Skip to main content
Clinical Trials/NCT04208113
NCT04208113CompletedNot Applicable

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.

University of Aarhus1 site in 1 country1,774 target enrollmentStarted: August 11, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,774
Locations
1
Primary Endpoint
The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report

Study Overview

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).

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
11 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •All pupils in the enrolled school classes

Exclusion Criteria

  • Not provided

Arms & Interventions

School teacher training /.b

Experimental

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.

Intervention: School teacher training /.b (Behavioral)

Usual practice

No Intervention

Usual practice

Outcomes

Primary Outcomes

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 Outcomes

  • The Strengths and Difficulties Questionnaire (SDQ)- youth self-report(23.03.21: Five months after baseline)
  • Child-Adolescent Mindfulness Measure (CAMM)(23.03.21: Seven months after baseline)
  • Bullying items from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version(23.03.21: Seven months after baseline)
  • Brief Resilience Scale (BRS)(23.03.21: Seven months after baseline)
  • School connectedness from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • Social competence from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • Self-efficacy from the Danish student well-being questionnaire (DSWQ)(23.03.21: Seven months after baseline)
  • EQ-5D-Y(23.03.21: Seven months after baseline)
  • Sleep quality(23.03.21: Seven months after baseline)
  • The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales(23.03.21: Seven months after baseline)
  • The Strengths and Difficulties Questionnaire (SDQ)- youth self-report(23.03.21: Seven months after baseline)
  • Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version(23.03.21: Five months after baseline)
  • Brief Resilience Scale (BRS)(23.03.21: Five months after baseline)
  • School connectedness from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • Social competence from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • Self-efficacy from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • Bullying items from the Danish student well-being questionnaire (DSWQ)(23.03.21: Five months after baseline)
  • EQ-5D-Y(23.03.21: Five months after baseline)
  • Sleep quality(23.03.21: Five months after baseline)
  • Child-Adolescent Mindfulness Measure (CAMM)(23.03.21: Five months after baseline)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials