Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:23 AM
Study NCT ID:
NCT05968833
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2023-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Pre-post design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2023-06-29', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment rates and withdrawal rates', 'timeFrame': 'Baseline to study completion, an average of 1 year', 'description': 'How many participants were recruited and have withdrawn from the program on average.'}, {'measure': 'Adherence with the iParent2Parent program', 'timeFrame': 'Baseline to study completion, an average of 1 year', 'description': 'When the participant completes 10 audio or video calls over 12 weeks and 100% when all online outcome measures completed.'}, {'measure': 'Acceptability (Mentees)', 'timeFrame': 'Baseline to 12 weeks after baseline/immediately after the intervention', 'description': 'Whether the innovation is agreeable, palatable or satisfactory.\n\nMeasured via semi-structured interview or focus group.'}, {'measure': 'Acceptability (Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': 'Whether the innovation is agreeable, palatable or satisfactory.\n\nMeasured via semi-structured interview or focus group.'}, {'measure': 'Level of engagement with the iParent2Parent program (Mentees)', 'timeFrame': 'Baseline to 12 weeks after baseline/immediately after the intervention', 'description': 'Measured via semi-structured interview or focus group.'}, {'measure': 'Level of engagement with the iParent2Parent program (Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': 'Measured via semi-structured interview or focus group.'}, {'measure': 'Barriers and enablers of the iParent2Parent program (Mentees)', 'timeFrame': 'Baseline to 12 weeks after baseline/immediately after the intervention', 'description': 'Measured via semi-structured interview or focus group.'}, {'measure': 'Barriers and enablers of the iParent2Parent program (Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': 'Measured via semi-structured interview or focus group.'}], 'secondaryOutcomes': [{'measure': 'Parenting stress (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Psychological distress (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Psychological distress (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Perceived social support (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Perceived social support (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Perceived social support (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Coping (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}, {'measure': 'Family Functioning (Mentees and Mentors)', 'timeFrame': 'Baseline to program completion, an average of one year', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Peer Support Mentorship', 'Parent Support Mentorship', 'Pediatrics', 'Transplant'], 'conditions': ['Kidney Transplant']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Mentee Inclusion Criteria:\n\n* Parent of a patient under 18 years of age who received a kidney transplant and is at least two months post-transplant,\n* Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and\n* English-speaking.\n\nMentor Inclusion Criteria:\n\n* Parent of a patient under 21 years of age who received a kidney transplant and is at least one year post-transplant,\n* 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),\n* Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and\n* English-speaking.\n\nExclusion Criteria:\n\n* Non-English speaking."}, 'identificationModule': {'nctId': 'NCT05968833', 'briefTitle': 'iParent2Parent Peer Support Program for Parents of Pediatric Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Addressing the Mental Health Needs of Parents of Pediatric Kidney Transplant Recipients With the iParent2Parent Peer Support Program', 'orgStudyIdInfo': {'id': '1000080780'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iParent2Parent Program', 'interventionNames': ['Behavioral: iParent2Parent Program']}], 'interventions': [{'name': 'iParent2Parent Program', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['iParent2Parent Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Samantha J. Anthony, PhD, MSW', 'role': 'CONTACT', 'email': 'samantha.anthony@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '303126'}], 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Samantha J. Anthony, PhD, MSW', 'role': 'CONTACT', 'email': 'samantha.anthony@sickkids.ca', 'phone': '416-813-7654', 'phoneExt': '303126'}, {'name': 'Sophie Bui, BHSc', 'role': 'CONTACT', 'email': 'sophie.bui@sickkids.ca'}], 'overallOfficials': [{'name': 'Samantha J. Anthony, PhD, MSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Samantha Anthony', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}