Health, Integration, Concentration: Mindfulness in Schools (GIK)

March 23, 2020 updated by: Holger Cramer, Universität Duisburg-Essen

Gesundheit, Integration, Konzentration: Achtsamkeitsbasierte Stabilisierung Von LehrerInnen Und SchülerInnen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Solingen, Nordrhein-Westfalen, Germany, 42697
        • Schulamt Stadt Solingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • reading ability
  • positive declaration of consent

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burnout (Teacher) assessed with the Burnout-Screening-Scale
Time Frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Burnout-Screening-Scale (Change from baseline)
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Classroom climate pupils
Time Frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Emotional and social school experience questionnaire (Change from baseline)
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory
Time Frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Stress and Anxiety Inventory for teacher (Change from baseline)
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory
Time Frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Freiburg Mindfulness Inventory (Change from baseline)
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Concentration (pupils) assessed with a d2-Concentration assessment tool
Time Frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
d2-Concentration assessment tool (Change from baseline)
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Health-related Quality of Life (pupils) assessed with the Kidscreen-10
Time Frame: Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)
Kidscreen-10 (Change from baseline)
Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ACTUAL)

August 1, 2018

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (ACTUAL)

May 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-6998-BO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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