- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
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Antrim, Regno Unito
- Post Primary Schools x2
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Newtownabbey, Regno Unito
- Post Primary Schools x 2
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Nessun intervento: Control
Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Recruitment Feasibility
Lasso di tempo: 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
Lasso di tempo: 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.
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At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
|
Intervention Attendance / Exposure
Lasso di tempo: 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.
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At each intervention session and at completion of the 4-session intervention.
|
|
Fidelity to Session Structure
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Exploratory indicators of potential effectiveness
Lasso di tempo: 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.
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At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Gavin Davidson, Queen's University Belfast, School of Social Sciences, Education and Social Work
- Investigatore principale: Ciaran Shannon, Northern Health & Social Care Trust
- Investigatore principale: Ciaran Mulholland, Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- QUB_SREC_166_2324
- CDA210005 (Altro numero di sovvenzione/finanziamento: Health Research Board Ireland)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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