SELFCARE: Stress-free Everyday LiFe for Children and Adolescents REsearch

Sponsor
University of Aarhus (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04208113
Collaborator
(none)
3,000
1
2
13.7
219.5

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: School teacher training /.b
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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.
Actual Study Start Date :
Aug 11, 2020
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: School 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 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
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.

No Intervention: Usual practice

Usual practice

Outcome Measures

Primary Outcome Measures

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

  1. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales [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 [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 [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 [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 [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 [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 [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 [23.03.21: Seven months after baseline]

    Change in the score among the total study population

  9. Brief Resilience Scale (BRS) [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) [23.03.21: Five months after baseline]

    Change in the score among the total study population

  11. Brief Resilience Scale (BRS) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [23.03.21: Seven months after baseline]

    Change in proportions among the total study population

  29. EQ-5D-Y [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 [23.03.21: Five months after baseline]

    Change in scores among the total study population

  31. EQ-5D-Y [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 [23.03.21: Seven months after baseline]

    Change in scores among the total study population

  33. Sleep quality [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 [23.03.21: Five months after baseline]

    Change in score among the total study population

  35. Sleep quality [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 [23.03.21: Seven months after baseline]

    Change in score among the total study population

  37. Child-Adolescent Mindfulness Measure (CAMM) [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) [23.03.21: Five months after baseline]

    Change in score among the total study population

  39. Child-Adolescent Mindfulness Measure (CAMM) [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) [23.03.21: Seven months after baseline]

    Change in score among the total study population

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • All pupils in the enrolled school classes
Exclusion Criteria:
  • None

Contacts and Locations

Locations

Site City State Country Postal Code
1 Danish Center for Mindfulness Aarhus Brabrand Denmark 8220

Sponsors and Collaborators

  • University of Aarhus

Investigators

  • Principal Investigator: Lise Juul, PhD, Danish Center for Mindfulness

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT04208113
Other Study ID Numbers:
  • 2016-051-000001/1145
First Posted:
Dec 23, 2019
Last Update Posted:
May 4, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus

Study Results

No Results Posted as of May 4, 2021