Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

Screening and Monitoring of Mental Health in Educational Settings: Programme for Detection, Psychoeducation and Self-help (SENSE)

Promoting Adolescent Mental Health Through School-based Screening, Psychoeducation and Self-help: Study Protocol for the SENSE Programme

Adolescence is a critical developmental stage during which many mental health problems first emerge. However, a large proportion of these issues go undetected and untreated. Globally, approximately one in seven adolescents experiences mental health difficulties, with increasing trends observed in recent years. Schools offer an important setting for early detection and intervention, yet existing programmes often lack structure or scalability. The MENTOR programme (MENtal Health Tracking, Outreach and Referral) was designed to identify adolescents under psychological distress in educational settings and offer tiered support including psychoeducation, self-help tools, and referral to mental health services when needed.

This is a prospective, longitudinal, multicentre study that will be implemented in eight educational centres in Spain, including secondary schools, sixth-form colleges, and vocational training centres. Adolescents and young adults will be invited to participate voluntarily. At baseline and at each trimester, participants will complete validated mental health screening tools assessing common conditions such as anxiety, depression, and emotional dysregulation. Based on results, participants will be assigned to one of several support pathways: access to digital self-help materials, small-group interventions, or referral to school-based or external mental health professionals. Follow-up assessments will measure changes in symptomatology, engagement with self-care tools, and help-seeking behaviour. Quantitative data will be analysed to assess feasibility, adherence, and effectiveness of the intervention over time, and conduct a cost-effectiveness analysis This protocol aims to improve adolescent mental health through a school-based, digitally delivered screening and intervention programme. By evaluating feasibility and acceptance across eight educational centres, the study seeks to generate real-time data on prevalent mental health issues, promote awareness and self-care, and facilitate early professional intervention. If effective, the programme could support scalable, tiered prevention strategies in educational settings, contributing to reduced rates of anxiety, depression, suicidal ideation, eating disorders, and addictions. Its implementation may also improve resource allocation, reduce wait times, and inform future health policies for longitudinal mental health monitoring from childhood. Findings will contribute to the development of accessible, evidence-based models for adolescent mental health promotion and early intervention.

Aperçu de l'étude

Description détaillée

The primary objective of this study is to implement and evaluate the effectiveness of a academic-based mental health promotion and prevention programme-MENTOR (MENtal Health Tracking, Outreach and Referral)-for adolescents and young adults in educational settings. The programme seeks to identify students experiencing psychological distress and provide them with appropriate support, including self-help tools, psychoeducational resources, and referral pathways to professional mental health services when needed.This is longitudinal, prospective, single-group (COMPROBAR), multicenter exploratory study will be conducted across four hospitals: Fundación Jiménez Díaz University Hospital, Rey Juan Carlos University Hospital, Infanta Elena University Hospital, and Villalba General University Hospital. Participants will be recruited from eight educational centres, two centres from the catchment area of each hospital. All secondary education, sixth form, and vocational training centres within the respective catchment areas were invited to participate in the study, from which eight centres were ultimately selected Our participants will be students from the selected groups within each participating educational centre. There will be no limit to the number of participants that can be included within this design. A formal sample size calculation has not been performed, as this is an implementation study intended to assess the feasibility of this type of programme. All consenting participants during the study period will be included. Inclusion criteria are:

  • Students from participating educational centres aged 12-22.
  • Authorisation and informed consent signed by parents/legal guardians for those under 18, and the ability to understand and sign informed assent for participants under 18.
  • Ability to understand and sign informed consent for participants over 18.
  • Fluency in Spanish (ability to understand the information sheet, consent and assent forms, the evaluations, and mobile application menus).

Participants will be excluded if they are unable to understand and sign the informed consent or assent for any reason.Once centres determine the groups and the number of participating students, relevant documentation (informed consent and anonymisation codes) will be provided. School management will contact parents to provide a summarised explanation of the project (either through a written information sheet or a meeting, depending on the centre's preference) and request their participation, along with signing informed consent or assent forms. Following the completion of the online psychological evaluation, students and their families will receive access-via an individual code-to a secure online platform. This platform hosts self-help resources tailored to each participant's psychometric profile results Materials include age-appropriate texts, audio files, videos, and exercises, primarily sourced from Stay Healthy, an educational programme developed by the Quirón health group and currently used by over 30,000 students through its virtual learning environment. Additional resources specifically developed for this study will also be integrated. Based on the aggregated results at each school, further in-person or online workshops and psychoeducational sessions will be designed to address the most prominent mental health needs identified in each cohort. Once students have completed the online questionnaire tailored to their age and submitted their answers, they will be granted access to self-help and self-care resources specific to their results. These materials include educational content, testimonial videos, interactive exercises, games, and recommended readings, which students can engage with voluntarily in their own time. The aim is to foster self-awareness and promote proactive mental health care. Based on questionnaire results, educational centres will be offered customised workshops, talks or school days dedicated to addressing prevalent issues. If necessary, A mental health consultation, either virtual or in-person, will be coordinated with one of the four collaborating hospitals

Type d'étude

Interventionnel

Inscription (Réel)

436

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Madrid, Espagne, 28040
        • Fundación Jimemez Díaz

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Oui

La description

Inclusion Criteria:

  • - Students from participating educational centres aged 12-22.
  • Authorisation and informed consent signed by parents/legal guardians for those under 18, and the ability to understand and sign informed assent for participants under 18.
  • Ability to understand and sign informed consent for participants over 18.
  • Fluency in Spanish (ability to understand the information sheet, consent and assent forms, the evaluations, and mobile application menus).

Exclusion Criteria:

  • if they are unable to understand and sign the informed consent or assent for any reason.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Intervention
interventions will include digital and non digital resourcews for mental health prevention, detection and promotion
the collaborative model it establishes between schools and mental health professionals, which can enhance coordination and promote early intervention. The longitudinal assessment enables an effectiveness analysis, and the use of digital tools for screening and self-care makes the program more accessible and engaging for adolescents. Moreover, enabling direct access to professional support without going through the full traditional referral pathway may reduce waiting times and prevent symptom escalation. The online component makes it more accessible and engaging
Autres noms:
  • Intervention psychologique

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Intervention Effectiveness: Rate of Treatment Continuation and Case Detection
Délai: Baseline to 6 months post-intervention
Percentage of participants actively in treatment post-intervention among those who were either already in treatment at baseline or were newly identified cases discovered during the intervention.
Baseline to 6 months post-intervention

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Feasibility: Student Informed Consent Rate
Délai: From initial recruitment through study enrollment (Up to 4 weeks)

Calculated as the percentage of eligible students providing written assent (or consent for those aged 18 and older) relative to the total number of eligible students in participating classes.

Metric/Unit: Percentage of participants

From initial recruitment through study enrollment (Up to 4 weeks)
Feasibility: Assessment Completion Rate
Délai: Immediately post-intervention (Week 8)

Percentage of enrolled students completing all required baseline and post-intervention study assessments relative to total enrolled students per class.

Metric/Unit: Percentage of participants

Immediately post-intervention (Week 8)
Acceptability: Teacher Satisfaction Rating
Délai: 2 years
Teacher acceptability assessed using a (1-5) Likert scale post-intervention items (1-5; 1 = "Not satisfied at all," 5 = "Very satisfied") Unit of Measure: Units on a scale
2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2025

Achèvement primaire (Réel)

31 décembre 2025

Achèvement de l'étude (Réel)

31 décembre 2025

Dates d'inscription aux études

Première soumission

17 novembre 2025

Première soumission répondant aux critères de contrôle qualité

9 septembre 2026

Première publication (Réel)

14 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner