Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.

June 16, 2026 updated by: Gavin Davidson, Queen's University, Belfast

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antrim, United Kingdom
        • Post Primary Schools x2
      • Newtownabbey, United Kingdom
        • Post Primary Schools x 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
No Intervention: Control
Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months from recruitment opening.
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.
At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
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.
At each intervention session and at completion of the 4-session intervention.
Fidelity to Session Structure
Time Frame: 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
Time Frame: 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
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.
Within 8 weeks of the final intervention session.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline, immediately after the final intervention session, and 1 month after the final intervention session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gavin Davidson, Queen's University Belfast, School of Social Sciences, Education and Social Work
  • Principal Investigator: Ciaran Shannon, Northern Health & Social Care Trust
  • Principal Investigator: Ciaran Mulholland, Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2025

Primary Completion (Actual)

April 30, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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