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Completed

NCT Number: NCT01307943

Mindfulness-based Stress Reduction for Pediatric Mental Health

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.

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Key information

Conditions

Mental Health Wellness 1 Behavior Personal Satisfaction Psychological Well-Being

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alberta

Edmonton, Alberta, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: MBSR

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.

Other names: standard care

Primary outcomes

  1. Behavioral Assessment System for Children - 2nd Edition

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

Secondary outcomes

  1. Child Acceptance and Mindfulness Measure (CAMM)

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

  2. EEG and fMRI

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

  3. Adverse events

    Time frame: at any stage during the study

  4. Qualitative interview

    Time frame: 12 weeks after start of intervention

    this will occur only for intervention group

  5. Emotion regulation in childhood and adolescence(ERQ-CA)

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

  6. 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

  7. Child Acceptance and Mindfulness Measure (CAMM)

    Time frame: change from baseline 3 months after intervention is complete and same time frame for control group

  8. 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

  9. Perceived Stress Scale (PSS)

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

  10. Perceived Stress Scale (PSS)

    Time frame: change from baseline 3 months after intervention is complete and same time frame for control group

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • CASA: Child, Adolescent and Family Mental Health

Registry information

Acronym: MBSR

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2011
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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