NCT05993026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,966

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

August 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

11 months

First QC Date

August 7, 2023

Last Update Submit

December 9, 2024

Conditions

Keywords

Mental HealthSelf EfficacySchoolsStudentsTeachersTeaching MaterialsDenmark

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • Social and emotional competence

    Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)

  • Student relationships

    Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)

  • Teacher support

    Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)

  • General school engagement

    Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)

Study Arms (1)

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

Behavioral: Mental health course

Interventions

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.

Mental health course

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Danish Committee for Health Education

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Maj Britt Nielsen, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

August 15, 2023

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations