Psychological Well-BeingNCT06488833
Evaluation of First Year Implementation of Komtü Programme to Improve Emotional Well-being in School.
A study testing Komtü Programme (Komtü) and Komtü Training and Reflective Practice in people with Psychological Well-Being and Mental Health Wellness, run by Universitat Autonoma de Barcelona at 1 site in Spain.
Trial summary
Objectives: (1) To analyse the benefits of Komtü Programme implementation in children's and teachers' well-being (primary outcomes); (2) to analyse the benefits of Komtü Programme implementation in teacher's assertiveness, mentalization and self-efficacy (secondary outcomes). Read more about this study
- Who is it for?
- Ages 9 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-Being, Mental Health Wellness
- What is being tested?
- Komtü Programme (Komtü) and Komtü Training and Reflective Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSpain
- Study dates
- 8 Oct 2024to May 2025
- 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 9 to 67 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Teachers at public school (6 y.o. - 12 y.o.) or preschool (3 y.o. - 6 y.o.) in active
- Students from 4th, 5th and 6th grade of Primary School (9 - 12 y.o.)
- Understanding Catalan
- Written Informed Consent
Who cannot join
- Teachers at private or charter schools.
- Teachers at rural schools.
- Preschool students (3-y.o. - 6 y.o.) and students from 1st, 2nd and 3rd grade of Primary School (6 y.o. - 8 y.o.).
- Schools that already have any training/knowledge related to emotional support or emotional intelligence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of First Year Implementation of Komtü Programme to Improve Children's Emotional Well-being in Pre-school and Primary School.
Objectives: (1) To analyse the benefits of Komtü Programme implementation in children's and teachers' well-being (primary outcomes); (2) to analyse the benefits of Komtü Programme implementation in teacher's assertiveness, mentalization and self-efficacy (secondary outcomes). (3) and to analyse the benefits of Komtü Programme implementation according to children's prosocial behaviour, self-esteem and mentalization (secondary outcomes).
Participants: Teachers will be placed in one of the 3 groups, according to the school's support needs they work at. In this case, randomization would not be possible in the allocation process. In one of the interventions, the participants will receive the planned actions for the first school year of the Komtü Programme. In the other intervention, the participants will only receive the training and the reflective practice planned for the Komtü. The last group will complete the school year as usual (TAU, control group).
Read more
Comparisons: Researchers will compare all 3 groups among them to see to what extent:
- Komtü Programme shows efficacy in fostering children's well-being compared with the training and TAU (control group).
- Komtü Programme shows efficacy in fostering teachers' well-being compared with the training and TAU (control group).
- Training and reflective practice shows efficacy in fostering children's well-being compared with TAU (control group).
- Training and reflective practice shows efficacy in fostering teachers' well-being compared with TAU (control group).
And as for the secondary outcomes, researchers will also compare all 3 group to observe possible inter-group differences.
Read the detailed description
Context: Lately, mental health has become an important issue of global priority, especially when it comes to child and youth population. Acting during this stage of life is crucial, as the symptomatology of some mental disorders present in adulthood could start before the age of 14 in 33.3% to 50% of cases. It seems that schools could be a great context to foster mental health, as children spend most of the day hours there. At school, children not only acquire academic knowledge, they also learn emotional and social competencies and, in this process, teachers can become a model for them. However, most of the school programmes that aim to enhance children's well-being are directly implemented with children, and few programmes are designed to work with teachers. Furthermore, when implementing a school programme, it is not usual to have a specialist within the school centre, that addresses teacher's worries and accompanies them through the programme completion. That is why Nous Cims Private Foundation decided to create the Komtü programme, which aims to impact children's well-being by accompanying teachers during 3 school years by a specialist that visits the centre twice a week. As this programme is relatively new, the researchers in this study intend to: (1) analyse the benefits of Komtü programme and, considering that this is a long-term programme, (2) the investigators want to study the effectiveness of a more cost-efficient approach by only implementing the training and reflective practice associated with the programme.
Methodology: 8-month 3-armed quasi-experimental pre-post design with control group.
Measures Operationalization: It is expected that Komtü programme could benefit teachers who receive the intervention and their students, since they share a lot of classroom time. Teacher benefits are expected in terms of higher emotional well-being (primary outcome) but also in terms of higher sense of self-efficacy, higher assertiveness and improved mentalizing capacities (secondary outcomes). Children benefits are expected in terms of higher emotional well-being (primary outcome) but also in terms of mentalization, prosocial behaviour and self-esteem (secondary outcomes). We will also consider teachers' burnout and faculty trust as process outcomes since they can impact teacher's well-being.
Statistical Analyses: The analysis will encompass all participants, with the utilization of multiple imputation techniques to address any missing data. Estimation of parameters, accounting for the specific statistical assumption of each model and the data's characteristics, will be carried out using general linear modelling adjusting for baseline values. Various Stata packages will be employed to execute these models, primarily SPSS and jamovi. Concerning statistical power, a sample size of 90 teachers (30 per arm) and 180 students (90 per arm) has been proposed as the minimum required to detect a medium effect size (d=0.50) -in case of teachers- and small effect size (d =0.30) -in case of students- in the design comprising 3 arms, 2 repeated measures (pre-post), and a power level of 0.80.
- Conditions
- Psychological Well-Being, Mental Health Wellness
- Being tested
- Komtü Programme (Komtü), Komtü Training and Reflective Practice
- Keywords
- Psychological Well-being, Emotional Well-being, Emotional Health, School Intervention
- 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.
Komtü Programme (Komtü)Behavioural
Also called Komtü
Mainly, 4 actions will take place:
- Training with reflective practice exercises. This is a 32-hours group training involving 21 sessions that last 60 minutes and 11 hours of inter-sessions work. The contents of the training will be 5 of the 10 total blocks of Komtü training: Block 1: Meeting, observing and listening; Block 2: Neuroscience applied in the educational context; Block 3: High- quality relationships; Block 4: Conflict management; Block 5: Boundary management
- Healing spaces to generate a collective restorative experience, offering tools that facilitate emotional management
- Individual support for teachers to offer them resources, tools, and intervention strategies to help improve educational practice and the emotional and relational well-being of the school community
- Coaching for the school management team to help them establish some objectives together and offer them the necessary resources and tools so that they can achieve them successfully.
Komtü Training and Reflective PracticeBehavioural
This is a 32-hours group training involving 21 sessions that last 60 minutes and 11 hours of inter-sessions work. The contents of the training will be 5 of the 10 total blocks of Komtü training: Block 1: Meeting, observing and listening; Block 2: Neuroscience applied in the educational context; Block 3: High- quality relationships; Block 4: Conflict management; Block 5: Boundary management
No other actions will take place in this group.
| Study group | Role | What they receive |
|---|---|---|
| Komtü Programme (Komtü) | Experimental | The Komtü is a programme that aims to enhance the well-being and the emotional support of children by providing training and support to the entire school community, with a particular focus on teachers.
The Komtü programme comprises two distinct phases: the first, the Implementation Phase, is conducted over a period of three school years. During this phase, a specialist visits the school twice a week during the 1st and 2nd school years, and once a week during the 3rd school year. Some actions take place during this phase. For example, the specialist will provide training with reflective practice exercises, healing spaces and support for teachers and will also provide coaching for the school management team.
The second phase, the Sustainability Phase, is also conducted over three school years. This phase is designed as a follow-up phase, which is meant to ensure the continuity of the programme at the school even in the absence of the specialist's weekly visits from the centre. Receives: Behavioral: Komtü Programme (Komtü) |
| Komtü Training and Reflective Practice | Experimental | This is a different version of the Komtü Programme that aims to enhance the well-being and the emotional support of children.
In Komtü Training and Reflective Practice, the Implementation Phase is modified. The 1st school year, the specialist will only provide training with reflective practice exercises. This means, the other actions that are usually carried out by the programme will not be offered.
In contrast to the original version, this would reduce the cost of the intervention and allow a greater number of schools to participate in the programme, as the specialist would have the time to intervene in more centres. It has been decided to prioritise training with reflective practice exercises as it is the core component that gives meaning to the functioning of the other activities that are developed throughout the programme. Receives: Behavioral: Komtü Training and Reflective Practice |
| Control group or Treatment as usual (TAU) | No intervention | The school year will be developed as normal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stirling Children's Well-Being Scale (SCWB)
This is a 15-item scale commonly used to measure children's happiness in the last 2 weeks. Items are scored from '1 = Never' to '5 = All the time'. The score ranges from 15 to 75. A higher score means more happiness (better outcome).
Measured: Through study completion, an average of 8 months
Child Well-being Level (CWBL)
This is Likert's 7-point scale to assess the child's level of happiness compared with other children of the same age. It is responded by children. It ranges from '1 = Very less happy' to '7 = Very happier'. A higher score means more happiness (better outcome).
Measured: Through study completion, an average of 8 months
Child Well-being Level - Teacher's version (CWBL-T)
This is Likert's 7-point scale to assess the child's level of happiness compared with other children of the same age. It is responded by teachers. It ranges from '1 = Very less happy' to '7 = Very happier'. A higher score means more happiness (better outcome).
Measured: Through study completion, an average of 8 months
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
This is a 14-item scale commonly used to measure mental well-being in general population in the last 2 weeks. Items are scored from '1 = None of the time' to '5 = All of the time'. The score ranges from 14 to 70. A higher score means more well-being (better outcome).
Measured: Through study completion, an average of 8 months
Teacher's Subjective Well-being Scale (TSWBS)
This is a 8-item scale used to measure teacher's subjective well-being according to 2 sub-scales: teaching efficacy (4 items) and school connectedness (4 items). Items are scored in 4-points Likert scale ranging from '1 = Almost never' to '4 = Almost always'. The score ranges from 8 to 32. A higher score means more well-being (better outcome).
Measured: Through study completion, an average of 8 months
Secondary outcomes (7)
Bar-On Emotional Quotient Inventory: Youth Version (BarOn EQ-i: YV)
BarOn's scales of intra-personal (6 items) and inter-personal (12 items) scales, which are scored in 4-points Likert scales ranging from '1 = Never' to '4 = Always'. The indicated subscales ranges are 4-24 and 12-48, respectively. A higher score indicates higher emotional intelligence (better outcome).
Measured: Through study completion, an average of 8 months
Self-Other Mentalization Scale (SOMS)
These are two Likert's 5-point scales to assess the child's mentalization compared with other children of the same age. It is responded by their teachers. It ranges from '1 = Far less than others' to '5 = Far more than others'. A higher score means more mentalization (better outcome).
Measured: Through study completion, an average of 8 months
Rosenberg's Self-Esteem Scale - Child version (RSES-C)
This is a gold standard measure of self-esteem using 10 items which are scored from '1 = Totally agree' to '4 = Totally disagree'. After inverting the total score, which ranges from 10 to 40, a higher score means higher self-esteem (better outcome).
Measured: Through study completion, an average of 8 months
Strengths and Difficulties Questionnaire (SDQ)
Prosocial SDQ scale (5 items), which are scored in 3-point Likert scales ranging from '0 = Not true' to '2 = Certainly true'. The indicated subscale range is 0 from 10. A higher score indicates more prosocial behaviour (better outcome).
Measured: Through study completion, an average of 8 months
Mentalization Scale (MentS)
This is a 28-item scale to assess 3 dimensions of mentalization: self-related mentalization, other-related mentalization and motivation to mentalize. Items are scored from '1 = Completely incorrect' to '5 = Completely correct'. The indicated subscales scores can range from 8 to 64, from 10 to 50 and from 10 to 50, respectively. A higher score means more mentalization (better outcome).
Measured: Through study completion, an average of 8 months
Teacher Self-Efficacy Scale - Short Form (TSES-S)
This is a 12-item scale to assess teacher's self-efficacy according to 3 subscales: efficacy in student engagement (4 items), efficacy in instructional strategies (4 items) and efficacy in classroom management (4 items). Items are scored from '1 = Nothing' to '9 = A Great Deal'. The indicated subscales range is 4-36. A higher score means more teachers' sense of efficacy (better outcome).
Measured: Through study completion, an average of 8 months
Self-reports of Assertive Behaviour: Attitudes and Values in Social Interactions (ADCAs)
This is a 35-item scale to assess auto-assertiveness (20 items) and hetero-assertiveness (15 items) in general population. It also contains a specific form to assess teacher's assertiveness in classroom interactions. Items are scored from '1 = Never or Hardly ever' to '4 = Always or Most of the time'. The indicated subscales ranges are 20-80 and 15-60, respectively. A higher score means more assertiveness (better outcome).
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start8 Oct 2024
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-BeingStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Model description
- Quasi-experimental pre-post design with control group
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Autonoma de Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Nous Cims Private Foundation
- Responsible party
- Principal investigator, Sergi Ballespí, Ph.D., Universitat Autonoma de Barcelona
- Investigators
- Sergi Ballespí, PhD, Study director, Universitat Autònoma de Barcelona (UAB)Elena Gervilla, PhD, Study director, Universitat de les Illes Balears (UIB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488833
- Sponsor's protocol ID
- 2023 DI 00057
- Status last verified
- Oct 2024
- First submitted
- 21 Jun 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of First Year Implementation of Komtü Programme to Improve Children's Emotional Well-being in Pre-school and Primary School.
- ClinicalTrials.gov ID
- NCT06488833
- Acronym / sponsor ID
- 2023 DI 00057
- Conditions
- Psychological Well-Being, Mental Health Wellness
- Keywords
- Psychological Well-being, Emotional Well-being, Emotional Health, School Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Universitat Autonoma de BarcelonaUniversity, hospital or other
- Collaborators
- Nous Cims Private Foundation
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 5 Jul 2024 (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.
Objectives: (1) To analyse the benefits of Komtü Programme implementation in children's and teachers' well-being (primary outcomes); (2) to analyse the benefits of Komtü Programme implementation in teacher's assertiveness, mentalization and self-efficacy (secondary outcomes). (3) and to analyse the benefits of Komtü Programme implementation according to children's prosocial behaviour, self-esteem and mentalization (secondary outcomes).
Participants: Teachers will be placed in one of the 3 groups, according to the school's support needs they work at. In this case, randomization would not be possible in the allocation process. In one of the interventions, the participants will receive the planned actions for the first school year of the Komtü Programme. In the other intervention, the participants will only receive the training and the reflective practice planned for the Komtü. The last group will complete the school year as usual (TAU, control group).
Comparisons: Researchers will compare all 3 groups among them to see to what extent:
- Komtü Programme shows efficacy in fostering children's well-being compared with the training and TAU (control group).
- Komtü Programme shows efficacy in fostering teachers' well-being compared with the training and TAU (control group).
- Training and reflective practice shows efficacy in fostering children's well-being compared with TAU (control group).
- Training and reflective practice shows efficacy in fostering teachers' well-being compared with TAU (control group).
And as for the secondary outcomes, researchers will also compare all 3 group to observe possible inter-group differences.
Detailed description
Context: Lately, mental health has become an important issue of global priority, especially when it comes to child and youth population. Acting during this stage of life is crucial, as the symptomatology of some mental disorders present in adulthood could start before the age of 14 in 33.3% to 50% of cases. It seems that schools could be a great context to foster mental health, as children spend most of the day hours there. At school, children not only acquire academic knowledge, they also learn emotional and social competencies and, in this process, teachers can become a model for them. However, most of the school programmes that aim to enhance children's well-being are directly implemented with children, and few programmes are designed to work with teachers. Furthermore, when implementing a school programme, it is not usual to have a specialist within the school centre, that addresses teacher's worries and accompanies them through the programme completion. That is why Nous Cims Private Foundation decided to create the Komtü programme, which aims to impact children's well-being by accompanying teachers during 3 school years by a specialist that visits the centre twice a week. As this programme is relatively new, the researchers in this study intend to: (1) analyse the benefits of Komtü programme and, considering that this is a long-term programme, (2) the investigators want to study the effectiveness of a more cost-efficient approach by only implementing the training and reflective practice associated with the programme.
Methodology: 8-month 3-armed quasi-experimental pre-post design with control group.
Measures Operationalization: It is expected that Komtü programme could benefit teachers who receive the intervention and their students, since they share a lot of classroom time. Teacher benefits are expected in terms of higher emotional well-being (primary outcome) but also in terms of higher sense of self-efficacy, higher assertiveness and improved mentalizing capacities (secondary outcomes). Children benefits are expected in terms of higher emotional well-being (primary outcome) but also in terms of mentalization, prosocial behaviour and self-esteem (secondary outcomes). We will also consider teachers' burnout and faculty trust as process outcomes since they can impact teacher's well-being.
Statistical Analyses: The analysis will encompass all participants, with the utilization of multiple imputation techniques to address any missing data. Estimation of parameters, accounting for the specific statistical assumption of each model and the data's characteristics, will be carried out using general linear modelling adjusting for baseline values. Various Stata packages will be employed to execute these models, primarily SPSS and jamovi. Concerning statistical power, a sample size of 90 teachers (30 per arm) and 180 students (90 per arm) has been proposed as the minimum required to detect a medium effect size (d=0.50) -in case of teachers- and small effect size (d =0.30) -in case of students- in the design comprising 3 arms, 2 repeated measures (pre-post), and a power level of 0.80.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Quasi-experimental pre-post design with control group
| Arm | Type | Receives |
|---|---|---|
| Komtü Programme (Komtü) | Experimental | Behavioral: Komtü Programme (Komtü)The Komtü is a programme that aims to enhance the well-being and the emotional support of children by providing training and support to the entire school community, with a particular focus on teachers. The Komtü programme comprises two distinct phases: the first, the Implementation Phase, is conducted over a period of three school years. During this phase, a specialist visits the school twice a week during the 1st and 2nd school years, and once a week during the 3rd school year. Some actions take place during this phase. For example, the specialist will provide training with reflective practice exercises, healing spaces and support for teachers and will also provide coaching for the school management team. The second phase, the Sustainability Phase, is also conducted over three school years. This phase is designed as a follow-up phase, which is meant to ensure the continuity of the programme at the school even in the absence of the specialist's weekly visits from the centre. |
| Komtü Training and Reflective Practice | Experimental | Behavioral: Komtü Training and Reflective PracticeThis is a different version of the Komtü Programme that aims to enhance the well-being and the emotional support of children. In Komtü Training and Reflective Practice, the Implementation Phase is modified. The 1st school year, the specialist will only provide training with reflective practice exercises. This means, the other actions that are usually carried out by the programme will not be offered. In contrast to the original version, this would reduce the cost of the intervention and allow a greater number of schools to participate in the programme, as the specialist would have the time to intervene in more centres. It has been decided to prioritise training with reflective practice exercises as it is the core component that gives meaning to the functioning of the other activities that are developed throughout the programme. |
| Control group or Treatment as usual (TAU) | No intervention | –The school year will be developed as normal. |
Who may qualify
- Ages
- 9 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Teachers at public school (6 y.o. - 12 y.o.) or preschool (3 y.o. - 6 y.o.) in active
- Students from 4th, 5th and 6th grade of Primary School (9 - 12 y.o.)
- Understanding Catalan
- Written Informed Consent
Key exclusion criteria (4 listed)
- Teachers at private or charter schools.
- Teachers at rural schools.
- Preschool students (3-y.o. - 6 y.o.) and students from 1st, 2nd and 3rd grade of Primary School (6 y.o. - 8 y.o.).
- Schools that already have any training/knowledge related to emotional support or emotional intelligence.
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 |
|---|---|---|
| Komtü Programme (Komtü)Also: KomtüMainly, 4 actions will take place: * Training with reflective practice exercises. This is a 32-hours group training involving 21 sessions that last 60 minutes and 11 hours of inter-sessions work. The contents of the training will be 5 of the 10 total blocks of Komtü training: Block 1: Meeting, observing and listening; Block 2: Neuroscience applied in the educational context; Block 3: High- quality relationships; Block 4: Conflict management; Block 5: Boundary management * Healing spaces to generate a collective restorative experience, offering tools that facilitate emotional management * Individual support for teachers to offer them resources, tools, and intervention strategies to help improve educational practice and the emotional and relational well-being of the school community * Coaching for the school management team to help them establish some objectives together and offer them the necessary resources and tools so that they can achieve them successfully. | Behavioural | Komtü Programme (Komtü) |
| Komtü Training and Reflective PracticeThis is a 32-hours group training involving 21 sessions that last 60 minutes and 11 hours of inter-sessions work. The contents of the training will be 5 of the 10 total blocks of Komtü training: Block 1: Meeting, observing and listening; Block 2: Neuroscience applied in the educational context; Block 3: High- quality relationships; Block 4: Conflict management; Block 5: Boundary management No other actions will take place in this group. | Behavioural | Komtü Training and Reflective Practice |
Primary outcome
Stirling Children's Well-Being Scale (SCWB)
Time frame: Through study completion, an average of 8 months
This is a 15-item scale commonly used to measure children's happiness in the last 2 weeks. Items are scored from '1 = Never' to '5 = All the time'. The score ranges from 15 to 75. A higher score means more happiness (better outcome).
Child Well-being Level (CWBL)
Time frame: Through study completion, an average of 8 months
This is Likert's 7-point scale to assess the child's level of happiness compared with other children of the same age. It is responded by children. It ranges from '1 = Very less happy' to '7 = Very happier'. A higher score means more happiness (better outcome).
Child Well-being Level - Teacher's version (CWBL-T)
Time frame: Through study completion, an average of 8 months
This is Likert's 7-point scale to assess the child's level of happiness compared with other children of the same age. It is responded by teachers. It ranges from '1 = Very less happy' to '7 = Very happier'. A higher score means more happiness (better outcome).
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: Through study completion, an average of 8 months
This is a 14-item scale commonly used to measure mental well-being in general population in the last 2 weeks. Items are scored from '1 = None of the time' to '5 = All of the time'. The score ranges from 14 to 70. A higher score means more well-being (better outcome).
Teacher's Subjective Well-being Scale (TSWBS)
Time frame: Through study completion, an average of 8 months
This is a 8-item scale used to measure teacher's subjective well-being according to 2 sub-scales: teaching efficacy (4 items) and school connectedness (4 items). Items are scored in 4-points Likert scale ranging from '1 = Almost never' to '4 = Almost always'. The score ranges from 8 to 32. A higher score means more well-being (better outcome).
7 secondary outcomes
Bar-On Emotional Quotient Inventory: Youth Version (BarOn EQ-i: YV)
Time frame: Through study completion, an average of 8 months
Self-Other Mentalization Scale (SOMS)
Time frame: Through study completion, an average of 8 months
Rosenberg's Self-Esteem Scale - Child version (RSES-C)
Time frame: Through study completion, an average of 8 months
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Through study completion, an average of 8 months
Mentalization Scale (MentS)
Time frame: Through study completion, an average of 8 months
Teacher Self-Efficacy Scale - Short Form (TSES-S)
Time frame: Through study completion, an average of 8 months
Self-reports of Assertive Behaviour: Attitudes and Values in Social Interactions (ADCAs)
Time frame: Through study completion, an average of 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Komtü Programme website (English not available)Link provided by the sponsor.
- Nous Cims Private Foundation website (English version)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Sergi Ballespí, PhD study director
Universitat Autònoma de Barcelona (UAB)
Elena Gervilla, PhD study director
Universitat de les Illes Balears (UIB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Komtü Programme (Komtü) and Komtü Training and Reflective Practice in people with Psychological Well-Being and Mental Health Wellness, run by Universitat Autonoma de Barcelona at 1 site in Spain.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 16 Oct 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 Spain. 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?
Results are not available in the source record.
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?
Stirling Children's Well-Being Scale (SCWB) (time frame: Through study completion, an average of 8 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.