iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05968833
Collaborator
(none)
55
1
2
23
2.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: iParent2Parent Program
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Waitlist randomized controlled trialWaitlist randomized controlled trial
Masking:
Single (Investigator)
Primary Purpose:
Other
Official Title:
Addressing the Mental Health Needs of Parents of Pediatric Kidney Transplant Recipients With the iParent2Parent Peer Support Program
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: iParent2Parent Program

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.

No Intervention: Standard of Care Waitlist Control Group

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary Outcome Measures

  1. 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.

  2. Psychological distress (Mentees and Mentors) [Baseline to program completion, an average of one year]

    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.

  3. Psychological distress (Mentees and Mentors) [Baseline to program completion, an average of one year]

    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.

  4. 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: 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.

  5. 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: 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.

  6. 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.

  7. 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.

  8. Family Functioning (Mentees and Mentors) [Baseline to program completion, an average of one year]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Samantha J. Anthony, PhD, MSW, The Hospital for Sick Children

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Samantha Anthony, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT05968833
Other Study ID Numbers:
  • 1000080780
First Posted:
Aug 1, 2023
Last Update Posted:
Aug 1, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Samantha Anthony, Principal Investigator, The Hospital for Sick Children

Study Results

No Results Posted as of Aug 1, 2023