Prevention of suicide behaviour in prison (work packages 3 and 4)

ISRCTN	ISRCTN14056534
DOI	https://doi.org/10.1186/ISRCTN14056534
IRAS number	274976
Secondary identifying numbers	CPMS 50267, Grant Codes: RP-PG-0218-20006, IRAS 274976

Submission date: 23/09/2021
Registration date: 24/09/2021
Last edited: 19/12/2024

Recruitment status: 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
The rate of suicide in prisons in the UK has doubled in the last ten years and represents a significant problem. Cognitive Behavioural Suicide Prevention (CBSP) is a psychological intervention that aims to address suicidal behaviour. In a small trial of CBSP, the therapy group was found to have engaged in fewer suicidal behaviours compared to controls. However, the study could not provide any definitive comment on efficacy. The pilot trial found that many participants in the treatment arm required substantial ‘pre-intervention support’ in order for the necessary open, warm therapeutic relationship to develop. The need for further modification to the standard delivery of CBSP therapy was identified. These modifications, including ‘pre-intervention support’ were addressed in the first two work packages of the research programme (submitted under IRAS ID: 266858) to produce the Prospect Programme.
This application represents the next phase of the research programme and involves assessing the clinical and cost-effectiveness of the new PROSPECT programme in a Randomised Controlled Trial (RCT). This application covers work packages 3 and 4.

Who can participate?
Male adults (aged over 18 years) who are currently detained in prison and are feeling suicidal

What does the study involve?
Work package 3:
We will conduct an RCT in four UK prisons, recruiting 360 participants who are currently detained in prison and are feeling suicidal. We will assess participants at baseline and then again six months later. After baseline assessments, half will be randomised to receive the PROSPECT programme plus treatment as usual and the other half will receive treatment as usual. We will then compare the two groups to determine whether the intervention was clinically and cost-effective. The study will take 27 months to complete.

Work package 4:
Alongside the RCT, we will conduct a process evaluation to assess the extent to which the intervention was delivered to participants in the PROSPECT programme group and to enhance our understanding of how the intervention worked.

What are the possible benefits and risks of participating?
There is no direct benefit for people in prison and staff participants who take part in the study. However, some participants may find it helpful to talk about their experiences and may be satisfied that they are contributing to an important area that aims to improve suicide prevention in prison. There is a risk that some people may find it distressing when answering questions about suicide, but previous studies have found that individuals are more likely to derive benefit from discussing suicide than experience harm.

Where is the study run from?
University of Manchester (UK)

When is the study starting and how long is it expected to run for?
October 2019 to March 2027

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

Who is the main contact?
Dr Daniel Pratt, Daniel.pratt@manchester.ac.uk
Dr Caroline Hendricks, caroline.stevenson@manchester.ac.uk

Study website

Contact information

Dr Daniel Pratt
Scientific

Room 3.27
3rd floor, Booth Street East Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0001-8843-1224
Phone	+44 (0)161 306 0400
Email	Daniel.pratt@manchester.ac.uk

Dr Caroline Hendricks
Scientific

Room 3.34
3rd floor, Booth Street East Building
Oxford Road
Manchester
M13 9PL
United Kingdom

ORCID ID	0000-0002-1176-5231
Email	caroline.stevenson@manchester.ac.uk

Study information

Study design	Interventional randomized controlled trial with quantitative follow up and parallel process evaluation
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Prison/detention
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The prevention of suicide behaviour in prison: enhancing access to therapy (PROSPECT) programme (work packages 3 and 4)
Study acronym	PROSPECT
Study objectives	The rate of suicide in prisons in the UK has doubled in the last ten years and represents a significant problem. Cognitive Behavioural Suicide Prevention (CBSP) is a psychological intervention that aims to address suicidal behaviour. In a small trial of CBSP, the therapy group was found to have engaged in fewer suicidal behaviours compared to controls. However, the study could not provide any definitive comment on efficacy. The pilot trial found that many participants in the treatment arm required substantial ‘pre-intervention support’ in order for the necessary open, warm therapeutic relationship to develop. The need for further modification to the standard delivery of CBSP therapy was identified. These modifications, including ‘pre-intervention support’ were addressed in the first two work packages of the research programme (submitted under IRAS ID: 266858) to produce the Prospect Programme. This application represents the next phase of the research programme and involves assessing the clinical and cost effectiveness of the new PROSPECT programme in a Randomised Controlled Trial (RCT). This application covers work packages 3 and 4. Work package 3: We will conduct an RCT in four UK prisons, recruiting 360 participants who are currently detained in prison and are feeling suicidal. We will assess participants at baseline and then again six months later. After baseline assessments, half will be randomised to receive the PROSPECT programme plus treatment as usual and the other half will receive treatment as usual. We will then compare the two groups to determine whether the intervention was clinically and cost effective. The study will take 27 months to complete. Work package 4: Alongside the RCT, we will conduct a process evaluation to assess the extent to which the intervention was delivered to participants in the PROSPECT programme group and to enhance our understanding of how the intervention worked.
Ethics approval(s)	Approved 28/10/2021, Wales REC 3 (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 230457; WALES.REC3@wales.nhs.uk), ref: 21/WA/0273
Health condition(s) or problem(s) studied	Suicidal behaviour
Intervention	WP3: Intervention Arm [PROSPECT programme plus TAU]: In addition to Treatment As Usual the intervention arm will receive targeted psychological therapy comprising of a preparatory phase which aims to develop the therapeutic relationship between therapist and participant followed by a delivered Cognitive Behavioural Suicide Prevention (CBSP) programme Control Arm [TAU only]: Treatment As Usual group will receive standard care in accordance with national and local service protocols. All outcome measures will be collected at baseline and 6 months (+ 3 months) follow-up. Process Evaluation (WP4): Process Evaluation interviews: Semi-structured interviews will focus on understanding the mechanisms of action, how the prison context and culture affect implementation, and why those receiving the PROSPECT programme did or did not engage in subsequent suicide behaviours. Observation study: As with the semi-structured interviews, observations will focus on understanding the mechanisms of action and how the prison context can affect the implementation of the intervention.
Intervention type	Behavioural
Primary outcome measure	1. Suicidal ideation as measured by the Beck Scale for Suicide Ideation at 6 months post randomisation 2. Number of occurrences of suicidal behaviour during the last 6 months collected via self-report from participants with researchers using an adapted version of the Suicide Attempt – Self-Injury Interview to improve recall and reporting of suicide behaviour
Secondary outcome measures	Current secondary outcome measures as of 07/03/2022: WP3: 1. Number of days from randomisation to first suicidal behaviour as measured participant self-report at 6 months post randomisation 2. Future suicide potential as measured by the Suicide Probability Scale at 6 months post randomisation 3. Suicide schema as measured by the Brief Suicide Cognitions Scale at 6 months post randomisation 4. Depression as measured by the Beck Depression Inventory II at 6 months post randomisation 5. General psychopathology as measured by the Brief Symptom Inventory at 6 months post randomisation 6. Personality dysfunction as measured by the Standardised Assessment of Personality – Abbreviated Scale at 6 months post randomisation 7. Hopelessness as measured by the Beck Hopelessness Scale at 6 months post randomisation 8. Defeat as measured by the Defeat Scale at 6 months post randomisation 9. Entrapment as measured by the Entrapment Scale at 6 months post randomisation 10. Self-esteem as measured by the Robson Self Concept Questionnaire at 6 months post randomisation 11. Coping as measured by the Coping Inventory for Stressful Situations at 6 months post randomisation 12. Wellbeing as measured by the ICEpop CAPability measure for adults at 6 months post randomisation 13. Therapeutic alliance as measured by the Working Alliance Inventory at regular intervals during the 6 months of intervention delivery NB: The 6-month follow-up will take place between 6-9 months post randomisation WP4: 14. Prisoner and staff experiences of receiving the Prospect programme (for prisoner participants), or their experience of managing suicide behaviour in prison (for staff participants) measured using interviews during the trial and after 6 month follow up Previous secondary outcome measures: WP3: 1. Future suicide potential as measured by the Suicide Probability Scale at 6 months post randomisation 2. Depression as measured by the Beck Depression Inventory II at 6 months post randomisation 3. General psychopathology as measured by the Brief Symptom Inventory as 6 months post randomisation 4. Personality dysfunction as measured by the Standardised Assessment of Personality – Abbreviated Scale at 6 months post randomisation 5. Hopelessness as measured by the Beck Hopelessness Scale at 6 months post randomisation 6. Defeat as measured by the Defeat Scale at 6 months post randomisation 7. Entrapment as measured by the Entrapment Scale at 6 months post randomisation 8. Suicide schema as measured by the Suicide Cognitions Scale at 6 months post randomisation 9. Self-esteem as measured by the Robson Self Concept Questionnaire at 6 months post randomisation 10. Coping as measured by the Coping Inventory for Stressful Situations at 6 months post randomisation 11. Wellbeing as measured by the ICEpop CAPability measure for adults at 6 months post randomisation 12. Therapeutic alliance as measured by the Working Alliance Inventory at regular intervals during the 6 months of intervention delivery NB: The 6 month follow-up will take place between 6-9 months post randomisation WP4: 13. Prisoner and staff experiences of receiving the Prospect programme (for prisoner participants), or their experience of managing suicide behaviour in prison (for staff participants) measured using interviews during the trial and after 6 month follow up.
Overall study start date	01/10/2019
Completion date	31/03/2027

