Stress-free Everyday LiFe for Children and Adolescents REsearch

NCT ID: NCT04208113

Last Updated: 2024-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2021-06-22

Brief Summary

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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

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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).

Conditions

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Mental Health Children Adolescent Mindfulness Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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 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.

Group Type EXPERIMENTAL

School teacher training /.b

Intervention Type 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.

Usual practice

Usual practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All pupils in the enrolled school classes

Exclusion Criteria

* None
Minimum Eligible Age

11 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise Juul, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Center for Mindfulness

Locations

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Danish Center for Mindfulness

Aarhus, Brabrand, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33597044 (View on PubMed)

Other Identifiers

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2016-051-000001/1145

Identifier Type: -

Identifier Source: org_study_id

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