iParent2Parent Support Program for Solid Organ Transplant Parents

Recruiting in Palo Alto (17 mi)

Overseen by Samantha J Anthony, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Hospital for Sick Children

Disqualifiers: Non-English speaking

No Placebo Group

Trial Summary

What is the purpose of this trial?

The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. Parents of children who received a SOT 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.

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 data supports the effectiveness of the iParent2Parent Support Program treatment for parents of children undergoing solid organ transplants?

The iParent2Parent Support Program may be effective based on similar interventions like the myFAMI program, which showed feasibility and acceptability in helping families manage post-transplant challenges. Although no significant differences were found, outcomes were positive, suggesting that support programs can improve coping and family quality of life. ^{1 2 3 4 5}

How is the iParent2Parent Support Program different from other treatments for parents of children undergoing solid organ transplants?

The iParent2Parent Support Program is unique because it focuses on providing emotional and psychosocial support to parents of children undergoing solid organ transplants, addressing the specific stresses and challenges they face during the transplant process. Unlike medical treatments that target the physical aspects of transplantation, this program aims to improve family functioning and reduce stress, which can positively impact the overall health outcomes for both the child and the family. ^{2 4 5 6 7}

Research Team

Samantha J Anthony, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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 2 months ago, have WhatsApp, and speak English.

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.

Trial Timeline

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

Treatment Details

Interventions

• iParent2Parent Program (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Perceptions of parenting stress and family relations by fathers of children evaluated for organ transplantation. [2006]

2. United States pubmed.ncbi.nlm.nih.gov

Parents' perspectives on caring for children after solid organ transplant. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a mHealth Self-Management Intervention for Pediatric Transplant Families. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Parents' quality of life and family functioning in pediatric organ transplantation. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Psychosocial issues in pediatric organ transplantation: the parents' perspective. [2004]

6. Denmark pubmed.ncbi.nlm.nih.gov

A systematic review of parent and family functioning in pediatric solid organ transplant populations. [2022]

7. Denmark pubmed.ncbi.nlm.nih.gov

Mothers of children evaluated for transplantation: stress, coping resources, and perceptions of family functioning. [2006]