Health, Integration, Concentration: Mindfulness in Schools (GIK)
Primary Purpose
Mindfulness, Child Development, Burnout Syndrome
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness based stress reduction
Sponsored by
About this trial
This is an interventional prevention trial for Mindfulness focused on measuring MBSR, Children, Teacher, School, Burnout, Classroom behavior
Eligibility Criteria
Inclusion Criteria:
- reading ability
- positive declaration of consent
Exclusion Criteria:
-
Sites / Locations
- Schulamt Stadt Solingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Waitlist
Arm Description
One school semester MBSR training for teacher; followed by one school semester mindfulness training for children and one school semester follow-up period.
One school semester waitlist; followed by one school semester MBSR training for teacher and one school semester MBSR training for children.
Outcomes
Primary Outcome Measures
Burnout (Teacher) assessed with the Burnout-Screening-Scale
Burnout-Screening-Scale (Change from baseline)
Classroom climate pupils
Emotional and social school experience questionnaire (Change from baseline)
Secondary Outcome Measures
Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory
Stress and Anxiety Inventory for teacher (Change from baseline)
Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory
Freiburg Mindfulness Inventory (Change from baseline)
Concentration (pupils) assessed with a d2-Concentration assessment tool
d2-Concentration assessment tool (Change from baseline)
Health-related Quality of Life (pupils) assessed with the Kidscreen-10
Kidscreen-10 (Change from baseline)
Full Information
NCT ID
NCT03141229
First Posted
February 9, 2017
Last Updated
March 23, 2020
Sponsor
Universität Duisburg-Essen
Collaborators
Ministerium für Schule und Weiterbildung, Land Nordrhein-Westfalen, Ministerium für Gesundheit, Emanzipation, Pflege und Alter, Land Nordrhein-Westfalen
1. Study Identification
Unique Protocol Identification Number
NCT03141229
Brief Title
Health, Integration, Concentration: Mindfulness in Schools
Acronym
GIK
Official Title
Gesundheit, Integration, Konzentration: Achtsamkeitsbasierte Stabilisierung Von LehrerInnen Und SchülerInnen
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
Collaborators
Ministerium für Schule und Weiterbildung, Land Nordrhein-Westfalen, Ministerium für Gesundheit, Emanzipation, Pflege und Alter, Land Nordrhein-Westfalen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mindfulness training for teacher and children of primary schools. Blinded and controlled study design. Burnout as primary outcome for teacher and classroom behavior for children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mindfulness, Child Development, Burnout Syndrome
Keywords
MBSR, Children, Teacher, School, Burnout, Classroom behavior
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Note: Either teacher and pupils are included in this study. We anticipate a number of 100 teacher and 500 pupils participating. Data from teacher and pupils will be analyzed separately.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
One school semester MBSR training for teacher; followed by one school semester mindfulness training for children and one school semester follow-up period.
Arm Title
Waitlist
Arm Type
Other
Arm Description
One school semester waitlist; followed by one school semester MBSR training for teacher and one school semester MBSR training for children.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction
Other Intervention Name(s)
MBSR
Primary Outcome Measure Information:
Title
Burnout (Teacher) assessed with the Burnout-Screening-Scale
Description
Burnout-Screening-Scale (Change from baseline)
Time Frame
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Title
Classroom climate pupils
Description
Emotional and social school experience questionnaire (Change from baseline)
Time Frame
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Secondary Outcome Measure Information:
Title
Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory
Description
Stress and Anxiety Inventory for teacher (Change from baseline)
Time Frame
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Title
Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory
Description
Freiburg Mindfulness Inventory (Change from baseline)
Time Frame
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Title
Concentration (pupils) assessed with a d2-Concentration assessment tool
Description
d2-Concentration assessment tool (Change from baseline)
Time Frame
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Title
Health-related Quality of Life (pupils) assessed with the Kidscreen-10
Description
Kidscreen-10 (Change from baseline)
Time Frame
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
reading ability
positive declaration of consent
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustav Dobos, MD
Organizational Affiliation
Universität Duisburg-Essen, Medizinische Fakultät, Klinik für Naturheilkunde und Integrative Medizin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schulamt Stadt Solingen
City
Solingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42697
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Health, Integration, Concentration: Mindfulness in Schools
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