NCT03796754CompletedNot Applicable
Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany
Charite University, Berlin, Germany1 site in 1 country250 target enrollmentStarted: January 21, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
Study Overview
Brief Summary
The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress reduction and concomitant psychological parameters.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Students from participating primary schools in Berlin aged 6-12 years
- •Written declaration of consent of the parent or legal guardian
Exclusion Criteria
- •Serious chronic or acute diseases
- •Immobility or serious restriction for gymnastic exercises due to orthopaedic, neurological or other medical causes
- •Participation in another study
Arms & Interventions
YoBEKA Intervention
Active Comparator
Intervention: YoBEKA (Behavioral)
Control group
No Intervention
Outcomes
Primary Outcomes
Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
Time Frame: Change baseline, 4 months
Filled out by students, assessing composite score (range 29-94): subscale 1 (stress-vulnerability \[range 7-28\]) summed with subscale 3 (stress symptoms and well-being \[range 22-66\]), lower score meaning a better outcome
Secondary Outcomes
- Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)(Change Baseline, 4 months, 12 months)
- Perceived Stress Scale (PSS)(Change Baseline, 4 months, 12 months)
- Teacher anxiety and stress inventory (LASI)(Change Baseline, 4 months, 12 months)
- Screening for somatoform disorders of childhood and adolescence (SOMS-E)(Change Baseline, 4 months, 12 months)
- Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)(Change Baseline, 4 months, 12 months)
Investigators
Andreas Michalsen
Principal Investigator
Charite University, Berlin, Germany
Study Sites (1)
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