Clinical trial NCT06144502: Promoting Wellbeing: The Five Ways at School Intervention
Official title: Promoting Mental Health and Wellbeing Through a School-based Intervention - a Study Using a Mixed-methods, Quasi-experimental Extended Selection Cohorts Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Wellbeing
Adolescent Health
Quality of Life
Lead sponsor: Moss Kommune
Sponsor class: OTHER_GOV
Collaborators: name: University of Oslo
name: Norwegian Institute of Public Health
name: Norwegian Council for Mental Health
First posted: 2023-11-22
Enrollment: 2476
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has a quasi-experimental Extended Selection Cohorts (ESC) design. The ESC design is a cohort-longitudinal design with adjacent cohorts, that are measured at two or more time points.

To separate any effects of the intervention from changes in variables due to other causes, a "wait list control group" element will be applied, i.e., delayed intervention/stepped wedge design: ½ of the schools will start the intervention in November 2023, while the remaining schools will start the intervention in January 2024.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to develop a teaching material built on the Five Ways to Wellbeing and investigate its effects on wellbeing and mental health among school pupils aged 10 to 16 years in Moss municipality, Norway. The main questions it aims to answer are:

1. How do participating pupils, teachers, and other school personnel experience the teaching material - is it acceptable and experienced as useful?
2. What are the immediate and long-term effects of the teaching material on the pupils' wellbeing and mental health?
3. For whom is the teaching material effective, and what mechanisms may explain potential improvements in wellbeing after exposure to the teaching material?

Pupils will be given a teaching program at school, delivered by their teacher. Participating pupils and their teachers will be invited to complete questionnaires. Some teachers, school leaders, school health nurses, and parents will be invited to share their experiences with the teaching material in focus group discussions.

Detailed description: Background:

Mental health problems are common among children and adolescents worldwide, and the prevalence of mental distress and common mental disorders has increased in recent years. The recent Coronavirus pandemic has been challenging for the mental health and wellbeing of many children and adolescents; and in Norway higher levels of depressive symptoms and less optimistic future life expectations have been observed among adolescents as a result of the pandemic.The global challenge of mental health problems calls for different approaches; both treating mental health disorders, preventing mental health problems, and promoting mental health and wellbeing for all. School-based interventions are a primary tool in universal prevention to promote mental health and wellbeing, but well-designed interventions with proven long-term effects are rare.

The aim:

The aim of this study is to develop a teaching material built on the Five Ways to Wellbeing and investigate its effects on wellbeing and mental health among school pupils aged 10 to 16 years in Moss municipality, Norway.

The objectives are:

1. To adapt the existing Five ways to wellbeing course for adults to a school setting, and to pilot the intervention in two schools.
2. To explore how participating pupils, teachers, and other school personnel experience the pilot intervention, and identify aspects that should be adjusted before proceeding to a full scale trial.
3. To examine how the teachers deliver the intervention in the full scale trial; their motivation, obstacles they encounter, general satisfaction with the intervention, and their adherence to the intervention manual (i.e., fidelity).
4. To investigate whether the intervention is acceptable and experienced as useful for participating school pupils, parents, teachers, and other school personnel.
5. To investigate whether the intervention have any adverse effects, such as triggering negative emotions.
6. To evaluate the process of implementation.
7. To describe the pupils' wellbeing and mental health at baseline (November 2023).
8. To examine the immediate and long-term effects of the intervention on the pupils' wellbeing and mental health.
9. To assess for whom the intervention is effective (i.e., subgroup analysis and moderation analysis, for example socioeconomic status, gender, and baseline symptom levels).
10. To investigate what mechanisms explain potential improvements in wellbeing after exposure to the interventions.

Sample and recruitment:

Moss municipality has decided to give the "5 Ways@School" teaching material to all pupils aged 10-16 years in the municipality's public schools (n=16) as part of the schools' regular curriculum. In some schools the teaching will start in November 2023 while the remaining schools will start teaching in February 2024, ensuring a "delayed intervention" effect for approximately 50 % of the pupils. All pupils (n=3324) and their teachers (n=156) will be invited to complete questionnaires. The teachers also will be invited to share their experiences with the teaching material in focus group discussions.

Procedures:

The teaching material consists of five elements; Take notice, Be active, Keep Learning, Connect, and Give. The intervention will be given in an ordinary classroom setting by the class' main teacher in two school hours of 45 minutes each week for six consecutive weeks, i.e., a total of 12 school hours. The teaching sessions will consist of presentations of the five elements, videos, reflection exercises, focused group discussions, creative group work, and giving the pupils small "challenges" to practice what they have learned between the weekly sessions. Web-based questionnaires will be administrated and distributed by the PI via the teachers.

Power analysis:

The PI assumes a participation rate of 70 percent among the invited pupils, i.e., approximately 2300 participants. An estimation of statistical power in this study revealed a power of 0.8411 to detect an effect equal to 0.16.

Eligibility criteria: Inclusion Criteria:

1. Being a pupil in 5th to 10th grade in a public school in Moss municipality, OR
2. Being a teacher who teaches the Five Ways at School to a school class in one of the participating schools.

Exclusion Criteria: None. However, one school for pupils with special needs (n=18) does not participate in the study.

Primary outcomes:
measure: Change in subjective wellbeing (global life satisfaction - present)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in subjective wellbeing (global life satisfaction - future)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in subjective wellbeing (life satisfaction and self-esteem)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in subjective wellbeing (satisfaction with different life domains)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in social relationships (friends in general)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in social relationships (friends during leisure time and school breaks)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in depressive symptoms
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in loneliness
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in leisure activities (time spent per week)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Change in leisure activities and screen time (time spent per day)
timeFrame: Week 0, 7, 12, 17, and 52
measure: Acceptability and feasibility 1 (teachers)
timeFrame: Post-intervention at week 7 and 12, respectively
measure: Acceptability and feasibility 2 (teachers)
timeFrame: Post-intervention at week 7 and 12, respectively
measure: Acceptability and feasibility 3 (pupils)
timeFrame: Post-intervention at week 7 and 12, respectively
Secondary outcomes:
measure: Socio-economic status
timeFrame: Week 0 and 17
measure: Other demographics
timeFrame: Week 0 and 17
measure: Pupils' knowledge of other health promoting programs
timeFrame: Post-intervention at week 7 and 12, respectively
Other outcomes:
Locations:
city: Moss
country: Norway
facility: Kristian Green Krogshus
Study officials:
affiliation: Norwegian Institute of Public Health
name: Ragnhild B Nes, PhD
role: PRINCIPAL_INVESTIGATOR
References: