Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06488833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-21
Brief Title:
Evaluation of First Year Implementation of Komtü Programme to Improve Emotional Well-being in School
Sponsor:
Universitat Autonoma de Barcelona
Organization:
Universitat Autonoma de Barcelona
Study Overview
Official Title:
Evaluation of First Year Implementation of Komtü Programme to Improve Childrens Emotional Well-being in Pre-school and Primary School
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives 1 To analyse the benefits of Komtü Programme implementation in childrens and teachers well-being primary outcomes 2 to analyse the benefits of Komtü Programme implementation in teachers assertiveness mentalization and self-efficacy secondary outcomes 3 and to analyse the benefits of Komtü Programme implementation according to childrens prosocial behaviour self-esteem and mentalization secondary outcomes
Participants Teachers will be placed in one of the 3 groups according to the schools 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 childrens 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 childrens 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
Participants Teachers will be placed in one of the 3 groups according to the schools 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 childrens 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 childrens 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 333 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 childrens 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 teachers 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 childrens 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 teachers 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 datas 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 d050 -in case of teachers- and small effect size d 030 -in case of students- in the design comprising 3 arms 2 repeated measures pre-post and a power level of 080
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 teachers 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 datas 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 d050 -in case of teachers- and small effect size d 030 -in case of students- in the design comprising 3 arms 2 repeated measures pre-post and a power level of 080
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None