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Recruiting

NCT Number: NCT05968833

iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients

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.

Recruiting

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Key information

Conditions

Kidney Transplant

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location status: Recruiting

Location contact

Samantha J. Anthony, PhD, MSW

CONTACT

[email protected]

416-813-7654 ext. 303126

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

iParent2Parent Program

Behavioral

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.

Primary outcomes

  1. Recruitment rates and withdrawal rates

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

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

    Measured via semi-structured interview or focus group.

Secondary outcomes

  1. Parenting stress (Mentees and Mentors)

    Time frame: 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)

    Time frame: 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)

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

    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.

  4. Perceived social support (Mentees and Mentors)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Samantha J. Anthony, PhD, MSW

CONTACT

[email protected]

416-813-7654 ext. 303126

Sophie Bui, BHSc

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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