NCT03141229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 24, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

February 9, 2017

Last Update Submit

March 23, 2020

Conditions

Keywords

MBSRChildrenTeacherSchoolBurnoutClassroom behavior

Outcome Measures

Primary Outcomes (2)

  • Burnout (Teacher) assessed with the Burnout-Screening-Scale

    Burnout-Screening-Scale (Change from baseline)

    Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

  • Classroom climate pupils

    Emotional and social school experience questionnaire (Change from baseline)

    Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Secondary Outcomes (4)

  • Stress and Anxiety (Teacher) assessed with the Stress and Anxiety Inventory

    Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

  • Mindfulness (Teacher) assessed with the Freiburg Mindfulness Inventory

    Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

  • Concentration (pupils) assessed with a d2-Concentration assessment tool

    Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

  • Health-related Quality of Life (pupils) assessed with the Kidscreen-10

    Baseline; Timepoint 1 (4 month); Timepoint 2 (12 month); Timepoint 3 (16 month)

Study Arms (2)

Intervention

EXPERIMENTAL

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

Waitlist

OTHER

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

Interventions

Also known as: MBSR
InterventionWaitlist

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • reading ability
  • positive declaration of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schulamt Stadt Solingen

Solingen, North Rhine-Westphalia, 42697, Germany

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gustav Dobos, MD

    Universität Duisburg-Essen, Medizinische Fakultät, Klinik für Naturheilkunde und Integrative Medizin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of research

Study Record Dates

First Submitted

February 9, 2017

First Posted

May 5, 2017

Study Start

December 1, 2016

Primary Completion

August 1, 2018

Study Completion

March 1, 2019

Last Updated

March 24, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations