NCT07660874

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Completed
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 3, 2026

Last Update Submit

June 16, 2026

Conditions

Keywords

Psychosisunusual sensory experiencespsychotic-like experiencespsychotic experiencesadolescent mental healthschool based interventionpsychoeducationmental health literacyearly intervention

Outcome Measures

Primary Outcomes (6)

  • Recruitment Feasibility

    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

    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

    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

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

    Immediately after each intervention session.

  • Student-Reported Acceptability Ratings 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

    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 Outcomes (1)

  • Exploratory indicators of potential effectiveness

    At baseline, immediately after the final intervention session, and 1 month after the final intervention session.

Study Arms (2)

Intervention

EXPERIMENTAL

Universal classroom-based psychoeducational programme delivered in four sessions within the school timetable.

Behavioral: School-Based Mental Health Programme

Control

NO INTERVENTION

Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist).

Interventions

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.

Intervention

Eligibility Criteria

Age16 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Students who decline consent or whose parent/carer opts them out, where applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Post Primary Schools x2

Antrim, United Kingdom

Location

Post Primary Schools x 2

Newtownabbey, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Non-randomised, parallel-group feasibility and acceptability study comparing a universal school-based psychoeducational intervention with teaching-as-usual control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Social Care

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 22, 2026

Study Start

October 6, 2025

Primary Completion

April 30, 2026

Study Completion

July 1, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations