Mental HealthNCT06204029
Everyone Can Sing: A Feasibility Study of a Mental Health Promoting Intervention Among 0-3rd Grade Students
A study testing Everyone can sing in people with Mental Health, run by University of Southern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- Everyone can sing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 910 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: All students in grades 0 to 3 (typically aged 5 to 10 years) in three different Danish elementary schools
Exclusion Criteria: None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Everyone Can Sing. A Feasibility Study of Class Choir as a Mental Health Promoting Intervention Among 0-3rd Grade Students
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.
Read the detailed description
Approximately every fifth child in Denmark experience mental health problems, mental illness, or low levels of school thriving before the age of ten, and 15% of Danish adolescent are diagnosed with a mental disorder before they turn 18. The experience of mental health problems, low school thriving and mental illness in childhood and adolescence is a severe risk factor for school segregation, low grades, school dropout and mental illness in youth and adulthood. There is therefore an urgent need for feasible and effective mental health promoting and preventive interventions from early childhood. High-quality music singing (e.g. choir singing) can promote well-being, social inclusion in school, and positive social relations among school-children, which are key prerequisites for strengthening children's mental health. However, the potential benefits of this type of intervention have not been evaluated in a Danish context. Therefore, we developed the Alle kan synge (AKS; in English: Everyone can sing) intervention as a prototype for implementation and dissemination.
The aim of this feasibility study is to explore the feasibility of implementing the AKS intervention in three Danish primary schools and assess feasibility of the evaluation design. Findings will provide knowledge on the critical aspects of the intervention, which may lead to a possible refinement of the AKS intervention, the implementation processes or evaluation design.
- Conditions
- Mental Health
- Being tested
- Everyone can sing
- Keywords
- Mental Health, Students, Teachers, Primary School, Mental health promotion, Intervention, Feasibility study, Denmark
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everyone can singBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Everyone can sing | Experimental | Students from 0-3rd grade receive class choir two lessons every week as part of their regular school schedule Receives: Behavioral: Everyone can sing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements at baseline and 1-year follow-up
Secondary outcomes (4)
Mental health. It will be completed by the students.
Measured with the five items of the World Health Organisation Five Well-Being Index (WHO-5). Response options range from 0 (Never) to 4 (All of the time): Total score range of 0-20 with higher values indicate higher mental well-being. In addition, one item about wellbeing: "That's how I feel most of the time" with responses from very happy to not happy and one item bout general self-efficacy: "Are you good at solving your problems".
Measured: Measurements at baseline and 1-year follow-up
School thriving. It will be completed by the students.
Measured by one item regarding the general feeling about school and two indicators of not thriving: Do you have stomach aches at school? Do you have headaches at school? I
Measured: Measurements at baseline and 1-year follow-up
Class coherence. It will be completed by the students.
Measured by four items regarding 1) I like my class, 2) students in the class are helpful, 3) students in the class enjoy being together, and 4) I believe the others in the class like me.
Measured: Measurements at baseline and 1-year follow-up
Social inclusion. It will be completed by the students.
Assessed through four items: 1) Do you feel alone at school, 2) Do you get teased at school, so it makes you feel sad, 3) Who from the class do you play with the most during recess, 4) If you could decide for yourself: Who would you like to sit next to in class.
Measured: Measurements at baseline and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start4 Jan 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 910 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Katrine R Madsen, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204029
- Sponsor's protocol ID
- 23/24953
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2023
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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;12(1):17. doi: 10.1186/s40814-025-01757-8.
PubMed 41469714
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Everyone Can Sing. A Feasibility Study of Class Choir as a Mental Health Promoting Intervention Among 0-3rd Grade Students
- ClinicalTrials.gov ID
- NCT06204029
- Acronym / sponsor ID
- 23/24953
- Conditions
- Mental Health
- Keywords
- Mental Health, Students, Teachers, Primary School, Mental health promotion, Intervention, Feasibility study, Denmark
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 910 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Approximately every fifth child in Denmark experience mental health problems, mental illness, or low levels of school thriving before the age of ten, and 15% of Danish adolescent are diagnosed with a mental disorder before they turn 18. The experience of mental health problems, low school thriving and mental illness in childhood and adolescence is a severe risk factor for school segregation, low grades, school dropout and mental illness in youth and adulthood. There is therefore an urgent need for feasible and effective mental health promoting and preventive interventions from early childhood. High-quality music singing (e.g. choir singing) can promote well-being, social inclusion in school, and positive social relations among school-children, which are key prerequisites for strengthening children's mental health. However, the potential benefits of this type of intervention have not been evaluated in a Danish context. Therefore, we developed the Alle kan synge (AKS; in English: Everyone can sing) intervention as a prototype for implementation and dissemination.
The aim of this feasibility study is to explore the feasibility of implementing the AKS intervention in three Danish primary schools and assess feasibility of the evaluation design. Findings will provide knowledge on the critical aspects of the intervention, which may lead to a possible refinement of the AKS intervention, the implementation processes or evaluation design.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Everyone can sing | Experimental | Behavioral: Everyone can singStudents from 0-3rd grade receive class choir two lessons every week as part of their regular school schedule |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Everyone can singThe 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. | Behavioural | Everyone can sing |
Primary outcome
Mental Health. It will be completed by the student's parents and schoolteacher.
Time frame: Measurements at baseline and 1-year follow-up
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.
4 secondary outcomes
Mental health. It will be completed by the students.
Time frame: Measurements at baseline and 1-year follow-up
School thriving. It will be completed by the students.
Time frame: Measurements at baseline and 1-year follow-up
Class coherence. It will be completed by the students.
Time frame: Measurements at baseline and 1-year follow-up
Social inclusion. It will be completed by the students.
Time frame: Measurements at baseline and 1-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 41469714Madsen 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;12(1):17. doi: 10.1186/s40814-025-01757-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine R Madsen principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Everyone can sing in people with Mental Health, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health. It will be completed by the student's parents and schoolteacher. (time frame: Measurements at baseline and 1-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06204029, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.