Clinical trial NCT04208113: Stress-free Everyday LiFe for Children and Adolescents REsearch
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Children
Adolescent
Mindfulness
Stress
Keywords: School-based intervention
Population-based preventive strategy
Public health
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-12-23
Enrollment: 1774
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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).

Eligibility criteria: Inclusion Criteria:

* All pupils in the enrolled school classes

Exclusion Criteria:

* None

Primary outcomes:
measure: The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report
timeFrame: 23.03.21: Seven months after baseline
Secondary outcomes:
measure: The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales
timeFrame: 23.03.21: Seven months after baseline
measure: The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
timeFrame: 23.03.21: Seven months after baseline
measure: The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
timeFrame: 23.03.21: Five months after baseline
measure: The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
timeFrame: 23.03.21: Five months after baseline
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
timeFrame: 23.03.21: Five months after baseline
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
timeFrame: 23.03.21: Five months after baseline
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
timeFrame: 23.03.21: Seven months after baseline
measure: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
timeFrame: 23.03.21: Seven months after baseline
measure: Brief Resilience Scale (BRS)
timeFrame: 23.03.21: Five months after baseline
measure: Brief Resilience Scale (BRS)
timeFrame: 23.03.21: Five months after baseline
measure: Brief Resilience Scale (BRS)
timeFrame: 23.03.21: Seven months after baseline
measure: Brief Resilience Scale (BRS)
timeFrame: 23.03.21: Seven months after baseline
measure: School connectedness from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: School connectedness from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: School connectedness from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: School connectedness from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: Social competence from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: Social competence from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: Social competence from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: Social competence from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: Self-efficacy from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: Self-efficacy from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: Self-efficacy from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: Self-efficacy from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: Bullying items from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: Bullying items from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Five months after baseline
measure: Bullying items from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: Bullying items from the Danish student well-being questionnaire (DSWQ)
timeFrame: 23.03.21: Seven months after baseline
measure: EQ-5D-Y
timeFrame: 23.03.21: Five months after baseline
measure: EQ-5D-Y
timeFrame: 23.03.21: Five months after baseline
measure: EQ-5D-Y
timeFrame: 23.03.21: Seven months after baseline
measure: EQ-5D-Y
timeFrame: 23.03.21: Seven months after baseline
measure: Sleep quality
timeFrame: 23.03.21: Five months after baseline
measure: Sleep quality
timeFrame: 23.03.21: Five months after baseline
measure: Sleep quality
timeFrame: 23.03.21: Seven months after baseline
measure: Sleep quality
timeFrame: 23.03.21: Seven months after baseline
measure: Child-Adolescent Mindfulness Measure (CAMM)
timeFrame: 23.03.21: Five months after baseline
measure: Child-Adolescent Mindfulness Measure (CAMM)
timeFrame: 23.03.21: Five months after baseline
measure: Child-Adolescent Mindfulness Measure (CAMM)
timeFrame: 23.03.21: Seven months after baseline
measure: Child-Adolescent Mindfulness Measure (CAMM)
timeFrame: 23.03.21: Seven 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:
citation: Juul L, Frydenberg M, Beck MS, Fjorback LO. Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE): a protocol for a cluster randomised trial testing a school teacher training programme to teach mindfulness (".b"). BMC Psychol. 2021 Feb 17;9(1):31. doi: 10.1186/s40359-021-00530-9.