Clinical trial NCT04610333: On Top of Everything
Official title: On Top of Everything. A Study Protocol for a Cluster-Randomised Controlled Trial Testing a Teacher Training Programme to Teach Mindfulness Among Students in Danish Upper Secondary Schools and Schools of Health and Social Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Youth
Mindfulness
Stress
Keywords: School-based intervention
Population-based preventive strategy
Public health
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 992
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our primary aim of this trial is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in the total population of students in Danish upper secondary schools and schools of health and social care, respectively, on students' self-reported mental health at six-month follow-up.

Our secondary aim is to evaluate the effectiveness of the teacher training programme to teach mindfulness in a vulnerable subgroup of students on their self-reported mental health at three and six months after baseline.

Detailed description: The study is designed as a pragmatic cluster randomised two-arm trial including 43 Danish schools (30 upper secondary schools and 13 schools of health and social care). The schools included a total of 76 school teachers for teacher training (44 teachers from upper secondary schools and 32 teachers from schools of health and social care). Each included teacher will be asked to recruit a class of students (15-30 students) to test the effectiveness of the modified MBSR programme (in total approx. 1.000 students).

Eligibility criteria: Inclusion Criteria:

* All students in the enrolled school classes

Exclusion Criteria:

* None

Primary outcomes:
measure: Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
timeFrame: Six months after baseline
Secondary outcomes:
measure: Warwick-Edinburgh Mental Well-Being Scale (SWEMWBS) - The short version
timeFrame: Three months after baseline
measure: Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version
timeFrame: Three months after baseline
measure: Strengths and Difficulties Questionnaire (SDQ) - The youth self-report version
timeFrame: Six months after baseline
measure: Perseived Stress Scale
timeFrame: Three months after baseline
measure: Perseived Stress Scale
timeFrame: Six months after baseline
measure: Depression Anxiety Stress Scale (DASS) - The short form version
timeFrame: Three months after baseline
measure: Depression Anxiety Stress Scale (DASS) - The short form version
timeFrame: Six months after baseline
measure: Brief Resilience Scale (BRS)
timeFrame: Three months after baseline
measure: Brief Resilience Scale (BRS)
timeFrame: Six months after baseline
measure: Three-Item Loneliness Scale (T-ILS)
timeFrame: Three months after baseline
measure: Three-Item Loneliness Scale (T-ILS)
timeFrame: Six months after baseline
measure: Experiences Questionnaire (EQ) - Decentering subscale
timeFrame: Three months after baseline
measure: Experiences Questionnaire (EQ) - Decentering subscale
timeFrame: Six months after baseline
measure: EQ-5D
timeFrame: Three months after baseline
measure: EQ-5D
timeFrame: Six months after baseline
measure: Karolinska Sleep Questionnaire - Modified version
timeFrame: Three months after baseline
measure: Karolinska Sleep Questionnaire - Modified version
timeFrame: Six months after baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Center for Mindfulness
state: Brabrand
Study officials:
affiliation: Danish Center for Mindfulness
name: Lise Juul, PhD
role: PRINCIPAL_INVESTIGATOR
References: