- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
-
Antrim, Det Forenede Kongerige
- Post Primary Schools x2
-
Newtownabbey, Det Forenede Kongerige
- Post Primary Schools x 2
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: Control
Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment Feasibility
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Exploratory indicators of potential effectiveness
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gavin Davidson, Queen's University Belfast, School of Social Sciences, Education and Social Work
- Ledende efterforsker: Ciaran Shannon, Northern Health & Social Care Trust
- Ledende efterforsker: Ciaran Mulholland, Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- QUB_SREC_166_2324
- CDA210005 (Andet bevillings-/finansieringsnummer: Health Research Board Ireland)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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