Stress-free Everyday LiFe for Children and Adolescents REsearch

Study Overview
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Brief Summary
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The primary aim is to evaluate the effectiveness of a profound school teacher training programme to teach a mindfulness-based programme (.b) in Danish schools on the pupils self-reported mental well-being at seven months. The secondary aims are to evaluate i) the effectiveness of the profound school teacher training programme to teach the .b-programme in Danish schools on the pupils self-reported mental well-being post intervention (at five months).

Detailed Description
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The study is a cluster randomised trial. From May 2018 - May 2019, we recruited the total of 110 Danish schools (27 schools from the Capital Region of Denmark, 18 schools from Region Zealand, 25 schools from Region of Southern Denmark, 30 schools from Central Denmark Region and 10 schools from Region of Northern Denmark). The schools included the total of 191 school teachers for teacher training (56 teachers from the Capital Region of Denmark, 28 teachers from Region Zealand, 42 teachers from Region of Southern Denmark, 50 teachers from Central Denmark Region and 15 teachers from Region of Northern Denmark). Each included teacher will be asked to recruit a class of pupils (15-25 pupils) to test the effectiveness of the .b-programme (in total approx. 3000 pupils).

Official Title
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Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE). A Protocol for a Cluster Randomised Trial Testing a School Teacher Training Programme to Deliver the .b Programme in Danish Schools.

Conditions
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Mental Health, Children, Adolescent, Mindfulness, Stress

Intervention / Treatment
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* Behavioral: School teacher training /.b


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All pupils in the enrolled school classes Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: School teacher training /.b<br>The intervention is a multi-level, multi-component complex intervention. It consists of a school teacher training programme and the .b-programme to be delivered to pupils 11-15 years in the schools. The school teacher training programme consists of three parts: 1) the establishment of own mindfulness practice by participation in the eight week MBSR programme (2,5 hour group meeting once a week) and sustaining mindfulness with a regular formal daily practice; 2) completion of the four days .b residential course, and 3) completion of the 3x2-days seminars on relational competences and implementation issues regarding teaching .b (48 hours) The .b programme consists of well-described, weekly 40-60 minutes classroom sessions over 10 weeks. All the sessions have a specific theme, associated teachers' notes, power points and animations. The .b programme can only be delivered with fidelity by a trained .b teacher. | Behavioral: School teacher training /.b<br>* The intervention is a multi-level, multi-component complex intervention. It consists of a school teacher training programme and the .b-programme to be delivered to pupils 11-15 years in the schools. The school teacher training programme consists of three parts: 1) the establishment of own mindfulness practice by participation in the MBSR programme and sustaining mindfulness with a regular formal daily practice; 2) completion of the four days .b residential course, and 3) completion of the 3x2-days seminars on relational competences and implementation issues regarding teaching .b . The .b programme consists of well-described, weekly 40-60 minutes classroom sessions over 10 weeks. All the sessions have a specific theme, associated teachers' notes, power points and animations. The .b programme can only be delivered with fidelity by a trained .b teacher.<br>|
| No Intervention: Usual practice<br>Usual practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| The Strengths and Difficulties Questionnaire (SDQ)- youth self-report | Changes in the scores among the total study population | 23.03.21: Seven months after baseline | 
| The Strengths and Difficulties Questionnaire (SDQ)- youth self-report | Changes in the scores among the total study population | 23.03.21: Five months after baseline | 
| The Strengths and Difficulties Questionnaire (SDQ)- youth self-report | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version | Change in the score among the total study population | 23.03.21: Five months after baseline | 
| Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version | Change in the score among the subgroup with a total difficulties score>13.5 | 23.03.21: Seven months after baseline | 
| Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version | Change in the score among the total study population | 23.03.21: Seven months after baseline | 
| Brief Resilience Scale (BRS) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Brief Resilience Scale (BRS) | Change in the score among the total study population | 23.03.21: Five months after baseline | 
| Brief Resilience Scale (BRS) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| Brief Resilience Scale (BRS) | Change in the score among the total study population | 23.03.21: Seven months after baseline | 
| School connectedness from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| School connectedness from the Danish student well-being questionnaire (DSWQ) | Change in the score among the total study population | 23.03.21: Five months after baseline | 
| School connectedness from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| School connectedness from the Danish student well-being questionnaire (DSWQ) | Change in the score among the total study population | 23.03.21: Seven months after baseline | 
| Social competence from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Social competence from the Danish student well-being questionnaire (DSWQ) | Change in the score among the total study population | 23.03.21: Five months after baseline | 
| Social competence from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| Social competence from the Danish student well-being questionnaire (DSWQ) | Change in the score among the total study population | 23.03.21: Seven months after baseline | 
| Self-efficacy from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Self-efficacy from the Danish student well-being questionnaire (DSWQ) | Change in the score among the total study population | 23.03.21: Five months after baseline | 
| Self-efficacy from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| Self-efficacy from the Danish student well-being questionnaire (DSWQ) | Change in the score among the total study population | 23.03.21: Seven months after baseline | 
| Bullying items from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Bullying items from the Danish student well-being questionnaire (DSWQ) | Change in proportions among the total study population | 23.03.21: Five months after baseline | 
| Bullying items from the Danish student well-being questionnaire (DSWQ) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| Bullying items from the Danish student well-being questionnaire (DSWQ) | Change in proportions among the total study population | 23.03.21: Seven months after baseline | 
| EQ-5D-Y | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| EQ-5D-Y | Change in scores among the total study population | 23.03.21: Five months after baseline | 
| EQ-5D-Y | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| EQ-5D-Y | Change in scores among the total study population | 23.03.21: Seven months after baseline | 
| Sleep quality | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Sleep quality | Change in score among the total study population | 23.03.21: Five months after baseline | 
| Sleep quality | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| Sleep quality | Change in score among the total study population | 23.03.21: Seven months after baseline | 
| Child-Adolescent Mindfulness Measure (CAMM) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Five months after baseline | 
| Child-Adolescent Mindfulness Measure (CAMM) | Change in score among the total study population | 23.03.21: Five months after baseline | 
| Child-Adolescent Mindfulness Measure (CAMM) | Change in the score among the subgroup with a SDQ total difficulties score >= the 80 % percentile (23.03.21: We have chosen to identify the vulnarable group according to the standard for SDQ norms which is the >=80 % percentile. We identify per gender due to well-known differences) | 23.03.21: Seven months after baseline | 
| Child-Adolescent Mindfulness Measure (CAMM) | Change in score among the total study population | 23.03.21: Seven months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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School-based intervention, Population-based preventive strategy, Public health