Stress-free Everyday LiFe for Children and Adolescents REsearch

Not Applicable

Completed

• Conditions: Mental Health; Children; Adolescent; Mindfulness; Stress

• Registration Number: NCT04208113
• Lead Sponsor: University of Aarhus

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 Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-23
• Study Start: 2020-08-11
• Primary Completion: 2021-06-22
• Study Completion: 2021-06-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1774

Inclusion Criteria

• All pupils in the enrolled school classes

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report	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

Name	Time	Method
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales	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)
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	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)	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)	23.03.21: Seven months after baseline	Change in proportions among the total study population
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report	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)	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)	23.03.21: Seven months after baseline	Change in the score among the total study population
EQ-5D-Y	23.03.21: Seven months after baseline	Change in scores among the total study population
Sleep quality	23.03.21: Seven months after baseline	Change in score among the total study population
Child-Adolescent Mindfulness Measure (CAMM)	23.03.21: Seven months after baseline	Change in score among the total study population
School connectedness from the Danish student well-being questionnaire (DSWQ)	23.03.21: Seven months after baseline	Change in the score among the total study population

Trial Locations

Locations (1)

Danish Center for Mindfulness; 🇩🇰 Aarhus, Brabrand, Denmark