- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05993026
A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade
December 9, 2024 updated by: University of Southern Denmark
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3966
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
-
-
-
Copenhagen, Denmark, 2100
- The Danish Committee for Health Education
-
-
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
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria: Student classes in grade 7 to grade 10. This corresponds to students who are typically ages between 12 and 16 years old.
Exclusion Criteria: None
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mental health course
A mental health-promoting student course offered to lower secondary school classes delivered by their teacher or another employee of the school.
T
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
|
|
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)
|
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?'
|
Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social and emotional competence
Time Frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
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
|
Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
|
Student relationships
Time Frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
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.
|
Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
|
Teacher support
Time Frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
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.
|
Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
|
General school engagement
Time Frame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
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
|
Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Maj Britt Nielsen, PhD, University of Southern Denmark
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 (Actual)
August 15, 2023
Primary Completion (Actual)
July 1, 2024
Study Completion (Actual)
July 1, 2024
Study Registration Dates
First Submitted
August 7, 2023
First Submitted That Met QC Criteria
August 7, 2023
First Posted (Actual)
August 15, 2023
Study Record Updates
Last Update Posted (Estimated)
December 11, 2024
Last Update Submitted That Met QC Criteria
December 9, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 31509
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Mental Health
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on Mental health course
-
Second Affiliated Hospital, School of Medicine,...RecruitingNon-suicidal Self-injuryChina
-
TN Foo Centre for Positive Mental HealthEnrolling by invitationHealthy Subjects (HS)Hong Kong
-
Asia UniversityCompleted
-
Terry L. WahlsRecruitingRheumatoid Arthritis | Systemic Lupus Erythematosus | Psoriatic Arthritis | Sjogren's Syndrome | Mixed Connective Tissue DiseaseUnited States
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruiting
-
McMaster UniversityHamilton Health Sciences Corporation; Ontario Mental Health Foundation; St. Joseph...CompletedMental Health ImpairmentCanada
-
National University of MalaysiaNot yet recruitingResilience | Depression - Major Depressive DisorderMalaysia
-
University of California, San DiegoDuke University; University of California, San Francisco; Harvard University; Mount... and other collaboratorsCompleted
-
University of Alabama at BirminghamRecruiting
-
Liverpool School of Tropical MedicineFundación Anesvad; University of Health and Allied Sciences, Ho; Effect:HopeNot yet recruitingOnchocerciasis | Yaws | Leprosy | Lymphatic Filariases | Buruli Ulcer