GIK: Health, Integration, Concentration: Mindfulness in Schools

Sponsor
Universität Duisburg-Essen (Other)
Overall Status
Completed
CT.gov ID
NCT03141229
Collaborator
Ministerium für Schule und Weiterbildung, Land Nordrhein-Westfalen (Other), Ministerium für Gesundheit, Emanzipation, Pflege und Alter, Land Nordrhein-Westfalen (Other)
90
1
2
26.9
3.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness based stress reduction
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Gesundheit, Integration, Konzentration: Achtsamkeitsbasierte Stabilisierung Von LehrerInnen Und SchülerInnen
Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

One school semester MBSR training for teacher; followed by one school semester mindfulness training for children and one school semester follow-up period.

Behavioral: Mindfulness based stress reduction
Other Names:
  • MBSR
  • Other: Waitlist

    One school semester waitlist; followed by one school semester MBSR training for teacher and one school semester MBSR training for children.

    Behavioral: Mindfulness based stress reduction
    Other Names:
  • MBSR
  • Outcome Measures

    Primary Outcome Measures

    1. Burnout (Teacher) assessed with the Burnout-Screening-Scale [Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)]

      Burnout-Screening-Scale (Change from baseline)

    2. Classroom climate pupils [Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)]

      Emotional and social school experience questionnaire (Change from baseline)

    Secondary Outcome Measures

    1. Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory [Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)]

      Stress and Anxiety Inventory for teacher (Change from baseline)

    2. Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory [Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)]

      Freiburg Mindfulness Inventory (Change from baseline)

    3. Concentration (pupils) assessed with a d2-Concentration assessment tool [Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)]

      d2-Concentration assessment tool (Change from baseline)

    4. Health-related Quality of Life (pupils) assessed with the Kidscreen-10 [Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)]

      Kidscreen-10 (Change from baseline)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • reading ability

    • positive declaration of consent

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schulamt Stadt Solingen Solingen Nordrhein-Westfalen Germany 42697

    Sponsors and Collaborators

    • Universität Duisburg-Essen
    • Ministerium für Schule und Weiterbildung, Land Nordrhein-Westfalen
    • Ministerium für Gesundheit, Emanzipation, Pflege und Alter, Land Nordrhein-Westfalen

    Investigators

    • Principal Investigator: Gustav Dobos, MD, Universität Duisburg-Essen, Medizinische Fakultät, Klinik für Naturheilkunde und Integrative Medizin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Holger Cramer, Director of research, Universität Duisburg-Essen
    ClinicalTrials.gov Identifier:
    NCT03141229
    Other Study ID Numbers:
    • 16-6998-BO
    First Posted:
    May 5, 2017
    Last Update Posted:
    Mar 24, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Holger Cramer, Director of research, Universität Duisburg-Essen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 24, 2020