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Self-HarmSHAPENCT06895668

Self-harm and the Prison Environment Mixed Methods Study

An observational study of Self-Harm and Self-harm Behavior, run by King's College London.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Self-harming behaviour is a major problem in UK prisons: the number of self-harm incidents has more than doubled over the past decade. People who self-harm in prison are at greater risk of subsequent death by suicide. Risk assessment processes for the prison population are rudimentary and critically under-informed. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
None (cohort study)
How many people
458 participants
Where
No sites listed yet
Study dates
1 Jul 2025to 31 Mar 2027
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: People entering one of three prisons in England

Who may be able to join

  • New entrants to prison

Who cannot join

  • Expected release/transfer date less than 12 weeks from date of entry
  • Lack capacity to give informed consent
  • Insufficient spoken English skills to participate
  • Assessed persistently as not safe to be seen face to face due to imminent high risk of violence.
  • Risk of psychological harm from participation more than minimal (based on risk assessment with prison's Safer Custody and mental health teams)

About this study

Official title: Self-harm and the Prison Environment (SHAPE): a Mixed Methods Study of the Role of Custody-specific Factors in Self-harm Behaviours Amongst Men and Women in Prison.

Self-harming behaviour is a major problem in UK prisons: the number of self-harm incidents has more than doubled over the past decade. People who self-harm in prison are at greater risk of subsequent death by suicide. Risk assessment processes for the prison population are rudimentary and critically under-informed. Research evidence shows that a person's life history and current mental health make some more vulnerable than others to such behaviour. However, the role of the prison environment in contributing to self-harm risk is poorly understood. A wide range of environmental factors might be important, such as the degree of contact with the outside world, stimulation in the daily regime and conflicts with peers and prison staff. In a pilot study that the investigators carried out in a male prison, prison environment characteristics such as placement in a single-occupancy cell and changing cell or cellmate more frequently were associated with self-harm. These environmental factors now require further study in larger-scale research in men and women's prisons. Understanding which environmental factors are relevant to self-harming behaviour will help prison and healthcare staff to make better informed assessments of self-harming risks and better management plans to reduce such behaviours.

This study aims to establish the impact of the prison environment on self-harming behaviour amongst both men and women in prison using a mixed methods approach. The investigators now want to establish the precise influence of such factors in both male and female prisoners to help to improve the management of such behaviour. This will be done by interviewing and following up groups of male and female prisoners for a 12 week period (the cohort study). The investigators will then use focus groups to explore prisoner, staff and other stakeholder views on the findings (the focus group study). Finally, female self-harming prisoners will be interviewed to explore the detailed perspectives of women (the interview study). The studies will take place at three prisons: HMP Wandsworth and HMP Pentonville (both medium security men's prisons) and HMP Bronzefield (a high security women's prison).

Read more

Cohort study: Adults entering either prison are eligible to participate. The investigators will recruit a random sample of 458 men and women (based on a power calculation informed by previous pilot work). Participants will complete two 1-hour baseline assessments before being followed up for 12 weeks. The researchers will conduct two further in-person assessments and examine the participant's health and custodial records at the prison and link this with local wing-level prison data. The results will establish which of a range of possible prison environmental factors are related to self-harming behaviour.

The following prison-related predictors of self-harm behaviour will be examined in the cohort study:

  • Placement in a single-occupancy cell
  • Frequency of cell changes
  • Placement in solitary confinement
  • Violence perpetration
  • Other disciplinary infractions
  • Violent/sexual victimisation
  • Work status in prison
  • Time in purposeful activities
  • Social visit status
  • Legal status
  • Time out of cell (cumulative exposure)
  • Staffing ratio (cumulative exposure)
  • Staff experience (cumulative exposure)
  • Staff responsivity to emergency bells (cumulative exposure)

Focus group study: The researchers will then use focus groups to explore the perspectives of prisoners and staff on our research findings and their implications for day-to-day practice. Adult self-harming prisoners, peer support workers, supervising officers and healthcare staff at the same prisons, alongside other stakeholders working in the field - including carers - will be eligible to participate in audio-recorded focus groups.

Interview study: The investigators will explore in more detail the impact of prison-related factors on self-harm behaviour amongst female prisoners (having already completed such interviews with male prisoners in our pilot work). 10 adult self-harming women at HMP Bronzefield will be recruited to take part in audio-recorded semi-structured interviews.

Answering these questions will help to inform prison-wide strategies for reducing self-harm in both male and female prisoners.

Being tested
None (cohort study)
Keywords
Self-harm, Self-injury, Prospective cohort study, Qualitative, Focus groups, Semi-structured interviews, Environmental factors, Prison, Custody, Offenders, Prisoners, Incarceration
Medical subject headings
Self-Injurious Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • None (cohort study)Other

    None (cohort study)

Study groups in NCT06895668
Study groupRoleWhat they receive
Prison entry cohortCohort of 458 prisoners from two men's local (remand) prisons and one female high security prison in England, recruited on entry to prison using series of random samples of prison admissions across the recruitment period.
Receives: Other: None (cohort study)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-harm behaviour

    Self-harm behaviour (any) in time-to-event format, assessed using a modified version of the Columbia - Suicide Severity Rating Scale (C-SSRS). Outcome will be self-harm behaviour survival time, analysed using a survival analysis approach (Cox shared frailty modelling) to produce Hazard Ratios for each predictor.

    Measured: From enrolment to the end of observation at 12 weeks

Secondary outcomes (1)
  1. Suicidal ideation

    Suicidal ideation (any) in binary format, assessed using a modified version of the Columbia - Suicide Severity Rating Scale (C-SSRS).

    Measured: From enrollment to the end of observation at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
458 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06895668
Sponsor's protocol ID
IRAS350490
Other IDs
NIHR304724
Acronym
SHAPE
Status last verified
Mar 2025
First submitted
17 Mar 2025
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Self-Harm and Self-harm Behavior, run by King's College London.

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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Self-harm behaviour (time frame: From enrolment to the end of observation at 12 weeks). 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 26 Mar 2025.

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