Recruiting

SMILENetwork-based Analysis of Mental Health and Vulnerabilities in Higher-education Students

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Study Aim

This observational study aims to understand the mental health and vulnerabilities in higher-education students by analyzing their adult ADHD symptoms, perceived social support, physical health, academic experiences, general mental health, anxiety, depression, psychological distress, resilience, sleep quality, and school engagement.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Behavior

+ Personal Satisfaction

+ Psychological Well-Being

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2025
See protocol details

Summary

Principal SponsorO-Kidia
Study ContactVanessa Douet Vannucci, PhDMore contacts
Last updated: September 2, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 21, 2025

Actual date on which the first participant was enrolled.

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. 2. To identify relevant variables associated with their cognitive ability, socioeconomic status, and motivational capacities in order to analyze their interrelationships. 3. To identify markers or risk factors for cognitive, emotional, and behavioral performance; 4. 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.

NCT07800585
Principal SponsorO-Kidia
Study ContactVanessa Douet Vannucci, PhDMore contacts
Last updated: September 2, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

13710 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorPersonal SatisfactionPsychological Well-Being

Criteria

4 inclusion criteria required to participate
Boys or girls

Possess a valid email address for contact related to University or higher education institution

Speak fluent French

Students in higher education in France or its overseas territories

1 exclusion criteria prevent from participating
Does not speak fluent French (the platform is available in English but the study is primarily intended for French speakers)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Université de la Côte d'Azur

Nice, FranceOpen Université de la Côte d'Azur in Google Maps
Recruiting
One Study Center