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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 12
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
McMaster Children's Hospital,
RECRUITING
Hamilton
LHSC Children' Hosptial
RECRUITING
London
Sickids
RECRUITING
Toronto
Contact Information
Primary
Sarah Wells
sarah.wells@lhsc.on.ca
519-685-8500
Backup
Roberta Berard, MD
roberta.berard@lhsc.on.ca
519-685-8266
Time Frame
Start Date: 2024-09-12
Estimated Completion Date: 2026-02
Participants
Target number of participants: 74
Treatments
Other: Experimental: Intervention Group
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)
Other: Other: Waitlist Control
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)
Sponsors
Leads: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborators: Brain Canada

This content was sourced from clinicaltrials.gov