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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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07660874
Enrollment
120
Registered
2026-06-22
Start date
2025-10-06
Completion date
2026-07-01
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health Promotion

Keywords

Psychosis, unusual sensory experiences, psychotic-like experiences, psychotic experiences, adolescent mental health, school based intervention, psychoeducation, mental health literacy, early intervention

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALSchool-Based Mental Health Programme

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.

Sponsors

Queen's University, Belfast
Lead SponsorOTHER
Health Research Board, Ireland
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Non-randomised, parallel-group feasibility and acceptability study comparing a universal school-based psychoeducational intervention with teaching-as-usual control.

Eligibility

Sex/Gender
ALL
Age
16 Years to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Recruitment FeasibilityUp to 3 months from recruitment opening.Number of students recruited and percentage of the planned recruitment target achieved, overall and by school/arm.
Data Collection FeasibilityAt 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.
Intervention Attendance / ExposureAt 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.
Fidelity to Session StructureImmediately after each intervention session.Proportion of planned session components delivered, assessed using researcher-completed session checklists.
Student-Reported Acceptability Ratings After Each SessionUp to 1 week after each session.Ratings of acceptability, relevance, and engagement collected through brief session reflections and questionnaires, summarised descriptively.
Qualitative themes relating to intervention acceptabilityWithin 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.

Secondary

MeasureTime frameDescription
Exploratory indicators of potential effectivenessAt 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.

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORGavin Davidson

Queen's University Belfast, School of Social Sciences, Education and Social Work

PRINCIPAL_INVESTIGATORCiaran Shannon

Northern Health & Social Care Trust

PRINCIPAL_INVESTIGATORCiaran Mulholland

Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 23, 2026