- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Madrid, Espanha, 28040
- Fundación Jimemez Díaz
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention
interventions will include digital and non digital resourcews for mental health prevention, detection and promotion
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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
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intervention Effectiveness: Rate of Treatment Continuation and Case Detection
Prazo: Baseline to 6 months post-intervention
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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.
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Baseline to 6 months post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility: Student Informed Consent Rate
Prazo: From initial recruitment through study enrollment (Up to 4 weeks)
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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)
|
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Feasibility: Assessment Completion Rate
Prazo: Immediately post-intervention (Week 8)
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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)
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Acceptability: Teacher Satisfaction Rating
Prazo: 2 years
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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
|
Colaboradores e Investigadores
Publicações e links úteis
Publicações Gerais
- 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.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Transtornos Mentais, Desordem Mental
- Sinais e Sintomas Digestivos
- Sintomas Comportamentais
- Comportamento compulsivo
- Comportamento impulsivo
- Agressão
- Condições Patológicas, Sinais e Sintomas
- Comportamento
- Sinais e sintomas
- Satisfação pessoal
- Comportamento social
- Assédio, Não Sexual
- Transtornos Psicóticos
- Transtornos de ansiedade
- Suicídio
- Comportamental, Viciante
- Assédio moral
- Alimentação e Distúrbios Alimentares
- Comportamento autolesivo
- Bem-estar psicológico
- Prática profissional
- Organização e administração
- Administração de Serviços de Saúde
- Psicoterapia
- Disciplinas e atividades comportamentais
- Referência e consulta
- Intervenção psicossocial
Outros números de identificação do estudo
- PIC009-25_4H
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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