M3-JIA: Making Mindfulness Matter for Children With JIA
NCT ID: NCT06376149
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
74 participants
INTERVENTIONAL
2024-09-12
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Measures will be obtained via questionnaires at 3 time points for the intervention group: baseline, 9 weeks and 2 months post-intervention. For the control group questionnaires will be obtained 4 time points: baseline, 9 weeks, 18 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.
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Experimental: Intervention Group
Child-parent dyads will undergo a standardized 8-week course of Making Mindfulness Matter© (M3). The program will be delivered online using live, interactive sessions to groups of 4 to 8, for 1.5 hours each week for the parent group and 1 hour each week for the child group. Children and parents will attend separate on-line sessions and at the end of each child session, the parent will be asked to join their child on-line for a shared mindful exercise. Once 4 to 8 dyads are assigned to the intervention group, participants will be given the baseline questionnaires and start the intervention in the following week.
Interventions:
Behavioural: Making Mindfulness Matter© (M3)
M3 Intervention group
The M3© program offered online concurrently for parents and children (4-12 years of age). Each parent session is 90 minutes long, and each child session is 60 minutes long. Parents and children learn similar concepts, at developmentally appropriate levels.
Other: Waitlist Control
Child-parent dyads randomized to the control arm will continue treatment as usual. Once 4 to 8 dyads are assigned to the control group, participants will be given the baseline questionnaires, They will complete Follow-up questionnaire and extended follow up questionnaires at comparable times to families in the intervention arm. With one extra set of questionnaires at the completion of the intervention. These dyads will be provided with the intervention at the next scheduled session; the goal is to provide the intervention to controls as soon as possible to avoid differential attrition between the intervention and control arm. During the intervention sessions, they will complete all feasibility surveys pertaining to the intervention and their satisfaction with each intervention session.
Interventions:
Behavioural: Making Mindfulness Matter© (M3)
M3 Waitlist Group
The M3© program offered online concurrently for parents and children (4-12 years of age). Each parent session is 90 minutes long, and each child session is 60 minutes long. Parents and children learn similar concepts, at developmentally appropriate levels.
Interventions
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M3 Intervention group
The M3© program offered online concurrently for parents and children (4-12 years of age). Each parent session is 90 minutes long, and each child session is 60 minutes long. Parents and children learn similar concepts, at developmentally appropriate levels.
M3 Waitlist Group
The M3© program offered online concurrently for parents and children (4-12 years of age). Each parent session is 90 minutes long, and each child session is 60 minutes long. Parents and children learn similar concepts, at developmentally appropriate levels.
Eligibility Criteria
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Inclusion Criteria
* Children have reasonable comprehension of spoken language and can follow simple instructions
* Children with JIA and their caregivers are willing to attend intervention sessions and have access to technology and internet to attend the online sessions.
* Children with JIA and their caregivers have an adequate understanding of English
Exclusion Criteria
* Concurrent enrollment in other intervention trials or practicing any complementary health interventions such as yoga, meditation, or daily mindfulness practice.
4 Years
12 Years
ALL
No
Sponsors
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Brain Canada
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Roberta Berard, MD
Role: PRINCIPAL_INVESTIGATOR
LHSC Children's Hospital/ Lawson Research
Locations
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McMaster Children's Hospital,
Hamilton, Ontario, Canada
LHSC Children' Hosptial
London, Ontario, Canada
Sickids
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Schonert-Reichl KA, Oberle E, Lawlor MS, Abbott D, Thomson K, Oberlander TF, Diamond A. Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial. Dev Psychol. 2015 Jan;51(1):52-66. doi: 10.1037/a0038454.
Puka K, Bax K, Andrade A, Devries-Rizzo M, Gangam H, Levin S, Nouri MN, Prasad AN, Secco M, Zou G, Speechley KN. A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter(c). Trials. 2020 Nov 11;21(1):922. doi: 10.1186/s13063-020-04792-3.
Treemarcki EB, Danguecan AN, Cunningham NR, Knight AM. Mental Health in Pediatric Rheumatology: An Opportunity to Improve Outcomes. Rheum Dis Clin North Am. 2022 Feb;48(1):67-90. doi: 10.1016/j.rdc.2021.09.012.
Other Identifiers
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124973
Identifier Type: -
Identifier Source: org_study_id
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