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Mindfulness-based Stress Reduction for Pediatric Mental Health

Mindfulness-based Stress Reduction for Pediatric Mental Health

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01307943
Acronym
MBSR
Enrollment
85
Registered
2011-03-03
Start date
2011-01-31
Completion date
2013-04-30
Last updated
2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Wellness 1

Keywords

MBSR, adolescent, mental health

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.

Interventions

Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat

OTHERUsual care

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.

Sponsors

CASA: Child, Adolescent and Family Mental Health
CollaboratorUNKNOWN
University of Alberta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Behavioral Assessment System for Children - 2nd Editionchange from baseline at 10 weeks after start of intervention (or control period)

Secondary

MeasureTime frameDescription
EEG and fMRIchange from baseline at 10 weeks after start of intervention (or control period)
Adverse eventsat any stage during the study
Qualitative interview12 weeks after start of interventionthis will occur only for intervention group
Child Acceptance and Mindfulness Measure (CAMM)change from baseline at 10 weeks after start of intervention (or control period)
Behavioral Assessment System for Children - 2nd Editionchange from baseline 3 months after intervention is complete and same time frame for control group
Perceived Stress Scale (PSS)change from baseline at 10 weeks after start of intervention (or control period)
Emotion regulation in childhood and adolescence(ERQ-CA)change from baseline at 10 weeks after start of intervention (or control period)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026