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Stress-free Everyday LiFe for Children and Adolescents REsearch (SELFCARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208113
Recruitment Status : Active, not recruiting
First Posted : December 23, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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
Mental Health Children Adolescent Mindfulness Stress Behavioral: School teacher training /.b Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 11, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021
Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All pupils in the enrolled school classes

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208113


Locations
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Denmark
Danish Center for Mindfulness
Aarhus, Brabrand, Denmark, 8220
Sponsors and Collaborators
University of Aarhus
Investigators
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Principal Investigator: Lise Juul, PhD Danish Center for Mindfulness
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04208113    
Other Study ID Numbers: 2016-051-000001/1145
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
School-based intervention
Population-based preventive strategy
Public health