Mental HealthNCT05993026
A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade
A study testing Mental health course in people with Mental Health and Self Efficacy, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Self Efficacy
- What is being tested?
- Mental health course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,966 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Aug 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Mental Health, Self Efficacy
- Being tested
- Mental health course
- Keywords
- Mental Health, Self Efficacy, Schools, Students, Teachers, Teaching Materials, Denmark
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental health courseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mental health course | Experimental | A mental health-promoting student course offered to lower secondary school classes delivered by their teacher or another employee of the school. T Receives: Behavioral: Mental health course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental wellbeing measured by the short version of the Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
Measured: 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
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?'
Measured: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Secondary outcomes (4)
Social and emotional competence
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
Measured: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Student relationships
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.
Measured: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Teacher support
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.
Measured: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
General school engagement
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
Measured: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Aug 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,966 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Committee for Health Education, Ole Kirks Fond
- Responsible party
- Sponsor
- Investigators
- Maj Britt Nielsen, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993026
- Sponsor's protocol ID
- 31509
- Status last verified
- Dec 2024
- First submitted
- 7 Aug 2023
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05993026
- Acronym / sponsor ID
- 31509
- Conditions
- Mental Health, Self Efficacy
- Keywords
- Mental Health, Self Efficacy, Schools, Students, Teachers, Teaching Materials, Denmark
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,966 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Danish Committee for Health Education, Ole Kirks Fond
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mental health course | Experimental | Behavioral: Mental health courseA mental health-promoting student course offered to lower secondary school classes delivered by their teacher or another employee of the school. T |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental health courseThe 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. | Behavioural | Mental health course |
Primary outcome
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)
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?'
4 secondary outcomes
Social and emotional competence
Time frame: 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)
Teacher support
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maj Britt Nielsen, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental health course in people with Mental Health and Self Efficacy, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.