Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144502
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-05
First Post:
2023-11-07
Brief Title:
Promoting Wellbeing The Five Ways at School Intervention
Sponsor:
Moss Kommune
Organization:
Moss Kommune
Study Overview
Official Title:
Promoting Mental Health and Wellbeing Through a School-based Intervention - a Study Using a Mixed-methods Quasi-experimental Extended Selection Cohorts Design
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5WaysSchool
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
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 pandemicThe 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 ie 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 ie 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 WaysSchool teaching material to all pupils aged 10-16 years in the municipalitys public schools n16 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 n3300 and their teachers n200 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
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 ie 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 ie approximately 2300 participants An estimation of statistical power in this study revealed a power of 08411 to detect an effect equal to 016
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 pandemicThe 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 ie 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 ie 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 WaysSchool teaching material to all pupils aged 10-16 years in the municipalitys public schools n16 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 n3300 and their teachers n200 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
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 ie 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 ie approximately 2300 participants An estimation of statistical power in this study revealed a power of 08411 to detect an effect equal to 016
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 345560 | OTHER_GRANT | The Research Council of Norway | None |