- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Antrim, Reino Unido
- Post Primary Schools x2
-
Newtownabbey, Reino Unido
- Post Primary Schools x 2
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Intervention
Universal classroom-based psychoeducational programme delivered in four sessions within the school timetable.
|
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.
|
|
Sin intervención: Control
Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Recruitment Feasibility
Periodo de tiempo: Up to 3 months from recruitment opening.
|
Number of students recruited and percentage of the planned recruitment target achieved, overall and by school/arm.
|
Up to 3 months from recruitment opening.
|
|
Data Collection Feasibility
Periodo de tiempo: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
Proportion of enrolled students completing planned questionnaire measures at T1, T2, and T3.
|
At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
|
Intervention Attendance / Exposure
Periodo de tiempo: At each intervention session and at completion of the 4-session intervention.
|
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.
|
At each intervention session and at completion of the 4-session intervention.
|
|
Fidelity to Session Structure
Periodo de tiempo: Immediately after each intervention session.
|
Proportion of planned session components delivered, assessed using researcher-completed session checklists.
|
Immediately after each intervention session.
|
|
Student-Reported Acceptability Ratings After Each Session
Periodo de tiempo: Up to 1 week after each session.
|
Ratings of acceptability, relevance, and engagement collected through brief session reflections and questionnaires, summarised descriptively.
|
Up to 1 week after each session.
|
|
Qualitative themes relating to intervention acceptability
Periodo de tiempo: Within 8 weeks of the final intervention session.
|
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.
|
Within 8 weeks of the final intervention session.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Exploratory indicators of potential effectiveness
Periodo de tiempo: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
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.
|
At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- QUB_SREC_166_2324
- CDA210005 (Otro número de subvención/financiamiento: Health Research Board Ireland)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Promoción de la salud mental
-
University of Dublin, Trinity CollegeDesconocidoAtletas de élite retirados de Brain Health
-
Queens College, The City University of New YorkReclutamientoPublicación de artículos enviados al American Journal of Public HealthEstados Unidos
-
WestatPlasma Protein Therapeutics AssociationAún no reclutandoHealth Effects (Niveles de Ferritina, Niveles de PCR, Niveles de IgG, Salud Auto-reportada)Estados Unidos
-
Chinese University of Hong KongReclutamientoSalud Mental Bienestar 1 | Bienestar mental | Problema de salud mental | Salud mental de precisiónHong Kong
-
Sword Health, SAInscripción por invitaciónResiliencia mental | Angustia mentalEstados Unidos
-
Neslihan LokTerminadoAdolescente | Salud mental | Cuidado de la salud mental | Condiciones de salud mentalPavo
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsAún no reclutandoSalud mental | Búsqueda de ayuda de salud mental | Alfabetización en salud mentalEstados Unidos
-
Chinese University of Hong KongTerminadoBienestar mental | Alfabetización en salud mentalHong Kong
-
King's College LondonTerminadoSalud Mental Bienestar 1 | Problema de salud mentalReino Unido
-
Chinese University of Hong KongTerminadoSalud Mental Bienestar 1 | Bienestar mental | Problema de salud mentalHong Kong
Ensayos clínicos sobre School-Based Mental Health Programme
-
VU University of AmsterdamUniversity of Copenhagen; University Hospital Heidelberg; World Health OrganizationReclutamientoEstrés | Agotamiento | Salud ocupacional | Condiciones de salud mental | Ausencia por enfermedadPaíses Bajos
-
citiesRISEAfrican Population and Health Research Center; Schizophrenia Research Foundation...TerminadoSalud mental juvenilIndia, Kenia
-
University of OklahomaActivo, no reclutandoDejar de fumar | Enfermedad mentalEstados Unidos