What is the feasibility of a school-based suicide prevention programme for young people in Northwest England?

ISRCTN	ISRCTN41891301
DOI	https://doi.org/10.1186/ISRCTN41891301
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	337649
Protocol serial number	IRAS 337649, CPMS 60221
Sponsor	Liverpool John Moores University
Funder	National Institute for Health and Care Research

Submission date: 24/01/2024
Registration date: 09/02/2024
Last edited: 21/10/2024

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Suicide is the second leading cause of death in young people under 25 in England. Suicidal behaviours are associated with a range of negative outcomes including risk of future suicide. The impact of suicide on a young person’s family, friends, and wider community can be devastating and also increase their own risk of suicide. There is therefore an urgent need to develop and test suitable ways to prevent suicide in young people. A suicide prevention program, the "Multimodal Approach to Preventing Suicide in Schools" (MAPSS), is planned for implementation in secondary schools across Northwest England. Currently undergoing testing in Melbourne, Australia, and having been previously trialled in two UK schools with Year 10 pupils (aged 14-15), the MAPSS program involves the delivery of a suicide awareness lesson (e.g., safeTALK), screening students for suicide risk, and providing online Cognitive Behavioral Therapy (CBT) (Reframe IT-UK) to those identified as high-risk for suicide. Following the completion of a scoping study to adapt the MAPSS intervention for the UK (https://tinyurl.com/MAPSSscoping), interviews were conducted with 26 young people (aged 14-18), 3 parents, and 16 professionals about MAPSS. Everyone overwhelmingly agreed that there is a need for school-based suicide prevention, as many young people are at risk of suicide, but there is not enough accessible support available. Schools were seen as an acceptable location for suicide prevention. This study aims to test the feasibility of a school-based suicide prevention programme comprising universal, selective, and indicated components in reducing suicide risk, improving risk recognition, and increasing health service use among young people aged 14-15 years in Northwest England.

Who can participate?
Pupils in Year 10 at school, aged 14-15 years

What does the study involve?
A 2-year study in six schools is scheduled to assess whether MAPPS can raise awareness of suicide prevention and promote help-seeking. Teachers and parents in participating schools will undergo free training by the suicide prevention charity 'Papyrus.' Subsequently, schools will be randomly assigned to receive the MAPSS intervention (4 schools) or continue with usual practice (control; 2 schools). Students in MAPSS schools will receive a suicide awareness lesson, and all students will complete surveys to identify those at high risk of suicide. High-risk students in MAPSS schools will undergo an online intervention (Reframe IT-UK), while those in control schools will receive standard care from their school. Surveys before and after the suicide prevention lesson and Reframe IT-UK will gauge whether MAPSS can reduce suicide risk, enhance help-seeking, and increase knowledge. Additionally, an assessment of the study process will determine necessary adjustments. If MAPSS proves safe, helpful, and acceptable, there is a plan to test it in more schools in England in a larger trial.

Public advisors have been involved in designing this study and will be involved throughout. Three parents with lived experience, the '3 dads walking', and youth associations working with young people at risk of suicide are working with us; ensuring the perspectives of those personally affected are heard within the project. Young people (aged 14-18) have advised on the recruitment process and survey questions. A public representative will lead and coordinate a young people’s advisory group for the study. The findings will be shared through co-developed journal articles, policy evidence briefings, international conferences, tailored reports for parents, children, and education professionals, and videos.

What are the possible benefits and risks of participating?
There will be no personal benefit to taking part in this research. However, if you score highly on thoughts of suicide, you may receive support from an online therapy programme designed for young people who are experiencing difficulties with their mental health. The information that you share with the team could help them work out how to support children and young people experiencing suicidal crises in the future.

Participating in the research is not expected to cause any disadvantages or discomfort. The potential physical and/or psychological harm or distress will be the same as any experienced in everyday life. However, some questions will discuss the theme of suicide. If participants feel they might find these discussions upsetting or think that they will impact their well-being, then the team will advise that they do not take part, or that they discuss this with the researcher or teacher before beginning. If they have any worries about their mood, the team suggest that they discuss this with their school’s safeguarding lead or head of pastoral care (the researcher will tell them who this is). If they feel worried or concerned about their mood or feelings after taking part, they can discuss this with their school’s safeguarding lead or head of pastoral care. They can also call Papyrus (https://www.papyrus-uk.org) on 0800 068 4141, or The Mix (https://www.themix.org.uk) on 0808 808 4994.

Where is the study run from?
Liverpool John Moores University (UK)

When is the study starting and how long is it expected to run for?
February 2024 to January 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Dr Pooja Saini, p.saini@ljmu.ac.uk

Contact information

Dr Pooja Saini
Principal investigator

Liverpool John Moores University
Tom Reilly Building
Byrom Street
Liverpool
L3 3AF
United Kingdom

ORCID ID	0000-0002-4981-7914
Phone	+ 44 (0)151 231 8121
Email	P.Saini@ljmu.ac.uk

Dr Emma Ashworth
Scientific

Liverpool John Moores University
Tom Reilly Building
Byrom Street
Liverpool
L3 3AF
United Kingdom

ORCID ID	0000-0002-5279-4514
Phone	+44 (0)151 904 1052
Email	E.L.Ashworth@ljmu.ac.uk

Miss Molly McCarthy
Public

Liverpool John Moores University
Tom Reilly Building
Byrom Street
Liverpool
L3 3AF
United Kingdom

ORCID ID	0000-0002-2504-6799
Phone	+44 (0)151 2318121
Email	M.McCarthy1@ljmu.ac.uk

Study information

Primary study design	Interventional
Study design	Two-arm cluster randomized controlled trial with mixed-methods implementation and process evaluation
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: A regionally-based feasibility trial of an integrated response to suicide risk among secondary school pupils
Study acronym	MAPSS
Study objectives	As this is a feasibility study no formal hypothesis testing will be undertaken. Research question: What is the feasibility of a school-based suicide prevention programme comprising universal, selective, and indicated components in reducing suicide risk, improving risk recognition, and increasing health service use among young people aged 14-15 years in Northwest England?
Ethics approval(s)	Approved 09/10/2023, Liverpool John Moores University Research Ethics Committee (Byrom Street, Liverpool, L3 3AF, United Kingdom; None provided; a.f.williams@ljmu.ac.uk), ref: 23/PSY/003
Health condition(s) or problem(s) studied	Suicidality
Intervention	The unit of randomisation is the schools. After baseline data collection is complete, 6 schools will be randomised into one of two study groups. Both study arms will be compared to test which, if any, is better. To create balance in terms of deprivation, ethnicity, rurality and educational outcomes, a minimisation algorithm will be used at an intervention-to-control ratio of 2:1 across Cheshire and Merseyside. Two schools will be allocated to the control arm and four schools will be allocated to the intervention arm by a university statistician, who is independent of the study and blind to school identities (blinding of schools and participants themselves is not possible due to obvious differences in intervention delivery). Methods of allocation concealment and randomisation processes will follow CONSORT. Schools will be randomised to receive a suicide prevention lesson and Reframe IT-UK and TAU, or TAU only, via a random sequence generation computer algorithm. The method of randomisation will be conducted using a routine within STATA to generate (stratified) randomised (block sizes of 2, 4 and 6) allocations. Researchers completing study assessments will be masked to intervention allocation. The trial will follow an Intent-To-Treat (ITT) protocol. Attrition will be recorded and reasons for drop-out recorded where possible. Planned Intervention of Online Cognitive Behavioural Therapy I. A minimum of 6 staff from each school will receive training from Papyrus: Suicide Prevention – Overview Tutorial (SP-OT), to ensure staff are equipped to manage any risk identified from the screening. SP-OT is delivered in a single session over 1.5 hours online. Papyrus will also provide an online information session, Suicide Prevention - Awareness, Resource, Knowledge (SP-ARK), along with support packs, for parents of all children in Year 10 at each participating school. #MyGPGuide; a guide for CYP with lived experience of self-harm and suicidality will be shared with schools and families.39 II. Suicide prevention lesson, a suicide alertness training workshop suitable for anyone over the age of 14. The lesson comprises a single 3-hour face-to-face workshop, designed to help participants understand suicide warning signs in themselves and others, gain knowledge about sources of support, and signpost others. Suicide prevention lessons will be delivered by trained Suicide Prevention Facilitators at Grassroots Suicide Prevention to classroom-sized groups of pupils (maximum 30 pupils per session with at least one teacher present). III. The screening will take the form of self-report measures embedded into the questionnaires at each timepoint. Researchers will inform each school after each timepoint of any pupils who are assessed to be at risk. Pupils who report suicidal ideation within the past four weeks (Suicide Ideation Attributes Scale [SIDAS] score of 21 or higher) or any level of current suicidal ideation (single multiple-choice item) will be flagged by the research team and followed up by the school safeguarding lead. IV. Reframe IT-UK has been adapted from the Reframe-IT intervention developed in Australia.7,11 It comprises eight 20-minute online self-guided CBT modules, following the stories of two young people who make video diaries about their day-to-day life and their experience of feeling suicidal. There is also a message board through which the participants can communicate with a moderator, a mood diary, and signposting information.
Intervention type	Behavioural
Primary outcome measure(s)	1. Acceptability: Operationalised in terms of the acceptability and safety of the intervention. A mixed-methods approach will be used to determine the acceptability and safety of trialling a suicide prevention programme in UK schools. The proportion of pupils who complete all agreed sessions will be recorded (>60% excellent. 40%-60% acceptable; <40% not acceptable) on the Reframe IT-UK website. Acceptability of the suicide prevention lesson, including whether participants thought it was “useful”, “interesting”, or “upsetting”, will be assessed at T2 only using purpose-designed items. Participant views on the Reframe IT-UK intervention will be assessed at T3. 2. Social validity measured using a process evaluation of bespoke quantitative surveys following the delivery of each component of the MAPSS programme at T2 and T3. Qualitative interviews will also be conducted with staff and focus groups with pupils across the study period. 3. Feasibility of the trial: Data will be collected on the following: 3.1. The missing data on completed assessment (<15%) 3.2. Change or variability on outcome measures (e.g., suicide ideation, depressive or hopelessness symptoms)
Key secondary outcome measure(s)	1. Past four-week suicidal ideation measured using the Suicidal Ideation Attributes Scale (SIDAS) at T2, T3 and T4 2. Symptoms of depression measured using the Patient Health Questionnaire – 9 item version at T1, T2, T3 and T4 3. Hopelessness measured using the positively worded brief measure of hopelessness (Brief-H-Pos) at T2, T3 and T4 4. Health service use and other resource use (education and local authority) comparing intervention and control groups measured using a bespoke questionnaire adapted from the Young Mind Matters Service Use questionnaire at T2, T3 and T4 5. Intentions to seek help measured using purposefully designed questions from informal sources T2, T3 and T4 6. Health-related quality of life during the trial measured using the Child Health Utility–9 (CHU9D) at T1, T2, T3, and T4. The CHU9D can be used to derive quality-adjusted life years (QALYs). These data will be used in combination with data from 3) above, to assess the feasibility of the full economic evaluation. 7. Suicide literacy measured using an adapted version of the Literacy of Suicide Scale (LOSS) at T1, T2, T3 and T4 8. Current provision (i.e., establish a clear counterfactual), identify the level of programme differentiation, and account for any potential compensatory rivalry or contamination in control schools measured using a usual practice survey completed by school staff (key contact or safeguarding lead) at T1 and T4
Completion date	31/01/2026

Eligibility

Participant type(s)	Learner/student
Age group	Child
Lower age limit	14 Years
Upper age limit	15 Years
Sex	All
Target sample size at registration	810
Key inclusion criteria	1. Pupils in Year 10 at school, aged 14-15 years 2. Attending a mainstream secondary school or pupil referral unit 3. For Reframe IT-UK only: a score of 21 or above on the SIDAS
Key exclusion criteria	1. Age below 14 or over 15 years 2. Attending a special school or other specialist education provision 3. No significant learning disability 4. For Reframe IT-UK: a score below 21 on the SIDAS
Date of first enrolment	14/02/2024
Date of final enrolment	31/10/2024

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Liverpool John Moores University

Byrom Street
Liverpool
L3 3AF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository, Available on request, Published as a supplement to the results publication
IPD sharing plan	Source data and documents: Source data for this trial will consist of paper copies of the consent form, data from online questionnaires (collected via QuestionPro), and audio recordings of interviews and focus groups. When a participant consents to take part in the trial, they will be provided with a unique participant identification number which will be used to link survey data across timepoints. Personal data entered via QuestionPro will be anonymised and stored on a password-protected database, housed on LJMU’s secure systems, and will only be accessible to members of the core research team. Consent forms and letters with personal identifiable data will be stored separately in a locked filing cabinet. Participant details will be anonymised in any publications that result from the trial. Encrypted Dictaphones will be used to record interviews and focus groups. Audio files will be immediately transferred to LJMU’s secure servers after the interviews are complete and will subsequently be deleted from the Dictaphone. Once transcribed, audio files will also be deleted from LJMU’s systems. Transcripts will be anonymised, with any identifiable information removed, and pseudonyms used. Only the research team will have access to the transcripts. Data handling and record keeping: This information is included in a data management plan so is not duplicated here. Access to Data: Direct access will be granted to authorised representatives from the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections - in line with participant consent. Archiving: This trial will be sponsored by LJMU who are also the data custodian. All research data will be retained in a secure location during the conduct of the trial and for 5 years after the end of the trial, when all paper records will be destroyed by confidential means. An archiving plan will be developed for all trial materials in accordance with the LJMU archiving policy.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1.0	19/01/2024	29/01/2024	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

44937_Protocol_v1.0_19Jan2024.pdf: Protocol file

Editorial Notes

21/10/2024: The study dates are correct.
07/03/2024: The recruitment start date was changed from 01/03/2024 to 14/02/2024.
26/01/2024: Study's existence confirmed by National Institute for Health and Care Research (NIHR) (UK).