iParent2Parent Program for Parents of Pediatric Solid Organ Transplant Recipients

Not Applicable

Recruiting

• Conditions: Solid Organ Transplant
• Interventions: Behavioral: iParent2Parent Program

• Registration Number: NCT05968807
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-28
• Study Start: 2023-08-01
• Study First Posted: 2023-08-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-06-26
• Study Completion: 2026-06-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iParent2Parent Program	iParent2Parent Program	-

Primary Outcome Measures

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and withdrawal rates	Baseline to study completion, an average of 1 year	How many participants were recruited and have withdrawn from the program on average over time.

Secondary Outcome Measures

Name	Time	Method
Coping (Mentees and Mentors)	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.
Parenting stress (Mentees and Mentors)	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.
Perceived social support (Mentees and Mentors)	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.
Family Functioning (Mentees and Mentors)	Baseline to program completion, an average of one year	Pediatric Quality of Life Inventory™ 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.
Psychological distress (Mentees and Mentors)	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.

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada