iParent2Parent Support Program for Kidney Transplant Parents

Overseen By Sophie Bui, BHSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new virtual mentorship program, the iParent2Parent Program, designed to support parents of children who have had kidney transplants. By connecting parents one-on-one with others who have experienced similar situations, the program aims to reduce feelings of isolation and improve mental health. Parents of children who received a kidney transplant at least two months ago and have access to a smartphone, tablet, or computer with WhatsApp can join as mentees. Meanwhile, parents of children who had a transplant at least a year ago can join as mentors if recommended by their child’s healthcare team. This unphased trial offers a unique opportunity to connect with others and enhance mental well-being.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the iParent2Parent Program is safe for participants?

Research has shown that the iParent2Parent (iP2P) program is a virtual mentorship initiative. It connects parents of children who have had kidney transplants with other parents for support. As it is not a medical treatment, it involves no drugs or medical procedures.

Unlike medicines, the program does not cause physical side effects. Instead, it offers emotional and mental support, helping to reduce feelings of loneliness and improve mental health. No negative effects have been reported from using the iP2P program. Participants connect online, which is generally safe and easy to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iParent2Parent Support Program because it offers a novel approach to supporting parents of kidney transplant patients. Unlike traditional medical treatments that focus on physical health, this program aims to enhance emotional and social support, which is often overlooked. The program connects parents with peers who have undergone similar experiences, fostering a sense of community and shared understanding. This peer-to-peer support could improve the overall well-being of families, potentially leading to better long-term outcomes for transplant patients.

What evidence suggests that the iParent2Parent Program is effective for supporting parents of pediatric kidney transplant recipients?

The iParent2Parent (iP2P) program, which participants in this trial will experience, connects parents of children who have had kidney transplants with trained mentors who have faced similar situations. Studies have shown that peer support programs like iP2P can improve mental health and reduce feelings of isolation. Research indicates that sharing experiences and receiving advice from someone in a similar situation can positively affect emotional well-being. This support can also indirectly benefit the child's health by helping parents manage stress and make informed decisions. Overall, the program aims to provide valuable emotional support and improve the quality of life for families dealing with pediatric kidney transplants. ^{1 2 3 5 6}

Who Is on the Research Team?

Samantha J Anthony, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for parents of children under 18 who had a kidney transplant at least two months ago, or under 21 if they're one year post-transplant. They need to speak English and have access to WhatsApp on a device. To be mentors, they must be recommended by their child's healthcare team.

Inclusion Criteria

I am a parent of a child who had a kidney transplant over a year ago, nominated as a mentor, have access to WhatsApp, and speak English.

Exclusion Criteria

Non-English speaking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

iParent2Parent Program

Participants engage in a virtual mentorship program connecting parents of pediatric kidney transplant recipients for peer support and mentorship

12 weeks

10 audio or video calls

Follow-up

Participants are monitored for outcomes such as parenting stress, coping, psychological distress, perceived social support, and family functioning

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• iParent2Parent Program

Trial Overview The iParent2Parent (iP2P) program is being tested. It's an online mentorship where parents of pediatric kidney transplant recipients give each other support. Participants are randomly chosen to either join iP2P or a control group without this peer support.

How Is the Trial Designed?

Group I: iParent2Parent Program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Published Research Related to This Trial

Kidney transplantation significantly enhances life expectancy and quality of life for children with end-stage kidney disease, but ongoing challenges from treatment and transplantation sequelae can hinder their overall health compared to healthy peers.

The NAPRTCS network has been pivotal in using multicenter data to improve care for pediatric kidney transplant recipients, while the newer Improving Renal Outcomes Collaborative focuses on engaging stakeholders to redesign healthcare delivery for better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicenter data to improve health for pediatric renal transplant recipients in North America: Complementary approaches of NAPRTCS and IROC. Hooper, DK., Misurac, J., Blydt-Hansen, T., et al.[2021]

Parents of children with chronic kidney disease (CKD) experience significant emotional and practical challenges, including trauma from medical procedures and feelings of disempowerment in navigating the healthcare system, as revealed through in-depth interviews with 20 parents.

The study highlights the need for improved support structures for these parents, as they often feel overwhelmed by their dual roles as caregivers and parents, and they benefit from connecting with other parents facing similar challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental perspectives on caring for a child with chronic kidney disease: an in-depth interview study. Tong, A., Lowe, A., Sainsbury, P., et al.[2022]

The Empowerment Education Program (EEP) significantly reduced uncertainty in kidney transplant patients, with improvements observed immediately after the program and four weeks later, indicating lasting effects.

Patients who participated in the EEP also showed significant increases in self-care ability and compliance with treatment, suggesting that the program effectively supports their health management post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The Effects of an Empowerment Education Program for Kidney Transplantation Patients]. Kim, SH., You, HS.[2019]

Despite 90% of parents believing they understood idiopathic nephrotic syndrome (INS), only 29% could accurately define a relapse and 24% could name potential complications, indicating a gap in true understanding.

Management of INS was generally effective, with 81% of parents testing urine correctly and 90% managing relapses well, but 57% imposed unnecessary dietary restrictions during remission, highlighting the need for better education and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parental understanding of relapsing idiopathic nephrotic syndrome-Where are the knowledge gaps? Lo Cao, E., Amir, N., McKay, A., et al.[2021]

A feasibility study involving 146 parents of children with chronic kidney disease tested the e-Powered Parents online support program, but no significant effects were found on parental stress, fatigue, or communication efficacy after 6 months and 1.5 years.

Despite 84% of parents accessing the program's information and interactive components, overall engagement with the training modules was low, suggesting that a more tailored approach may be necessary for effective support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect and Process Evaluation of e-Powered Parents, a Web-Based Support Program for Parents of Children With a Chronic Kidney Disease: Feasibility Randomized Controlled Trial. Geense, WW., van Gaal, BG., Knoll, JL., et al.[2019]

The Online Parent Information and Support (OPIS) resource was developed to assist parents in managing their child's chronic kidney disease (CKD) at home, addressing a critical need for support.

This web resource aims to provide valuable information and guidance, helping parents navigate the challenges associated with their child's CKD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborating to develop an online resource for parents. Smith, T., Swallow, V., Stephenson, M.[2017]

Living-donor kidney exchange programs can provide a solution for patients with incompatible donors, and these programs have been successfully implemented in various regions with different matching algorithms and results.

To enhance the effectiveness of these programs, it is recommended to establish national or regional cooperation, limit exchange chains to a maximum of three pairs for logistical efficiency, and utilize a central laboratory for cross-match procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On chain lengths, domino-paired and unbalanced altruistic kidney donations. de Klerk, M., Zuidema, WC., Ijzermans, JN., et al.[2010]

Parents of children with chronic kidney disease undergoing dialysis experience significant distress due to multiple factors, including the demands of caregiving and lack of resources, as identified in a systematic review of 13 qualitative studies involving 183 parents.

Healthcare professionals should proactively screen these parents for distress and connect them with psychosocial and community support services to help alleviate their burdens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sources of Distress Experienced by Parents of Children with Chronic Kidney Disease on Dialysis: A Qualitative Systematic Review. Ong, ZH., Ng, CH., Tok, PL., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-kidney-transplantation-7-2023-bc591

iParent2Parent Support Program for Kidney Transplant ... The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05968807

iParent2Parent Program for Parents of Pediatric Solid ... The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid ...

3. mnitf.org mnitf.org/funded-grants-2022/

Funded Grants - 2022 - Mendez National ... The iParent2Parent (iP2P) program is a virtual peer mentorship program that will offer support to parents of pediatric solid organ transplant (SOT) recipients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05968833?locStr=Canada&country=Canada&cond=renal%20transplant&rank=5

iParent2Parent Peer Support Program for Parents of ... Results database. A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and ...

5. clinconnect.io clinconnect.io/trials/NCT05968833

iParent2Parent Peer Support Program for Parents of This program connects parents one-on-one with trained mentors who are also parents of transplant recipients. By sharing experiences and providing support, the ...

6. withpower.com withpower.com/trial/phase-solid-organ-transplant-7-2023-2ff34

iParent2Parent Support Program for Solid Organ ... The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid ...