iParent2Parent Support Program for Solid Organ 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: Unknown

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual mentorship program, the iParent2Parent Program, designed to support parents of children who have had solid organ transplants. The goal is to determine if connecting parents with trained peer mentors can reduce feelings of isolation and improve mental health, potentially benefiting the child's health as well. Parents of children who received a transplant at least two months ago and have access to a device with WhatsApp can participate. Mentors must have a child who had a transplant at least a year ago and be nominated by their healthcare team. As an unphased trial, this study provides a unique opportunity for parents to connect and support each other, potentially enhancing their well-being and their child's health.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on a mentorship program for parents, so it's unlikely to require changes to your medication.

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

Research has shown that the iParent2Parent (iP2P) program is an online mentorship initiative. It connects parents of children who have had organ transplants with other parents in similar situations, offering peer support and guidance.

As an online mentorship program, it involves no physical treatments or medications, minimizing the risk of physical side effects. The program aims to reduce feelings of isolation and improve mental health. These support programs are generally safe, focusing on emotional and social support rather than medical treatments.

Participants in similar peer support programs have reported positive experiences, such as feeling more connected and less alone. No evidence suggests harmful effects from joining this type of program, making it a safe option for those interested in participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iParent2Parent Support Program because it offers a unique approach to helping parents of children who have undergone solid organ transplants. Unlike traditional treatments that primarily focus on medical management and follow-up care, this program aims to provide emotional and peer support by connecting parents who have been through similar experiences. This peer-to-peer connection can help reduce feelings of isolation and stress, potentially improving overall family well-being and the child's post-transplant adjustment. This innovative support system could fill a significant gap in current care options, which often overlook the psychological and social challenges faced by these families.

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

Research shows that the iParent2Parent (iP2P) program, which participants in this trial may receive, can help parents of children who have had a solid organ transplant feel less isolated. Studies have found that connecting with others in similar situations boosts mental health and provides important peer support. This online mentorship program matches parents with trained mentors who have faced similar challenges, positively affecting both mental and emotional well-being. While specific data from this program is still being gathered, other peer support programs have successfully offered emotional support and improved overall satisfaction. The iP2P program aims to use these benefits to assist parents during their child's transplant journey. ^{1 2 3 4 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 solid organ 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 an organ transplant over a year ago, nominated to be a mentor, and can use WhatsApp.

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 solid organ transplant recipients for peer support

12 weeks

Virtual interactions

Follow-up

Participants are monitored for engagement and outcomes after the intervention

up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• iParent2Parent Program

Trial Overview The iParent2Parent Program connects parents of pediatric SOT recipients with trained parent mentors through virtual mentorship. The study will assess whether this program helps reduce isolation and improve mental health among these parents.

How Is the Trial Designed?

Group I: iParent2Parent Program Experimental Treatment 1 Intervention

Group II: Standard of Care Waitlist Control Group Active Control 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

Pediatric organ transplantation significantly affects the quality of life for parents and family functioning, highlighting the need for support systems during this challenging time.

A systematic review of 31 studies was conducted to consolidate findings on the impact of organ transplantation on families, paving the way for future research and improved clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' quality of life and family functioning in pediatric organ transplantation. Kikuchi, R., Kamibeppu, K.[2017]

In a study of 36 mothers of children awaiting transplantation, 20% reported clinically elevated stress levels, with higher parenting stress noted in those with children awaiting solid organ transplants compared to bone marrow transplants.

Coping strategies that focus on maintaining family stability were linked to lower parenting stress, highlighting the importance of support and interventions to help families manage stress during the transplantation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mothers of children evaluated for transplantation: stress, coping resources, and perceptions of family functioning. Rodrigue, JR., Hoffmann, RG., MacNaughton, K., et al.[2006]

Fathers of children undergoing solid organ or bone marrow transplantation reported lower levels of parenting stress and family conflict compared to normative data, suggesting they may cope better than expected in these challenging situations.

Despite lower stress and conflict, these fathers expressed greater concerns about family finances and reported more limitations in family activities, indicating that financial and activity-related challenges remain significant issues for families in pediatric transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of parenting stress and family relations by fathers of children evaluated for organ transplantation. Rodrigue, JR., MacNaughton, K., Hoffmann, RG., et al.[2006]

The myFAMI mobile health intervention was found to be feasible and acceptable for families of pediatric solid organ transplant recipients, with 81% of participants completing the program for at least 24 out of 30 days.

While there were no significant differences in primary outcomes, the intervention showed positive trends in coping, family quality of life, and self-efficacy, indicating potential benefits for future post-discharge support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a mHealth Self-Management Intervention for Pediatric Transplant Families. Lerret, SM., Schiffman, R., White-Traut, R., et al.[2023]

Parents of children undergoing heart and liver transplantation experience significant psychosocial stress throughout three key stages: preoperative, perioperative, and long-term postoperative.

Understanding these stages and the associated challenges can help healthcare professionals better support families during the transplant process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial issues in pediatric organ transplantation: the parents' perspective. Gold, LM., Kirkpatrick, BS., Fricker, FJ., et al.[2004]

Parents of children who received solid organ transplants face significant challenges during the transition from hospital to home, which evolves over time into three distinct phases: 'getting back to normal' at 3 weeks, 'becoming routine' at 3 months, and 'facing a future' at 6 months.

Nurses play a crucial role in supporting these families by preparing them to manage complex care needs, helping to build their confidence and knowledge for effective post-discharge care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' perspectives on caring for children after solid organ transplant. Lerret, SM., Johnson, NL., Haglund, KA.[2019]

Parents of pediatric solid organ transplant (SOT) patients often experience heightened stress and mental health issues, including posttraumatic stress disorder, indicating a need for psychological support during and after the transplant process.

Family functioning is linked to critical health outcomes such as medication adherence and hospitalizations, suggesting that improving family dynamics could enhance the overall health and recovery of pediatric transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of parent and family functioning in pediatric solid organ transplant populations. Cousino, MK., Rea, KE., Schumacher, KR., et al.[2022]

Citations

1. 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 ...

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

iParent2Parent Support Program for Solid Organ Transplant ... 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. 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 ...

4. irl.umsl.edu irl.umsl.edu/cgi/viewcontent.cgi?article=2233&context=dissertation

Family Mentorship Program in the Pediatric Organ ... A regulated and structured family mentor/support program for transplant patients and their families can provide the outlet they require to feel supported by ...

5. clinconnect.io clinconnect.io/trials/NCT05968807

iParent2Parent Program for Parents of Pediatric Solid The iParent2Parent (iP2P) program is a new online support initiative designed to help parents of children who have received a solid organ transplant. This ...

6. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05968807?keyword=%22Organ%20Transplant%22

iParent2Parent Program for Parents of Pediatric Solid ... 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 ...