Comparing M3 Intervention group with M3 Waitlist Group for juvenile idiopathic arthritis
Official title: 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
Interventions
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.
Canadian Sites (3)
McMaster Children's Hospital,
Hamilton, Ontario, Canada
LHSC Children' Hosptial
London, Ontario, Canada
Sickids
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for6 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
Exclusion
- −Other major co-morbid disorders (e.g. Crohn's disease, diabetes, renal failure).
- −Concurrent enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → in other intervention trials or practicing any complementary health interventions such as yoga, meditation, or daily mindfulness practice.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: M3 Intervention group, M3 Waitlist Group.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 4 years to 12 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 74 people.
The study is currently expected to finish around February 2026.
The main measurement is taken over: Throughout the study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → period and over the 8 weeks of intervention.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
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) — measured over Throughout the study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → period and over the 8 weeks of intervention.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06376149 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About M3 Intervention groupBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About M3 Waitlist GroupBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 4 years to 12 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 4 years to 12 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Throughout the study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → period and over the 8 weeks of intervention..
The study as a whole is currently expected to finish around 2026-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 74 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 3 locations, including: Hamilton, Ontario, Canada; London, Ontario, Canada; Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.