- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06204029
Everyone Can Sing: A Feasibility Study of a Mental Health Promoting Intervention Among 0-3rd Grade Students
Everyone Can Sing. A Feasibility Study of Class Choir as a Mental Health Promoting Intervention Among 0-3rd Grade Students
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen, Denmark, 1455
- University of Southern Denmark
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria: All students in grades 0 to 3 (typically aged 5 to 10 years) in three different Danish elementary schools
Exclusion Criteria: None
Study Plan
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 |
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Experimental: Everyone can sing
Students from 0-3rd grade receive class choir two lessons every week as part of their regular school schedule
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health. It will be completed by the student's parents and schoolteacher.
Time Frame: Measurements at baseline and 1-year follow-up
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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.
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Measurements at baseline and 1-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental health. It will be completed by the students.
Time Frame: Measurements at baseline and 1-year follow-up
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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".
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Measurements at baseline and 1-year follow-up
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School thriving. It will be completed by the students.
Time Frame: Measurements at baseline and 1-year follow-up
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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
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Measurements at baseline and 1-year follow-up
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Class coherence. It will be completed by the students.
Time Frame: Measurements at baseline and 1-year follow-up
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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.
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Measurements at baseline and 1-year follow-up
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Social inclusion. It will be completed by the students.
Time Frame: Measurements at baseline and 1-year follow-up
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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.
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Measurements at baseline and 1-year follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katrine R Madsen, University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 23/24953
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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