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Stress-free Everyday LiFe for Children and Adolescents REsearch

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04208113
Acronym
SELFCARE
Enrollment
1774
Registered
2019-12-23
Start date
2020-08-11
Completion date
2021-06-22
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Children, Mental Health, Mindfulness, Stress

Keywords

School-based intervention, Population-based preventive strategy, Public health

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).

Interventions

BEHAVIORALSchool teacher training /.b

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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
Yes

Inclusion criteria

* All pupils in the enrolled school classes

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report23.03.21: Seven months after baselineChange 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)

Secondary

MeasureTime frameDescription
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales23.03.21: Seven months after baselineChange 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)
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report23.03.21: Seven months after baselineChanges in the scores among the total study population
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version23.03.21: Five months after baselineChange 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)
Brief Resilience Scale (BRS)23.03.21: Five months after baselineChange 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)
School connectedness from the Danish student well-being questionnaire (DSWQ)23.03.21: Five months after baselineChange 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)
Social competence from the Danish student well-being questionnaire (DSWQ)23.03.21: Five months after baselineChange 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)
Self-efficacy from the Danish student well-being questionnaire (DSWQ)23.03.21: Five months after baselineChange 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)
Bullying items from the Danish student well-being questionnaire (DSWQ)23.03.21: Five months after baselineChange 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)
EQ-5D-Y23.03.21: Five months after baselineChange 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)
Sleep quality23.03.21: Five months after baselineChange 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)
Child-Adolescent Mindfulness Measure (CAMM)23.03.21: Five months after baselineChange 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)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026