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Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327714
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : February 25, 2020
Sponsor:
Collaborator:
Region Skane
Information provided by (Responsible Party):
Lund University

Brief Summary:

This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old. The mindfulness intervention will last for 10 weeks and the results will be compared to children who do not perform mindfulness in school. Due to practical reasons, the study is not randomized; classes are instead placed in the mindfulness or control group. Anxiety, mental, physical and social health, quality of life, and school performance will be evaluated via questionnaires and school registries, before and after the intervention and thereafter once a year until the end of ninth grade (age 16 years). Long term health (diagnoses, medical consumption, and drug prescriptions) and family income (proxy for socioeconomic status) will be followed in regional and national registries until 25 years of age.

The hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and increase well-being in children and adolescents. The primary aim is to subsequently evaluate if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and mental disorders in children and adolescents. Secondary aims are to evaluate 1) the effect of mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of mindfulness on school performance; 3) the effect of mindfulness and compassion on the class room environment; 4) the effect of potential individual, family, and school-level risk factors on mental health in children and adolescents; 5) the effect of mindfulness on these potential risk factors.

Sessions are led by school teachers who have been educated in mindfulness. Their own levels of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in control classes both before and after the intervention. The teachers will also be interviewed to evaluate the effect of mindfulness on the class room environment.

In a sub-study, the effect of mindfulness on brain structure and function will be examined by magnetic resonance imaging in school pupils aged 15-16 year old. This will be preceded by a pilot study, in which feasibility of the method is tested in the target group.

To achieve sufficient statistical power, taking into account a cluster effect to adjust for grouping of the pupils, 1750 children and adolescents will be recruited. Written informed consent is a prerequisite for participation.


Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: Mindfulness and compassion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1750 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Children in classes that perform regular mindfulness are compared to children in classes that do not.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils in Grades 0-9 (Ages 6-16)
Actual Study Start Date : October 12, 2016
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : June 30, 2039

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mindfulness and compassion
Children aged between 6-16 years old will perform 5-10 minutes daily mindfulness and compassion training in school. The intervention will last for 10 weeks.
Behavioral: Mindfulness and compassion
No Intervention: Control group
The control group consists of children who do not perform mindfulness in school.



Primary Outcome Measures :
  1. Effect of mindfulness on change in anxiety and depression in children, grade 3-9, as measured by the Beck Depression Inventory for Youth and the Beck Anxiety Inventory for Youth. [ Time Frame: Change from baseline depression and anxiety levels at 10 weeks ]
    The primary aim is to evaluate if regular, daily, mindfulness and compassion practice (5-10 minutes) for 10 weeks prevents anxiety and depression in children, grade 3-9. Results will be compared within respective group (change from baseline) and between mindfulness and control group.


Secondary Outcome Measures :
  1. Effect of mindfulness on changes in daily life as measured by questions about school and leisure time (adapted from the Scania Public Health Survey). [ Time Frame: Change from baseline daily life status at 10 weeks ]
    To evaluate the effect of regular mindfulness on daily life in children, grade 0-9, as measured by a number of questions about school and leisure time (adapted from the Scania Public Health Survey).

  2. Effect of regular mindfulness practice on school performance (data collected from school registers) [ Time Frame: Grade 0 (pupils aged 6-7 years) and will continue on a yearly basis until grade 9 (pupils aged 15-16). ]
    To evaluate the effect of regular mindfulness on grades and attendance. The report cards will be collected before the Swedish summer holidays commence in June

  3. Effect of mindfulness on change in class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers). [ Time Frame: Change from baseline class room environment at 10 weeks ]
    To evaluate the effect of regular mindfulness on class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).

  4. Effect of risk factors on mental health: longitudinal follow-up study. [ Time Frame: Baseline, 10 weeks, 52 weeks. Thereafter yearly until 25 years of age. ]
    To evaluate the association between, and effect of, potential individual, family, and school-level factors on mental health in children and adolescents. First results are obtained at baseline via questionnaires, the next 10 weeks later. Thereafter yearly until ninth grade (questionnaires) and until 25 years of age (diagnoses via registers)

  5. Effect of mindfulness on risk factors: longitudinal follow-up study. [ Time Frame: 10 weeks, 52 weeks. Thereafter yearly until 25 years of age. ]
    The effect of mindfulness on potential individual, family, and school-level risk factors. First evaluation after 10 weeks. Thereafter yearly until ninth grade (questionnaires) and 25 years of age (diagnoses via registers).

  6. Effect of mindfulness on changes in quality of life as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC) [ Time Frame: Change from baseline quality of life at 10 weeks ]
    To evaluate the effect of regular mindfulness on quality of life in children, grade 0-9, as measured by questions adapted from the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC)

  7. Effect of mindfulness on changes in health as measured by questions about school and leisure time (adapted from the Scania Public Health Survey). [ Time Frame: Change from baseline health at 10 weeks ]
    To evaluate the effect of regular mindfulness on health in children, grade 0-9, as measured by a number of questions about general health (adapted from the Scania Public Health Survey)

  8. Long-term effect of mindfulness practice on anxiety, depression, daily life, quality of life and health as measured by the BDI Youth, the Scania Public Health Survey and Living Conditions Surveys (ULF/SILC) and registries: longitudinal follow-up study [ Time Frame: 52 weeks and thereafter yearly until 25 years of age. ]
    Long-term follow-up of outcomes # 1, 2, 7 and 8 via questionnaires once a year until ninth grade, and health until 25 years of age (diagnoses via registers)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • School pupils in grade 0-9

Exclusion Criteria:

  • No exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327714


Contacts
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Contact: Jan Sundquist, PhD, MD +4640391378 jan.sundquist@med.lu.se
Contact: Kristina Sundquist, PhD, MD +4640391376 kristina.sundquist@med.lu.se

Locations
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Sweden
Center for Primary Health Care Research Recruiting
Malmö, Sweden, 20502
Contact: Jan Sundquist, PhD, MD    +4640391378    jan.sundquist@med.lu.se   
Contact: Kristina Sundquist, PhD, MD    +4640391376    kristina.sundquist@med.lu.se   
Sponsors and Collaborators
Lund University
Region Skane
Investigators
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Principal Investigator: Jan Sundquist, PhD, MD Center for Primary Health Care Research, Institution of Clinical Sciences, Malmö, Sweden

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03327714    
Other Study ID Numbers: 2016/299
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Lund University:
mindfulness
children
anxiety
depression
mental disorder
risk factor
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms