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AnxietySENSENCT07818603

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

A study testing program for the detection, referral, and psychoeducation in adolescents in people with Anxiety and Depression Disorder, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression Disorder, Bullying
What is being tested?
program for the detection, referral, and psychoeducation in adolescents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
436 participants
Where
1 siteSpain
Study dates
1 Jan 2025to 31 Dec 2025
Phase
Interventional

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 12 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • - 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).

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Fundación Jimemez Díaz

    Madrid, 28040

Other trials in Spain

About this study

Official title: 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.

Read the detailed description

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

Being tested
program for the detection, referral, and psychoeducation in adolescents
Keywords
adolescents, mental health, psychoeducation, screening, psychological prevention program
Medical subject headings
Anxiety Disorders, Bullying, Behavior, Addictive, Suicide, Self-Injurious Behavior, Psychotic Disorders, Feeding and Eating Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • program for the detection, referral, and psychoeducation in adolescentsOther

    Also called Psychological intervention

    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

Study groups in NCT07818603
Study groupRoleWhat they receive
InterventionExperimentalinterventions will include digital and non digital resourcews for mental health prevention, detection and promotion
Receives: Other: program for the detection, referral, and psychoeducation in adolescents

What is being measured

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

  1. Intervention Effectiveness: Rate of Treatment Continuation and Case Detection

    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.

    Measured: Baseline to 6 months post-intervention

Secondary outcomes (3)
  1. Feasibility: Student Informed Consent Rate

    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

    Measured: From initial recruitment through study enrollment (Up to 4 weeks)

  2. Feasibility: Assessment Completion Rate

    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

    Measured: Immediately post-intervention (Week 8)

  3. Acceptability: Teacher Satisfaction Rating

    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

    Measured: 2 years

Timeline

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

  1. First posted14 Sep 2026
  2. Study start1 Jan 2025
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
436 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07818603
Sponsor's protocol ID
PIC009-25_4H
Acronym
SENSE
Status last verified
Sep 2026
First submitted
17 Nov 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18664995
  • 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.

    PubMed 23274298

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