Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-01-08 @ 2:01 AM
Study NCT ID:
NCT06488833
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-16
First Post:
2024-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of First Year Implementation of Komtü Programme to Improve Emotional Well-being in School.
Sponsor:
Universitat Autonoma de Barcelona
Organization:
Study Overview
Official Title:
Evaluation of First Year Implementation of Komtü Programme to Improve Children's 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 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.
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.
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 Oversight
Has Oversight DMC:
False
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?: