Mental Health PromotionNCT07660874
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
A study testing School-Based Mental Health Programme in people with Mental Health Promotion, run by Queen's University, Belfast at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Promotion
- What is being tested?
- School-Based Mental Health Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 6 Oct 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Students who decline consent or whose parent/carer opts them out, where applicable.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Post Primary Schools x2
Antrim
Post Primary Schools x 2
Newtownabbey
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Mental Health Promotion
- Being tested
- School-Based Mental Health Programme
- Keywords
- Psychosis, unusual sensory experiences, psychotic-like experiences, psychotic experiences, adolescent mental health, school based intervention, psychoeducation, mental health literacy, early intervention
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-Based Mental Health ProgrammeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Universal classroom-based psychoeducational programme delivered in four sessions within the school timetable. Receives: Behavioral: School-Based Mental Health Programme |
| Control | No intervention | Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Number of students recruited and percentage of the planned recruitment target achieved, overall and by school/arm.
Measured: Up to 3 months from recruitment opening.
Data Collection Feasibility
Proportion of enrolled students completing planned questionnaire measures at T1, T2, and T3.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 8 weeks of the final intervention session.
Secondary outcomes (1)
Exploratory indicators of potential effectiveness
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.
Measured: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start6 Oct 2025
- Primary completion30 Apr 2026
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health PromotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised, parallel-group feasibility and acceptability study comparing a universal school-based psychoeducational intervention with teaching-as-usual control.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Board, Ireland
- Responsible party
- Principal investigator, Gavin Davidson, Queen's University, Belfast
- Investigators
- Gavin Davidson, Principal investigator, Queen's University Belfast, School of Social Sciences, Education and Social WorkCiaran Shannon, Principal investigator, Northern Health & Social Care TrustCiaran Mulholland, Principal investigator, Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660874
- Sponsor's protocol ID
- QUB_SREC_166_2324
- Other IDs
- CDA210005
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development, Feasibility, and Acceptability of a Classroom-based Psychoeducational Programme About Psychosis for Adolescents.
- ClinicalTrials.gov ID
- NCT07660874
- Acronym / sponsor ID
- QUB_SREC_166_2324
- Conditions
- Mental Health Promotion
- Keywords
- Psychosis, unusual sensory experiences, psychotic-like experiences, psychotic experiences, adolescent mental health, school based intervention, psychoeducation, mental health literacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- Health Research Board, Ireland
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised, parallel-group feasibility and acceptability study comparing a universal school-based psychoeducational intervention with teaching-as-usual control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: School-Based Mental Health ProgrammeUniversal classroom-based psychoeducational programme delivered in four sessions within the school timetable. |
| Control | No intervention | –Teaching-as-usual during data collection; students offered the intervention afterwards (waitlist). |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Students who decline consent or whose parent/carer opts them out, where applicable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-Based Mental Health ProgrammeFour 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. | Behavioural | Intervention |
Primary outcome
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.
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.
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.
Fidelity to Session Structure
Time frame: Immediately after each intervention session.
Proportion of planned session components delivered, assessed using researcher-completed session checklists.
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.
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.
1 secondary outcome
Exploratory indicators of potential effectiveness
Time frame: At baseline, immediately after the final intervention session, and 1 month after the final intervention session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- This protocol forms part of Psychosis Ireland Structured Training and Research Programme (PSI-STAR), an all-Ireland, cross-disciplinary doctoral training programme in psychosis research, involving a network of experts and people with lived experience.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gavin Davidson principal investigator
Queen's University Belfast, School of Social Sciences, Education and Social Work
Ciaran Shannon principal investigator
Northern Health & Social Care Trust
Ciaran Mulholland principal investigator
Queen's University Belfast, School of Medicine, Dentistry and Biomedical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-Based Mental Health Programme in people with Mental Health Promotion, run by Queen's University, Belfast at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Up to 3 months from recruitment opening.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.