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

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.

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).

Study Overview

• Status: Completed
• Conditions: Adolescent; Stress; Children; Mental Health; Mindfulness
• Intervention / Treatment: Behavioral: School teacher training /.b

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 Type: Interventional
• Enrollment (Actual): 1774
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Brabrand
    • Aarhus, Brabrand, Denmark, 8220
      • Danish Center for Mindfulness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All pupils in the enrolled school classes

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report	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)	23.03.21: Seven months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales	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)	23.03.21: Seven months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report	Changes in the scores among the total study population	23.03.21: Seven months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report	Changes in the scores among the total study population	23.03.21: Five months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report	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)	23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	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)	23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	Change in the score among the total study population	23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	Change in the score among the subgroup with a total difficulties score>13.5	23.03.21: Seven months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	Change in the score among the total study population	23.03.21: Seven months after baseline
Brief Resilience Scale (BRS)	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)	23.03.21: Five months after baseline
Brief Resilience Scale (BRS)	Change in the score among the total study population	23.03.21: Five months after baseline
Brief Resilience Scale (BRS)	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)	23.03.21: Seven months after baseline
Brief Resilience Scale (BRS)	Change in the score among the total study population	23.03.21: Seven months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Five months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)	Change in the score among the total study population	23.03.21: Five months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Seven months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)	Change in the score among the total study population	23.03.21: Seven months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Five months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)	Change in the score among the total study population	23.03.21: Five months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Seven months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)	Change in the score among the total study population	23.03.21: Seven months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Five months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)	Change in the score among the total study population	23.03.21: Five months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Seven months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)	Change in the score among the total study population	23.03.21: Seven months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Five months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)	Change in proportions among the total study population	23.03.21: Five months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)	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)	23.03.21: Seven months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)	Change in proportions among the total study population	23.03.21: Seven months after baseline
EQ-5D-Y	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)	23.03.21: Five months after baseline
EQ-5D-Y	Change in scores among the total study population	23.03.21: Five months after baseline
EQ-5D-Y	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)	23.03.21: Seven months after baseline
EQ-5D-Y	Change in scores among the total study population	23.03.21: Seven months after baseline
Sleep quality	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)	23.03.21: Five months after baseline
Sleep quality	Change in score among the total study population	23.03.21: Five months after baseline
Sleep quality	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)	23.03.21: Seven months after baseline
Sleep quality	Change in score among the total study population	23.03.21: Seven months after baseline
Child-Adolescent Mindfulness Measure (CAMM)	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)	23.03.21: Five months after baseline
Child-Adolescent Mindfulness Measure (CAMM)	Change in score among the total study population	23.03.21: Five months after baseline
Child-Adolescent Mindfulness Measure (CAMM)	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)	23.03.21: Seven months after baseline
Child-Adolescent Mindfulness Measure (CAMM)	Change in score among the total study population	23.03.21: Seven months after baseline

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Lise Juul, PhD, Danish Center for Mindfulness

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2020
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): June 22, 2021

Study Registration Dates

• First Submitted: December 19, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 23, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: School-based intervention; Public health; Population-based preventive strategy
• Other Study ID Numbers: 2016-051-000001/1145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No