Actively Recruiting

Phase Not Applicable
Age: 4Years - 12Years
All Genders
ID06376149

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

Led by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Updated on 2025-06-11

74

Participants Needed

3

Research Sites

8 weeks

Total Duration

On this page

Sponsors

L

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

B

Brain Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the effects of Making Mindfulness Matter (M3), an online mindfulness program for children aged 4 to 12 with Juvenile Idiopathic Arthritis (JIA) and their caregivers. This pilot randomized controlled trial aims to assess whether the M3 program improves the child's health-related quality of life and mental health, as well as the caregivers' well-being. The study also seeks to understand the link between mental health and disease outcomes in children with JIA. The trial involves two groups: one receiving the M3 intervention and the other serving as a waitlist control. The intervention consists of an 8-week online program with live sessions led by facilitators. Parents participate in weekly 90-minute sessions, while children attend separate 60-minute sessions tailored to their age and developmental level. Children and parents join together for a shared mindfulness exercise after each child session. Control group participants continue usual treatment and complete questionnaires during the study period; they will receive the M3 program after the trial to reduce dropouts. Participants and their caregivers will complete questionnaires at the start, during, and after the intervention to measure quality of life, mental health, disease severity, and executive function. The program's feasibility and participant satisfaction will also be evaluated. The study will last through the 8-week intervention and include follow-up assessments up to two months afterward. This trial is sponsored by the London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's.

CONDITIONS

Brief Title

M3-JIA: Making Mindfulness Matter for Children With JIA

Who Can Participate

Age: 4Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 4 to 12 years diagnosed with JIA
  • 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
Not Eligible

You will not qualify if you...

  • Other major co-morbid disorders (e.g. Crohn's disease, diabetes, renal failure)
  • Concurrent enrollment in other intervention trials or practicing any complementary health interventions such as yoga, meditation, or daily mindfulness practice

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or online)

Outpatient Treatment

Duration - 8 weeks

Participants attend a standardized 8-week online mindfulness program called Making Mindfulness Matter (M3), with separate weekly live sessions for children and their caregivers. Children attend 1-hour sessions and parents attend 1.5-hour sessions, learning mindfulness concepts at developmentally appropriate levels.

Weekly online sessions for 8 weeks

Follow-up

Duration - Approximately 4 months

Participants complete follow-up questionnaires to assess health related quality of life, mental health, and disease outcomes at multiple time points after the intervention.

3 online questionnaire timepoints at 9 weeks, 18 weeks, and 2 months after intervention completion

Trial Site Locations

Total: 3 locations

1

McMaster Children's Hospital,

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

2

LHSC Children' Hosptial

London, Ontario, Canada, N6A 5W9

Actively Recruiting

3

Sickids

Toronto, Ontario, Canada, M5G 1E8

Actively Recruiting

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Research Team

S

Sarah Wells

R

Roberta Berard, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Enhancing cognitive and social-emotional development through a simple-to-administer mindfulness-based school program for elementary school children: a randomized controlled trial.

Kimberly A Schonert-Reichl, Eva Oberle, Molly Stewart Lawlor...

https://pubmed.ncbi.nlm.nih.gov/25546595

A live-online mindfulness-based intervention for children living with epilepsy and their families: protocol for a randomized controlled trial of Making Mindfulness Matter©.

Klajdi Puka, Karen Bax, Andrea Andrade...

https://pubmed.ncbi.nlm.nih.gov/33176853