Promoting Wellbeing: The Five Ways at School Intervention

NCT ID: NCT06144502

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2024-12-19

Brief Summary

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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

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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.

Conditions

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Child Wellbeing Adolescent Health Quality of Life

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention from November 2023

Pupils in this arm receive the teaching material from November 2023

Group Type EXPERIMENTAL

5Ways@School

Intervention Type BEHAVIORAL

The 5Ways@School intervention is a teaching material consisting 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.

Wait-list control from November 2023 and intervention from January 2024

Pupils in this arm constitute a control group from November 2023 until they receive the teaching material from January 2024

Group Type OTHER

5Ways@School

Intervention Type BEHAVIORAL

The 5Ways@School intervention is a teaching material consisting 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.

Interventions

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5Ways@School

The 5Ways@School intervention is a teaching material consisting 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role collaborator

Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Norwegian Council for Mental Health

OTHER

Sponsor Role collaborator

Moss Kommune

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kristian Green Krogshus, MD

District Medical Officer and PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragnhild B Nes, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Institute of Public Health

Locations

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Kristian Green Krogshus

Moss, , Norway

Site Status

Countries

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Norway

References

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Krogshus KG, Bjertness E, Czajkowski NO, Rodriguez-Cano R, Nes RB. Study protocol for 5Ways@School - An implementation and effectiveness trial of a school-based wellbeing intervention in 16 schools in Norway. Scand J Public Health. 2025 Sep 8:14034948251370109. doi: 10.1177/14034948251370109. Online ahead of print.

Reference Type DERIVED
PMID: 40916894 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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345560

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

110419

Identifier Type: -

Identifier Source: org_study_id

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