Solid Organ Transplant Clinical Trial
Official title:
"The Isolation I Feel is Profound": The iParent2Parent Online Peer Support Program for Parents of Pediatric Solid Organ Transplantation Recipients
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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | June 26, 2026 |
Est. primary completion date | June 26, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
The Hospital for Sick Children |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment rates and withdrawal rates | How many participants were recruited and have withdrawn from the program on average over time. | Baseline to study completion, an average of 1 year | |
Primary | Adherence with the iParent2Parent program | When the participant completes 10 audio or video calls over 12 weeks and 100% when all online outcome measures completed. | Baseline to study completion, an average of 1 year | |
Primary | Acceptability (Mentees) | Whether the innovation is agreeable, palatable or satisfactory.
Measured via semi-structured interview or focus group. |
Baseline to 12 weeks after baseline/immediately after the intervention | |
Primary | Acceptability (Mentors) | Whether the innovation is agreeable, palatable or satisfactory.
Measured via semi-structured interview or focus group. |
Baseline to program completion, an average of one year | |
Primary | Level of engagement with the iParent2Parent program (Mentees) | Measured via semi-structured interview or focus group. | Baseline to 12 weeks after baseline/immediately after the intervention | |
Primary | Level of engagement with the iParent2Parent program (Mentors) | Measured via semi-structured interview or focus group. | Baseline to program completion, an average of one year | |
Primary | Barriers and enablers of the iParent2Parent program (Mentees) | Measured via semi-structured interview or focus group. | Baseline to 12 weeks after baseline/immediately after the intervention | |
Primary | Barriers and enablers of the iParent2Parent program (Mentors) | Measured via semi-structured interview or focus group. | Baseline to program completion, an average of one year | |
Secondary | Parenting stress (Mentees and Mentors) | 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. | Baseline to program completion, an average of one year | |
Secondary | Psychological distress (Mentees and Mentors) | General Anxiety Disorder-7; 7-item questionnaire. Each question is scored on a scale from 0 to 3, with scores ranging from 0 to 21. An overall higher score means a worse outcome. | Baseline to program completion, an average of one year | |
Secondary | Psychological distress (Mentees and Mentors) | 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. | Baseline to program completion, an average of one year | |
Secondary | Perceived social support (Mentees and Mentors) | Short form version 2.0 of the PROMIS battery for: Social Isolation; 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 worse outcome. | Baseline to program completion, an average of one year | |
Secondary | Perceived social support (Mentees and Mentors) | Short form version 2.0 of the PROMIS battery for: Informational 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. | Baseline to program completion, an average of one year | |
Secondary | Perceived social support (Mentees and Mentors) | 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. | Baseline to program completion, an average of one year | |
Secondary | Coping (Mentees and Mentors) | 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. | Baseline to program completion, an average of one year | |
Secondary | Family Functioning (Mentees and Mentors) | 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. | Baseline to program completion, an average of one year |
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