Mental HealthSELFCARENCT04208113
Stress-free Everyday LiFe for Children and Adolescents REsearch
A study testing School teacher training /.b in people with Mental Health and Children, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Children, Adolescent
- What is being tested?
- School teacher training /.b
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,774 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Aug 2020to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All pupils in the enrolled school classes
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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).
- Conditions
- Mental Health, Children, Adolescent, Mindfulness, Stress
- Being tested
- School teacher training /.b
- Keywords
- School-based intervention, Population-based preventive strategy, Public health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School teacher training /.bBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: School teacher training /.b |
| Usual practice | No intervention | Usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 23.03.21: Seven months after baseline
Secondary outcomes (40)
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)
Measured: 23.03.21: Seven months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
Changes in the scores among the total study population
Measured: 23.03.21: Seven months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
Changes in the scores among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Change in the score among the total study population
Measured: 23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Change in the score among the subgroup with a total difficulties score>13.5
Measured: 23.03.21: Seven months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Change in the score among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
Brief Resilience Scale (BRS)
Change in the score among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
Brief Resilience Scale (BRS)
Change in the score among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)
Change in the score among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)
Change in the score among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)
Change in the score among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)
Change in the score among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)
Change in the score among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)
Change in the score among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)
Change in proportions among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)
Change in proportions among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
EQ-5D-Y
Change in scores among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
EQ-5D-Y
Change in scores among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
Sleep quality
Change in score among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
Sleep quality
Change in score among the total study population
Measured: 23.03.21: Seven months after baseline
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)
Measured: 23.03.21: Five months after baseline
Child-Adolescent Mindfulness Measure (CAMM)
Change in score among the total study population
Measured: 23.03.21: Five months after baseline
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)
Measured: 23.03.21: Seven months after baseline
Child-Adolescent Mindfulness Measure (CAMM)
Change in score among the total study population
Measured: 23.03.21: Seven months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start11 Aug 2020
- Primary completion22 Jun 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,774 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lise Juul, PhD, Principal investigator, Danish Center for Mindfulness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208113
- Sponsor's protocol ID
- 2016-051-000001/1145
- Acronym
- SELFCARE
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2019
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
Publications
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.
PubMed 33597044
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04208113
- Acronym / sponsor ID
- SELFCARE / 2016-051-000001/1145
- Conditions
- Mental Health, Children, Adolescent, Mindfulness, Stress
- Keywords
- School-based intervention, Population-based preventive strategy, Public health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,774 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 11 Aug 2020 (actual)
- Primary completion
- 22 Jun 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 23 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School teacher training /.b | Experimental | Behavioral: School teacher training /.bThe 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. |
| Usual practice | No intervention | –Usual practice |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All pupils in the enrolled school classes
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School teacher training /.bThe 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. | Behavioural | School teacher training /.b |
Primary outcome
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)
40 secondary outcomes
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report -subscales
Time frame: 23.03.21: Seven months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
Time frame: 23.03.21: Seven months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
Time frame: 23.03.21: Five months after baseline
The Strengths and Difficulties Questionnaire (SDQ)- youth self-report
Time frame: 23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Time frame: 23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Time frame: 23.03.21: Five months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Time frame: 23.03.21: Seven months after baseline
Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) -short version
Time frame: 23.03.21: Seven months after baseline
Brief Resilience Scale (BRS)
Time frame: 23.03.21: Five months after baseline
Brief Resilience Scale (BRS)
Time frame: 23.03.21: Five months after baseline
Brief Resilience Scale (BRS)
Time frame: 23.03.21: Seven months after baseline
Brief Resilience Scale (BRS)
Time frame: 23.03.21: Seven months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
School connectedness from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
Social competence from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
Self-efficacy from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Five months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
Bullying items from the Danish student well-being questionnaire (DSWQ)
Time frame: 23.03.21: Seven months after baseline
EQ-5D-Y
Time frame: 23.03.21: Five months after baseline
EQ-5D-Y
Time frame: 23.03.21: Five months after baseline
EQ-5D-Y
Time frame: 23.03.21: Seven months after baseline
EQ-5D-Y
Time frame: 23.03.21: Seven months after baseline
Sleep quality
Time frame: 23.03.21: Five months after baseline
Sleep quality
Time frame: 23.03.21: Five months after baseline
Sleep quality
Time frame: 23.03.21: Seven months after baseline
Sleep quality
Time frame: 23.03.21: Seven months after baseline
Child-Adolescent Mindfulness Measure (CAMM)
Time frame: 23.03.21: Five months after baseline
Child-Adolescent Mindfulness Measure (CAMM)
Time frame: 23.03.21: Five months after baseline
Child-Adolescent Mindfulness Measure (CAMM)
Time frame: 23.03.21: Seven months after baseline
Child-Adolescent Mindfulness Measure (CAMM)
Time frame: 23.03.21: Seven months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Derived from this study: PubMed 33597044Juul 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.
- Individual participant dataSharing planned: Yes. Individual deidentified participant data will be shared by reasonable request, following publication of planned papers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Juul, PhD principal investigator
Danish Center for Mindfulness
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School teacher training /.b in people with Mental Health and Children, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The total difficulties score of the Strengths and Difficulties Questionnaire (SDQ)- youth self-report (time frame: 23.03.21: Seven months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04208113, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.