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

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.

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

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.

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