xml: <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/NCT05993026</url>
    </required_header>
    <id_info>
      <org_study_id>31509</org_study_id>
      <nct_id>NCT05993026</nct_id>
    </id_info>
    <brief_title>A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade</brief_title>
    <official_title>Evaluation of a School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade in Denmark: A Single-group Pre- and Post-test Design</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Southern Denmark</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Danish Committee for Health Education</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Ole Kirks Fond</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Southern Denmark</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The present study is an evaluation of school-based intervention. The intervention aims to&#xD;
        strengthen students' well-being and increase their mental health through training in tools&#xD;
        that increase self-efficacy and ability to understand themselves and others. The Danish&#xD;
        Committee for Health Education is responsible for developing and implementing the&#xD;
        intervention and for recruiting schools, while the the Danish National Institute of Public&#xD;
        Health at University of Southern Denmark is responsible for the evaluation of the&#xD;
        intervention, including data collection, analysis and reporting.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">April 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mental wellbeing measured by the short version of the Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)</measure>
      <time_frame>Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Self-efficacy measured by two items used in the Danish Health Behaviour in School-aged Children (HBSC) study</measure>
      <time_frame>Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)</time_frame>
      <description>Inspired by R. Schwarzer and M. Jerusalem two indicators to measure general self-efficacy: 'How often can you find a solution to problems if you try hard enough?' and 'How often can you manage the things you set your mind to?'</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Social and emotional competence</measure>
      <time_frame>Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)</time_frame>
      <description>Nine items (e.g. I speak my mind when I think something is unfair), see Nielsen, L., Meilstrup, C., Nelausen, M.K., Koushede, V. and Holstein, B.E. (2015), &quot;Promotion of social and emotional competence: Experiences from a mental health intervention applying a whole school approach&quot;, Health Education, Vol. 115 No. 3/4, pp. 339-356. https://doi.org/10.1108/HE-03-2014-0039</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Student relationships</measure>
      <time_frame>Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)</time_frame>
      <description>Three items from Danish Health Behaviour in School-aged Children (HBSC) study about whether the student feel (1) students in their class enjoy being together, (2) students in their class are kind and helpful and (3) accept them as they are.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Teacher support</measure>
      <time_frame>Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)</time_frame>
      <description>Three HBSC items from Danish Health Behaviour in School-aged Children (HBSC) questionnaire about whether the student feel (1) accepted by their teachers, (2) that their teachers care about them as a person and (3) that they trust their teachers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General school engagement</measure>
      <time_frame>Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)</time_frame>
      <description>One HBSC item 'Liking school' from Danish Health Behaviour in School-aged Children (HBSC) questionnaire about how the student likes the school for the moment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Mental Health</condition>
    <condition>Self Efficacy</condition>
    <arm_group>
      <arm_group_label>Mental health course</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A mental health-promoting student course offered to lower secondary school classes delivered by their teacher or another employee of the school. T</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Mental health course</intervention_name>
      <description>The student course involves classroom-based teaching of eight lessons over eight weeks. The aim is to strengthen students' faith in their own abilities (self-efficacy) and ability to understand themselves and others (mentalization). In this way, students become better at entering into positive relationships and communities as well as better at handling everyday challenges both academically and socially. The student course includes teaching, exercises and training in simple tools for mastery and mentalization. The student courses in the classes are handled by staff close to the students and are based on both physical and digital material as well as an app for the students. The employees initially participate in a competency development course.</description>
      <arm_group_label>Mental health course</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria: Student classes in grade 7 to grade 10. This corresponds to students&#xD;
          who are typically ages between 12 and 16 years old.&#xD;
  &#xD;
          Exclusion Criteria: None&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maj Britt Nielsen, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Southern Denmark</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maj Britt Nielsen, PhD</last_name>
      <phone>+45 65 50 77 84</phone>
      <email>mbdn@sdu.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Susan Andersen, PhD</last_name>
      <phone>+45 65 50 78 16</phone>
      <email>suan@sdu.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Danish Committee for Health Education</name>
        <address>
          <city>Copenhagen</city>
          <zip>2100</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Malene Petersson</last_name>
        <phone>+45 30 27 77 47</phone>
        <email>mn@sundkom.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Mental Health</keyword>
    <keyword>Self Efficacy</keyword>
    <keyword>Schools</keyword>
    <keyword>Students</keyword>
    <keyword>Teachers</keyword>
    <keyword>Teaching Materials</keyword>
    <keyword>Denmark</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993026
  org study id: 31509
  nct id: NCT05993026
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present study is an evaluation of school-based intervention. The intervention aims to
        strengthen students' well-being and increase their mental health through training in tools
        that increase self-efficacy and ability to understand themselves and others. The Danish
        Committee for Health Education is responsible for developing and implementing the
        intervention and for recruiting schools, while the the Danish National Institute of Public
        Health at University of Southern Denmark is responsible for the evaluation of the
        intervention, including data collection, analysis and reporting.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Mental wellbeing measured by the short version of the Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
  time frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
  measure: Self-efficacy measured by two items used in the Danish Health Behaviour in School-aged Children (HBSC) study
  time frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
  description: Inspired by R. Schwarzer and M. Jerusalem two indicators to measure general self-efficacy: 'How often can you find a solution to problems if you try hard enough?' and 'How often can you manage the things you set your mind to?'
  measure: Social and emotional competence
  time frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
  description: Nine items (e.g. I speak my mind when I think something is unfair), see Nielsen, L., Meilstrup, C., Nelausen, M.K., Koushede, V. and Holstein, B.E. (2015), "Promotion of social and emotional competence: Experiences from a mental health intervention applying a whole school approach", Health Education, Vol. 115 No. 3/4, pp. 339-356. https://doi.org/10.1108/HE-03-2014-0039
  measure: Student relationships
  time frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
  description: Three items from Danish Health Behaviour in School-aged Children (HBSC) study about whether the student feel (1) students in their class enjoy being together, (2) students in their class are kind and helpful and (3) accept them as they are.
  measure: Teacher support
  time frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
  description: Three HBSC items from Danish Health Behaviour in School-aged Children (HBSC) questionnaire about whether the student feel (1) accepted by their teachers, (2) that their teachers care about them as a person and (3) that they trust their teachers.
  measure: General school engagement
  time frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
  description: One HBSC item 'Liking school' from Danish Health Behaviour in School-aged Children (HBSC) questionnaire about how the student likes the school for the moment
  arm group label: Mental health course
  arm group type: Experimental
  description: A mental health-promoting student course offered to lower secondary school classes delivered by their teacher or another employee of the school. T
  intervention type: Behavioral
  intervention name: Mental health course
  description: The student course involves classroom-based teaching of eight lessons over eight weeks. The aim is to strengthen students' faith in their own abilities (self-efficacy) and ability to understand themselves and others (mentalization). In this way, students become better at entering into positive relationships and communities as well as better at handling everyday challenges both academically and socially. The student course includes teaching, exercises and training in simple tools for mastery and mentalization. The student courses in the classes are handled by staff close to the students and are based on both physical and digital material as well as an app for the students. The employees initially participate in a competency development course.
  arm group label: Mental health course
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maj Britt Nielsen, PhD
  role: Principal Investigator
  affiliation: University of Southern Denmark
  last name: Maj Britt Nielsen, PhD
  phone: +45 65 50 77 84
  email: mbdn@sdu.dk
  last name: Susan Andersen, PhD
  phone: +45 65 50 78 16
  email: suan@sdu.dk
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Sponsor
  sharing ipd: No