Mental Health PromotionNCT06131229
Two Tutorial Action Programs, Incidental and Structured, on the General Welfare of Elementary School Students.
A study testing Structured emotional education program (PEE) and Incidental tutorial action based on the school's regular curriculum (PCO) in people with Mental Health Promotion and Emotional Intelligence, run by OIHANA SAGASTI ARRIEN at 1 site in Spain.
Trial summary
The aim of this paper is twofold: on the one hand, to test the effectiveness of a structured emotional education program in second, third and fourth grade primary school students and, on the other hand, to test the differential effect of such a program in relation to an incidental tutorial action focused on the… Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Promotion, Emotional Intelligence, Self-Concept
- What is being tested?
- Structured emotional education program (PEE) and Incidental tutorial action based on the school's regular curriculum (PCO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2023to 9 Dec 2024
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age from 7 to 10 years.
- To be enrolled in Lauro School.
- To be in second, third or fourth grade of elementary school.
Who cannot join
- Any physical or psychological condition incompatible with the intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emotional Education Program for the Promotion and Prevention of Mental Health in 2nd, 3rd and 4th Grade Primary School Students (ULERTUZ)
The aim of this paper is twofold: on the one hand, to test the effectiveness of a structured emotional education program in second, third and fourth grade primary school students and, on the other hand, to test the differential effect of such a program in relation to an incidental tutorial action focused on the ordinary school curriculum. A randomized controlled trial is proposed in Lauro Ikastola with three experimental groups (second, third and fourth of primary education) and three active control groups (one for each of the three courses) with pretest and posttest and with the duration of a school year.
Read the detailed description
The implementation of emotional education in educational centers is increasingly necessary for the promotion of a complete state of physical, mental and social well-being in children throughout the entire educational stage, and especially in early stages of development.
The present work aims at a double verification. On the one hand, it is intended to test the effectiveness of a structured program of emotional education in second, third and fourth grade of primary education and, on the other hand, to test the differential effect of this program in relation to an incidental tutorial action based on the ordinary school curriculum. A randomized controlled trial is proposed in Lauro Ikastola with three experimental groups (second, third and fourth year of primary education) and three active control groups (one for each of the three courses) with pretest and posttest and with the duration of a school year.
The general objective of the proposal is the promotion of the emotional well-being of children in a particularly turbulent stage of the school cycle (2nd, 3rd and 4th grades of Primary Education) and the prevention of behavioral and/or emotional problems that may arise in later stages. The specific objectives to be achieved through the intervention in the priority population are the improvement in the following aspects: 1) Emotional intelligence; 2) Self-concept; 3) Socialization; 4) Emotional problems (depression and anxiety); 5) Behavioral problems (anger control, behavioral problems and impulsivity); and 6) Contextual problems (problems among peers).
The total sample is made up of 157 primary school students from Lauro Ikastola HLBHIP, a private school for infant, primary, secondary and high school education (municipality of Lujua, Vizcaya). From each of the three grades for which the program is intended (2nd, 3rd and 4th), two classes per grade will be selected by accessibility, which will be randomly assigned to the control group (CG) or the experimental group (GE). The emotional education program (ULERTUZ) will be applied to the experimental group and the control group will follow the academic curriculum provided by each school for each school year. The main measurement instruments will be the the Bar-On Emotional Intelligence Inventory EQ-I:YV, the Socialization Battery (BAS 2), the System for the Assessment of Children and Adolescents (SENA) and the Beck Inventory for Children and Adolescents-2 (BYI-2).
- Conditions
- Mental Health Promotion, Emotional Intelligence, Self-Concept, Emotional and Behavioral Problems, Social and Emotional Development
- Being tested
- Structured emotional education program (PEE), Incidental tutorial action based on the school's regular curriculum (PCO)
- Keywords
- Emotional education, School-Based Intervention, Social and Emotional Learning, Primary School Children
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured emotional education program (PEE)Behavioural
The principal investigator, together with the class-tutor of the experimental groups, conducts the 20 activities of which the program is composed during the hour dedicated to tutorial action. The sessions are held at Lauro School on Monday mornings in the respective classrooms, with the possibility of using the courtyard and other multipurpose rooms if the activities so require. Each session lasts one hour and is held throughout the school year 23-24.
Incidental tutorial action based on the school's regular curriculum (PCO)Behavioural
One hour tutorial action per week according to the regular school curriculum. This curriculum contemplates the incidental approach to the problems that arise in daily life and the work with the KIVA program.
| Study group | Role | What they receive |
|---|---|---|
| Structured emotional education program (PEE) | Experimental | A tutorial action focused on a structured program of emotional education with 20 activities divided into 5 blocks with specific objectives. The program involves 36 hours of group work, one per week in the tutoring hour, throughout the 23-24 school year. Receives: Behavioral: Structured emotional education program (PEE) |
| Incidental tutorial action based on the school's regular curriculum (PCO) | Active comparator | An incidental tutorial action focused on the ordinary school curriculum for the 23-24 school year. Receives: Behavioral: Incidental tutorial action based on the school's regular curriculum (PCO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in emotional intelligence
Bar-On EQ-I:YV. BarOn Emotional Intelligence Inventory: youth version. Spanish version Age of application: 7 to 18 years old. The inventory is composed of 60 items to assess emotional intelligence and its different socioemotional components by means of several scales (Intrapersonal, Interpersonal, Adaptability, Stress Management and General Mood), in addition to providing an index of total Emotional Intelligence. It has two response control scales (Inconsistencies and Positive Impression), can be applied in individual or group format and lasts approximately 20-25 minutes.
Measured: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in self-concept
BYI-2, Beck Inventories for Children and Adolescents-2. Spanish adaptation. The Beck Child and Adolescent Inventories-2 (BYI-2) are five questionnaires published by Pearson and aimed at the assessment of depression, anxiety, anger, disruptive behavior, and self-concept in children and adolescents aged 7 to 18 years and 11 months. They are short, self-administered questionnaires that can be used separately or combined, and are simple and quick to administer. Each inventory consists of 20 statements, formulated in the first person, about thoughts, feelings or behaviors related to emotional and social disorders, to be answered with a frequency scale of four options (Never = 0; Sometimes = 1; Often = 2; Always = 3). The application time is between 5 and 10 minutes for each inventory. In the present case, we will only use the Beck Self-Concept Inventory for Children and Adolescents (BSCI-Y).
Measured: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Secondary outcomes (4)
Change in in emotional problems: anxiety and depression
SENA. Child and Adolescent Assessment System (Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A. and del Barrio, V. 2015). The purpose of the SENA is the multi-source assessment of a broad spectrum of emotional and behavioral problems (depression, anxiety, hyperactivity and impulsivity, disruptive behavior, substance use, eating behavior problems, learning problems...), contextual problems (problems with family, school and peers), as well as areas of vulnerability (emotional regulation problems, isolation, rigidity...) and psychological resources (self-esteem, social integration and competence, emotional intelligence...). The age of application is from 3 to 18 years old and has 3 different levels depending on the age of the persons assessed .
Measured: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in behavioral problems: attention problems, hyperactivity-impulsivity and anger control problems
SENA. Child and Adolescent Assessment System (Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A. and del Barrio, V. 2015). The purpose of the SENA is the multi-source assessment of a broad spectrum of emotional and behavioral problems (depression, anxiety, hyperactivity and impulsivity, disruptive behavior, substance use, eating behavior problems, learning problems...), contextual problems (problems with family, school and peers), as well as areas of vulnerability (emotional regulation problems, isolation, rigidity...) and psychological resources (self-esteem, social integration and competence, emotional intelligence...). The age of application is from 3 to 18 years old and has 3 different levels depending on the age of the persons assessed .
Measured: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in contextual problems: peer problems and family problems
SENA. Child and Adolescent Assessment System (Fernández-Pinto, I., Santamaría, P., Sánchez-Sánchez, F., Carrasco, M. A. and del Barrio, V. 2015). The purpose of the SENA is the multi-source assessment of a broad spectrum of emotional and behavioral problems (depression, anxiety, hyperactivity and impulsivity, disruptive behavior, substance use, eating behavior problems, learning problems...), contextual problems (problems with family, school and peers), as well as areas of vulnerability (emotional regulation problems, isolation, rigidity...) and psychological resources (self-esteem, social integration and competence, emotional intelligence...). The age of application is from 3 to 18 years old and has 3 different levels depending on the age of the persons assessed .
Measured: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in socialization
BAS. Socialization Battery (Silva and Martorell, 1983). Version for parents (BAS-2). Age of application: 6 to 15 years old. These are rating scales in four facilitating dimensions of socialization (Leadership, Joviality, Social sensitivity and Respect-self-control), three disturbing ones (Aggressiveness-tertiality, Apathy-withdrawal and Anxiety-timidity) and a global scale of social adaptation or criterion-socialization. The BAS-2 is composed of 114 items.
Measured: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start2 Oct 2023
- Primary completion21 Jun 2024
- Study completion9 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health PromotionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- A randomized controlled trial of three experimental groups and three control groups is proposed, with pretest, posttest.
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- OIHANA SAGASTI ARRIEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, OIHANA SAGASTI ARRIEN, Oihana Sagasti
- Investigators
- OIHANA SAGASTI ARRIEN, PhDcandidate, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06131229
- Sponsor's protocol ID
- OSA-16054158C-23
- Status last verified
- Oct 2026
- First submitted
- 9 Nov 2023
- Last updated
- 20 Oct 2026
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotional Education Program for the Promotion and Prevention of Mental Health in 2nd, 3rd and 4th Grade Primary School Students (ULERTUZ)
- ClinicalTrials.gov ID
- NCT06131229
- Acronym / sponsor ID
- OSA-16054158C-23
- Conditions
- Mental Health Promotion, Emotional Intelligence, Self-Concept, Emotional and Behavioral Problems, Social and Emotional Development
- Keywords
- Emotional education, School-Based Intervention, Social and Emotional Learning, Primary School Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- OIHANA SAGASTI ARRIENUniversity, hospital or other
- Study start
- 2 Oct 2023 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- 9 Dec 2024 (actual)
- First posted
- 14 Nov 2023 (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 aim of this paper is twofold: on the one hand, to test the effectiveness of a structured emotional education program in second, third and fourth grade primary school students and, on the other hand, to test the differential effect of such a program in relation to an incidental tutorial action focused on the ordinary school curriculum. A randomized controlled trial is proposed in Lauro Ikastola with three experimental groups (second, third and fourth of primary education) and three active control groups (one for each of the three courses) with pretest and posttest and with the duration of a school year.
Detailed description
The implementation of emotional education in educational centers is increasingly necessary for the promotion of a complete state of physical, mental and social well-being in children throughout the entire educational stage, and especially in early stages of development.
The present work aims at a double verification. On the one hand, it is intended to test the effectiveness of a structured program of emotional education in second, third and fourth grade of primary education and, on the other hand, to test the differential effect of this program in relation to an incidental tutorial action based on the ordinary school curriculum. A randomized controlled trial is proposed in Lauro Ikastola with three experimental groups (second, third and fourth year of primary education) and three active control groups (one for each of the three courses) with pretest and posttest and with the duration of a school year.
The general objective of the proposal is the promotion of the emotional well-being of children in a particularly turbulent stage of the school cycle (2nd, 3rd and 4th grades of Primary Education) and the prevention of behavioral and/or emotional problems that may arise in later stages. The specific objectives to be achieved through the intervention in the priority population are the improvement in the following aspects: 1) Emotional intelligence; 2) Self-concept; 3) Socialization; 4) Emotional problems (depression and anxiety); 5) Behavioral problems (anger control, behavioral problems and impulsivity); and 6) Contextual problems (problems among peers).
The total sample is made up of 157 primary school students from Lauro Ikastola HLBHIP, a private school for infant, primary, secondary and high school education (municipality of Lujua, Vizcaya). From each of the three grades for which the program is intended (2nd, 3rd and 4th), two classes per grade will be selected by accessibility, which will be randomly assigned to the control group (CG) or the experimental group (GE). The emotional education program (ULERTUZ) will be applied to the experimental group and the control group will follow the academic curriculum provided by each school for each school year. The main measurement instruments will be the the Bar-On Emotional Intelligence Inventory EQ-I:YV, the Socialization Battery (BAS 2), the System for the Assessment of Children and Adolescents (SENA) and the Beck Inventory for Children and Adolescents-2 (BYI-2).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial of three experimental groups and three control groups is proposed, with pretest, posttest.
| Arm | Type | Receives |
|---|---|---|
| Structured emotional education program (PEE) | Experimental | Behavioral: Structured emotional education program (PEE)A tutorial action focused on a structured program of emotional education with 20 activities divided into 5 blocks with specific objectives. The program involves 36 hours of group work, one per week in the tutoring hour, throughout the 23-24 school year. |
| Incidental tutorial action based on the school's regular curriculum (PCO) | Active comparator | Behavioral: Incidental tutorial action based on the school's regular curriculum (PCO)An incidental tutorial action focused on the ordinary school curriculum for the 23-24 school year. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 7 to 10 years.
- To be enrolled in Lauro School.
- To be in second, third or fourth grade of elementary school.
Key exclusion criteria (1 listed)
- Any physical or psychological condition incompatible with the intervention
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 |
|---|---|---|
| Structured emotional education program (PEE)The principal investigator, together with the class-tutor of the experimental groups, conducts the 20 activities of which the program is composed during the hour dedicated to tutorial action. The sessions are held at Lauro School on Monday mornings in the respective classrooms, with the possibility of using the courtyard and other multipurpose rooms if the activities so require. Each session lasts one hour and is held throughout the school year 23-24. | Behavioural | Structured emotional education program (PEE) |
| Incidental tutorial action based on the school's regular curriculum (PCO)One hour tutorial action per week according to the regular school curriculum. This curriculum contemplates the incidental approach to the problems that arise in daily life and the work with the KIVA program. | Behavioural | Incidental tutorial action based on the school's regular curriculum (PCO) |
Primary outcome
Change in emotional intelligence
Time frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Bar-On EQ-I:YV. BarOn Emotional Intelligence Inventory: youth version. Spanish version Age of application: 7 to 18 years old. The inventory is composed of 60 items to assess emotional intelligence and its different socioemotional components by means of several scales (Intrapersonal, Interpersonal, Adaptability, Stress Management and General Mood), in addition to providing an index of total Emotional Intelligence. It has two response control scales (Inconsistencies and Positive Impression), can be applied in individual or group format and lasts approximately 20-25 minutes.
Change in self-concept
Time frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
BYI-2, Beck Inventories for Children and Adolescents-2. Spanish adaptation. The Beck Child and Adolescent Inventories-2 (BYI-2) are five questionnaires published by Pearson and aimed at the assessment of depression, anxiety, anger, disruptive behavior, and self-concept in children and adolescents aged 7 to 18 years and 11 months. They are short, self-administered questionnaires that can be used separately or combined, and are simple and quick to administer. Each inventory consists of 20 statements, formulated in the first person, about thoughts, feelings or behaviors related to emotional and social disorders, to be answered with a frequency scale of four options (Never = 0; Sometimes = 1; Often = 2; Always = 3). The application time is between 5 and 10 minutes for each inventory. In the present case, we will only use the Beck Self-Concept Inventory for Children and Adolescents (BSCI-Y).
4 secondary outcomes
Change in in emotional problems: anxiety and depression
Time frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in behavioral problems: attention problems, hyperactivity-impulsivity and anger control problems
Time frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in contextual problems: peer problems and family problems
Time frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline
Change in socialization
Time frame: Baseline 1 week before treatment, Post-treatment 8 months from 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 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Mental Health Promotion
Active, not recruiting
Preventing Anxiety and Depression in Older Hispanics
Depression, Anxiety
Recruiting
Project Q: Cue-based Treatment Intervention to Promote Cessation Among People Who Smoke Lightly or Non-daily
Tobacco Use Disorder
Not yet recruitingEarly Phase 1
reALIGNing Circadian Rhythm and Promoting Sleep in the Intensive Care Unit
Sleep, Circadian Dysregulation
Active, not recruiting
Effectiveness of the Self-Control Module of a Positive Mental Health Promotion Programme for Adult Informal Caregivers of People With Dementia: Protocol for a Randomised Controlled Trial
Mental Health
Recruiting
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
Postpartum Depression, Postpartum Anxiety
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.
OIHANA SAGASTI ARRIEN, PhDcandidate principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured emotional education program (PEE) and Incidental tutorial action based on the school's regular curriculum (PCO) in people with Mental Health Promotion and Emotional Intelligence, run by OIHANA SAGASTI ARRIEN 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 3 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 20 Oct 2026. 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?
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?
Change in emotional intelligence (time frame: Baseline 1 week before treatment, Post-treatment 8 months from baseline). The study lists 2 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 20 Oct 2026.