protocolSection identificationModule nctId: NCT06376149, orgStudyIdInfo id: 124973, briefTitle: M3-JIA: Making Mindfulness Matter for Children With JIA, acronym: M3-JIA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Lawson Health Research Institute, class: OTHER, collaborators name: Brain Canada, descriptionModule briefSummary: The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level., conditionsModule conditions: Juvenile Idiopathic Arthritis, conditions: Children, conditions: Mental Health, conditions: Mental Well-being, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The primary objective is to conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s).Measures will be obtained via questionnaires at 3 time points: baseline, 9 weeks and 2 months post-intervention.Additionally, at the start of each session, parents will complete a one-page semi-structured questionnaire evaluating treatment fidelity and at home utilization of M3© skills. At the end of each session, parent participants will complete a one-page structured questionnaire providing feedback on the session, and facilitators will complete the M3© Adherence Checklist, evaluating whether planned activities were completed, and any modifications made., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: DOUBLE, maskingDescription: Participants will be blinded to their group assignment: all participants will be told that they will receive the intervention. Program facilitators will be blinded to participant group assignment order, since sessions for both study arms would run on a rolling basis. The statistician will also be blinded to the group assignment and order., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, enrollmentInfo count: 74, type: ESTIMATED, armsInterventionsModule interventions name: M3 Intervention group, interventions name: M3 Waitlist Group, outcomesModule primaryOutcomes measure: conduct a pilot RCT to evaluate the effectiveness of a live-online mindfulness-based family intervention program, Making Mindfulness Matter (M3©) for children with JIA and their caregiver(s)., secondaryOutcomes measure: Effects of M3 on health related quality of life of children with JIA, secondaryOutcomes measure: Effects of M3 on health quality of life for parents, secondaryOutcomes measure: Does M3 have a positive effect on children's severity of JIA, secondaryOutcomes measure: Does M3 have a positive effect on children's executive function, otherOutcomes measure: Does M3 have a positive effect on parents' stress, otherOutcomes measure: Does M3 have a positive effect on parents' depression and anxiety, otherOutcomes measure: Does M3 have a positive effect on Child's' depression and anxiety, otherOutcomes measure: Does M3 have a positive effect on children's resiliency, otherOutcomes measure: Does M3 have a positive effect on parent resiliency, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: McMaster Children's Hospital,, city: Hamilton, state: Ontario, zip: L8N 3Z5, country: Canada, contacts name: Karen Beatie, role: CONTACT, phone: (905) 521-2100, email: beattik@mcmaster.ca, contacts name: Michelle Dr. Batthish, role: CONTACT, phone: (905) 521-2100, email: batthim@mcmaster.ca, contacts name: Michelle Batthish, role: SUB_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: London Health Sciences Centre- Children's Hosptial, city: London, state: Ontario, zip: N6J 4L8, country: Canada, contacts name: Sarah Wells, role: CONTACT, phone: 519-685-8500, phoneExt: 56816, email: sarah.wells@lhsc.on.ca, contacts name: Roberta Berard, role: CONTACT, phone: 519-685-8500, phoneExt: 52479, email: roberta.berard@lhsc.on.ca, contacts name: Roberta Berard, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.98339, lon: -81.23304, locations facility: Sickids, city: Toronto, state: Ontario, zip: M5G 1E8, country: Canada, contacts name: Andrea Knight, role: CONTACT, phone: (416) 813-1500, email: andrea.knight@sickkids.ca, contacts name: Andrea Dr. Knight, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False