NCT06144502

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,476

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
completed

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

November 7, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

November 20, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
Last Updated

May 9, 2025

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

November 7, 2023

Last Update Submit

May 6, 2025

Conditions

Outcome Measures

Primary Outcomes (13)

  • Change in subjective wellbeing (global life satisfaction - present)

    As a measure of present wellbeing, a version of the Cantril Ladder Scale will be used, one that has been used in the Young in Norway study (Cantril, 1965). Pupils are asked to evaluate their life at the present time, on a scale from 0 (feeling very poor) to 10 (feeling very well).

    Week 0, 7, 12, 17, and 52

  • Change in subjective wellbeing (global life satisfaction - future)

    As a measure of the pupils' expected future wellbeing, a version of the Cantril Ladder Scale will be used, one that has been used in the Young in Norway study (Cantril, 1965). Pupils are asked to estimate how good or bad their life will be in five years from now, on a scale from 0 (feeling very poor) to 10 (feeling very well).

    Week 0, 7, 12, 17, and 52

  • Change in subjective wellbeing (life satisfaction and self-esteem)

    The following measures of life satisfaction and self-esteem will be assessed on a four-point scale ranging from "totally agree" to "totally disagree": "My life is good", "I have all I want in life", "I like myself the way I am", and "I am very satisfied with how I am".

    Week 0, 7, 12, 17, and 52

  • Change in subjective wellbeing (satisfaction with different life domains)

    Satisfaction with the different life domains will be measured by asking the pupils "how satisfied are you with the following aspects of your life: your parents, your friends, your school, your neighborhood, your health, and your appearance?". Pupils respond to each item on a four-point scale ranging from "not at all" to "very satisfied".

    Week 0, 7, 12, 17, and 52

  • Change in social relationships (friends in general)

    Relationships with friends will be assessed by asking the pupils: "Do you have a friend whom you can trust and talk to about everything?", with response options "Yes, I am sure", "Yes, I think so", "I don't think so", and "I have no friends, nowadays".

    Week 0, 7, 12, 17, and 52

  • Change in social relationships (friends during leisure time and school breaks)

    The pupils will be asked two items; "Do you have \[a friend\] to be with during 1) your leisure time and 2) in the school breaks?" These items will be measured by a four-point scale ranging from "Yes, always" to "No, never".

    Week 0, 7, 12, 17, and 52

  • Change in depressive symptoms

    Depressive symptoms will be measured by Kandel and Davies's six-item Depressive Mood Inventory, assessing depressive symptoms during the preceding week on a four-point scale from 'affected not at all' to 'affected extremely'. In addition, the prosocial items from the Strengths and Difficulties Questionnaire (SDQ) will be used.

    Week 0, 7, 12, 17, and 52

  • Change in loneliness

    Loneliness will be assessed by one item on feelings of loneliness in the past week, on a four-point scale from 'affected not at all' to 'affected extremely'.

    Week 0, 7, 12, 17, and 52

  • Change in leisure activities (time spent per week)

    The respondents' weekly leisure activities will be assessed with the following items: "In your leisure time, how often do you 1) meet with friends in their homes, 2) hang out with friends \[outdoor\], 3) exercise or do sports, 4) ride a horse, 5) stay at a youth activity club, 6) play an instrument, 7) do things together with your family, 8) help at home doing chores, 9) relax on your own most of the evening". The pupils will respond on a six-point scale ranging from "never" to "every day".

    Week 0, 7, 12, 17, and 52

  • Change in leisure activities and screen time (time spent per day)

    The respondents' daily leisure activities and screen time will be assessed with the following items: "In your leisure time, how many hours a day do you 1) watch tv, tv series, or online videos 2) read books, 3) play computer games, 4) play games on your mobile phone, 5) use social media, 6) read/watch news". The pupils will respond on a six-point scale ranging from "no time" to "3 hours or more".

    Week 0, 7, 12, 17, and 52

  • Acceptability and feasibility 1 (teachers)

    The teachers will respond on a four-point scale from "agree completely" to "disagree completely" to the following items: "1) I was well motivated to teach the 5Ways@School, 2) I enjoyed teaching the 5Ways@School, 3) Teaching life skills through the 5Ways@School is a natural part of my job as a teacher, 4) I got sufficient information and/or training before I started teaching the 5Ways@School, 5) I think the pupils learned something new and useful, 6) There was too little activities in the 5Ways@School, 7) There was too much activities in the 5Ways@School, 8) I followed the teaching manual to a high degree, 9) I completed all the six lessons in the 5Ways@School, 10) I had to abbreviate one or more lesson(s), 11) I think that the 5Ways@School should be part of the ordinary school curriculum in 5h to 7th grade, and 12) I think that the 5Ways@School should be part of the ordinary school curriculum in 8th to 10th grade."

    Post-intervention at week 7 and 12, respectively

  • Acceptability and feasibility 2 (teachers)

    The teachers who will be teaching the interventions will be asked: "Based on your experiences, which of the five elements in the 5Ways@School do you think was 1) most useful for the pupils?, easiest for you to teach, and 3) most challenging for you to teach?" The teachers will respond to these questions by choosing any of the five elements of the 5Ways@School: Take notice, Be active, Keep Learning, Connect, and Give.

    Post-intervention at week 7 and 12, respectively

  • Acceptability and feasibility 3 (pupils)

    The pupils will be given a questionnaire with the following items: "1) I enjoyed learning about 5Ways@School, 2) I learned something new, that I can make use of, 3) The teaching was easy to understand, 4) The teaching was boring, 5) The teaching was interesting, 6) There was too little activities, 7) There was too much activities, 8) The teaching made me sad, afraid, or angry, 9) The teaching made me happy, 10) I will practise more of the five ways in the future, 11) I think all pupils should learn about the five ways." The pupils will respond on a four-point scale from "agree completely" to "disagree completely"

    Post-intervention at week 7 and 12, respectively

Secondary Outcomes (3)

  • Socio-economic status

    Week 0 and 17

  • Other demographics

    Week 0 and 17

  • Pupils' knowledge of other health promoting programs

    Post-intervention at week 7 and 12, respectively

Study Arms (2)

Intervention from November 2023

EXPERIMENTAL

Pupils in this arm receive the teaching material from November 2023

Behavioral: 5Ways@School

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

OTHER

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

Behavioral: 5Ways@School

Interventions

5Ways@SchoolBEHAVIORAL

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

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kristian Green Krogshus

Moss, 1501, Norway

Location

Related Publications (1)

  • 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.

Related Links

Study Officials

  • Ragnhild B Nes, PhD

    Norwegian Institute of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
District Medical Officer and PhD candidate

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 22, 2023

Study Start

November 20, 2023

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

May 9, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations