- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07804940
Improving School Climate and Children's Well-being Through the Life Skills "Feel Good" Intervention in French Schools: A Controlled Before-and-After Study (FEEL GOOD)
Implementation and Evaluation of a Health Intervention to Develop Life Skills in Schools to Improve the School Climate and Children's Well-being
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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:
- A playful, interactive, and repeated life skills development program in schools will have specific implementation conditions related to the children's contexts and the National Education, involving specific actors and program components;
- This life skills development intervention will reach a large number of students, ensuring satisfaction among children and stakeholders, while also identifying recommendations for content and implementation improvements;
- Pragmatic consensus-based recommendations will support child health stakeholders in designing, implementing, and evaluating life skills development programs in schools.
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:
- Evaluate the processes and feasibility elements of a school-based life skills development intervention to improve school climate and well-being (STEP 1);
- Assess the reach, the satisfaction, and adaptation proposals from stakeholders (children, teachers, parents) regarding the implemented intervention, based on existing data or interviews with participants (STEP 1);
- Develop recommendations/guidelines for designing, implementing, and evaluating interventions of this type (STEP 3).
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.
- Delphi survey among stakeholders (field actors, researchers, decision-makers, others).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Philippe MARTIN, PhD Public Health
- Número de teléfono: +33676606491
- Correo electrónico: philippe.martin@inserm.fr
Ubicaciones de estudio
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Paris, Francia
- Reclutamiento
- CRIPS Ile-de-France
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Contacto:
- Alexia THEODOSIOU, Master degree Psychology
- Número de teléfono: +33607163865
- Correo electrónico: atheodosiou@lecrips.net
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children enrolled in grades 4 or 5 during the 2025-2026 school year who will participate in the Feel Good intervention (for pre- and post-program implementation)
- Children who are able to read and answer the questions on the questionnaire
- French-speaking children.
Exclusion Criteria:
- Children not enrolled in grades 4 or 5 during the 2025-2026 school year who will participate in the Feel Good intervention (for pre- and post-program assessments)
- Children who are not able to read and answer the questions on the questionnaire
- Non French-speaking children.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Intervention group
Group receiving life skills development intervention
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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.
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Sin intervención: Control group
Group that does not receive life skills development intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Life skills
Periodo de tiempo: 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.
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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. |
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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Well-being at school
Periodo de tiempo: 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.
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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. |
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.
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School climate
Periodo de tiempo: 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.
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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. |
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.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Philippe MARTIN, PhD Public Health, Université Paris Cité, Inserm
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Université Paris Cité, Inserm
- IReSP-AAP SIP 2024 - 345601 (Otro número de subvención/financiamiento: IRESP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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