Stress-free Everyday LiFe for Children and Adolescents REsearch

NCT04208113 | Completed

• 1 other identifier: 2016-051-000001/1145
• Study Type: interventional
• Target: 1,774
• Locations: 1 country
• Sites: 1

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).

Conditions

Mental Health; Children; Adolescent; Mindfulness; Stress

Keywords

School-based intervention; Population-based preventive strategy; Public health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (40)

• 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

• The Strengths and Difficulties Questionnaire (SDQ)- youth self-report

  23.03.21: Five months after baseline

• The Strengths and Difficulties Questionnaire (SDQ)- youth self-report

  23.03.21: Five months after baseline

• Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version

  23.03.21: Five months after baseline

Study Arms (2)

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.

Behavioral: School teacher training /.b

Usual practice

NO INTERVENTION

Usual practice

Interventions

School teacher training /.b BEHAVIORAL

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.

School teacher training /.b

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All pupils in the enrolled school classes

You may not qualify if:

• None

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Danish Center for Mindfulness

Aarhus, Brabrand, 8220, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33597044 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Lise Juul, PhD

  Danish Center for Mindfulness

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 23, 2019
• Study Start: August 11, 2020
• Primary Completion: June 22, 2021
• Study Completion: June 22, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

DK (1)