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NCT Number: NCT07660874

Designing and Evaluating a Classroom-Based Mental Health Programme 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.

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Key information

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Post Primary Schools x2, Antrim, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

School-Based Mental Health Programme

Behavioral

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.

Primary outcomes

  1. Recruitment Feasibility

    Time frame: Up to 3 months from recruitment opening.

    Number of students recruited and percentage of the planned recruitment target achieved, overall and by school/arm.

  2. Data Collection Feasibility

    Time frame: 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.

  3. Intervention Attendance / Exposure

    Time frame: 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.

  4. Fidelity to Session Structure

    Time frame: Immediately after each intervention session.

    Proportion of planned session components delivered, assessed using researcher-completed session checklists.

  5. Student-Reported Acceptability Ratings After Each Session

    Time frame: Up to 1 week after each session.

    Ratings of acceptability, relevance, and engagement collected through brief session reflections and questionnaires, summarised descriptively.

  6. Qualitative themes relating to intervention acceptability

    Time frame: 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.

Secondary outcomes

  1. Exploratory indicators of potential effectiveness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Queen's University, Belfast

Other

Collaborators

  • Health Research Board, Ireland

Registry information

Official study title

The Development, Feasibility, and Acceptability of a Classroom-based Psychoeducational Programme About Psychosis for Adolescents.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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