Stress-free Everyday LiFe for Children and Adolescents REsearch

Overview

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).

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 22, 2021

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).

Interventions

  • 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 3×2-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.

Arms, Groups and Cohorts

  • 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 3×2-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.
  • No Intervention: Usual practice
    • Usual practice

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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
  • 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
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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)
  • Brief Resilience Scale (BRS)
    • Time Frame: 23.03.21: Five months after baseline
    • Change in the score among the total study population
  • 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)
  • Brief Resilience Scale (BRS)
    • Time Frame: 23.03.21: Seven months after baseline
    • Change in the score among the total study population
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • 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
  • 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)
  • EQ-5D-Y
    • Time Frame: 23.03.21: Five months after baseline
    • Change in scores among the total study population
  • 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)
  • EQ-5D-Y
    • Time Frame: 23.03.21: Seven months after baseline
    • Change in scores among the total study population
  • 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)
  • Sleep quality
    • Time Frame: 23.03.21: Five months after baseline
    • Change in score among the total study population
  • 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)
  • Sleep quality
    • Time Frame: 23.03.21: Seven months after baseline
    • Change in score among the total study population
  • 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)
  • Child-Adolescent Mindfulness Measure (CAMM)
    • Time Frame: 23.03.21: Five months after baseline
    • Change in score among the total study population
  • 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)
  • Child-Adolescent Mindfulness Measure (CAMM)
    • Time Frame: 23.03.21: Seven months after baseline
    • Change in score among the total study population

Participating in This Clinical Trial

Inclusion Criteria

  • All pupils in the enrolled school classes Exclusion Criteria:

  • None

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Aarhus
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lise Juul, PhD, Principal Investigator, Danish Center for Mindfulness

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