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/NCT05968833</url>
    </required_header>
    <id_info>
      <org_study_id>1000080780</org_study_id>
      <nct_id>NCT05968833</nct_id>
    </id_info>
    <brief_title>iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients</brief_title>
    <official_title>Addressing the Mental Health Needs of Parents of Pediatric Kidney Transplant Recipients With the iParent2Parent Peer Support Program</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Hospital for Sick Children</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The Hospital for Sick Children</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 iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will&#xD;
        connect parents one-to-one with other parents of pediatric kidney transplant recipients who&#xD;
        are trained to offer vital peer support and mentorship. Parents of children who received a&#xD;
        kidney transplant at The Hospital for Sick Children will be invited to participate as mentors&#xD;
        and mentees (randomized into the iP2P or control group). The iP2P program can decrease&#xD;
        feelings of isolation, improve mental health and have a long-term positive impact on patient&#xD;
        health. This research will increase our understanding of one-to-one peer support and leverage&#xD;
        eHealth technologies to improve the access to and acceptability of parent peer support&#xD;
        interventions.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>
      <intervention_model_description>Waitlist randomized controlled trial</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rates and withdrawal rates</measure>
      <time_frame>Baseline to study completion, an average of 1 year</time_frame>
      <description>How many participants were recruited and have withdrawn from the program on average.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence with the iParent2Parent program</measure>
      <time_frame>Baseline to study completion, an average of 1 year</time_frame>
      <description>When the participant completes 10 audio or video calls over 12 weeks and 100% when all online outcome measures completed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability (Mentees)</measure>
      <time_frame>Baseline to 12 weeks after baseline/immediately after the intervention</time_frame>
      <description>Whether the innovation is agreeable, palatable or satisfactory.&#xD;
  Measured via semi-structured interview or focus group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability (Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Whether the innovation is agreeable, palatable or satisfactory.&#xD;
  Measured via semi-structured interview or focus group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of engagement with the iParent2Parent program (Mentees)</measure>
      <time_frame>Baseline to 12 weeks after baseline/immediately after the intervention</time_frame>
      <description>Measured via semi-structured interview or focus group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Level of engagement with the iParent2Parent program (Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Measured via semi-structured interview or focus group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Barriers and enablers of the iParent2Parent program (Mentees)</measure>
      <time_frame>Baseline to 12 weeks after baseline/immediately after the intervention</time_frame>
      <description>Measured via semi-structured interview or focus group.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Barriers and enablers of the iParent2Parent program (Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Measured via semi-structured interview or focus group.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Parenting stress (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Parental Stress Scale; 18-item questionnaire. Each question is scored on a scale from 1 to 5, with scores ranging from 18 to 90. An overall higher score means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological distress (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>General Anxiety Disorder-7; 7-item questionnaire. Each question is scored on a scale from 0 to 3, with scores ranging from 0 to 21. An overall higher score means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Psychological distress (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Personal Health Questionnaire Depression Scale; 8-item questionnaire. Each question is scored on a scale from 0 to 3, with scores ranging from 0 to 24. An overall higher score means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived social support (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Short form version 2.0 of the PROMIS battery for: Social Isolation; 6-item questionnaire. Each question is scored on a scale from 1 to 5 and generates a T-score. An overall higher score means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived social support (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Short form version 2.0 of the PROMIS battery for: Informational Support; 6-item questionnaire. Each question is scored on a scale from 1 to 5 and generates a T-score. An overall higher score means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived social support (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Short form version 2.0 of the PROMIS battery for: Emotional Support; 6-item questionnaire. Each question is scored on a scale from 1 to 5 and generates a T-score. An overall higher score means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Coping (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Coping Health Inventory for Parents; 16-item questionnaire. Each question about coping behaviour is scored on a scale from 0 to 3, with a possible response of &quot;Did not use&quot; the coping behaviour. Scores range from 0 to 48. An overall higher score means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family Functioning (Mentees and Mentors)</measure>
      <time_frame>Baseline to program completion, an average of one year</time_frame>
      <description>Pediatric Quality of Life Inventory(TM) 2.0 Family Impact Module; 36-item questionnaire with 8 different sections: Physical Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Communication, Worry, Daily Activities, and Family Relationships. Each question is scored on a scale from 0 to 4. Items are reverse-scored and linearly transformed to a 0-100 scale. An overall higher score means a better outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">55</enrollment>
    <condition>Kidney Transplant</condition>
    <arm_group>
      <arm_group_label>iParent2Parent Program</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care Waitlist Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>iParent2Parent Program</intervention_name>
      <description>iParent2Parent is an online peer support mentorship program that is based on the iPeer2Peer online peer support mentorship program, which has been established in multiple chronic disease populations as a self-management intervention, including in chronic pain and juvenile idiopathic arthritis populations. The iParent2Parent program connect parents one-to-one with other parents of pediatric kidney transplant recipients who are trained to offer vital peer support and mentorship.</description>
      <arm_group_label>iParent2Parent Program</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Mentee Inclusion Criteria:&#xD;
  &#xD;
            -  Parent of a patient under 18 years of age who received a kidney transplant and is at&#xD;
               least two months post-transplant,&#xD;
  &#xD;
            -  Access to a device (e.g., smart phone, tablet, computer) capable of using free&#xD;
               WhatsApp software, and&#xD;
  &#xD;
            -  English-speaking.&#xD;
  &#xD;
          Mentor Inclusion Criteria:&#xD;
  &#xD;
            -  Parent of a patient under 21 years of age who received a kidney transplant and is at&#xD;
               least one year post-transplant,&#xD;
  &#xD;
            -  Nominated by their child's healthcare team as a good candidate to act in the mentor&#xD;
               role (e.g., good communication skills, positive adaptation and adjustment&#xD;
               post-transplant, strong support network),&#xD;
  &#xD;
            -  Access to a device (e.g., smart phone, tablet, computer) capable of using free&#xD;
               WhatsApp software, and&#xD;
  &#xD;
            -  English-speaking.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English speaking.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Samantha J. Anthony, PhD, MSW</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Hospital for Sick Children</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Samantha J. Anthony, PhD, MSW</last_name>
      <phone>416-813-7654</phone>
      <phone_ext>303126</phone_ext>
      <email>samantha.anthony@sickkids.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Izabelle Siqueira, MPH</last_name>
      <email>izabelle.siqueira@sickkids.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Hospital for Sick Children</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M5G 1X8</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
      <investigator_full_name>Samantha Anthony</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Peer Support Mentorship</keyword>
    <keyword>Parent Support Mentorship</keyword>
    <keyword>Pediatrics</keyword>
    <keyword>Transplant</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05968833
  org study id: 1000080780
  nct id: NCT05968833
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will
        connect parents one-to-one with other parents of pediatric kidney transplant recipients who
        are trained to offer vital peer support and mentorship. Parents of children who received a
        kidney transplant at The Hospital for Sick Children will be invited to participate as mentors
        and mentees (randomized into the iP2P or control group). The iP2P program can decrease
        feelings of isolation, improve mental health and have a long-term positive impact on patient
        health. This research will increase our understanding of one-to-one peer support and leverage
        eHealth technologies to improve the access to and acceptability of parent peer support
        interventions.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Waitlist randomized controlled trial
  primary purpose: Other
  masking: Single (Investigator)
  measure: Recruitment rates and withdrawal rates
  time frame: Baseline to study completion, an average of 1 year
  description: How many participants were recruited and have withdrawn from the program on average.
  measure: Adherence with the iParent2Parent program
  time frame: Baseline to study completion, an average of 1 year
  description: When the participant completes 10 audio or video calls over 12 weeks and 100% when all online outcome measures completed.
  measure: Acceptability (Mentees)
  time frame: Baseline to 12 weeks after baseline/immediately after the intervention
  description: Whether the innovation is agreeable, palatable or satisfactory.
