None - Study is to Determine Safety in Healthy ParticipantsSEL4@llNCT07093645
Serious Game-Based School Intervention to Enhance Socio-Emotional Competence and Well-Being in European Adolescents
A study testing SEL4@ll in people with None - Study is to Determine Safety in Healthy Participants, run by University of Valencia at 1 site in Spain.
Trial summary
The goal of this study is to evaluate whether a digital, game-based social-emotional education intervention (SEL4@ll) can improve socio-emotional competencies, well-being, and inclusion in primary and secondary school students aged 10-16 across four European countries. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- None - Study is to Determine Safety in Healthy Participants
- What is being tested?
- SEL4@ll
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants must meet all of the following criteria to be included in the study:
- Be within the target age range (typically 10-16 years old, corresponding to 5th-6th grade of primary or 1st-4th year of secondary education).
- Have written informed consent provided by a parent or legal guardian.
- Complete all three measurement points (pre-test, post-test, and follow-up assessments).
- Attend school regularly (i.e., not chronically absent).
Who cannot join
- Participants will be excluded from the study if they:
- Do not obtain parental/legal guardian consent.
- Have significant cognitive, developmental, or language impairments that prevent them from understanding or completing the intervention or assessment tools.
- Are absent for a prolonged period during the implementation phase (e.g., due to illness, transfer, or other reasons).
- Participate in another intervention targeting similar outcomes during the study period, which may confound results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Promoting Well-being Among European Adolescents - an Inclusive and Digital Program to Strengthen Social-emotional Competences (SEL4@ll)
The goal of this study is to evaluate whether a digital, game-based social-emotional education intervention (SEL4@ll) can improve socio-emotional competencies, well-being, and inclusion in primary and secondary school students aged 10-16 across four European countries. The main questions it aims to answer are:
- Does participating in the SEL4@ll serious game increase students' socio-emotional competencies, such as self-awareness, empathy, and decision-making?
- Does the program enhance students' sense of well-being and social inclusion within the classroom environment?
Read more
Researchers will compare outcomes between students who participate in the SEL4@ll intervention and those in the control group who follow standard curricular activities to see if the game-based program leads to significant improvements.
Participants will:
- Play a serious game focused on five themed "portals" that develop emotional intelligence, leadership, gratitude, resilience, and justice.
- Complete questionnaires at three different time points (pre-, post-, and follow-up) to assess changes in competencies.
- Take part in focus groups (students) and provide implementation feedback (teachers).
- Engage in teacher-led activities and worksheets designed to support reflection and integration of SEL4@ll content.
Read the detailed description
SEL4@ll is an EU-funded, cross-national intervention designed to promote social-emotional learning (SEL) among primary and secondary school children using a serious game supported by pedagogical resources. The intervention aligns with the Collaborative for Academic, Social, and Emotional Learning (CASEL) framework and draws on evidence-based models of SEL, life skills development, character education, and positive youth development.
The serious game is the centerpiece of the intervention and is structured around five narrative "gates or portals," each of which targets three interrelated competencies:
Gate of Self: sense of meaning, resilience, leadership
Gate of Emotion: emotional intelligence, empathy, compassion
Gate of People: communication, gratitude, positive influence
Gate of Knowledge: motivation, growth mindset, critical thinking
Final Mission: equality, responsibility, justice
The game presents students as protagonists navigating magical environments to overcome a symbolic "dark force" by mastering SEL competencies, represented as branches of a "skill tree." The game is hosted online, accessible through a browser, and available in English, Spanish, Italian, German, and Finnish.
To facilitate educational integration, SEL4@ll provides a digital teacher handbook and didactic materials-including lesson plans and reflection worksheets-that help structure learning around the game content. Teachers play a vital role by guiding discussions and activities before and after gameplay.
The evaluation strategy includes both quantitative and qualitative components and follows a co-creation approach:
A three-wave design assesses students' development over time (pre-test, post-test, and delayed follow-up).
Quantitative measures include validated self-report questionnaires focused on SEL competencies, well-being, and perceived social inclusion.
Qualitative data are gathered through student focus groups and teacher interviews to explore experiences, perceptions, and implementation barriers.
