Clinical trial NCT05968807: iParent2Parent Program for Parents of Pediatric Solid Organ Transplant Recipients
Official title: "The Isolation I Feel is Profound": The iParent2Parent Online Peer Support Program for Parents of Pediatric Solid Organ Transplantation Recipients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Organ Transplant
Keywords: Peer Support Mentorship
Parent Support Mentorship
Pediatrics
Transplant
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist randomized controlled trial
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Mentee Inclusion Criteria:

* Parent of a patient under 18 years of age who received a solid organ 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 solid organ 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.

Primary outcomes:
measure: Recruitment rates and withdrawal rates
timeFrame: Baseline to study completion, an average of 1 year
measure: Adherence with the iParent2Parent program
timeFrame: Baseline to study completion, an average of 1 year
measure: Acceptability (Mentees)
timeFrame: Baseline to 12 weeks after baseline/immediately after the intervention
measure: Acceptability (Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Level of engagement with the iParent2Parent program (Mentees)
timeFrame: Baseline to 12 weeks after baseline/immediately after the intervention
measure: Level of engagement with the iParent2Parent program (Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Barriers and enablers of the iParent2Parent program (Mentees)
timeFrame: Baseline to 12 weeks after baseline/immediately after the intervention
measure: Barriers and enablers of the iParent2Parent program (Mentors)
timeFrame: Baseline to program completion, an average of one year
Secondary outcomes:
measure: Parenting stress (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Psychological distress (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Psychological distress (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Perceived social support (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Perceived social support (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Perceived social support (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Coping (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
measure: Family Functioning (Mentees and Mentors)
timeFrame: Baseline to program completion, an average of one year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Samantha J. Anthony, PhD, MSW
role: PRINCIPAL_INVESTIGATOR
References: