Mindfulness-based Stress Reduction for Pediatric Mental Health

NCT01307943 | Completed Phase 3 DMC

• 1 other identifier: MBSR1
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Wellness 1

Keywords

MBSR; adolescent; mental health

Outcome Measures

Primary Outcomes (1)

• Behavioral Assessment System for Children - 2nd Edition

  change from baseline at 10 weeks after start of intervention (or control period)

Secondary Outcomes (10)

• Child Acceptance and Mindfulness Measure (CAMM)

  change from baseline at 10 weeks after start of intervention (or control period)

• 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

• Emotion regulation in childhood and adolescence(ERQ-CA)

  change from baseline at 10 weeks after start of intervention (or control period)

Study Arms (2)

Mindfulness Based Stress Reduction

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Mindfulness-based stress reduction program OTHER

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

Also known as: MBSR

Mindfulness Based Stress Reduction

Usual care OTHER

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.

Also known as: standard care

Usual Care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• CASA: Child, Adolescent and Family Mental Health: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Vohra S, Punja S, Sibinga E, Baydala L, Wikman E, Singhal A, Dolcos F, Van Vliet KJ. Mindfulness-based stress reduction for mental health in youth: a cluster randomized controlled trial. Child Adolesc Ment Health. 2019 Feb;24(1):29-35. doi: 10.1111/camh.12302. Epub 2018 Oct 15.

  PMID: 32677243 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Sunita Vohra, MD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: March 3, 2011
• Study Start: January 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: December 10, 2013

Record last verified: 2013-12

Locations

CA (1)