Mindfulness Program for Children with Juvenile Arthritis

(M3-JIA Trial)

Recruiting at 3 trial locations

Overseen By Roberta Berard, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Crohn's, Diabetes, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 8 weeks

74 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online mindfulness program, called M3, designed to assist children with juvenile arthritis and their caregivers. The goal is to determine if this program can enhance coping and resilience by teaching mindfulness and emotional learning skills. The program spans eight weeks and includes separate, interactive sessions for both children and their parents. Children aged 4 to 12 years with juvenile arthritis, who understand English and can access online sessions, may be suitable participants. As an unphased trial, this study provides a unique opportunity for families to explore innovative coping strategies and contribute to valuable research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot be enrolled in other intervention trials or practice complementary health interventions like yoga or meditation.

What prior data suggests that the M3 program is safe for children with juvenile arthritis?

Research shows that the Making Mindfulness Matter (M3) program is generally easy for participants to handle, with no evidence of major negative effects. This program focuses on mindfulness, a mental practice that improves focus and reduces stress, and has been used in many situations with good results.

As a behavioral program, not a drug or medical treatment, M3 carries a low risk of causing physical side effects. Previous studies have shown that mindfulness programs can be safely included in children's daily activities. Participants often report feeling more relaxed and better able to handle challenges.

In summary, the M3 program appears to be a safe choice for children with juvenile arthritis and their families. It aims to support mental well-being without the usual side effects of medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness Program for Children with Juvenile Arthritis because it offers a unique, holistic approach compared to traditional medications like NSAIDs, DMARDs, or biologics. Unlike these standard treatments, which primarily focus on reducing inflammation and pain, the Making Mindfulness Matter© (M3) program aims to address the mental and emotional well-being of both children and their parents. Delivered online in interactive sessions, this program not only enhances accessibility but also promotes a shared experience between parent and child, potentially improving their coping strategies and quality of life. This innovative approach could complement existing treatments by targeting the psychological aspects of living with juvenile arthritis.

What evidence suggests that the M3 program is effective for children with juvenile arthritis?

Research shows that the Making Mindfulness Matter (M3) program can help children with Juvenile Idiopathic Arthritis (JIA). Past studies have found that mindfulness-based methods like M3 improve coping skills and reduce pain in children. These methods also enhance quality of life by teaching better stress and emotion management. Early results suggest that these practices strengthen children and families in facing the challenges of long-term illnesses. This trial will compare the M3 program in an intervention group with a waitlist control group. Although specific data on M3's effectiveness for JIA is limited, similar programs have shown good results in related conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Roberta Berard, MD

Principal Investigator

LHSC Children's Hospital/ Lawson Research

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Children with JIA and their caregivers have an adequate understanding of English

My child has JIA and we can attend online sessions.

Children have reasonable comprehension of spoken language and can follow simple instructions

Exclusion Criteria

I am not enrolled in other clinical trials and do not practice daily complementary health activities like yoga or meditation.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week online mindfulness-based intervention program called Making Mindfulness Matter (M3), with weekly sessions for children and parents.

8 weeks

8 online sessions

Follow-up

Participants complete follow-up questionnaires to assess the impact of the intervention on various health and psychological outcomes.

18 weeks

Questionnaires at 9 weeks, 18 weeks, and 2 months later

Waitlist Control

Control group participants receive the intervention after the initial treatment group, ensuring all participants eventually receive the program.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• M3

Trial Overview 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.

How Is the Trial Designed?

Group I: Other: Waitlist Control Experimental Treatment 1 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 Group Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

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

Lead Sponsor

Trials

686

Recruited

427,000+

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

Lead Sponsor

Trials

678

Recruited

421,000+

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

Lead Sponsor

Trials

668

Recruited

424,000+

Brain Canada

Collaborator

Trials

22

Recruited

6,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06376149

M3-JIA: Making Mindfulness Matter for Children With JIA The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their ...

2. trialx.com trialx.com/clinical-trials/listings/323080/m3-jia-making-mindfulness-matter-for-children-with-jia/

M3-JIA: Making Mindfulness Matter for Children With JIA Overview. The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers.

3. withpower.com withpower.com/trial/phase-children-7-2024-6f3b4

Mindfulness Program for Children with Juvenile Arthritis The M3 treatment, a mindfulness program, is unique because it focuses on improving coping strategies and mindfulness to reduce pain and improve quality of life ...

4. ctv.veeva.com ctv.veeva.com/study/m3-jia-making-mindfulness-matter-for-children-with-jia

M3-JIA: Making Mindfulness Matter for Children With JIA The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile ...

5. braincanada.ca braincanada.ca/funded_grants/a-pilot-randomized-controlled-trial-evaluating-the-efficacy-of-a-live-online-mindfulness-based-intervention-for-children-with-juvenile-idiopathic-arthritis-and-their-families-the-making-mind/

The Making Mindfulness Matter© in Children with Juvenile ... A pilot randomized-controlled trial evaluating the efficacy of a Live-Online Mindfulness-Based Intervention for Children with Juvenile Idiopathic Arthritis and ...

6. app.trialscreen.org app.trialscreen.org/trials/m3-jia-making-mindfulness-matter-children-trial-nct06376149

M3-JIA: Making Mindfulness Matter for Children With JIA Participation in the M3 program may improve the child's health-related quality of life (HRQOL) and mental health, as well as the mental health of caregivers.