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Mental HealthSMILENCT07800585

Mental Health and Innovation for French Higher-education Students

An observational study of Mental Health and Neurodevelomental Disorders, run by O-Kidia at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To fully grasp mental health, it is essential to understand and assess it by considering all the factors that affect it: family environment, school environment, emotional relationships, living conditions, social networks, etc. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health, Neurodevelomental Disorders
How many people
13,710 participants
Where
1 siteFrance
Study dates
21 Jul 2025to 18 Dec 2029
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 4,000 students across France during 3 years of their university studies (from 1 to 8 years post-baccalaureate)

Who may be able to join

  • Boys or girls
  • Students in higher education in France or its overseas territories
  • Possess a valid email address for contact related to University or higher education institution
  • Speak fluent French

Who cannot join

  • Does not speak fluent French (the platform is available in English but the study is primarily intended for French speakers).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vanessa Douet Vannucci, PhD contact

+33768717649

vanessa.douet@o-kidia.com

Lucie Pisella, PhD contact

+33673825798

clinic@o-kidia.com

France1 site, 1 recruiting

  • Université de la Côte d'Azur

    Nice, 06100

    Vanessa O-Kidia, +33768717649, vanessa.douet@univ-cotedazur.fr

    O-Kidia, clinic@o-kidia.com

    Recruiting

Other trials in France

About this study

Official title: The SMILE Protocol: a Longitudinal Study of Mental Health and Inherent Vulnerabilities of French Higher-education Students Through a Symptom-network Analysis

To fully grasp mental health, it is essential to understand and assess it by considering all the factors that affect it: family environment, school environment, emotional relationships, living conditions, social networks, etc.

The symptom network approach takes into account a network of overlapping, multi-layered interactions. These networks evolve over time and are constantly mediated by other nodes, i.e., symptoms, which allows for the identification of markers (vulnerabilities or comorbidities) and the establishment of the dynamics of causal mechanisms. Mental health is thus a sum of stable states within a dynamic network structure of symptoms.

Beyond determining prevalence, the SMILE project therefore aims for an analytical, network-based approach to symptoms of mental health and the inherent vulnerabilities of students through a self-administered questionnaire designed to examine various cognitive, emotional, social, and behavioral functions, and to address this new approach. The SMILE study could also help advance public health and identify the impact of university actions on the mental health of their own students.

Read the detailed description

The main objective of the SMILE study is to conduct a survey on the mental health and inherent vulnerabilities of the student population in France over the three years of higher education. More specifically, it aims to examine their health status, behaviors, perceptions, and practices, thereby addressing key scientific and societal questions.

Participants will be assessed using a single self-administered questionnaire. The collected variables will be analyzed using a symptom network approach that combines recurrent neural network algorithms and autotransformers. In parallel, subgroup analyses and correlations will be sought between responses and/or scores from the study questionnaires.

Beyond determining the prevalence of student mental health and inherent vulnerabilities during higher education, the SMILE study could contribute to advancements in public health and identify the impact of institutional actions on the mental health of their own students.

Several secondary objectives were defined:

  1. To describe subgroups of young people according to:
  • The intensity of behavioral skills (inattention and hyperactivity/impulsivity), and social skills as a measure of behavioral and emotional psychopathological traits;
  • Handedness preference;
  • The quality of life of young people based on their sleep capacity, behavior, and motivation/engagement.
  1. To identify relevant variables associated with their cognitive ability, socioeconomic status, and motivational capacities in order to analyze their interrelationships.
  2. To identify markers or risk factors for cognitive, emotional, and behavioral performance;
  3. To assess the relevance of such a survey for students. Associations and correlations will be sought between cognitive, emotional, and behavioral performance, as defined by the primary objective, and the various variables studied in the secondary objective above, using parametric or non-parametric techniques or multivariate regressions.
Keywords
non-interventional research, self-report questionnaire, France, machine learning, university students, symptom network, longitudinal cohort protocol, mental health
Medical subject headings
Psychological Well-Being

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adult ADHD Self-Report Scale (ASRS v1.1)

    The Adult ADHD Self-Report Scale (ASRS v1.1) is an 18-item self-report questionnaire developed by Kessler and colleagues in collaboration with the World Health Organization to screen for ADHD symptoms in adults, based on DSM-IV/DSM-5 criteria. Each item is rated on a 5-point frequency scale from 0 ("Never") to 4 ("Very Often"). Part A (the first six items, most predictive of an ADHD diagnosis) ranges from 0 to 24, with a score of 14 or higher generally considered a positive screen; Part B (the remaining twelve items) ranges from 0 to 48; and the combined total score ranges from 0 to 72. Reference: Kessler, R. C., Adler, L., Ames, M., Demler, O., Faraone, S., Hiripi, E., Howes, M. J., Jin, R., Secnik, K., Spencer, T., Ustun, T. B., \& Walters, E. E. (2005). The World Health Organization Adult ADHD Self-Report Scale (ASRS): A short screening scale for use in the general population. Psychological Medicine, 35(2), 245-256.

    Measured: every year for 3 years

  2. Social Provisions Scale (SPS-10)

    The Social Provisions Scale (SPS-10) is a 10-item self-report instrument developed by Caron (2013) as a brief version of Cutrona and Russell's (1987) original 24-item Social Provisions Scale, designed to assess perceived social support across dimensions such as attachment, social integration, reassurance of worth, guidance, and reliable alliance. Each item is rated on a 4-point Likert scale from 1 ("Strongly Disagree") to 4 ("Strongly Agree"), producing (cite index="30-1">a total score ranging from 10 to 40, with higher scores indicating greater perceived social support</cite>. Reference: Cutrona, C. E., \& Russell, D. W. (1987). The provisions of social relationships and adaptation to stress. In Advances in Personal Relationships (Vol. 1, pp. 37-67). JAI Press; Caron, J. (2013). Un outil de mesure du soutien social: Le Questionnaire de Support Social - version abrégée (QSS-8) et l'Échelle de provisions sociales (EPS-10 items). Santé mentale au Québec.

    Measured: every year for 3 years

  3. Physical health - sport activitites, health-service use

    Derived from The Physical Activity Questionnaire for Adolescents (PAQ-A), developed by Kowalski, Crocker, and Donen (2004), is a self-administered 7-day recall instrument assessing general physical activity in adolescents aged 14-19. It contains 9 items rated on a 5-point scale, with the final score calculated as the mean of items, yielding a score from 1 (low activity) to 5 (high activity). The child version, PAQ-C, uses the same logic for ages 8-14. Reference: Kowalski, K. C., Crocker, P. R. E., \& Donen, R. M. (2004).

    Derived from The Health Care Utilization Questionnaire (HCUQ) is an interview-based tool assessing health care resource use over a recall period (often six months), covering items like physician visits, ER visits, hospital days, and medication use. Unlike psychometric scales, it has no fixed total score - each item is a raw count with no upper bound, and scoring varies by study. Reference: LIFE Study HCUQ v1.1, National Institute on Aging Aging Research Biobank.

    Measured: every year for 3 years

  4. Academic experience -

    The Academic experience measure used in this context is derived from Reynolds' (1988) Academic Self-Concept Scale but adapted with open-ended questions rather than the original 4-point Likert-scale items. As such, it does not yield a standardized numeric min/max score like the original 40-item version (1 to 4, averaged); responses are instead analyzed qualitatively (e.g., through thematic or content coding). Reference: adapted from Reynolds, W. M. (1988). Measurement of academic self-concept in college students. Journal of Personality Assessment, 52(2), 223-240.

    Measured: every year for 3 years

  5. Mental Health Continuum-Short Form (MHC-SF)

    The Mental Health Continuum-Short Form (MHC-SF) is a 14-item measure developed by Corey L. M. Keyes to assess positive mental health across three dimensions: emotional, social, and psychological well-being. Each item is rated on a 6-point frequency scale from 0 ("Never") to 5 ("Every day"), producing a total score ranging from 0 to 70, with higher scores reflecting greater well-being; respondents can additionally be classified as "flourishing," "languishing," or "moderately mentally healthy" based on their response pattern. Reference: Keyes, C. L. M. (2002). The mental health continuum: From languishing to flourishing in life. Journal of Health and Social Behavior, 43(2), 207-222.

