Mental Health and Innovation for French Higher-education Students

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)

Trial locations and contacts

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

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

Conditions

Mental Health, Neurodevelomental Disorders

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

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

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (5)Papers the sponsor has linked to this study.
• Other trials for Mental HealthStudies 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.