A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade

Mental Health Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05993026
• Other study ID #: 31509
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 5000
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Health
• Self Efficacy

Intervention

Behavioral:
• Mental health course
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.

Locations

Country	Name	City	State
Denmark	The Danish Committee for Health Education	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Committee for Health Education, Ole Kirks Fond

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental wellbeing measured by the short version of the Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)		Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Primary	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?'	Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Secondary	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	Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Secondary	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.	Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Secondary	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.	Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Secondary	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	Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)