Mindfulness-based Stress Reduction for Pediatric Mental Health - Full Text View

Purpose

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.

Condition	Intervention	Phase
Mental Health Wellness 1	Other: Mindfulness-based stress reduction program Other: Usual care	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Mindfulness-based Stress Reduction for Pediatric Mental Health

Resource links provided by NLM:

MedlinePlus related topics: Child Mental Health Mental Health

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:

Behavioral Assessment System for Children - 2nd Edition [ Time Frame: change from baseline at 10 weeks after start of intervention (or control period) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: change from baseline at 10 weeks after start of intervention (or control period) ] [ Designated as safety issue: No ]
EEG and fMRI [ Time Frame: change from baseline at 10 weeks after start of intervention (or control period) ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: at any stage during the study ] [ Designated as safety issue: Yes ]
Qualitative interview [ Time Frame: 12 weeks after start of intervention ] [ Designated as safety issue: No ]
this will occur only for intervention group
Emotion regulation in childhood and adolescence(ERQ-CA) [ Time Frame: change from baseline at 10 weeks after start of intervention (or control period) ] [ Designated as safety issue: No ]
Behavioral Assessment System for Children - 2nd Edition [ Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group ] [ Designated as safety issue: No ]
Child Acceptance and Mindfulness Measure (CAMM) [ Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group ] [ Designated as safety issue: No ]
Emotion regulation in childhood and adolescence(ERQ-CA) [ Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group ] [ Designated as safety issue: No ]
Perceived Stress Scale (PSS) [ Time Frame: change from baseline at 10 weeks after start of intervention (or control period) ] [ Designated as safety issue: No ]
Perceived Stress Scale (PSS) [ Time Frame: change from baseline 3 months after intervention is complete and same time frame for control group ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	January 2011
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Mindfulness Based Stress Reduction 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").	Other: Mindfulness-based stress reduction program Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat Other Name: MBSR
Active Comparator: 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.	Other: Usual 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. Other Name: standard care

Arms

Assigned Interventions

Experimental: Mindfulness Based Stress Reduction

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").

Other: Mindfulness-based stress reduction program

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

Other Name: MBSR

Active Comparator: 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.

Other: Usual 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.

Other Name: standard care

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.

Eligibility

Ages Eligible for Study:	12 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01307943

Contacts

Contact: Sunita Vohra, MD, MSc	780-342-8592
Contact: Denise Adams, PhD	780-342-8528	denise.adams@ualberta.ca

Locations

Canada, Alberta
University of Alberta	Recruiting
Edmonton, Alberta, Canada
Contact: Denise Adams, PhD 780-342-8528 denise.adams@ualberta.ca
Principal Investigator: Sunita Vohra, MD, MSc
Sub-Investigator: Lola Baydala, MD
Sub-Investigator: Jessica Van Vliet, PhD
Sub-Investigator: Florin Dolcos, PhD
Sub-Investigator: Anthony Singhal, PhD
Sub-Investigator: Denise Adams, PhD
Sub-Investigator: Erica Sibinga, MD
Sub-Investigator: Catherine Phillips, MD
Sub-Investigator: Andrew Bremness, MD
Sub-Investigator: Tula Paul, PhD
Sub-Investigator: Liana Urichuk, PhD
Sub-Investigator: Brian Malloy
Sub-Investigator: Erik Wikman, MD

Sponsors and Collaborators

University of Alberta

CASA: Child, Adolescent and Family Mental Health

Investigators

Principal Investigator:

Sunita Vohra, MD, MSc

University of Alberta

More Information

No publications provided

Responsible Party:	Sunita Vohra, Professor, University of Alberta
ClinicalTrials.gov Identifier:	NCT01307943 History of Changes
Other Study ID Numbers:	MBSR1
Study First Received:	February 25, 2011
Last Updated:	September 25, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Alberta:

MBSR
adolescent
mental health

ClinicalTrials.gov processed this record on May 19, 2013

Mindfulness-based Stress Reduction for Pediatric Mental Health (MBSR)