- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07660874
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
The Development, Feasibility, and Acceptability of a Classroom-based Psychoeducational Programme About Psychosis for Adolescents.
This study is a mixed-methods feasibility trial designed to examine whether a universal classroom-based psychoeducational programme which covers unusual sensory experiences, psychosis, mental health stigma, and coping strategies can be delivered in secondary schools in Northern Ireland.
The study aims to determine whether the programme is feasible to deliver, whether students find it acceptable, and whether it is possible to collect questionnaire and reflection data at multiple time points.
Students will attend four classroom sessions delivered by the researcher as part of timetabled enrichment lessons. They will complete questionnaires before the programme, after it ends, and one month later. Brief reflections will also be completed after each session.
A small number of students may take part in an interview to explore their experiences of the programme. As a feasibility study, this trial does not assess intervention effectiveness but will inform the design of a future full-scale trial.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is a mixed-methods feasibility study to evaluate the delivery, feasibility and acceptability of a universal psychoeducational programme. The intervention aims to build students' mental-health literacy and confidence in recognising and responding to distress. The programme is educational in focus; it is not designed to diagnose, treat symptoms, or identify individuals at clinical risk.
The trial uses a non-randomised parallel-group design in which participating secondary schools are allocated to either the intervention arm or a teaching-as-usual control arm. The intervention comprises four structured classroom sessions delivered within the normal school timetable. Session content includes: (1) understanding mental health and the stress response; (2) understanding unusual sensory experiences and psychosis; (3) understanding stigma and media influences; and (4) understanding thoughts and feelings using cognitive behavioural therapy-informed coping strategies. Sessions use multimedia materials, group discussion, and workbook activities. All content was co-designed with individuals with lived experience of psychosis, mental health professionals, and teachers. Students in the control arm will continue with teaching-as-usual during data collection and will be offered the intervention after the study follow-up period (waitlist).
Quantitive data will be collected at multiple timepoints to assess feasibility including recruitment, retention, data completeness, adherence to planned session components. Students will complete baseline, post intervention and one month follow up questionnaires, as well as brief surveys and reflections after each session to capture engagement and acceptability.
Pre-post changes in key outcomes will be explored descriptively using repeated measures approaches to examine patterns of change and to estimate variance for planning a future definitive trial, where data completeness permits.
Psychotic-like experiences, emotional and behavioural functioning, and help-seeking intentions will be assessed using validated self-report tools. These include the Prodromal Questionnaire-16 (PQ-16), the Strengths and Difficulties Questionnaire (SDQ) and the Mental Help Seeking Intention Scale (MHSIS).
A qualitative component, consisting of semi-structured interviews with a subset of participants will explore experiences of the programme, perceived relevance, acceptability and suggestions for refinement.
The primary purpose of this study is feasibility rather than efficacy. Findings will inform decisions about progression to a future trial, including necessary refinements to content, delivery and evaluation procedures.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
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Antrim, Reino Unido
- Post Primary Schools x2
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Newtownabbey, Reino Unido
- Post Primary Schools x 2
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Students aged 16-18 years enrolled in participating secondary schools in Northern Ireland.
- Able to provide informed consent in accordance with the approved ethics protocol.
Exclusion Criteria:
- Students who decline consent or whose parent/carer opts them out, where applicable.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention
Universal classroom-based psychoeducational programme delivered in four sessions within the school timetable.
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Four structured classroom sessions delivered by the researcher covering mental health literacy, unusual sensory experiences, psychosis awareness, stigma, and coping strategies.
Sessions involve multimedia materials, discussion, and group activities.
|
|
Sem intervenção: Control
Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Recruitment Feasibility
Prazo: Up to 3 months from recruitment opening.
|
Number of students recruited and percentage of the planned recruitment target achieved, overall and by school/arm.
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Up to 3 months from recruitment opening.
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Data Collection Feasibility
Prazo: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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Proportion of enrolled students completing planned questionnaire measures at T1, T2, and T3.
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At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
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Intervention Attendance / Exposure
Prazo: At each intervention session and at completion of the 4-session intervention.
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Number and proportion of recruited students attending each intervention session, and number/proportion attending one or more sessions, two or more sessions, three or more sessions, and all four sessions.
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At each intervention session and at completion of the 4-session intervention.
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Fidelity to Session Structure
Prazo: Immediately after each intervention session.
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Proportion of planned session components delivered, assessed using researcher-completed session checklists.
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Immediately after each intervention session.
|
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Student-Reported Acceptability Ratings After Each Session
Prazo: Up to 1 week after each session.
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Ratings of acceptability, relevance, and engagement collected through brief session reflections and questionnaires, summarised descriptively.
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Up to 1 week after each session.
|
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Qualitative themes relating to intervention acceptability
Prazo: Within 8 weeks of the final intervention session.
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Themes identified through thematic analysis of semi-structured interviews with students, examining perceived acceptability, relevance, engagement, barriers and facilitators to participation, and suggestions for programme refinement.
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Within 8 weeks of the final intervention session.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Exploratory indicators of potential effectiveness
Prazo: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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Descriptive exploration of pre-post changes using repeated-measures approaches to examine patterns of change and estimate variance for planning a future definitive trial, without inferential hypothesis testing.
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At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Gavin Davidson, Queen's University Belfast, School of Social Sciences, Education and Social Work
- Investigador principal: Ciaran Shannon, Northern Health & Social Care Trust
- Investigador principal: Ciaran Mulholland, Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
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
Outros números de identificação do estudo
- QUB_SREC_166_2324
- CDA210005 (Número de outro subsídio/financiamento: Health Research Board Ireland)
Plano para dados de participantes individuais (IPD)
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Informações sobre medicamentos e dispositivos, documentos de estudo
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