ClinicalTrials.gg
Status unknownNCT05968833Updated Jul 19, 2024

iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

An interventional study of iParent2Parent Program in Kidney Transplant, sponsored by The Hospital for Sick Children. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Kidney Transplant

Keywords

  • Peer Support Mentorship
  • Parent Support Mentorship
  • Pediatrics
  • Transplant
03

In context

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 577 studies on the registry; 83 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    iParent2Parent Program

    Behavioral: iParent2Parent Program

Interventions

  • BehavioraliParent2Parent 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.

06

What researchers measure

Primary outcomes

  1. Recruitment rates and withdrawal rates

    How many participants were recruited and have withdrawn from the program on average.

    Time frame: Baseline to study completion, an average of 1 year

  2. 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.

    Time frame: Baseline to study completion, an average of 1 year

  3. Acceptability (Mentees)

    Whether the innovation is agreeable, palatable or satisfactory. Measured via semi-structured interview or focus group.

    Time frame: Baseline to 12 weeks after baseline/immediately after the intervention

  4. Acceptability (Mentors)

    Whether the innovation is agreeable, palatable or satisfactory. Measured via semi-structured interview or focus group.

    Time frame: Baseline to program completion, an average of one year

  5. Level of engagement with the iParent2Parent program (Mentees)

    Measured via semi-structured interview or focus group.

    Time frame: Baseline to 12 weeks after baseline/immediately after the intervention

  6. Level of engagement with the iParent2Parent program (Mentors)

    Measured via semi-structured interview or focus group.

    Time frame: Baseline to program completion, an average of one year

  7. Barriers and enablers of the iParent2Parent program (Mentees)

    Measured via semi-structured interview or focus group.

    Time frame: Baseline to 12 weeks after baseline/immediately after the intervention

  8. Barriers and enablers of the iParent2Parent program (Mentors)

    Measured via semi-structured interview or focus group.

    Time frame: Baseline to program completion, an average of one year

Secondary outcomes

  1. 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.

    Time frame: Baseline to program completion, an average of one year

  2. 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.

    Time frame: Baseline to program completion, an average of one year

  3. 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.

    Time frame: Baseline to program completion, an average of one year

  4. 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.

    Time frame: Baseline to program completion, an average of one year

  5. 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.

    Time frame: Baseline to program completion, an average of one year

  6. 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.

    Time frame: Baseline to program completion, an average of one year

  7. 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.

    Time frame: Baseline to program completion, an average of one year

  8. 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.

    Time frame: Baseline to program completion, an average of one year

07

Study locations

1 of 1 sites recruiting
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Jul 2025, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2023
First posted
Aug 1, 2023
StartActual
Aug 1, 2023
Primary completionEst.
Jul 1, 2025
CompletionEst.
Jul 1, 2025
Last update
Jul 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05968833
Responsible party
Samantha Anthony (Principal Investigator, The Hospital for Sick Children) — Principal investigator
First posted
Aug 1, 2023
Start date
Aug 1, 2023
Primary completion
Jul 1, 2025 (estimated)
Completion
Jul 1, 2025 (estimated)
Last update
Jul 19, 2024

Study contacts

Samantha J. Anthony, PhD, MSW
Contact
samantha.anthony@sickkids.ca
416-813-7654 ext. 303126
Sophie Bui, BHSc
Contact
sophie.bui@sickkids.ca
Samantha J. Anthony, PhD, MSW
principal investigator · The Hospital for Sick Children

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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