Mindfulness-based Stress Reduction for Pediatric Mental Health

Phase 3

Completed

• Conditions: Mental Health Wellness 1
• Interventions: Other: Usual care; Other: Mindfulness-based stress reduction program

• Registration Number: NCT01307943
• Lead Sponsor: University of Alberta

Brief Summary

Mindfulness-based stress reduction (MBSR) is a group program in which participants are taught to be mindful or present-focused. MBSR programs consist of instruction in a variety of mindfulness meditations including body scan, sitting meditation, mindful yoga, and discussion of these practices. Our study purpose is to develop and conduct a pilot mixed-methods randomized controlled trial (RCT), combining clinical outcomes, qualitative interviews, and brain imaging to assess the impact of the intervention on children with mental health challenges.

Detailed Description

This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-03-02
• Study First Posted: 2011-03-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-09
• Last Update Posted: 2013-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• between the ages of 12 and 18
• residents of study site
• communication and comprehension of English
• not currently abusing substances

Exclusion Criteria

• participants diagnosed with psychosis, as meditation has rarely been associated with precipitation of psychosis and/or psychotic episodes in individuals with pre-existing schizophrenia or significant thought disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual care	The control group will be youth receiving therapies and programs already used at the site. The site provides family centered treatment where adolescents take part in therapy from Sunday evening until Friday afternoon. In addition to a structured day and evening schedule, standard treatment includes: Daily group therapy; ii) Medications; iii) Schooling by Edmonton Public School Board teachers; iv) Physical education and recreation; and v) Weekly Multiple Family Therapy.
Mindfulness Based Stress Reduction	Mindfulness-based stress reduction program	Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat at the completion of the eight sessions to review and consolidate experience with the various mindfulness practices. The MBSR concepts and techniques will emphasize portability. Participants will be encouraged to find moments throughout their day in which to practice the techniques. The language used to describe mindfulness practices will be accessible to youth. Mindfulness concepts will be linked with tag phrases like "breathing break," "autopilot," and "choice points." Homework will emphasize experiential, concrete tasks ("notice five new things today"; "eat one meal mindfully this week").

Primary Outcome Measures

Name	Time	Method
Behavioral Assessment System for Children - 2nd Edition	change from baseline at 10 weeks after start of intervention (or control period)

Secondary Outcome Measures

Name	Time	Method
Child Acceptance and Mindfulness Measure (CAMM)	change from baseline 3 months after intervention is complete and same time frame for control group
EEG and fMRI	change from baseline at 10 weeks after start of intervention (or control period)
Adverse events	at any stage during the study
Qualitative interview	12 weeks after start of intervention	this will occur only for intervention group
Emotion regulation in childhood and adolescence(ERQ-CA)	change from baseline 3 months after intervention is complete and same time frame for control group
Behavioral Assessment System for Children - 2nd Edition	change from baseline 3 months after intervention is complete and same time frame for control group
Perceived Stress Scale (PSS)	change from baseline 3 months after intervention is complete and same time frame for control group

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada