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Behavioral Intervention

Experimental: Intervention Group for Juvenile Idiopathic 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 9 weeks and 2 months later

Awards & highlights

M3-JIA Trial 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.Check my eligibility

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.See study design

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.

M3-JIA Trial 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.

M3-JIA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 9 weeks and 2 months later

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 9 weeks and 2 months later

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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).

Secondary outcome measures

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 outcome measures

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

M3-JIA 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. 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor

659 Previous Clinical Trials

413,658 Total Patients Enrolled

Brain CanadaOTHER

18 Previous Clinical Trials

5,964 Total Patients Enrolled

Roberta Berard, MDPrincipal InvestigatorLHSC Children's Hospital/ Lawson Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participating in this research trial?

"Prospective participants must have offspring aged between 4 and 12 years to be considered for this study. A total of 74 individuals will be accepted into the trial."

Answered by AI

Is the enrollment of participants ongoing for this study?

"As per the details on clinicaltrials.gov, this research is not currently seeking volunteers. Its initial posting was on August 1st, 2024, with the latest update made on April 18th of that year. While this specific trial is no longer open for enrollment, it's worth noting that there are a substantial number of other active studies - precisely 486 trials - actively searching for eligible participants at present."

Answered by AI

Is the research study allowing individuals younger than 65 years to participate?

"To be considered for participation in this research, candidates must fall within the age bracket of 4 to 12 years. There are a total of 132 trials catering to individuals under 18 and another 363 studies focusing on those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

M3-JIA: Making Mindfulness Matter for Children With JIA

2024. "M3-JIA: Making Mindfulness Matter for Children With JIA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06376149.

All > Juvenile Idiopathic Arthritis