NCT06204029

Brief Summary

This study aims to explore the feasibility of implementing and evaluating a class-based intervention in three Danish primary schools. The intervention includes class choir among all students in 0 to 3rd grade as part of the regular school schedule.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
910

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

January 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

1.2 years

First QC Date

December 12, 2023

Last Update Submit

December 17, 2024

Conditions

Mental Health

Keywords

Mental HealthStudentsTeachersPrimary SchoolMental health promotionInterventionFeasibility studyDenmark

Outcome Measures

Primary Outcomes (1)

  • Mental Health. It will be completed by the student's parents and schoolteacher.

    Measured by the Strengths and Difficulties Questionnaire (SDQ). SDQ consists of 25-items rated on a 3-point Likert scale (not true, somewhat true, and certainly true), with a positive and negatively phrased items. 'Somewhat True' is always scored as 1, but the scoring of 'Not True' and 'Certainly True' varies with the item. The SDQ can be divided between five sub-scales (five questions each): Emotional Symptoms, Conduct Problems, Hyperactivity-Inattention, Peer Problems, Pro-Social Behaviour. Total Difficulties Score is adding scores from all scales except the prosocial scale (score range 0-40). Higher scores represent more problems. This is supplemented with a brief impact supplement, where items on distress and impairment can be added up to generate an impact score that ranges from 0 to 10 for parent-report, and from 0 to 6 for teacher-report.

    Measurements at baseline and 1-year follow-up

Secondary Outcomes (4)

  • Mental health. It will be completed by the students.

    Measurements at baseline and 1-year follow-up

  • School thriving. It will be completed by the students.

    Measurements at baseline and 1-year follow-up

  • Class coherence. It will be completed by the students.

    Measurements at baseline and 1-year follow-up

  • Social inclusion. It will be completed by the students.

    Measurements at baseline and 1-year follow-up

Study Arms (1)

Everyone can sing

EXPERIMENTAL

Students from 0-3rd grade receive class choir two lessons every week as part of their regular school schedule

Behavioral: Everyone can sing

Interventions

Everyone can singBEHAVIORAL

The choir lessons are taught by a trained choir leader in close collaboration with the teacher in each class. The choir leaders and music teachers at the school also facilitate choir in the morning for selected or all classes. A special AKS pedagogy is developed and based on the inclusive nature of joyful musicking with body and voice. The pedagogy is developed to ensure that everyone is taken care of, so all children regardless of social or cultural background develop social and professional competencies central to a positive school life. The most important elements in this pedagogy include: A co-teacher system; Each student has a "choir partner"; Discipline in the classroom lessons is maintained by clear, simple, and subtle means.

Everyone can sing

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Copenhagen, 1455, Denmark

Location

Related Publications (1)

  • Madsen KR, Tetens A, Bonde LO, Kusier AO, Jeppesen P, Andersen S. Everyone Can Sing: Protocol for a non-randomized feasibility study of class choir as mental health promotion among primary school children (ages 5-10) in Denmark. Pilot Feasibility Stud. 2025 Dec 31. doi: 10.1186/s40814-025-01757-8. Online ahead of print.

    PMID: 41469714DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Katrine R Madsen

    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

December 12, 2023

First Posted

January 12, 2024

Study Start

January 4, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)