iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

Kidney Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968833
• Other study ID #: 1000080780
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: January 2024
• Source: The Hospital for Sick Children
• Contact: Samantha J. Anthony, PhD, MSW
• Phone: 416-813-7654
• Email: samantha.anthony[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• 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 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.

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

Behavioral:
• iParent2Parent Program
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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

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.	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(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