- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07818603
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Madrid, Spanje, 28040
- Fundación Jimemez Díaz
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Intervention Effectiveness: Rate of Treatment Continuation and Case Detection
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility: Student Informed Consent Rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- Layne CM, Saltzman WR, Poppleton L, Burlingame GM, Pasalic A, Durakovic E, Music M, Campara N, Dapo N, Arslanagic B, Steinberg AM, Pynoos RS. Effectiveness of a school-based group psychotherapy program for war-exposed adolescents: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2008 Sep;47(9):1048-62. doi: 10.1097/CHI.0b013e31817eecae.
- Eisenberg D, Hunt J, Speer N. Mental health in American colleges and universities: variation across student subgroups and across campuses. J Nerv Ment Dis. 2013 Jan;201(1):60-7. doi: 10.1097/NMD.0b013e31827ab077.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Schizofreniespectrum en andere psychotische stoornissen
- Psychische aandoening
- Tekenen en symptomen, spijsvertering
- Gedragssymptomen
- Compulsief gedrag
- Impulsief gedrag
- Agressie
- Pathologische aandoeningen, tekenen en symptomen
- Gedrag
- Tekenen en symptomen
- Persoonlijke voldoening
- Sociaal gedrag
- Intimidatie, niet-seksueel
- Psychotische stoornissen
- Angst stoornissen
- Zelfmoord
- Gedrag, verslavend
- Pesten
- Voedings- en eetstoornissen
- Zelfbeschadigend gedrag
- Geestelijk welzijn
- Professionele praktijk
- Organisatie en administratie
- Health Services Administration
- Psychotherapie
- Gedragsdisciplines en activiteiten
- Verwijzing en overleg
- Psychosociale interventie
Andere studie-ID-nummers
- PIC009-25_4H
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .