaluating the&#xD;
      efficacy of a peer mentoring program for improving the self-management of youth with IBD. The&#xD;
      primary outcomes are youth QOL and functioning in typical life activities, which can remain&#xD;
      significantly impaired even when the disease is in remission, but have received little&#xD;
      empirical attention. Secondary outcomes are disease outcomes, including disease severity and&#xD;
      clinical outcomes (hospital admissions, clinic appointments, missed appointments,&#xD;
      procedures). Mentor and parent QOL will also be assessed as secondary outcomes. Mechanisms&#xD;
      that may contribute to the effects of the Mentoring Program will be investigated: Parent and&#xD;
      child self-efficacy, illness uncertainty, coping, social support and child perceived stigma&#xD;
      may mediate relationships between mentoring and outcomes. Sex will be explored as a&#xD;
      moderator.&#xD;
&#xD;
      A total of 200 youth and their parents and 100 mentors will be enrolled in the study.&#xD;
      Eligibility criteria for youth include age 10-17 years, parent and child English fluency, and&#xD;
      no documented neurodevelopmental disorder or history of hospitalization for a psychiatric or&#xD;
      behavioral disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing&#xD;
      their IBD well. They will be rigorously screened via online application, interview, checks of&#xD;
      references, driving records, and social media, background check, and successful completion of&#xD;
      a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an&#xD;
      &quot;Educational Activity&quot; comparison group, with baseline assessments occurring prior to&#xD;
      randomization. Follow-up assessments will occur post-intervention and 6 months later. Youth&#xD;
      in the Educational Activity group will be yoked to those in Mentoring Program, and the timing&#xD;
      of their follow-up assessments will correspond to their yoked peer.&#xD;
&#xD;
      The Mentoring Program was developed via focus groups, an NIH-funded pilot study, national&#xD;
      mentoring resources, and the PI's 10 years of experience with Big Brothers Big Sisters. It&#xD;
      consists of year-long, 1:1 mentee-mentor relationships with group educational activities,&#xD;
      online educational information, and a parent support component. Matching mentors and mentees&#xD;
      is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and&#xD;
      mentees are expected to have weekly contact (e.g., text, phone), as well as participate in an&#xD;
      activity (in person or virtually) 1 - 2 times per month, one of which can be attending a&#xD;
      group activity together. The investigators expect the relationship to last 1 year, which is&#xD;
      associated with better outcomes than shorter relationships.&#xD;
&#xD;
      Group activities target self-management skills through experiential opportunities, modeling,&#xD;
      and direct instruction. Educational topics include nutrition, stress, IBD and school, and&#xD;
      disease management, and are taught by experts in each content area (e.g., dietitian,&#xD;
      pediatric gastroenterologists). They also provide opportunities to socialize with other&#xD;
      mentors and mentees: lunch and games are provided before or after the educational event.&#xD;
      Parents in the Mentoring Program participate in a social/support group facilitated by an&#xD;
      Investigator while mentees and mentors are socializing. Parents join the mentees and mentors&#xD;
      for the educational topics.&#xD;
&#xD;
      The Educational Activity comparison group consists of separate educational group events on&#xD;
      the same topics (with no social or support time), educational information posted online, and&#xD;
      monthly encouragement to engage in activities in the community.&#xD;
&#xD;
      Due to the COVID-19 pandemic, a modification was approved so that all study activities can be&#xD;
      conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via&#xD;
      Skype, and group activities are live streamed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 12, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>12 month youth quality of life: PedsQL</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>18 month youth quality of life: PedsQL</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12 month change from baseline Youth quality of life: PedsQL</measure>
    <time_frame>Baseline to 12 months post mentor-mentee introduction</time_frame>
    <description>PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>18 month change from baseline Youth quality of life: PedsQL</measure>
    <time_frame>Baseline to 18 months post mentor-mentee introduction</time_frame>
    <description>PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12 month youth functional disability</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>18 month youth functional disability</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>12 month change from baseline youth functional disability</measure>
    <time_frame>Baseline to 12 months post mentor-mentee introduction</time_frame>
    <description>Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>18 month change from baseline youth functional disability</measure>
    <time_frame>Baseline to 18 months post mentor-mentee introduction</time_frame>
    <description>Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>12 month Youth disease outcomes - Crohn's Disease severity</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month Youth disease outcomes - Ulcerative Colitis severity</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 month Youth disease outcomes - Crohn's Disease severity</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 month Youth disease outcomes - Ulcerative Colitis severity</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month number of hospital admissions in previous 6 months</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>12 month number of hospital admissions in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 month number of hospital admissions in previous 6 months</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>18 month number of hospital admissions in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month number of clinic appointments in previous 6 months</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>12 month number of clinic appointments in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 month number of clinic appointments in previous 6 months</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>18 month number of clinic appointments in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month number of missed appointments in previous 6 months</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>12 month number of missed appointments in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 month number of missed appointments in previous 6 months</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>18 month number of missed appointments in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month number of procedures in previous 6 months</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>12 month number of procedures appointments in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 month number of procedures in previous 6 months</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>18 month number of procedures appointments in previous 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 months Mentor QOL</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>18 months Mentor QOL</measure>
    <time_frame>18 months post mentor-mentee introduction</time_frame>
    <description>PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month change from baseline Mentor QOL</measure>
    <time_frame>Baseline to 12 months post mentor-mentee introduction</time_frame>
    <description>PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month Parent QOL</measure>
    <time_frame>12 months post mentor-mentee introduction</time_frame>
    <description>PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12 month change from baseline Parent QOL</measure>
    <time_frame>Baseline to 12 months post mentor-mentee introduction</time_frame>
    <description>PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Pediatric Crohns Disease</condition>
  <condition>Pediatric Ulcerative Colitis</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>Mentoring program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month. Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics. Due to the COVID-19 pandemic, these activities can be conducted virtually.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Educational activity program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Educational Activity comparison group consists of separate educational group events on the same topics (with no social time), educational information posted online, and monthly encouragement to engage in activities in the community. Due to the COVID-19 pandemic, participants are encouraged to interact socially in safe ways, e.g., outdoors or virtually.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group educational activities</intervention_name>
    <description>Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.</description>
    <arm_group_label>Educational activity program</arm_group_label>
    <arm_group_label>Mentoring program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IBD educational website</intervention_name>
    <description>Website with age-appropriate educational information, including information from the group educational activities.</description>
    <arm_group_label>Educational activity program</arm_group_label>
    <arm_group_label>Mentoring program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Monthly check-in calls from program coordinator</intervention_name>
    <description>Phone calls from coordinator to encourage youth to do something fun with a friend (comparison group) or mentor (Mentoring Program). During the COVID-19 pandemic, virtual activities are encouraged. For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.</description>
    <arm_group_label>Educational activity program</arm_group_label>
    <arm_group_label>Mentoring program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mentor</intervention_name>
    <description>Mentees will be matched with a mentor for a year-long, 1:1 mentee-mentor relationship. Matching mentors and mentees is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month, one of which can be attending a group activity together. Due to the COVID-19 pandemic, a modification was approved so that all study activities can be conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via Skype, and group activities are live streamed</description>
    <arm_group_label>Mentoring program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fun group activities</intervention_name>
    <description>Program participants vote on &quot;fun&quot; group activities to participate in for support and to learn self-management skills through experiential opportunities and modeling. These are live streamed during the COVID-19 pandemic.</description>
    <arm_group_label>Mentoring program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parent support group</intervention_name>
    <description>Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing during group events (virtually during the COVID-19 pandemic).</description>
    <arm_group_label>Mentoring program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Mentees:&#xD;
&#xD;
          -  Diagnosis of IBD&#xD;
&#xD;
          -  Age 10 - 17 years&#xD;
&#xD;
          -  Parent and child English fluency&#xD;
&#xD;
          -  No documented neuro-developmental disorder or history of hospitalization for a&#xD;
             psychiatric or behavioral disorder&#xD;
&#xD;
        Mentors:&#xD;
&#xD;
          -  ≥16 years&#xD;
&#xD;
          -  ≥1 year post-diagnosis of IBD&#xD;
&#xD;
          -  Managing their IBD well&#xD;
&#xD;
          -  Pass a screening that includes an online application, interview, 3 character&#xD;
             references, checks of driving records and social media, background check, mentor&#xD;
             training&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Mentees: No documented neuro-developmental disorder or history of hospitalization for a&#xD;
        psychiatric or behavioral disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Laura Mackner, PhD</last_name>
    <phone>614-722-4716</phone>
    <email>Laura.Mackner@nationwidechildrens.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Abigail Wexner Research Institute at Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laura Mackner, PhD</last_name>
      <phone>614-722-4716</phone>
      <email>Laura.Mackner@nationwidechildrens.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nationwide Children's Hospital</investigator_affiliation>
    <investigator_full_name>Laura Mackner</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified data will be archived with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR). NCH is a member of ICPSR via the Ohio State University; thus ICPSR can curate the data using funds provided by membership dues. ICPSR can archive the full dataset and its documentation, supporting the data through future changing technologies, new media, and data formats. ICPSR will make the data available to the broader research community via files that may be accessed directly via the ICPSR Web site. Approximately 776 universities, government agencies, and other institutions are members of ICPSR. Member institutions have full direct access to ICPSR's data archives and to all of ICPSR's services and can download the data. Non-members may purchase the files. The data will be deposited with the repository at the completion of the study and disseminated in one year to give the investigators time to publish their findings.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>The data will be deposited with the repository at the completion of the study but not disseminated for one year to give the investigators time to publish their findings.</ipd_time_frame>
    <ipd_access_criteria>Users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03827109/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 26, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03827109/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03827109
org study id: R01NR017533
nct id: NCT03827109
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a multi-site randomized controlled clinical trial evaluating the efficacy of a
      peer mentoring program for improving the self-management of youth with IBD. The primary
      outcomes are youth QOL and functioning in typical life activities. Secondary outcomes are
      disease outcomes, including disease severity and clinical outcomes (hospital admissions,
      clinic appointments, missed appointments, procedures). Mentor and parent QOL will also be
      assessed as secondary outcomes. Mechanisms that may contribute to the effects of the
      Mentoring Program will be investigated: Parent and child self-efficacy, illness uncertainty,
      coping, social support and child perceived stigma. Sex will be explored as a moderator.

      A total of 200 youth and their parents and 100 mentors will be enrolled. Eligibility criteria
      for youth include age 10-17 years, parent and child English fluency, and no documented
      neurodevelopmental disorder or history of hospitalization for a psychiatric or behavioral
      disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing their IBD
      well. They will be rigorously screened via online application, interview, checks of
      references, driving records, and social media, background check, and successful completion of
      a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an
      "Educational Activity" comparison group, with baseline assessments occurring prior to
      randomization. Follow-up assessments will occur post-intervention and 6 months later.

      The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group
      educational activities, online educational information, and a parent support component.
      Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person
      contact 1 - 2 times per month.

      Group activities target self-management skills through experiential opportunities, modeling,
      and direct instruction. Educational topics include nutrition, stress, IBD and school, and
      disease management, and are taught by experts in each content area. They also provide
      opportunities to socialize with other mentors and mentees: lunch and games are provided
      before or after the educational event.

      The Educational Activity comparison group consists of separate educational group events on
      the same topics (with no social time), educational information posted online, and monthly
      encouragement to engage in activities in the community.
The proposed study is a multi-site randomized controlled clinical trial evaluating the
      efficacy of a peer mentoring program for improving the self-management of youth with IBD. The
      primary outcomes are youth QOL and functioning in typical life activities, which can remain
      significantly impaired even when the disease is in remission, but have received little
      empirical attention. Secondary outcomes are disease outcomes, including disease severity and
      clinical outcomes (hospital admissions, clinic appointments, missed appointments,
      procedures). Mentor and parent QOL will also be assessed as secondary outcomes. Mechanisms
      that may contribute to the effects of the Mentoring Program will be investigated: Parent and
      child self-efficacy, illness uncertainty, coping, social support and child perceived stigma
      may mediate relationships between mentoring and outcomes. Sex will be explored as a
      moderator.

      A total of 200 youth and their parents and 100 mentors will be enrolled in the study.
      Eligibility criteria for youth include age 10-17 years, parent and child English fluency, and
      no documented neurodevelopmental disorder or history of hospitalization for a psychiatric or
      behavioral disorder. Mentors will be ≥16 years, ≥1 year post-diagnosis of IBD and managing
      their IBD well. They will be rigorously screened via online application, interview, checks of
      references, driving records, and social media, background check, and successful completion of
      a 3-hour training. Youth will be randomly assigned to the Mentoring Program or an
      "Educational Activity" comparison group, with baseline assessments occurring prior to
      randomization. Follow-up assessments will occur post-intervention and 6 months later. Youth
      in the Educational Activity group will be yoked to those in Mentoring Program, and the timing
      of their follow-up assessments will correspond to their yoked peer.

      The Mentoring Program was developed via focus groups, an NIH-funded pilot study, national
      mentoring resources, and the PI's 10 years of experience with Big Brothers Big Sisters. It
      consists of year-long, 1:1 mentee-mentor relationships with group educational activities,
      online educational information, and a parent support component. Matching mentors and mentees
      is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and
      mentees are expected to have weekly contact (e.g., text, phone), as well as participate in an
      activity (in person or virtually) 1 - 2 times per month, one of which can be attending a
      group activity together. The investigators expect the relationship to last 1 year, which is
      associated with better outcomes than shorter relationships.

      Group activities target self-management skills through experiential opportunities, modeling,
      and direct instruction. Educational topics include nutrition, stress, IBD and school, and
      disease management, and are taught by experts in each content area (e.g., dietitian,
      pediatric gastroenterologists). They also provide opportunities to socialize with other
      mentors and mentees: lunch and games are provided before or after the educational event.
      Parents in the Mentoring Program participate in a social/support group facilitated by an
      Investigator while mentees and mentors are socializing. Parents join the mentees and mentors
      for the educational topics.

      The Educational Activity comparison group consists of separate educational group events on
      the same topics (with no social or support time), educational information posted online, and
      monthly encouragement to engage in activities in the community.

      Due to the COVID-19 pandemic, a modification was approved so that all study activities can be
      conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via
      Skype, and group activities are live streamed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 12 month youth quality of life: PedsQL
time frame: 12 months post mentor-mentee introduction
description: PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 18 month youth quality of life: PedsQL
time frame: 18 months post mentor-mentee introduction
description: PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 12 month change from baseline Youth quality of life: PedsQL
time frame: Baseline to 12 months post mentor-mentee introduction
description: PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 18 month change from baseline Youth quality of life: PedsQL
time frame: Baseline to 18 months post mentor-mentee introduction
description: PedsQL (full, unabbreviated scale name). Construct: Youth quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 12 month youth functional disability
time frame: 12 months post mentor-mentee introduction
description: Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
measure: 18 month youth functional disability
time frame: 18 months post mentor-mentee introduction
description: Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
measure: 12 month change from baseline youth functional disability
time frame: Baseline to 12 months post mentor-mentee introduction
description: Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
measure: 18 month change from baseline youth functional disability
time frame: Baseline to 18 months post mentor-mentee introduction
description: Functional Disability Inventory. Assess adaptive functioning in every day life. Scores range from 0 - 60 with higher scores indicating greater disability. Total score will be used.
measure: 12 month Youth disease outcomes - Crohn's Disease severity
time frame: 12 months post mentor-mentee introduction
description: Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.
measure: 12 month Youth disease outcomes - Ulcerative Colitis severity
time frame: 12 months post mentor-mentee introduction
description: Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.
measure: 18 month Youth disease outcomes - Crohn's Disease severity
time frame: 18 months post mentor-mentee introduction
description: Disease severity: Pediatric Crohn's Disease Activity Index total score. A standard measure of disease severity that is comprised of information obtained from patient recall (pain severity, stool frequency, limitation of activities), examination (weight, height, abdominal tenderness, perirectal disease, extra- intestinal manifestations), and laboratory data. The Pediatric Crohn's Disease Activity Index total score will be used. Higher scores indicate more severe disease.
measure: 18 month Youth disease outcomes - Ulcerative Colitis severity
time frame: 18 months post mentor-mentee introduction
description: Disease severity: Pediatric Ulcerative Colitis Activity Index total score. A standard Pediatric Ulcerative Colitis Activity Index. a standard measure of disease severity that is comprised pain severity, stool frequency and consistency, rectal bleeding, nocturnal bowel movements, and limitation of activities. The Pediatric Ulcerative Colitis Activity Index total score will be used. Higher scores indicate more severe disease.
measure: 12 month number of hospital admissions in previous 6 months
time frame: 12 months post mentor-mentee introduction
description: 12 month number of hospital admissions in previous 6 months
measure: 18 month number of hospital admissions in previous 6 months
time frame: 18 months post mentor-mentee introduction
description: 18 month number of hospital admissions in previous 6 months
measure: 12 month number of clinic appointments in previous 6 months
time frame: 12 months post mentor-mentee introduction
description: 12 month number of clinic appointments in previous 6 months
measure: 18 month number of clinic appointments in previous 6 months
time frame: 18 months post mentor-mentee introduction
description: 18 month number of clinic appointments in previous 6 months
measure: 12 month number of missed appointments in previous 6 months
time frame: 12 months post mentor-mentee introduction
description: 12 month number of missed appointments in previous 6 months
measure: 18 month number of missed appointments in previous 6 months
time frame: 18 months post mentor-mentee introduction
description: 18 month number of missed appointments in previous 6 months
measure: 12 month number of procedures in previous 6 months
time frame: 12 months post mentor-mentee introduction
description: 12 month number of procedures appointments in previous 6 months
measure: 18 month number of procedures in previous 6 months
time frame: 18 months post mentor-mentee introduction
description: 18 month number of procedures appointments in previous 6 months
measure: 12 months Mentor QOL
time frame: 12 months post mentor-mentee introduction
description: PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 18 months Mentor QOL
time frame: 18 months post mentor-mentee introduction
description: PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 12 month change from baseline Mentor QOL
time frame: Baseline to 12 months post mentor-mentee introduction
description: PedsQL Adult Report (full, unabbreviated scale name). Construct: Mentor quality of life. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 12 month Parent QOL
time frame: 12 months post mentor-mentee introduction
description: PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
measure: 12 month change from baseline Parent QOL
time frame: Baseline to 12 months post mentor-mentee introduction
description: PedsQL Family Impact Module (full, unabbreviated scale name). Construct: Parent quality of life and the impact a child's chronic illness has on the family. Scores range from 0-100 with higher scores indicating higher quality of life. Total score will be used.
arm group label: Mentoring program
arm group type: Experimental
description: The Mentoring Program consists of year-long, 1:1 mentee-mentor relationships with group educational activities, online educational information, and a parent support component. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month. Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. They also provide opportunities to socialize with other mentors and mentees: lunch and games are provided before or after the educational event. Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing. Parents join the mentees and mentors for the educational topics. Due to the COVID-19 pandemic, these activities can be conducted virtually.
arm group label: Educational activity program
arm group type: Active Comparator
description: The Educational Activity comparison group consists of separate educational group events on the same topics (with no social time), educational information posted online, and monthly encouragement to engage in activities in the community. Due to the COVID-19 pandemic, participants are encouraged to interact socially in safe ways, e.g., outdoors or virtually.
intervention type: Behavioral
intervention name: Group educational activities
description: Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.
arm group label: Educational activity program
arm group label: Mentoring program
intervention type: Behavioral
intervention name: IBD educational website
description: Website with age-appropriate educational information, including information from the group educational activities.
arm group label: Educational activity program
arm group label: Mentoring program
intervention type: Behavioral
intervention name: Monthly check-in calls from program coordinator
description: Phone calls from coordinator to encourage youth to do something fun with a friend (comparison group) or mentor (Mentoring Program). During the COVID-19 pandemic, virtual activities are encouraged. For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.
arm group label: Educational activity program
arm group label: Mentoring program
intervention type: Behavioral
intervention name: Mentor
description: Mentees will be matched with a mentor for a year-long, 1:1 mentee-mentor relationship. Matching mentors and mentees is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month, one of which can be attending a group activity together. Due to the COVID-19 pandemic, a modification was approved so that all study activities can be conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via Skype, and group activities are live streamed
arm group label: Mentoring program
intervention type: Behavioral
intervention name: Fun group activities
description: Program participants vote on "fun" group activities to participate in for support and to learn self-management skills through experiential opportunities and modeling. These are live streamed during the COVID-19 pandemic.
arm group label: Mentoring program
intervention type: Behavioral
intervention name: Parent support group
description: Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing during group events (virtually during the COVID-19 pandemic).
arm group label: Mentoring program
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Laura Mackner, PhD
phone: 614-722-4716
email: Laura.Mackner@nationwidechildrens.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Nationwide Children's Hospital
investigator full name: Laura Mackner
investigator title: Principal Investigator
mesh term: Crohn Disease
mesh term: Inflammatory Bowel Diseases
sharing ipd: Yes
ipd description: De-identified data will be archived with the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR). NCH is a member of ICPSR via the Ohio State University; thus ICPSR can curate the data using funds provided by membership dues. ICPSR can archive the full dataset and its documentation, supporting the data through future changing technologies, new media, and data formats. ICPSR will make the data available to the broader research community via files that may be accessed directly via the ICPSR Web site. Approximately 776 universities, government agencies, and other institutions are members of ICPSR. Member institutions have full direct access to ICPSR's data archives and to all of ICPSR's services and can download the data. Non-members may purchase the files. The data will be deposited with the repository at the completion of the study and disseminated in one year to give the investigators time to publish their findings.
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: The data will be deposited with the repository at the completion of the study but not disseminated for one year to give the investigators time to publish their findings.
ipd access criteria: Users with an ICPSR MyData account and an authorized IP address from a member institution may download the data, and non-members may purchase the files.
provided document: 
provided document: 