An interventional study of Peer mentorship in Congenital Heart Disease (CHD), Mentorship and Transition of Care, sponsored by The Hospital for Sick Children. Not yet recruiting at 1 site in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Supportive care
Adolescents and young adults (AYA) with congenital heart disease (CHD) face psychosocial stresses as they transition to adult care. Parents of AYA with CHD also experience increased caregiver burden and psychosocial stresses. Peer support provided by a person with a similar experience has been found to improve disease self-management and psychosocial health outcomes in pediatric healthcare. However, many AYA with CHD still do not have access to formal social support resources. The aim of this study is to improve pediatric to adult transitions in healthcare by evaluating peer mentorship programs for AYA with CHD and their parents.
Established, online mentorship programs, iPeer2Peer(iP2P)/iParent2Parent, will be employed through a pilot feasibility waitlist randomized controlled trial with repeated measures across four sites. Eighty mentees (AYA and parents of AYA) will be recruited and randomized into intervention and control groups. Forty mentees in the intervention group will be matched 1:1 with 30 trained mentors (young adults and parents of AYA). AYA mentees will be matched with young adult mentors and parents of AYA will be matched with other parent mentors. These pairings will connect over 12 weeks through video calls and text messaging to provide peer support to improve self-management and psychosocial health outcomes.
Primary Objective: to evaluate the feasibility of virtual intervention programs (iP2P and iParent2Parent) for AYA with CHD and their parents as both mentors and mentees in terms of: (a) enrollment and withdrawal rates (b) adherence with the programs (c) perceptions regarding the acceptability and level of engagement in the programs of both mentees and mentors, and (d) perceptions of barriers and enablers of the programs. Secondary Objective: to explore these programs impact on preliminary psychosocial outcomes. Specifically,
Impact of the iP2P program on:
(a) transition readiness including self-management skills, (b) perceived social support, and (c) emotional distress, in AYA mentees.
(a) perceived social role satisfaction and (b) emotional distress, in young adult mentors.
Impact of the iParent2Parent program on:
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A waitlist pilot RCT allows for an effective comparison of the study intervention with a control group receiving standard of care while not disadvantaging the control group who will have the option of participating in the intervention following the completion of the trial. This design therefore ensures that a potentially useful and effective intervention is accessible to all participants.
Up to 110 participants will be enrolled in the study from CHD programs in Toronto (SickKids/Toronto General Hospital), Edmonton (Stollery Children's Hospital/Mazankowski Alberta Heart Institute), Vancouver (BC Children's Hospital/St. Paul's Hospital), andMontreal (Ste. Justine/Montreal Heart Institute).
Up to 40 AYA (ages 16-25) and 40 parent mentees will be enrolled across the CHD programs, with about 10 AYA and about 10parent mentees per city.
Up to 15 young adults (ages 21-30) and 15 parent mentors will be enrolled across the adult sites of these CHD programs(Toronto General Hospital, Mazankowski Alberta Heart Institute, St. Paul's Hospital, and Montreal Heart Institute). The investigators anticipate 3-4 young adult mentors, and 3-4 parent mentors will be enrolled per site.
All mentees (40 mentees) will be asked to participate in semi-structured individual interviews at baseline (ME T1) and and all mentees in the intervention group (20 mentees) will be asked to participate in semi-structured interviews at 12 weeks - immediately post-intervention (ME T2). Interviews will be conducted by an interviewer trained in qualitative methods by telephone, in-person or virtually via the PHIPA-compliant version of Zoom or Microsoft Teams (depending on participants' preference), at a time that is convenient for the participant. Interviews will be guided by a semi-structured interview guide. ME T1 interviews will aim to assess motivations for participation, hopes and expectations, and preferences around mentor characteristics; and ME T2 interviews will aim to assess the primary outcomes evaluating feasibility.
All mentors (30 mentors) will be asked to participate in a focus group/semi-structured interview prior to mentor training (MR T1) and study end (MR T2). MR T1 focus groups/interviews will aim to assess motivations for participation and hopes and expectations, and MR T2 focus groups/interviews will aim to assess the primary outcomes evaluating feasibility. Focus groups/interviews will be conducted by an interviewer trained in qualitative methods. Focus groups/interviews will be conducted on a mutually agreed upon date and over the internet via a web-based video communication program (e.g., PHIPA-compliant version of Zoom or Microsoft Teams).
The semi-structured individual interviews and focus groups will be audiotaped, transcribed and analyzed using qualitative descriptive approach using thematic and content analysis.
1,032 studies on the registry are indexed under Heart Defects, Congenital; 262 are open to participants now.
This study's planned enrollment of 110 is above the median of 60 across 531 interventional studies indexed under Heart Defects, Congenital.
Browse Heart Defects, Congenital studies →The Hospital for Sick Children is the lead sponsor of 578 studies on the registry; 84 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
AYA with CHD
Parents of AYA with CHD
Parent mentors
Exclusion Criteria:
Parent mentees will be excluded if
Young adult and parent mentors
In addition to their standard medical care, mentees in the experimental group will receive mentorship and support via the iP2P/iParent2Parent program. Trained mentors will provide information and support to mentee participants to encourage participation in self-management skill-building tailored to their needs. Each mentor will work with no more than two mentees at once for the study. Efforts will be made to pair mentors and mentees who share similar characteristics (e.g., similar disease severity, symptom profile, treatment regimen experiences, caregiver role, sex/gender, geographic area of residence). To ensure safety, a member of the research team will monitor all calls and messaging conversations as well as intervene in any potential safety concerns (e.g., discussion of suicidal ideation) or inappropriate behavior (e.g. bullying).
