Trials / Recruiting
RecruitingNCT06376149
M3-JIA: Making Mindfulness Matter for Children With JIA
A Pilot Randomized-controlled Trial Evaluating the Efficacy of a Live-Online Mindfulness-Based Intervention: The Making Mindfulness Matter© in Children With Juvenile Idiopathic Arthritis Study
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 74 (estimated)
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
- Sex
- All
- Age
- 4 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This pilot RCT is essential to refine the implementation of the intervention to families with a child with JIA and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multicentred trial across Canada. The investigator will propose to test if the M3© program improves the child's health related quality of life (HRQOL) and mental health for Children with JIA and caregivers. Additionally, to address the knowledge gap on the relationship between mental health and disease outcomes in JIA. M3 is a promising mindfulness-based intervention which may have mental health benefits for children with JIA and caregivers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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. |
| BEHAVIORAL | 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. |
Timeline
- Start date
- 2024-09-12
- Primary completion
- 2025-12-01
- Completion
- 2026-02-01
- First posted
- 2024-04-19
- Last updated
- 2025-06-11
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT06376149. Inclusion in this directory is not an endorsement.