iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

July 17, 2024 updated by: Samantha Anthony, The Hospital for Sick Children

Addressing the Mental Health Needs of Parents of Pediatric Kidney Transplant Recipients With the iParent2Parent Peer Support Program

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. 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Recruiting
        • The Hospital for Sick Children
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Mentee Inclusion Criteria:

  • Parent of a patient under 18 years of age who received a kidney transplant and is at least two months post-transplant,
  • Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and
  • English-speaking.

Mentor Inclusion Criteria:

  • Parent of a patient under 21 years of age who received a kidney transplant and is at least one year post-transplant,
  • Nominated by their child's healthcare team as a good candidate to act in the mentor role (e.g., good communication skills, positive adaptation and adjustment post-transplant, strong support network),
  • Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and
  • English-speaking.

Exclusion Criteria:

  • Non-English speaking.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iParent2Parent Program
Behavioral: iParent2Parent Program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence with the iParent2Parent program
Time Frame: Baseline to study completion, an average of 1 year
When the participant completes 10 audio or video calls over 12 weeks and 100% when all online outcome measures completed.
Baseline to study completion, an average of 1 year
Acceptability (Mentees)
Time Frame: Baseline to 12 weeks after baseline/immediately after the intervention

Whether the innovation is agreeable, palatable or satisfactory.

Measured via semi-structured interview or focus group.
Baseline to 12 weeks after baseline/immediately after the intervention
Acceptability (Mentors)
Time Frame: Baseline to program completion, an average of one year

Whether the innovation is agreeable, palatable or satisfactory.

Measured via semi-structured interview or focus group.
Baseline to program completion, an average of one year
Level of engagement with the iParent2Parent program (Mentees)
Time Frame: Baseline to 12 weeks after baseline/immediately after the intervention
Measured via semi-structured interview or focus group.
Baseline to 12 weeks after baseline/immediately after the intervention
Level of engagement with the iParent2Parent program (Mentors)
Time Frame: Baseline to program completion, an average of one year
Measured via semi-structured interview or focus group.
Baseline to program completion, an average of one year
Barriers and enablers of the iParent2Parent program (Mentees)
Time Frame: Baseline to 12 weeks after baseline/immediately after the intervention
Measured via semi-structured interview or focus group.
Baseline to 12 weeks after baseline/immediately after the intervention
Barriers and enablers of the iParent2Parent program (Mentors)
Time Frame: Baseline to program completion, an average of one year
Measured via semi-structured interview or focus group.
Baseline to program completion, an average of one year
Recruitment rates and withdrawal rates
Time Frame: Baseline to study completion, an average of 1 year
How many participants were recruited and have withdrawn from the program on average.
Baseline to study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parenting stress (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Psychological distress (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Perceived social support (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Perceived social support (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Perceived social support (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Coping (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Family Functioning (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
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.
Baseline to program completion, an average of one year
Psychological distress (Mentees and Mentors)
Time Frame: Baseline to program completion, an average of one year
Patient 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.
Baseline to program completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Samantha J. Anthony, PhD, MSW, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

June 29, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1000080780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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