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Target number of participants for the RCT is 360. The minimum target sample size for the process evaluation is 36. For the process evaluation we aim to interview between 12-48 prisoner participants who are involved in the RCT and receiving the PROSPCECT intervention, between 8-16 members of staff and the 4 therapists delivering the PROSPECT intervention. For the observation study, we aim to observe between 8-16 members of staff and 4-8 prisoners who are receiving the PROSPECT intervention.
Key inclusion criteria	Current inclusion criteria as of 14/03/2022: For the RCT (WP3): 1. Male Prisoner (defined as a person sentenced to imprisonment in a male prison) 2. Aged over 18 years - updated 07/03/2022: aged 18 years or over 3. At current risk of suicide behaviour as indicated by currently being on the host prison's ACCT system, or on the ACCT system within the four weeks prior to consent. 4. Able to complete a battery of self-report measures with breaks if needed 5. Willing to consent to being subject to a 'holding order' to require them to remain within the host prison for the duration of their participation in the trial. For the Process Evaluation Interviews (WP4) Prison participants: 1. Is a participant on the Prospect RCT randomised to receive the Prospect programme. Staff participants: 2. Is a member of staff currently working in the prison in a role that involves the care and/or management of prisoners who engage in suicide behaviour. OR 3. Is a member of staff directly involved in delivering the Prospect programme. Observation study: Shadowing of prisoner participants: 1. Is a participant on the Prospect RCT randomised to receive the Prospect programme. Staff participants: 2. Is a member of staff currently working in the prison in a role that involve the care and/or management of prisoners who engage in suicide behaviour. 3. Has taken part in the process evaluation interviews But observation could also include: Any prisoner or member of staff present during an observation session and not having asked to be excluded. _____ Previous inclusion criteria: For the RCT (WP3): 1. Male Prisoner (defined as a person sentenced to imprisonment in a male prison) 2. Aged over 18 years - updated 07/03/2022: aged 18 years or over 3. At current risk of suicide behaviour according to the host prison’s ACCT system 4. Able to complete a battery of self-report measures with breaks if needed 5. Willing to be placed on a holding order to remain in the host prison for the duration of their participation. For the Process Evaluation Interviews (WP4) Prison participants: 1. Is a participant on the Prospect RCT randomised to receive the Prospect programme. Staff participants: 2. Is a member of staff currently working in the prison in a role that involves the care and/or management of prisoners who engage in suicide behaviour. OR 3. Is a member of staff directly involved in delivering the Prospect programme. Observation study: Shadowing of prisoner participants: 1. Is a participant on the Prospect RCT randomised to receive the Prospect programme. Staff participants: 2. Is a member of staff currently working in the prison in a role that involve the care and/or management of prisoners who engage in suicide behaviour. 3. Has taken part in the process evaluation interviews But observation could also include: Any prisoner or member of staff present during an observation session and not having asked to be excluded.
Key exclusion criteria	For the RCT (WP3): 1. Planned release within next 9 months 2. Insufficient knowledge of English to enable adequate participation in the assessment process 3. Deemed by prison staff to be too dangerous/elevated risk of harm to the researcher 4. Lacking capacity to provide informed consent For the process evaluation (WP4): Prison participants: 1. Deemed by prison staff to be too dangerous/elevated risk of harm to the researcher Staff participants: There are no exclusion criteria for staff participants Observation study: 1. Any member of staff or prisoner who informs the researcher that they do not wish to be included in the observation study.
Date of first enrolment	17/03/2022
Date of final enrolment	31/12/2025

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

4 prisons in the North of England

M13 9PL
United Kingdom

Sponsor information

University of Manchester
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone	+44 (0)161 275 5436
Email	fbmhethics@manchester.ac.uk
Website	http://www.manchester.ac.uk/
"ROR"	https://ror.org/027m9bs27

Funders

Funder type

Government

NIHR Central Commissioning Facility (CCF)

No information available

National Institute for Health Research (NIHR) (UK)
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/09/2027
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are available from the corresponding author Dr Kerry Gutridge (kerry.gutridge@manchester.ac.uk) on reasonable request

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No
Protocol article		18/12/2024	19/12/2024	Yes	No

Editorial Notes

19/12/2024: Publication reference added.
06/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2024 to 31/12/2025.
2. The overall study end date was changed from 31/03/2026 to 31/03/2027.
3. The intention to publish date was changed from 30/09/2026 to 30/09/2027.
28/10/2024: A contact was removed and the contact address details were updated.
30/07/2024: The plain English summary was updated to reflect the overall end date change on 19/06/2024.
24/06/2024: Contact details corrected.
19/06/2024: The following changes were made to the study record:
1. Contact details updated.
2. The recruitment end date was changed from 30/06/2024 to 31/12/2024.
3. The overall study end date was changed from 30/09/2024 to 31/03/2026.
4. The intention to publish date was changed from 01/09/2025 to 30/09/2026.
15/09/2023: Contact details updated.
16/06/2023: Contact details updated.
15/06/2023: The recruitment end date was changed from 30/06/2023 to 30/06/2024.
24/01/2023: The study setting has been updated from ‘Other’.
14/03/2022: The inclusion criteria were changed.
07/03/2022: The following changes were made to the trial record:
1. Acronym added.
2. The secondary outcome measures and inclusion criteria were updated.
3. The recruitment start date was changed from 28/01/2022 to 17/03/2022.
19/01/2022: The following changes were made to the trial record:
1. The ethics approval was added.
2. The recruitment start date was changed from 10/01/2022 to 28/01/2022.
07/10/2021: Internal review.
23/09/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).