NCT07093645

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

7 months

First QC Date

May 16, 2025

Last Update Submit

July 22, 2025

Conditions

Keywords

socioemotional competencesinclusionadolescencewell-beingschool well-beingstudent burnout

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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)

    Three measurement points: T1 (one week before intervention "baseline"), T2 (after intervention, eight weeks after T1) and T3 (follow-up, three months after T1).

Study Arms (2)

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.

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.

Interventions

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.

Playing serious game and using didactic material at school

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, Valencia, Spain

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Konstanze Schoeps

    University of Valencia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstanze Schoeps

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Personality, Evaluation and Psychological Treatments

Study Record Dates

First Submitted

May 16, 2025

First Posted

July 30, 2025

Study Start

February 20, 2025

Primary Completion

September 15, 2025

Study Completion

December 20, 2025

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations