Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT04168034
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2019-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iParent2Parent Program for Parents of Children With Juvenile Idiopathic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-31', 'size': 195273, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-08T12:57', 'hasProtocol': True}, {'date': '2019-01-31', 'size': 195569, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-04T12:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2019-10-18', 'studyFirstSubmitQcDate': '2019-11-15', 'lastUpdatePostDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trial feasibility of iParent2Parent program', 'timeFrame': 'At study completion; an average of 2 years', 'description': 'Criteria for feasibility are based on studies previously conducted by our group and will be: accrual rate of \\>70 percent, attrition rate of \\<15percent, technical difficulties reported by \\<10 percent of parents and mentors, adherence rate of \\>80 percent, \\<5 percent missed responses on outcome measures and high acceptability (based on qualitative analyses). Data related to the primary outcome will be recorded on investigator-developed forms.'}], 'secondaryOutcomes': [{'measure': 'PROMIS Adult Profile 25', 'timeFrame': 'baseline; up to 12 weeks after baseline, 6 months post program', 'description': '29 item collection of short forms from 7 health domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance and ability to participate in social roles and activities. The scale is scored from 1 to 5. The higher the score the worse the outcome'}, {'measure': 'Short form version of the PROMIS', 'timeFrame': 'baseline; up to 12 weeks after baseline, 6 months post program', 'description': 'Short form version of the PROMIS battery for Social Isolation; Informational support; and Emotional support. The scale is scored from 1 to 5. The higher the score the better the outcome (emotional and informational support). The higher the score the worse the outcome for social isolation)'}, {'measure': 'Coping Health Inventory for Parents', 'timeFrame': 'baseline; up to 12 weeks after baseline, 6 months post program', 'description': "45-item measure of a parent's response to managing demands when a child has a serious or chronic medical condition. The lower the score, the worse the outcome. Minimum value 0 and maximum value 3."}, {'measure': 'Parental Stress Scale', 'timeFrame': 'baseline; up to 12 weeks after baseline, 6 months post program', 'description': 'Attempts to measure the levels of stress experienced by parents. The scale is scored from 1 to 5. The lower the score the lower the level of stress and the higher the score the higher the level of stress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['JIA']}, 'descriptionModule': {'briefSummary': 'The iParent2Parent program matches parents of children living with arthritis with a trained parent mentor who will provide parents of children newly diagnosed with arthritis: practical coping advice and social support through shared lived experiences. This study will compare two groups of parents: those who are in the iParent2Parent program and those in the control group (no mentor).', 'detailedDescription': "Parents/primary caregiver of children with JIA are an often overlooked but essential member of their child's health care team. They are responsible for managing their child's treatment program, and act as advocates for their child to support positive adaptation to JIA and to learn self-management skills for the disease. This is in the context of managing the financial, logistical, emotional, and social demands of parenting in general. Within pediatric tertiary care centres, peer-support programs for parents of children with JIA are often limited or difficult to access. The iParent2Parent Program aims to fill this gap in services by offering a program of trained parent peer mentors who can provide practical coping advice, foster adaptive problem solving, and provide social support via shared lived experience."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* English speaking caregiver of a child diagnosed with JIA according to ILAR criteria prior to their 18th birthday\n* Access to computer capable of using free Skype software\n\nExclusion Criteria:\n\n* Significant cognitive impairment or major co-morbid illness of parent that impeded ability to engage in program (e.g.; psychosis, active suicidal ideation, cognitive delays that would impact ability to participate and complete questionnaires.)'}, 'identificationModule': {'nctId': 'NCT04168034', 'acronym': 'iPa2PaJIA', 'briefTitle': 'iParent2Parent Program for Parents of Children With Juvenile Idiopathic Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'The iParent2Parent Program: Peer Mentoring for Parents of Children With Juvenile Idiopathic Arthritis', 'orgStudyIdInfo': {'id': '1000061063'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: iParent2Parent Mentorship', 'description': '10 sessions of 20-30 minute Skype video calls conducted over 2 to 3 months', 'interventionNames': ['Behavioral: iParent2Parent Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Waitlist Control Group', 'description': 'The control group will receive standard care but without the iParent2Parent program', 'interventionNames': ['Behavioral: Waitlist Control']}], 'interventions': [{'name': 'iParent2Parent Program', 'type': 'BEHAVIORAL', 'description': 'In addition to standard care, parents in the experimental group will receive the iParent2Parent program. The iParent2Parent program is a tailored peer mentorship program that provides modeling and reinforcement by peers (trained parents of children with JIA) to parents of children diagnosed with JIA.', 'armGroupLabels': ['Experimental: iParent2Parent Mentorship']}, {'name': 'Waitlist Control', 'type': 'BEHAVIORAL', 'description': 'The control group will receive standard care but without the iParent2Parent program', 'armGroupLabels': ['Waitlist Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'The IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Sara Ahola Kohut, PhD', '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': 'Psychologist', 'investigatorFullName': 'Sara Ahola Kohut', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}