An interventional study of FEEL GOOD in Child Behavior, Life Skill Development and School Health, sponsored by Université Paris Cité. Recruiting at 1 site in France. Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Université Paris Cité · Not applicable, Interventional, and Prevention
Life skills are major determinants of health that can be influenced through health promotion initiatives. Numerous educational interventions exist to foster the development of life skills. However, few interventions have been validated in France. The Feel Good program has been implemented for six years by CRIPS Île-de-France, particularly to address these public health challenges related to promoting children's health. Its goal is to improve life skills and the school climate among children in the 4th and 5th grades (CM1 and CM2). A playful, interactive, and recurring approach to developing PSS at school is expected to effectively promote a positive school climate and enhance children's well-being at school.
The main objective of this study is to evaluate the effectiveness of a school-based life skills development program in improving school climate and children's well-being, through a before-after, here-elsewhere (control group) design.
This action-research project adopts an interdisciplinary approach and will use mixed methods to evaluate the intervention. Three components are planned: 1) the study of implementation, 2) the effectiveness evaluation (main objective), and 3) the development of recommendations for the development and evaluation of such interventions. A theoretical model of change has been developed for the effectiveness study, aligned with process data. The project has received ethical and regulatory approvals (UPC and Inserm), and a pilot study has already been conducted. The expected outcomes include scientific knowledge on the validity of health promotion programs based on the development of life skills for children. The project also aims to develop research methodologies for evaluating health promotion interventions (evidence-based data) and to establish recommendations (replicability), as well as for other themes or populations (transferability).
Main Research Hypothesis: A playful, interactive, and repeated life skills development program in schools, co-designed with socio-educational stakeholders, will be effective in promoting positive school climate and children's well-being at school.
Specific Research Hypotheses:
Primary Objective: Evaluate the effectiveness of a school-based life skills development intervention (4th and 5th grade) for improving school climate and children's well-being (STEP 2).
Specific Objectives:
Step 1: Process study (objectives 1 and 2) Type of study: Mixed-method study including: a quantitative step analyzing process indicators (fidelity, dose, adaptation, reach) and economic consideration of costs inherent to implementation. A qualitative step studying implementation contexts, reception (including understanding), acceptability, feasibility, and satisfaction among stakeholders. This qualitative step has already been carried out and a scientific article is in the process of submission.
Methodological framework: Medical Research Council (MRC) on Process Evaluation of Complex Interventions, Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines in the context of qualitative studies, and Consolidated Framework for Implementation Research (CFIR).
Step 2: Effectiveness study of the action (main objective) Type of study: Pre-post, here-elsewhere study to evaluate the effectiveness of the intervention, by measuring and monitoring the health determinants of the theoretical change model associated with the Feel Good intervention. Intervention group: children receiving the 10 sessions of the Feel Good intervention in Ile-de-France (n=1500) / Control group: children not receiving the intervention (n=1500), in Ile-de-France with similar characteristics for comparability (schools, classes, geographical areas).
Methodological framework: MRC recommendations regarding complex public health interventions.
Step 3: Implementation and evaluation recommendations for such actions (objective 3) Type of study: Consensus study for developing recommendations for implementation and evaluation practices of life skills development actions in schools, following the Delphi method.
Measures and data collection: Development of guidelines in two rounds:
Questionnaire development based on evaluation data (Steps 1-2) and a literature review.
The questionnaire will be structured around: i) life skills intervention development and implementation modalities in schools (including recommendations for using the Feel Good intervention), ii) modalities/recommendations for full evaluation (process, effectiveness) of PPS interventions in schools.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →Université Paris Cité is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Group receiving life skills development intervention
Behavioral: FEEL GOOD
Group that does not receive life skills development intervention
The Feel Good intervention has been implemented for 6 years with a child population. The intervention is based on a validated intervention : the Well-Being and School Climate program (BECS). It is built on scientific contributions from Positive Psychology research, tested and validated in several United Kingdom schools. Ten 1-hour sessions are conducted with 4th and 5th grade children, with themed sessions such as: Developing strengths and observing the diversity of strengths in class / Learning and applying principles of empathetic listening to improve social relationships / Identifying emotions and exploring their role. Sessions are co-facilitated by a CRIPS facilitator and a trained teacher. Three parent workshops are offered.
Life skills
Life skills measured by Psychosocial Skills Measurement Scale For the Psychosocial Skills Measurement Scale developed by Tessier, no validated universal cut-off scores have been established to classify psychosocial skills as low, moderate, or high. Scores are therefore interpreted continuously, with higher scores generally indicating a more frequent use or stronger expression of the psychosocial skills assessed.
Time frame: Day 1 of participation (just before the start of the intervention); 2 weeks after the end of the intervention (intervention duration = 2 months); 6 months after the intervention.
Well-being at school
Well-being at school measured by the Multidimensional Students' Life Satisfaction Scale (MSLSS) The MSLSS assesses students' life satisfaction across five domains (family, friends, school, living environment, and self); the higher the score, the greater the level of life satisfaction perceived by the student, although there are no universal cut-off points for defining low, moderate, or high levels of satisfaction.
Time frame: Day 1 of participation (just before the start of the intervention); 2 weeks after the end of the intervention (intervention duration = 2 months); 6 months after the intervention.
School climate
School climate measured by Elementary School Class Social Climate Scale (EMCCE), subscales "Frictions" and "Engagement and school involvement" There are no established universal cut-off scores for the EMCCE subscales "Frictions" and "Engagement and school involvement"; higher scores on Frictions indicate more negative classroom interactions, whereas higher scores on Engagement and school involvement indicate a more positive level of student engagement and involvement.
Time frame: Day 1 of participation (just before the start of the intervention); 2 weeks after the end of the intervention (intervention duration = 2 months); 6 months after the intervention.
Plan to share: Undecided
Started Jan 2026 (actual). Primary completion is estimated for Jan 2027, 12 months after the start.
Of 140 non-industry interventional studies with no phase under Child Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 12 months is below that.
Counting every sponsor, half of 141 studies reached it within 20 months; a quarter within 8 and three quarters within 41.
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