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

Sponsor
University of Southern Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05993026
Collaborator
Danish Committee for Health Education (Other), Ole Kirks Fond (Other)
5,000
1
1
15.6
321.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mental health course
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
5000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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)]

  2. Self-efficacy measured by two items used in the Danish Health Behaviour in School-aged Children (HBSC) study [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?'

Secondary Outcome Measures

  1. Social and emotional competence [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

  2. Student relationships [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.

  3. Teacher support [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.

  4. General school engagement [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Danish Committee for Health Education Copenhagen Denmark 2100

Sponsors and Collaborators

  • University of Southern Denmark
  • Danish Committee for Health Education
  • Ole Kirks Fond

Investigators

  • Principal Investigator: Maj Britt Nielsen, PhD, University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT05993026
Other Study ID Numbers:
  • 31509
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Southern Denmark

Study Results

No Results Posted as of Aug 21, 2023