Solid Organ TransplantNCT05968807
iParent2Parent Program for Parents of Pediatric Solid Organ Transplant Recipients
A study testing iParent2Parent Program in people with Solid Organ Transplant, run by The Hospital for Sick Children at 1 site in Canada.
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 solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Organ Transplant
- What is being tested?
- iParent2Parent Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 26 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Non-English speaking.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie Bui, BHSc contact
Canada1 site, 1 recruiting
- Recruiting
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Samantha J Anthony, PhD, MSW, 4168137654 ext. 303126, samantha.anthony@sickkids.ca
About this study
Official title: "The Isolation I Feel is Profound": The iParent2Parent Online Peer Support Program for Parents of Pediatric Solid Organ Transplantation Recipients
The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. Parents of children who received a SOT 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.
- Conditions
- Solid Organ Transplant
- Being tested
- iParent2Parent Program
- Keywords
- Peer Support Mentorship, Parent Support Mentorship, Pediatrics, Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iParent2Parent ProgramBehavioural
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 solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship.
| Study group | Role | What they receive |
|---|---|---|
| iParent2Parent Program | Experimental | Not described Receives: Behavioral: iParent2Parent Program |
| Standard of Care Waitlist Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates and withdrawal rates
How many participants were recruited and have withdrawn from the program on average over time.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to program completion, an average of one year
Secondary outcomes (8)
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.
Measured: 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.
Measured: Baseline to program completion, an average of one year
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to program completion, an average of one year
Family Functioning (Mentees and Mentors)
Pediatric Quality of Life Inventory™ 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.
Measured: Baseline to program completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Aug 2023
- Primary completion26 Jun 2026 (estimated)
- Study completion26 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ TransplantStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samantha Anthony, The Hospital for Sick Children
- Investigators
- Samantha J. Anthony, PhD, MSW, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968807
- Sponsor's protocol ID
- 1000080779
- Status last verified
- May 2025
- First submitted
- 29 Jun 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Isolation I Feel is Profound": The iParent2Parent Online Peer Support Program for Parents of Pediatric Solid Organ Transplantation Recipients
- ClinicalTrials.gov ID
- NCT05968807
- Acronym / sponsor ID
- 1000080779
- Conditions
- Solid Organ Transplant
- Keywords
- Peer Support Mentorship, Parent Support Mentorship, Pediatrics, Transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 26 Jun 2026 (estimated)
- Study completion
- 26 Jun 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. Parents of children who received a SOT 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Waitlist randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| iParent2Parent Program | Experimental | Behavioral: iParent2Parent Program |
| Standard of Care Waitlist Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Non-English speaking.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iParent2Parent ProgramiParent2Parent 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 solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. | Behavioural | iParent2Parent Program |
Primary outcome
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 over time.
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.
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.
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.
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.
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.
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.
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.
8 secondary outcomes
Parenting stress (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Psychological distress (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Psychological distress (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Perceived social support (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Perceived social support (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Perceived social support (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Coping (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Family Functioning (Mentees and Mentors)
Time frame: Baseline to program completion, an average of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: No
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High vs.Standard Dose Influenza Vaccine in Pediatric Solid Organ Transplant (SOT) Recipients
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COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
Active, not recruitingPhase 2
Viral Specific T-cells for Treatment of Viral Infections After Solid Organ Transplant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sophie Bui, BHSc contact
Samantha J. Anthony, PhD, MSW principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iParent2Parent Program in people with Solid Organ Transplant, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samantha J. Anthony, PhD, MSW (416-813-7654 ext. 303126, samantha.anthony@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates and withdrawal rates (time frame: Baseline to study completion, an average of 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.