Stress-free Everyday LiFe for Children and Adolescents REsearch

Stress Clinical Trial

— SELFCARE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208113
• Other study ID #: 2016-051-000001/1145
• Status: Completed
• Phase: N/A
• Start date: August 11, 2020
• Est. completion date: June 22, 2021

Study information

• Verified date: March 2024
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1774
• Est. completion date: June 22, 2021
• Est. primary completion date: June 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 16 Years

Eligibility

Inclusion Criteria:

• All pupils in the enrolled school classes

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Adolescent
• Children
• Mental Health
• Mindfulness
• Stress

Intervention

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.

Locations

Country	Name	City	State
Denmark	Danish Center for Mindfulness	Aarhus	Brabrand

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	Change in the score among the total study population	23.03.21: Five months after baseline
Secondary	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
Secondary	Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version	Change in the score among the total study population	23.03.21: Seven months after baseline
Secondary	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
Secondary	Brief Resilience Scale (BRS)	Change in the score among the total study population	23.03.21: Five months after baseline
Secondary	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
Secondary	Brief Resilience Scale (BRS)	Change in the score among the total study population	23.03.21: Seven months after baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	EQ-5D-Y	Change in scores among the total study population	23.03.21: Five months after baseline
Secondary	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
Secondary	EQ-5D-Y	Change in scores among the total study population	23.03.21: Seven months after baseline
Secondary	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
Secondary	Sleep quality	Change in score among the total study population	23.03.21: Five months after baseline
Secondary	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
Secondary	Sleep quality	Change in score among the total study population	23.03.21: Seven months after baseline
Secondary	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
Secondary	Child-Adolescent Mindfulness Measure (CAMM)	Change in score among the total study population	23.03.21: Five months after baseline
Secondary	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
Secondary	Child-Adolescent Mindfulness Measure (CAMM)	Change in score among the total study population	23.03.21: Seven months after baseline