Feedback from critical friends and stakeholders is used to iteratively refine the program materials and processes.
This study is conducted simultaneously in Germany, Spain, Italy, and Finland, allowing for a robust cross-cultural analysis of the intervention's effectiveness. Data will be analyzed both within and across countries to identify universal impacts and culturally specific outcomes, thereby informing future adaptation and scalability of the SEL4@ll model in broader European educational contexts.
This study is part of the Erasmus+ project "Promoting well-being among European adolescents: An inclusive and digital programme to strengthen socio-emotional competencies - SEL4@ll" and aims to contribute to evidence-based innovation in the transition form primary to secondary education by leveraging digital tools and inclusive pedagogy.
- Being tested
- SEL4@ll
- Keywords
- socioemotional competences, inclusion, adolescence, well-being, school well-being, student burnout
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEL4@llDevice
SEL4@ll is a school-based digital intervention targeting students aged 10-16 (Primary and Secondary Education). It combines: (1) a serious game with five missions promoting SEL skills (1/week), playable online at home or school; (2) a digital teacher handbook with classroom activities used 1-2 times per week; and (3) online surveys to assess impact. The program lasts 8 weeks: 2 weeks for pre/post assessments and 6 weeks of gameplay and classroom sessions. Surveys are administered online (3 waves), and optional focus groups are conducted with a subsample of students. Teachers complete an online evaluation after implementation.
| Study group | Role | What they receive |
|---|---|---|
| Playing serious game and using didactic material at school | Experimental | The experimental group will play the game and complete pre- and post-game evaluations, as well as a follow-up impact assessment. This will help assess the game's effectiveness in improving socio-emotional competencies and overall well-being. Receives: Device: SEL4@ll |
| Only assessment with serious games as the reward | No intervention | The control group will undergo the same evaluations as the experimental group, but will not play the game. They will receive the game as a reward after completing the assessments, allowing for a comparison of results between the two groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Skills Improvement System Social and Emotional Learning Brief Scales (Anthony et al., 2020)
The SSIS SEL Brief Scales is a 20-item questionnaire developed to assess social and emotional learning (SEL) competencies in children and adolescents. The items are organized into five domains that align with the core SEL areas defined by the CASEL framework (2020): self-awareness, self-management, social awareness, relationship skills, and responsible decision-making. Each item is rated on a 4-point Likert scale, from 1 (Not True) to 4 (Very True), resulting in a total score ranging from 20 (minimum) to 80 (maximum). Higher scores reflect stronger perceived social and emotional competencies.
Measured: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).
Secondary outcomes (2)
Questionnaire about student well-being (Hascher et al., 2018)
The questionnaire consists of 19 items rated on a 6-point Likert scale ranging from 1 (Never) to 6 (Very Often), and is designed to assess six dimensions of student well-being: positive attitudes toward school, enjoyment in school, worries in school, physical complaints in school, social problems in school, and positive academic self-concept. Each dimension is measured with three items, resulting in a minimum score of 3 and a maximum score of 18 per scale.
Three of the dimensions-positive attitudes toward school, enjoyment in school, and positive academic self-concept-are positive indicators, where higher scores reflect higher levels of well-being. The other three dimensions-worries in school, physical complaints in school, and social problems in school-are negative indicators, where higher scores indicate lower levels of well-being.
Measured: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).
Perception of Inclusion Questionnaire (Venetz et al., 2015)
The questionnaire consists of 12 items rated on a 4-point Likert scale, ranging from 1 (Not at all true) to 4 (Certainly true). It measures three key aspects of students' social inclusion at school: emotional self-inclusion (feeling accepted and valued), social inclusion (feeling part of the peer group), and academic self-concept (perception of one's own academic competence). Each dimension is assessed through four items, resulting in a minimum score of 4 and a maximum score of 16 per subscale, and a total score ranging from 12 (minimum) to 48 (maximum).
Higher scores reflect greater levels of perceived inclusion, indicating that the student feels more emotionally connected, socially integrated, and academically competent within the school environment.
Measured: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Jan 2026
- Primary completion30 May 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
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 None - Study is to Determine Safety in Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups: one experimental and one control. The experimental group will play the game and undergo pre- and post-game evaluations, as well as an impact evaluation some time after playing. The control group will undergo the same evaluations and will be offered the game as a reward.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Politècnica de València, University Of Perugia, University of Eastern Finland, University of Greifswald, European Union
- Responsible party
- Principal investigator, Konstanze Schoeps, University of Valencia
- Investigators
- Konstanze Schoeps, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093645
- Sponsor's protocol ID
- 2024-PSILOG-3715935
- Other IDs
- KA220-MV-22-36-89514
- Acronym
- SEL4@ll
- Status last verified
- Jul 2025
- First submitted
- 16 May 2025
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schoeps K, Postigo-Zegarra S, Signorelli A, Morganti A, Lozano-Quilis JA, Hoferichter F. SEL4@ll program for social and emotional development among European adolescents: a study protocol for a randomized controlled trial. BMC Psychol. 2025 Nov 28;13(1):1318. doi: 10.1186/s40359-025-03678-w.
PubMed 41316371
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Well-being Among European Adolescents - an Inclusive and Digital Program to Strengthen Social-emotional Competences (SEL4@ll)
- ClinicalTrials.gov ID
- NCT07093645
- Acronym / sponsor ID
- SEL4@ll / 2024-PSILOG-3715935
- Keywords
- socioemotional competences, inclusion, adolescence, well-being, school well-being, student burnout
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Universitat Politècnica de València, University Of Perugia, University of Eastern Finland, University of Greifswald, European Union
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 30 Jul 2025 (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 goal of this study is to evaluate whether a digital, game-based social-emotional education intervention (SEL4@ll) can improve socio-emotional competencies, well-being, and inclusion in primary and secondary school students aged 10-16 across four European countries. The main questions it aims to answer are:
- Does participating in the SEL4@ll serious game increase students' socio-emotional competencies, such as self-awareness, empathy, and decision-making?
- Does the program enhance students' sense of well-being and social inclusion within the classroom environment?
Researchers will compare outcomes between students who participate in the SEL4@ll intervention and those in the control group who follow standard curricular activities to see if the game-based program leads to significant improvements.
Participants will:
- Play a serious game focused on five themed "portals" that develop emotional intelligence, leadership, gratitude, resilience, and justice.
- Complete questionnaires at three different time points (pre-, post-, and follow-up) to assess changes in competencies.
- Take part in focus groups (students) and provide implementation feedback (teachers).
- Engage in teacher-led activities and worksheets designed to support reflection and integration of SEL4@ll content.
Detailed description
SEL4@ll is an EU-funded, cross-national intervention designed to promote social-emotional learning (SEL) among primary and secondary school children using a serious game supported by pedagogical resources. The intervention aligns with the Collaborative for Academic, Social, and Emotional Learning (CASEL) framework and draws on evidence-based models of SEL, life skills development, character education, and positive youth development.
The serious game is the centerpiece of the intervention and is structured around five narrative "gates or portals," each of which targets three interrelated competencies:
Gate of Self: sense of meaning, resilience, leadership
Gate of Emotion: emotional intelligence, empathy, compassion
Gate of People: communication, gratitude, positive influence
Gate of Knowledge: motivation, growth mindset, critical thinking
Final Mission: equality, responsibility, justice
The game presents students as protagonists navigating magical environments to overcome a symbolic "dark force" by mastering SEL competencies, represented as branches of a "skill tree." The game is hosted online, accessible through a browser, and available in English, Spanish, Italian, German, and Finnish.
To facilitate educational integration, SEL4@ll provides a digital teacher handbook and didactic materials-including lesson plans and reflection worksheets-that help structure learning around the game content. Teachers play a vital role by guiding discussions and activities before and after gameplay.
The evaluation strategy includes both quantitative and qualitative components and follows a co-creation approach:
A three-wave design assesses students' development over time (pre-test, post-test, and delayed follow-up).
Quantitative measures include validated self-report questionnaires focused on SEL competencies, well-being, and perceived social inclusion.
Qualitative data are gathered through student focus groups and teacher interviews to explore experiences, perceptions, and implementation barriers.
Feedback from critical friends and stakeholders is used to iteratively refine the program materials and processes.
This study is conducted simultaneously in Germany, Spain, Italy, and Finland, allowing for a robust cross-cultural analysis of the intervention's effectiveness. Data will be analyzed both within and across countries to identify universal impacts and culturally specific outcomes, thereby informing future adaptation and scalability of the SEL4@ll model in broader European educational contexts.
This study is part of the Erasmus+ project "Promoting well-being among European adolescents: An inclusive and digital programme to strengthen socio-emotional competencies - SEL4@ll" and aims to contribute to evidence-based innovation in the transition form primary to secondary education by leveraging digital tools and inclusive pedagogy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are two groups: one experimental and one control. The experimental group will play the game and undergo pre- and post-game evaluations, as well as an impact evaluation some time after playing. The control group will undergo the same evaluations and will be offered the game as a reward.
| Arm | Type | Receives |
|---|---|---|
| Playing serious game and using didactic material at school | Experimental | Device: SEL4@llThe experimental group will play the game and complete pre- and post-game evaluations, as well as a follow-up impact assessment. This will help assess the game's effectiveness in improving socio-emotional competencies and overall well-being. |
| Only assessment with serious games as the reward | No intervention | –The control group will undergo the same evaluations as the experimental group, but will not play the game. They will receive the game as a reward after completing the assessments, allowing for a comparison of results between the two groups. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Be within the target age range (typically 10-16 years old, corresponding to 5th-6th grade of primary or 1st-4th year of secondary education).
- Have written informed consent provided by a parent or legal guardian.
- Complete all three measurement points (pre-test, post-test, and follow-up assessments).
- Attend school regularly (i.e., not chronically absent).
Key exclusion criteria (5 listed)
- Do not obtain parental/legal guardian consent.
- Have significant cognitive, developmental, or language impairments that prevent them from understanding or completing the intervention or assessment tools.
- Are absent for a prolonged period during the implementation phase (e.g., due to illness, transfer, or other reasons).
- Participate in another intervention targeting similar outcomes during the study period, which may confound results.
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 |
|---|---|---|
| SEL4@llSEL4@ll is a school-based digital intervention targeting students aged 10-16 (Primary and Secondary Education). It combines: (1) a serious game with five missions promoting SEL skills (1/week), playable online at home or school; (2) a digital teacher handbook with classroom activities used 1-2 times per week; and (3) online surveys to assess impact. The program lasts 8 weeks: 2 weeks for pre/post assessments and 6 weeks of gameplay and classroom sessions. Surveys are administered online (3 waves), and optional focus groups are conducted with a subsample of students. Teachers complete an online evaluation after implementation. | Device | Playing serious game and using didactic material at school |
Primary outcome
Social Skills Improvement System Social and Emotional Learning Brief Scales (Anthony et al., 2020)
Time frame: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).
The SSIS SEL Brief Scales is a 20-item questionnaire developed to assess social and emotional learning (SEL) competencies in children and adolescents. The items are organized into five domains that align with the core SEL areas defined by the CASEL framework (2020): self-awareness, self-management, social awareness, relationship skills, and responsible decision-making. Each item is rated on a 4-point Likert scale, from 1 (Not True) to 4 (Very True), resulting in a total score ranging from 20 (minimum) to 80 (maximum). Higher scores reflect stronger perceived social and emotional competencies.
2 secondary outcomes
Questionnaire about student well-being (Hascher et al., 2018)
Time frame: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).
Perception of Inclusion Questionnaire (Venetz et al., 2015)
Time frame: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 41316371Schoeps K, Postigo-Zegarra S, Signorelli A, Morganti A, Lozano-Quilis JA, Hoferichter F. SEL4@ll program for social and emotional development among European adolescents: a study protocol for a randomized controlled trial. BMC Psychol. 2025 Nov 28;13(1):1318. doi: 10.1186/s40359-025-03678-w.
- Individual participant dataSharing planned: No
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.
Konstanze Schoeps principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEL4@ll in people with None - Study is to Determine Safety in Healthy Participants, run by University of Valencia 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 19 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Social Skills Improvement System Social and Emotional Learning Brief Scales (Anthony et al., 2020) (time frame: Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).). 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 NCT07093645, 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 19 May 2026.