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.
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
- Are there results?
- None posted in the registry
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.
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | interventions 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.
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)
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)
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)
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.
- First posted14 Sep 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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.
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)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Rey Juan Carlos, Hospital Universitario Infanta Elena, Universidad Carlos III de Madrid, Centro de Investigación Biomédica en Red de Salud Mental
- Responsible party
- Sponsor
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 18664995Eisenberg 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Adolescent Mental Health Through School-based Screening, Psychoeducation and Self-help: Study Protocol for the SENSE Programme
- ClinicalTrials.gov ID
- NCT07818603
- Acronym / sponsor ID
- SENSE / PIC009-25_4H
- Keywords
- adolescents, mental health, psychoeducation, screening, psychological prevention program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Hospital Universitario Rey Juan Carlos, Hospital Universitario Infanta Elena, Universidad Carlos III de Madrid, Centro de Investigación Biomédica en Red de Salud Mental
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: program for the detection, referral, and psychoeducation in adolescentsinterventions will include digital and non digital resourcews for mental health prevention, detection and promotion |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- - 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).
Key exclusion criteria (1 listed)
- if they are unable to understand and sign the informed consent or assent for any reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| program for the detection, referral, and psychoeducation in adolescentsAlso: Psychological interventionthe 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 | Other | Intervention |
Primary outcome
Intervention Effectiveness: Rate of Treatment Continuation and Case Detection
Time frame: 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.
3 secondary outcomes
Feasibility: Student Informed Consent Rate
Time frame: From initial recruitment through study enrollment (Up to 4 weeks)
Feasibility: Assessment Completion Rate
Time frame: Immediately post-intervention (Week 8)
Acceptability: Teacher Satisfaction Rating
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 18664995Layne 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.
- Results publication: PubMed 23274298Eisenberg 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.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Effectiveness: Rate of Treatment Continuation and Case Detection (time frame: Baseline to 6 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07818603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.