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?

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.

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.

Is the mindfulness program safe for children with juvenile arthritis?

The research on similar interventions like yoga and cognitive-behavioral techniques for children with juvenile arthritis suggests they are generally safe and can help reduce pain and improve mood. These approaches have been well-received by participants and show potential as part of a comprehensive treatment plan. ^{1 2 3 4 5}

How does the M3 treatment differ from other treatments for 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 in children with juvenile arthritis, unlike traditional treatments that primarily address physical symptoms. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment M3 for children with juvenile arthritis?

The research suggests that using coping strategies like problem-solving and positive self-statements can help reduce pain in children with juvenile arthritis. Mindfulness programs, which often include similar techniques, might also be effective in managing pain and improving well-being in these children. ^{3 5 7 8 9}

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

My child has JIA and we can attend online sessions.

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

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. Denmark pubmed.ncbi.nlm.nih.gov

[Pain and coping strategies in juvenile idiopathic arthritis]. [2015]

2. Italy pubmed.ncbi.nlm.nih.gov

Empirical classification of children with JIA: a multidimensional approach to pain and well-being. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Development and preliminary validation of a children's arthritis self-efficacy scale. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Outcome measures and medical progress: why outcome measures are needed in childhood arthritis. [2019]

5. India pubmed.ncbi.nlm.nih.gov

A study of school adjustment, self-concept, self-esteem, general wellbeing and parent child relationship in Juvenile Idiopathic Arthritis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Yoga Intervention for an Adolescent With Juvenile Idiopathic Arthritis: A Case Study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Parent pain responses as predictors of daily activities and mood in children with juvenile idiopathic arthritis: the utility of electronic diaries. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral pain management in children with juvenile rheumatoid arthritis. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Psychological intervention for adolescents with juvenile idiopathic arthritis: for whom and when? [2013]