    Measured: every year for 3 years

  6. Generalized Anxiety Disorder-7 (GAD-7)

    The Generalized Anxiety Disorder-7 (GAD-7) is a brief 7-item self-report questionnaire designed to screen for and assess the severity of generalized anxiety symptoms experienced over the past two weeks. Each item is rated on a 4-point scale from 0 ("Not at all") to 3 ("Nearly every day"), producing a total score ranging from 0 to 21, with commonly used severity thresholds at 5, 10, and 15 for mild, moderate, and severe anxiety, respectively. Reference: Spitzer, R. L., Kroenke, K., Williams, J. B. W., \& Löwe, B. (2006). A brief measure for assessing generalized anxiety disorder: The GAD-7. Archives of Internal Medicine, 166(10), 1092-1097.

    Measured: every year for 3 years

  7. Center for Epidemiologic Studies Depression Scale (CES-D)

    The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20-item self-report instrument originally developed for use in general population studies to assess depressive symptomatology experienced over the past week, including depressed mood, feelings of guilt or worthlessness, sleep disturbance, and loss of appetite. Each item is rated on a 4-point scale from 0 to 3, yielding a total score ranging from 0 to 60, with a score of 16 or higher commonly used as a cutoff indicating clinically significant depressive symptoms. Reference: Radloff, L. S. (1977). The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement, 1(3), 385-401.

    Measured: every year for 3 years

  8. Kessler Psychological Distress Scale (K6)

    The Kessler Psychological Distress Scale (K6) is a brief 6-item screener developed to assess nonspecific psychological distress, primarily symptoms of anxiety and depression, experienced over the past 30 days. Each item is rated on a 5-point scale from 0 ("None of the time") to 4 ("All of the time"), producing a total score ranging from 0 to 24, with higher scores indicating greater psychological distress; scores of 13 or above are often used to identify serious mental illness. Reference: Kessler, R. C., Andrews, G., Colpe, L. J., Hiripi, E., Mroczek, D. K., Normand, S.-L. T., Walters, E. E., \& Zaslavsky, A. M. (2002). Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychological Medicine, 32(6), 959-976.

    Measured: every year for 3 years

  9. Short Grit Scale (Grit-S)

    The Short Grit Scale (Grit-S) is an 8-item self-report measure developed by Duckworth and Quinn (2009) as a brief version of the original 12-item Grit Scale, assessing trait-level perseverance and passion for long-term goals across two facets: Consistency of Interest and Perseverance of Effort. Each item is rated on a 5-point scale, and (cite index="35-1">scores can vary from 1 point (low grit) to a maximum of 5 points (high grit), with the adult population average around 3.4</cite> (the score is typically expressed as a mean rather than a sum). Reference: Duckworth, A. L., \& Quinn, P. D. (2009). Development and validation of the Short Grit Scale (Grit-S). Journal of Personality Assessment, 91(2), 166-174.

    Measured: every year for 3 years

  10. Pittsburgh Sleep Quality Index (PSQI)

    The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-rated questionnaire developed by Buysse and colleagues to assess subjective sleep quality and disturbances over the preceding one-month period. The 19 items combine into seven component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction), (cite index="52-1">each ranging from 0 to 3, which are then summed to obtain a global PSQI score ranging from 0 to 21; higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties</cite>. Reference: Buysse, D. J., Reynolds, C. F., Monk, T. H., Berman, S. R., \& Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: A new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193-213.

    Measured: every year for 3 years

  11. School/Academic engagement

    Derived from the School Engagement Measure (SEM), developed by Fredricks, Blumenfeld, Friedel, and Paris (2005) as part of the MacArthur Network research on school engagement, is a self-report instrument assessing three dimensions of student engagement: behavioral, emotional, and cognitive. The original version consists of 19 items rated on a 5-point Likert-type scale from 1 ("Never") to 5 ("Always"), so (cite index="63-1">each item can be scored from 1 to 5, with subscales for emotional engagement (6 items), behavioral engagement (5 items), and cognitive engagement (8 items)</cite>; a summed total score would therefore range from 19 to 95, though the measure is more commonly reported as subscale or item means rather than a single composite score. Reference: Fredricks, J. A., Blumenfeld, P. C., Friedel, J., \& Paris, A. (2005). School engagement. In K. A. Moore \& L. Lippman (Eds.) (pp. 305-321).

