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

• ClinicalTrials.gov Identifier: NCT04208113
• Recruitment Status: Not yet recruiting
• First Posted: December 23, 2019
• Last Update Posted: September 18, 2020
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

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 six 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 twelve weeks).

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

• 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.
• Estimated Study Start Date: September 2020
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: October 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 [ Time Frame: Six months after baseline ]
   Change in the score among the subgroup with a total difficulties score>13.5. (This cut-point refers to the 20% with highest scores in a Danish population. It is defined a risk-group according to Danish Norms for SDQ)

Secondary Outcome Measures :

1. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales [ Time Frame: Six months after baseline ]
   Changes in the scores among the subgroup with a total difficulties score>13.5
2. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report [ Time Frame: Six months after baseline ]
   Changes in the scores among the total study population
3. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report [ Time Frame: Twelve weeks after baseline ]
   Changes in the scores among the total study population
4. The Strengths and Difficulties Questionnaire (SDQ)- youth self-report [ Time Frame: Twelve weeks after baseline ]
   Changes in the scores among the subgroup with a total difficulties score>13.5
5. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version [ Time Frame: Twelve weeks after baseline ]
   Change in the score among the subgroup with a total difficulties score>13.5
6. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version [ Time Frame: Twelve weeks after baseline ]
   Change in the score among the total study population
7. Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version [ Time Frame: Six 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: Six months after baseline ]
   Change in the score among the total study population
9. Brief Resilience Scale (BRS) [ Time Frame: Twelve weeks after baseline ]
   Change in the score among the subgroup with a total difficulties score>13.5
10. Brief Resilience Scale (BRS) [ Time Frame: Twelve weeks after baseline ]
    Change in the score among the total study population
11. Brief Resilience Scale (BRS) [ Time Frame: Six months after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
12. Brief Resilience Scale (BRS) [ Time Frame: Six 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: Twelve weeks after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
14. School connectedness from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Twelve weeks after baseline ]
    Change in the score among the total study population
15. School connectedness from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six months after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
16. School connectedness from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six 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: Twelve weeks after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
18. Social competence from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Twelve weeks after baseline ]
    Change in the score among the total study population
19. Social competence from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six months after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
20. Social competence from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six 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: Twelve weeks after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
22. Self-efficacy from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Twelve weeks after baseline ]
    Change in the score among the total study population
23. Self-efficacy from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six months after baseline ]
    Change in the score among the subgroup with a total difficulties score>13.5
24. Self-efficacy from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six 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: Twelve weeks after baseline ]
    Change in proportions among the subgroup with a total difficulties score>13.5
26. Bullying items from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Twelve weeks after baseline ]
    Change in proportions among the total study population
27. Bullying items from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six months after baseline ]
    Change in proportions among the subgroup with a total difficulties score>13.5
28. Bullying items from the Danish student well-being questionnaire (DSWQ) [ Time Frame: Six months after baseline ]
    Change in proportions among the total study population
29. EQ-5D-Y [ Time Frame: Twelve weeks after baseline ]
    Change in scores among the subgroup with a total difficulties score>13.5
30. EQ-5D-Y [ Time Frame: Twelve weeks after baseline ]
    Change in scores among the total study population
31. EQ-5D-Y [ Time Frame: Six months after baseline ]
    Change in scores among the subgroup with a total difficulties score>13.5
32. EQ-5D-Y [ Time Frame: Six months after baseline ]
    Change in scores among the total study population
33. Sleep quality [ Time Frame: Twelve weeks after baseline ]
    Change in score among the subgroup with a total difficulties score>13.5
34. Sleep quality [ Time Frame: Twelve weeks after baseline ]
    Change in score among the total study population
35. Sleep quality [ Time Frame: Six months after baseline ]
    Change in score among the subgroup with a total difficulties score>13.5
36. Sleep quality [ Time Frame: Six months after baseline ]
    Change in score among the total study population
37. Child-Adolescent Mindfulness Measure (CAMM) [ Time Frame: Twelve weeks after baseline ]
    Change in score among the subgroup with a total difficulties score>13.5
38. Child-Adolescent Mindfulness Measure (CAMM) [ Time Frame: Twelve weeks after baseline ]
    Change in score among the total study population
39. Child-Adolescent Mindfulness Measure (CAMM) [ Time Frame: Six months after baseline ]
    Change in score among the subgroup with a total difficulties score>13.5
40. Child-Adolescent Mindfulness Measure (CAMM) [ Time Frame: Six months after baseline ]
    Change in score among the total study population

Eligibility Criteria

• 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

Contacts

Contact: Lise Juul, PhD; 24619664; lise.juul@clin.au.dk

Contact: Lone Fjorback, PhD; 24619664; lone.overby.fjorback@clin.au.dk

Sponsors and Collaborators

University of Aarhus

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT04208113
• Other Study ID Numbers: 2016-051-000001/1145
• First Posted: December 23, 2019
• Last Update Posted: September 18, 2020
• Last Verified: December 2019

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)

• 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