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Behavioral Intervention

Mindfulness Program for Children with Juvenile Arthritis (M3-JIA Trial)

N/A

Waitlist Available

Led By Roberta Berard, MD

Research Sponsored by Lawson Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children aged 4 to 12 years diagnosed with JIA

Be younger than 18 years old

Must not have

Presence of other major co-morbid disorders (e.g. Crohn's disease, diabetes, renal failure)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9 weeks, 18 weeks and 2 months later.

Awards & highlights

No Placebo-Only Group

Summary

"This trial will assess the effectiveness of a program called Making Mindfulness Matter (M3) for children with Juvenile arthritis and their parents. The program is an 8-week online intervention that combines mindfulness

Who is the study for?

This trial is for children aged 4-12 with Juvenile Idiopathic Arthritis (JIA) and their caregivers. It's designed to help them cope with the challenges of chronic disease through an online program focusing on mindfulness and positive psychology.

What is being tested?

The 'Making Mindfulness Matter' (M3) program, which includes mindfulness, social-emotional learning, neuroscience, and positive psychology techniques over an 8-week course, is being tested against a waitlist group to see if it improves coping in children with JIA.

What are the potential side effects?

Since M3 is a non-medical intervention focusing on mental health education and practices, there are no direct medical side effects. However, participants may experience varying levels of engagement or emotional responses to the material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child is between 4 and 12 years old and has juvenile idiopathic arthritis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a major health condition like Crohn's, diabetes, or kidney failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 weeks, 18 weeks and 2 months later.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 weeks, 18 weeks and 2 months later.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 weeks, 18 weeks and 2 months later. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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).

Secondary study objectives

Does M3 have a positive effect on children's executive function

Does M3 have a positive effect on children's severity of JIA

Effects of M3 on health quality of life for parents

+1 more

Other study objectives

Does M3 have a positive effect on Child's' depression and anxiety

Does M3 have a positive effect on children's resiliency

Does M3 have a positive effect on parent resiliency

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Other: Waitlist ControlExperimental Treatment1 Intervention

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)

Group II: Experimental: Intervention GroupExperimental Treatment1 Intervention

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)

0 / 2Eligibility criteria met