    Measured: every year for 3 years

Secondary outcomes (2)

  1. Socio-demographic and educational

    A derived form of The Hollingshead Four Factor Index of Socioeconomic Status, developed by Hollingshead (1975), estimates an individual's or household's socioeconomic status by combining education and occupation scores (weighted for the participant and spouse where applicable), (cite index="124-1">with total scores ranging from 8 to 66, reflecting social stratification in contemporary society</cite>. In this study, a derived version adapted into French was used, drawing on the same education and occupation weighting principles as the original but reformulated to fit the French educational and occupational classification system rather than the original American categories. Reference: Hollingshead, A. B. (1975). Four Factor Index of Social Status. Department of Sociology, Yale University, New Haven, CT.

    Measured: at baseline

  2. Quality of life and well-being : The World Health Organization Quality of Life - Brief (WHOQOL-BREF)

    The World Health Organization Quality of Life - Brief (WHOQOL-BREF) is a 26-item self-report instrument developed by the WHOQOL Group as an abbreviated version of the WHOQOL-100, assessing quality of life across four domains: physical health, psychological health, social relationships, and environment, plus two standalone items on overall quality of life and general health. Each item is rated on a 5-point scale from 1 to 5, and (cite index="133-1">domain raw scores range from 7 to 35 for Physical Health, 6 to 30 for Psychological, 3 to 15 for Social Relationships, and 8 to 40 for Environment, with a total raw score ranging from 26 to 130</cite>; domain scores are commonly transformed to a 0-100 scale for easier interpretation, with higher scores indicating better quality of life. Reference: The WHOQOL Group (1998). Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychological Medicine, 28(3), 551-558.

    Measured: every year for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2026
  2. Study start21 Jul 2025
  3. Primary completion18 Dec 2027 (estimated)
  4. Study completion18 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
13,710 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07800585
Sponsor's protocol ID
2024-A01865-42
Other IDs
2022-002949-17
Acronym
SMILE
Status last verified
Aug 2026
First submitted
14 Aug 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data sharing In accordance with the FAIR principles, data is anonymized before being shared with other researchers without ever having access to personal data.

Publications

  • Gauld C, Micoulaud-Franchi JA, Dumas G. Comment on Starke et al.: "Computing schizophrenia: ethical challenges for machine learning in psychiatry": From machine learning to student learning: pedagogical challenges for psychiatry - Corrigendum. Psychol Med. 2021 Oct;51(14):2514. doi: 10.1017/S0033291721000684. Epub 2021 Mar 4. No abstract available.

    PubMed 33658093

  • Borsboom D. A network theory of mental disorders. World Psychiatry. 2017 Feb;16(1):5-13. doi: 10.1002/wps.20375.

    PubMed 28127906

  • Robinaugh DJ, Hoekstra RHA, Toner ER, Borsboom D. The network approach to psychopathology: a review of the literature 2008-2018 and an agenda for future research. Psychol Med. 2020 Feb;50(3):353-366. doi: 10.1017/S0033291719003404. Epub 2019 Dec 26.

    PubMed 31875792

  • Morvan Y, Frajerman A. [Student's mental health: better measurement and considereration of the challenges]. Encephale. 2021 Dec;47(6):620-629. doi: 10.1016/j.encep.2020.10.009. Epub 2021 Mar 19. French.

    PubMed 33745696

  • Jean FAM, Moulin F, Schwartz AN, Castel L, Montagni I, Macalli M, Notredame CE, Cote SM, Galera C. Association between ADHD symptoms and illicit stimulants use following 1 year among French university students of the i-Share cohort. Soc Psychiatry Psychiatr Epidemiol. 2024 May;59(5):887-897. doi: 10.1007/s00127-023-02499-9. Epub 2023 Jun 2.

    PubMed 37268785

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health and Neurodevelomental Disorders, run by O-Kidia 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 4 inclusion and 1 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 2 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 Vanessa Douet Vannucci, PhD (+33768717649, vanessa.douet@o-kidia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adult ADHD Self-Report Scale (ASRS v1.1) (time frame: every year for 3 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07800585, which also lists 5 linked publications.

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 2 Sep 2026.

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