Behavioral: Peer mentorship
The control group will receive standard care without the iP2P/iParent2Parent intervention. The control group will be offered the iP2P/iParent2Parent intervention after completion of all outcome measures for a period of 12 weeks with the same research team support.
The iPeer2Peer/iParent2Parent intervention is a peer support mentorship program that will provide modelling and reinforcement by pre-screened and trained peer mentors to the mentees. The mentorship program will encourage mentees to develop and engage in self-management and transition skills and support the participants; practice of these skills. The mentors will provide information and support to mentee participants via 5-10 calls (using WhatsApp) of 20-30 minute durations and text messaging (using WhatsApp) for 12 weeks to encourage participation in self-management skill building tailored to their needs.
Also known as: Peer mentoring, Peer support
Recruitment and withdrawal rates
Recruitment rates (more than 70%) and withdrawal rates (less than 15%) as calculated using data recorded in participant recruitment log.
Time frame: 12 weeks
Adherence
Adherence with iP2P/iParent2Parent program (more than 80% rate of completion of at least five audio or video calls over 12 weeks and 100% rate of completion of all online outcome measures) as calculated using data recorded in participant program tracking log.
Time frame: 12 weeks
Acceptability/Level of engagement
Acceptability and level of engagement of the iP2P/iParent2Parent program intervention as measured through focus groups/interviews with mentors and interviews with mentees guided by the Theoretical Framework of Acceptability. Focus groups and interviews will take approximately 45 minutes per timepoint.
Time frame: 12 weeks
Barriers/Enablers
Barriers and enablers of the iP2P/iParent2Parent program intervention as measured through focus groups/interviews with mentors and interviews with mentees.
Time frame: 12 weeks
Perceived social role satisfaction (young adult mentor outcome)
Perceived social role satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities. Minimum value: 0 Maximum value: 100 Higher score indicates better outcome
Time frame: 12 weeks
Emotional distress (young adult mentor outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Time frame: 12 weeks
Emotional distress (young adult mentor outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Time frame: 12 weeks
Perceived social role satisfaction (parent mentor outcome)
Perceived social role satisfaction measured by the PROMIS Satisfaction with Social Roles and Activities. Minimum value: 0 Maximum value: 100 Higher score indicates better outcome
Time frame: 12 weeks
Emotional distress (parent mentor outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Time frame: 12 weeks
Emotional distress (parent mentor outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Time frame: 12 weeks
Emotional distress (parent mentor outcome)
Emotional distress measured by the Parental Stress Scale (PSS). Minimum value: 18 Maximum value: 90 Higher score indicates worse outcome
Time frame: 12 weeks
Transition readiness (adolescent/young adult mentee outcome)
Transition readiness measured by the Transition Readiness Assessment Questionnaire (TRAQ). Minimum value: 20 Maximum value: 100 Higher score indicates better outcome
Time frame: 12 and 24 weeks
Perceived social support (adolescent/young adult mentee outcome)
Perceived social support measured by the Multidimensional Scale of Perceived Social Support (MSPSS). Minimum value: 12 Maximum value: 84 Higher score indicates better outcome
Time frame: 12 and 24 weeks
Emotional distress (adolescent/young adult mentee outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Time frame: 12 and 24 weeks
Emotional distress (adolescent/young adult mentee outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Time frame: 12 and 24 weeks
Mentor quality (adolescent/young adult mentee outcome)
Mentor quality measured by the Mentor Behaviour Scale. Minimum value: 15 Maximum value: 75 Higher score indicates better outcome
Time frame: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Emotional distress measured by the Generalized Anxiety Disorder-7 (GAD-7). Minimum value: 0 Maximum value: 21 Higher score indicates worse outcome
Time frame: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Emotional distress measured by the Patient Health Questionnaire-8 (PHQ-8). Minimum value: 0 Maximum value: 24 Higher score indicates worse outcome
Time frame: 12 and 24 weeks
Emotional distress (parent mentee outcome)
Emotional distress measured by the Parental Stress Scale (PSS). Minimum value: 18 Maximum value: 90 Higher score indicates worse outcome
Time frame: 12 and 24 weeks
Coping (parent mentee outcome)
Coping as measured by the Coping Health Inventory for Parents (CHIP-16). Minimum value: 0 Maximum value: 48 Higher score indicates better outcome
Time frame: 12 and 24 weeks
Mentor quality (parent mentee outcome)
Mentor quality measured by the Mentor Behaviour Scale. Minimum value: 15 Maximum value: 75 Higher score indicates better outcome
Time frame: 12 and 24 weeks
Perceived social support (parent mentee outcome)
Perceived social support measured by Multidimensional Scale Of Perceived Social Support (MSPSS). Minimum value: 12 Maximum value: 84 Higher score indicates better outcome
Time frame: 12 and 24 weeks
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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