  Measured via semi-structured interview or focus group.
  measure: Acceptability (Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Whether the innovation is agreeable, palatable or satisfactory.
  Measured via semi-structured interview or focus group.
  measure: Level of engagement with the iParent2Parent program (Mentees)
  time frame: Baseline to 12 weeks after baseline/immediately after the intervention
  description: Measured via semi-structured interview or focus group.
  measure: Level of engagement with the iParent2Parent program (Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Measured via semi-structured interview or focus group.
  measure: Barriers and enablers of the iParent2Parent program (Mentees)
  time frame: Baseline to 12 weeks after baseline/immediately after the intervention
  description: Measured via semi-structured interview or focus group.
  measure: Barriers and enablers of the iParent2Parent program (Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Measured via semi-structured interview or focus group.
  measure: Parenting stress (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Parental Stress Scale; 18-item questionnaire. Each question is scored on a scale from 1 to 5, with scores ranging from 18 to 90. An overall higher score means a worse outcome.
  measure: Psychological distress (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: General Anxiety Disorder-7; 7-item questionnaire. Each question is scored on a scale from 0 to 3, with scores ranging from 0 to 21. An overall higher score means a worse outcome.
  measure: Psychological distress (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Personal Health Questionnaire Depression Scale; 8-item questionnaire. Each question is scored on a scale from 0 to 3, with scores ranging from 0 to 24. An overall higher score means a worse outcome.
  measure: Perceived social support (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Short form version 2.0 of the PROMIS battery for: Social Isolation; 6-item questionnaire. Each question is scored on a scale from 1 to 5 and generates a T-score. An overall higher score means a worse outcome.
  measure: Perceived social support (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Short form version 2.0 of the PROMIS battery for: Informational Support; 6-item questionnaire. Each question is scored on a scale from 1 to 5 and generates a T-score. An overall higher score means a better outcome.
  measure: Perceived social support (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Short form version 2.0 of the PROMIS battery for: Emotional Support; 6-item questionnaire. Each question is scored on a scale from 1 to 5 and generates a T-score. An overall higher score means a better outcome.
  measure: Coping (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Coping Health Inventory for Parents; 16-item questionnaire. Each question about coping behaviour is scored on a scale from 0 to 3, with a possible response of "Did not use" the coping behaviour. Scores range from 0 to 48. An overall higher score means a better outcome.
  measure: Family Functioning (Mentees and Mentors)
  time frame: Baseline to program completion, an average of one year
  description: Pediatric Quality of Life Inventory(TM) 2.0 Family Impact Module; 36-item questionnaire with 8 different sections: Physical Functioning, Emotional Functioning, Social Functioning, Cognitive Functioning, Communication, Worry, Daily Activities, and Family Relationships. Each question is scored on a scale from 0 to 4. Items are reverse-scored and linearly transformed to a 0-100 scale. An overall higher score means a better outcome.
  arm group label: iParent2Parent Program
  arm group type: Experimental
  arm group label: Standard of Care Waitlist Control Group
  arm group type: No Intervention
  intervention type: Behavioral
  intervention name: iParent2Parent Program
  description: iParent2Parent is an online peer support mentorship program that is based on the iPeer2Peer online peer support mentorship program, which has been established in multiple chronic disease populations as a self-management intervention, including in chronic pain and juvenile idiopathic arthritis populations. The iParent2Parent program connect parents one-to-one with other parents of pediatric kidney transplant recipients who are trained to offer vital peer support and mentorship.
  arm group label: iParent2Parent Program
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Samantha J. Anthony, PhD, MSW
  role: Principal Investigator
  affiliation: The Hospital for Sick Children
  last name: Samantha J. Anthony, PhD, MSW
  phone: 416-813-7654
  phone ext: 303126
  email: samantha.anthony@sickkids.ca
  last name: Izabelle Siqueira, MPH
  email: izabelle.siqueira@sickkids.ca
  facility: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: The Hospital for Sick Children
  investigator full name: Samantha Anthony
  investigator title: Principal Investigator
  sharing ipd: No