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Completed

NCT Number: NCT04208113

Stress-free Everyday LiFe for Children and Adolescents REsearch

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).

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Key information

Conditions

Mental Health Adolescent Behavior Children Mindfulness Personal Satisfaction Psychological Well-Being Stress

Age range

11 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Center for Mindfulness

Aarhus, Brabrand, 8220, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pupils in the enrolled school classes

Exclusion criteria

  • None

Treatment and study plan

School teacher training /.b

Behavioral

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.

Primary outcomes

  1. The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report

    Time frame: 23.03.21: Seven months after baseline

    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)

Secondary outcomes

  1. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales

    Time frame: 23.03.21: Seven months after baseline

    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)

  2. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report

    Time frame: 23.03.21: Seven months after baseline

    Changes in the scores among the total study population

  3. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report

    Time frame: 23.03.21: Five months after baseline

    Changes in the scores among the total study population

  4. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report

    Time frame: 23.03.21: Five months after baseline

    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)

  5. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version

    Time frame: 23.03.21: Five months after baseline

    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)

  6. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version

    Time frame: 23.03.21: Five months after baseline

    Change in the score among the total study population

  7. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version

    Time frame: 23.03.21: Seven months after baseline

    Change in the score among the subgroup with a total difficulties score>13.5

  8. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version

    Time frame: 23.03.21: Seven months after baseline

    Change in the score among the total study population

  9. Brief Resilience Scale (BRS)

    Time frame: 23.03.21: Five months after baseline

    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)

  10. Brief Resilience Scale (BRS)

    Time frame: 23.03.21: Five months after baseline

    Change in the score among the total study population

  11. Brief Resilience Scale (BRS)

    Time frame: 23.03.21: Seven months after baseline

    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)

  12. Brief Resilience Scale (BRS)

    Time frame: 23.03.21: Seven months after baseline

    Change in the score among the total study population

  13. School connectedness from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    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)

  14. School connectedness from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    Change in the score among the total study population

  15. School connectedness from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    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)

  16. School connectedness from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    Change in the score among the total study population

  17. Social competence from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    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)

  18. Social competence from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    Change in the score among the total study population

  19. Social competence from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    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)

  20. Social competence from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    Change in the score among the total study population

  21. Self-efficacy from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    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)

  22. Self-efficacy from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    Change in the score among the total study population

  23. Self-efficacy from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    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)

  24. Self-efficacy from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    Change in the score among the total study population

  25. Bullying items from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    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)

  26. Bullying items from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Five months after baseline

    Change in proportions among the total study population

  27. Bullying items from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    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)

  28. Bullying items from the Danish student well-being questionnaire (DSWQ)

    Time frame: 23.03.21: Seven months after baseline

    Change in proportions among the total study population

  29. EQ-5D-Y

    Time frame: 23.03.21: Five months after baseline

    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)

  30. EQ-5D-Y

    Time frame: 23.03.21: Five months after baseline

    Change in scores among the total study population

  31. EQ-5D-Y

    Time frame: 23.03.21: Seven months after baseline

    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)

  32. EQ-5D-Y

    Time frame: 23.03.21: Seven months after baseline

    Change in scores among the total study population

  33. Sleep quality

    Time frame: 23.03.21: Five months after baseline

    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)

  34. Sleep quality

    Time frame: 23.03.21: Five months after baseline

    Change in score among the total study population

  35. Sleep quality

    Time frame: 23.03.21: Seven months after baseline

    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)

  36. Sleep quality

    Time frame: 23.03.21: Seven months after baseline

    Change in score among the total study population

  37. Child-Adolescent Mindfulness Measure (CAMM)

    Time frame: 23.03.21: Five months after baseline

    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)

  38. Child-Adolescent Mindfulness Measure (CAMM)

    Time frame: 23.03.21: Five months after baseline

    Change in score among the total study population

  39. Child-Adolescent Mindfulness Measure (CAMM)

    Time frame: 23.03.21: Seven months after baseline

    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)

  40. Child-Adolescent Mindfulness Measure (CAMM)

    Time frame: 23.03.21: Seven months after baseline

    Change in score among the total study population

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study 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.

Acronym: SELFCARE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2019
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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