<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03796754</url>
  </required_header>
  <id_info>
    <org_study_id>YoBEKA</org_study_id>
    <nct_id>NCT03796754</nct_id>
  </id_info>
  <brief_title>YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) in Elementary Schools</brief_title>
  <official_title>Integration of the YoBEKA Program (Yoga, Movement, Relaxation, Concentration and Mindfulness) Into Elementary Schools in Germany</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charite University, Berlin, Germany</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is a first evaluation of the effectiveness of the YoBEKA Program (Yoga,&#xD;
      Movement, Relaxation, Concentration and Mindfulness) to evaluate potential effects in stress&#xD;
      reduction and concomitant psychological parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Actual">February 15, 2020</completion_date>
  <primary_completion_date type="Actual">February 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)</measure>
    <time_frame>Change baseline, 4 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)</measure>
    <time_frame>Change Baseline, 4 months, 12 months</time_frame>
    <description>Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS)</measure>
    <time_frame>Change Baseline, 4 months, 12 months</time_frame>
    <description>Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Teacher anxiety and stress inventory (LASI)</measure>
    <time_frame>Change Baseline, 4 months, 12 months</time_frame>
    <description>Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screening for somatoform disorders of childhood and adolescence (SOMS-E)</measure>
    <time_frame>Change Baseline, 4 months, 12 months</time_frame>
    <description>Filled out by parents, assessing full scale, range 55-110, lower score meaning a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)</measure>
    <time_frame>Change Baseline, 4 months, 12 months</time_frame>
    <description>Filled out by parents, assessing full scale, range 27-135, lower score meaning a better outcome</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>Baseline, 4 months, 12 months</time_frame>
    <description>Assessed with Faros 180 over 24 hours</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative interviews</measure>
    <time_frame>4 months, 12 months</time_frame>
    <description>Semi-structured interviews in focus groups</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">250</enrollment>
  <condition>Stress, Psychological</condition>
  <arm_group>
    <arm_group_label>YoBEKA Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>YoBEKA</intervention_name>
    <description>The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life.</description>
    <arm_group_label>YoBEKA Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Students from participating primary schools in Berlin aged 6-12 years&#xD;
&#xD;
          -  Written declaration of consent of the parent or legal guardian&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Serious chronic or acute diseases&#xD;
&#xD;
          -  Immobility or serious restriction for gymnastic exercises due to orthopaedic,&#xD;
             neurological or other medical causes&#xD;
&#xD;
          -  Participation in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Charite University</name>
      <address>
        <city>Berlin</city>
        <zip>14109</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>September 28, 2022</last_update_submitted>
  <last_update_submitted_qc>September 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charite University, Berlin, Germany</investigator_affiliation>
    <investigator_full_name>Andreas Michalsen</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03796754
org study id: YoBEKA
nct id: NCT03796754
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Questionnaire on the assessment of stress and stress management in childhood and adolescence - Revision (SSKJ 3-8 R)
time frame: Change baseline, 4 months
description: 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
measure: Inventory of the quality of life of children and adolescents (KIDSCREEN-27 children)
time frame: Change Baseline, 4 months, 12 months
description: Filled out by students, assessing full scale, range 27-135, lower score meaning a better outcome
measure: Perceived Stress Scale (PSS)
time frame: Change Baseline, 4 months, 12 months
description: Filled out by teachers, assessing full scale, range 0-40, lower score meaning a better outcome
measure: Teacher anxiety and stress inventory (LASI)
time frame: Change Baseline, 4 months, 12 months
description: Filled out by teachers, assessing LASI 2, range 46-230, higher score meaning a better outcome
measure: Screening for somatoform disorders of childhood and adolescence (SOMS-E)
time frame: Change Baseline, 4 months, 12 months
description: Filled out by parents, assessing full scale, range 55-110, lower score meaning a better outcome
measure: Inventory of the quality of life of children and adolescents (KIDSCREEN-52 parents)
time frame: Change Baseline, 4 months, 12 months
description: Filled out by parents, assessing full scale, range 27-135, lower score meaning a better outcome
measure: Heart rate variability
time frame: Baseline, 4 months, 12 months
description: Assessed with Faros 180 over 24 hours
measure: Qualitative interviews
time frame: 4 months, 12 months
description: Semi-structured interviews in focus groups
arm group label: YoBEKA Intervention
arm group type: Active Comparator
arm group label: Control group
arm group type: No Intervention
intervention type: Behavioral
intervention name: YoBEKA
description: The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life.
arm group label: YoBEKA Intervention
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Charite University, Berlin, Germany
investigator full name: Andreas Michalsen
investigator title: Principal Investigator
mesh term: Stress, Psychological