Active — Not RecruitingNot Applicable

SCIENCE DES ÉMOTIONS : Evaluation of a Psychosocial Skills Development Program for Middle School Students

France2,500 participantsStarted 2025-07-01

Plain-language summary

The goal of this Quasi-experimental cluster randomized trial is: * 1a. Primary purpose: to determine the feasibility of the "Science des Emotions" curriculum through a participatory and translational research methodology, involving educators in evaluating programme fidelity, acceptability, perceived usefulness, and overall experience through quantitative and qualitative measures. * 1b. Primary purpose: to assess the feasibility of the "Science des Emotions" curriculum from students' perspectives, including feasibility, acceptability, perceived usefulness, and overall experience, using quantitative and qualitative measures. * 1c. Primary purpose: to determine whether the "Science des Emotions" curriculum improves psychosocial skills, emotional awareness, and adaptive emotion regulation strategies among 6th- and 7th-grade students. * 2a. Secondary purpose: to determine whether the programme affects peer relationships, perceived closeness with classmates, and problematic behaviours among students. * 2b. Secondary purpose: to determine whether the programme improves classroom climate reported by educators. * 2c. Secondary purpose: to determine whether the programme improves educators' psychosocial skills and emotional awareness. * 2d. Secondary purpose: to examine whether improvements in emotional awareness mediate the effect of the programme on educators' psychosocial skills. * 2e. Secondary purpose: to examine whether improvements in emotional awareness and adaptive emotion regulation mediate the effect of the programme on students' psychosocial skills. * 2f. Secondary purpose: to explore moderating factors of programme effectiveness, including students' behavioural difficulties and socio-economic background. * 2g. Secondary purpose: to evaluate programme implementation through session-level assessments of clarity, feasibility, satisfaction, and visual materials completed by educators after each session. Changes in knowledge related to emotions and emotion regulation will also be assessed among students and educators. This analysis will support recommendations for large-scale implementation and public policy. Participants Educators and educational staff delivering the programme (n = 100) Students aged 10-13 participating in the programme (n = 2400) Measures Primary objectives * Students (both arms) will complete psychosocial skills, emotion regulation, and emotional awareness measures at pre-test (t0), post-test (t1), and 5-month follow-up (t2). * Students in the intervention arm will complete a post-programme questionnaire assessing satisfaction, perceived usefulness, and acceptability, and may participate in a semi-structured interview assessing feasibility, usefulness, and overall experience. * Educators in the intervention arm will complete a post-programme questionnaire assessing implementation fidelity and perceived usefulness, and may participate in a semi-structured interview assessing acceptability, usefulness, and overall experience. Secondary objectives * Students (both arms) will complete peer relationship, perceived closeness, problematic behaviour, and socio-demographic measures. * Educators (both arms) will complete classroom climate, psychosocial skills, emotional awareness, and knowledge questionnaires at t0, t1, and t2. Schools will also provide absenteeism and behavioural data. * Students (both arms) will complete an ad hoc knowledge questionnaire at t0, t1, and t2. * Educators in the intervention arm will complete session-level feasibility, clarity, and satisfaction measures after each session.

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Youth participants must meet all of the following criteria: * Be enrolled in 6th or 7th grade in a school within the Créteil or Paris Districts * Have parental authorization * Provide written informed consent, as appropriate * Be able to speak and understand French Staff participants must meet all of the following criteria: * Be part of the educational staff in a school within the Créteil or Paris Districts * Provide written informed consent Exclusion Criteria: Youth participants: * Students with diagnosed severe neurodevelopmental or psychiatric disorders preventing participation in mainstream classroom activities * SEGPA students (specialized adapted general and vocational education sections) * Allophone students (recent non-French-speaking arrivals) * Deaf students No student is excluded from participating in the "Science des Emotions program itself, nor from completing the questionnaires (unless parental authorization is missing). The exclusions apply only to data analysis, in order to avoid any form of stigmatization or perception of exclusion. Staff participants : none

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Educators' Implementation Fidelity and Perceived Usefulness Assessed by a Study-Specific Questionnaire

Timeframe: Immediately post-intervention (approximately 8 months after baseline).

Educators' Acceptability, Perceived Usefulness, and Overall Experience Assessed by Semi-Structured Interviews

Timeframe: Immediately post-intervention (approximately 8 months after baseline).

Students' Satisfaction, Perceived Usefulness, and Acceptability Assessed by a Study-Specific Questionnaire

Timeframe: Immediately post-intervention (approximately 8 months after baseline).

Students' Faisability, Perceived Usefulness, and Overall Experience Assessed via Semi-Structured Interviews

Timeframe: Immediately post-intervention (approximately 8 months after baseline).

Student Psychosocial skills Assessed by the Psychosocial skills scale

Timeframe: Baseline, immediately post-intervention (approximately 8 months), and 5 months post-intervention (approximately 13 months from baseline)

Students' Emotion Regulation Assessed by the Contextualized Emotion Regulation Survey for Adolescents (CERSA)

Trial details

NCT IDNCT07686874

SponsorUniversity Paris 8 Vincennes Saint Denis

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-20

View on ClinicalTrials.gov More Feasibility Studies - Efficacy of Intervention Psychosocial Skills Learning trials