M3-JIA: Making Mindfulness Matter for Children With JIA

Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study ID
NCT06376149
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • M3 Intervention group — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 12, 2024
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Feb 28, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: 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)
  • Other: 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)

Primary Outcome 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). [ Time Frame: Throughout the study enrollment period and over the 8 weeks of intervention. ]

Central Contacts

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