iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

Study Overview
=================
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 kidney transplant recipients who are trained to offer vital peer support and mentorship. Parents of children who received a kidney transplant 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.

Official Title
-----------------
Addressing the Mental Health Needs of Parents of Pediatric Kidney Transplant Recipients With the iParent2Parent Peer Support Program

Conditions
-----------------
Kidney Transplant

Intervention / Treatment
-----------------
* Behavioral: iParent2Parent Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Mentee Inclusion Criteria: Parent of a patient under 18 years of age who received a kidney 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 kidney 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Waitlist randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iParent2Parent Program<br> | Behavioral: iParent2Parent Program<br>* iParent2Parent is an online peer support mentorship program that is based on the iPeer2Peer online peer support mentorship program, which has been established in multiple chronic disease populations as a self-management intervention, including in chronic pain and juvenile idiopathic arthritis populations. The iParent2Parent program connect parents one-to-one with other parents of pediatric kidney transplant recipients who are trained to offer vital peer support and mentorship.<br>|
| No Intervention: Standard of Care Waitlist Control Group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rates and withdrawal rates | How many participants were recruited and have withdrawn from the program on average. | Baseline to study completion, an average of 1 year | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Psychological distress (Mentees and Mentors) | Personal 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Family Functioning (Mentees and Mentors) | Pediatric Quality of Life Inventory(TM) 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peer Support Mentorship, Parent Support Mentorship, Pediatrics, Transplant