Child BehaviorFEEL GOODNCT07804940
Improving School Climate and Children's Well-being Through the Life Skills "Feel Good" Intervention in French Schools: A Controlled Before-and-After Study
A study testing FEEL GOOD in people with Child Behavior and Life Skill Development, run by Université Paris Cité at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Behavior, Life Skill Development, School Health
- What is being tested?
- FEEL GOOD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Jan 2027
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CRIPS Ile-de-France
Paris
Alexia THEODOSIOU, Master degree Psychology, +33607163865, atheodosiou@lecrips.net
About this study
Official title: 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).
Read the detailed description
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).
- Conditions
- Child Behavior, Life Skill Development, School Health, School, Mental Health, Children
- Being tested
- FEEL GOOD
- Keywords
- Children, Well being, School, Life skills, Comparative study
- Medical subject headings
- Child Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEEL GOODBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Group receiving life skills development intervention Receives: Behavioral: FEEL GOOD |
| Control group | No intervention | Group that does not receive life skills development intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child BehaviorStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- Before-after, here-elsewhere (control group) design
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Paris Cité
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1123 ECEVE, APHP Robert Debré Public health department
- Responsible party
- Principal investigator, Philippe Martin, Université Paris Cité
- Investigators
- Philippe MARTIN, PhD Public Health, Principal investigator, Université Paris Cité, Inserm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804940
- Sponsor's protocol ID
- Université Paris Cité, Inserm
- Other IDs
- IReSP-AAP SIP 2024 - 345601
- Acronym
- FEEL GOOD
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Health Intervention to Develop Life Skills in Schools to Improve the School Climate and Children's Well-being
- ClinicalTrials.gov ID
- NCT07804940
- Acronym / sponsor ID
- FEEL GOOD / Université Paris Cité, Inserm
- Conditions
- Child Behavior, Life Skill Development, School Health, School, Mental Health, Children
- Keywords
- Children, Well being, School, Life skills, Comparative study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Université Paris CitéUniversity, hospital or other
- Collaborators
- INSERM U1123 ECEVE, APHP Robert Debré Public health department
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
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).
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Before-after, here-elsewhere (control group) design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: FEEL GOODGroup receiving life skills development intervention |
| Control group | No intervention | –Group that does not receive life skills development intervention |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| FEEL GOODThe 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. | Behavioural | Intervention group |
Primary outcome
Life skills
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.
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.
2 secondary outcomes
Well-being at school
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
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.
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 4 Sep 2026.
- Feel Good Intervention descriptionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Philippe MARTIN, PhD Public Health principal investigator
Université Paris Cité, Inserm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEEL GOOD in people with Child Behavior and Life Skill Development, run by Université Paris Cité at 1 site in France.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 France. 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?
Contact Philippe MARTIN, PhD Public Health (+33676606491, philippe.martin@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Life skills (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.