ISRCTN10115835进行中（未招募）未知
Women Offenders Repeat Self-Harm Intervention Pragmatic Trial (WORSHIP III)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Current inclusion criteria as of 25/07/2019:
- •For women participating in the randomised controlled trial and qualitative follow-up (as piloted in WORSHIP I and II):
- •1. The participant is a remand or sentenced woman in prison who is on an ACCT currently or has been on an ACCT in the last month. ACCT refers to the Assessment Care in Custody and Teamwork process which is used in prisons for self-harm monitoring and management. The ACCT process is started when women are at risk and often experiencing thoughts of self-harm. It is designed to target people who are at risk of self-harm repetition.
- •2. The participant is a woman in prison who has self-harmed in the last month.
- •3. The participant is 18 years or over. The intervention has been piloted with adults as women under 18 may have different needs.
- •4. The participant has been screened for date of release or trial and has a minimum of 8 weeks left in prison, at baseline, to complete the intervention sessions
- •For staff participating in the qualitative follow-up:
- •Have worked with women involved in the intervention
- •Previous inclusion criteria:
- •For women participating in the randomised controlled trial and qualitative follow-up (as piloted in WORSHIP I and II):
- •1. Remand and sentenced women in prison who are on an ACCT currently or have been on an ACCT in the last month. ACCT refers to the Assessment Care in Custody and Teamwork process which is used in prisons for self-harm monitoring and management. The ACCT process is started when women are at risk and often experiencing thoughts of self-harm. It is designed to target people who are at risk of self-harm repetition
- •2. Women who have recently self-harmed in the last month
- •3. Women will be 18 years or over. The intervention has been piloted with adults as women under 18 may have different needs.
- •4. Women will be screened for date of release or trial and will need to be in the prison for a minimum of 8 weeks to complete the intervention sessions.
- •5. Women currently involved in another psychological intervention in the prison establishment which has aims that overlap with PIT, e.g. it is designed to address their distress or self-harm via a talking therapy approach.
- •For staff participating in the qualitative follow-up:
- •Have worked with women involved in the intervention
排除标准
- •Current exclusion criteria as of 25/07/2019:
- •For women participating in the randomised controlled trial and qualitative follow up:
- •1. The participant is currently involved in another psychological intervention in the prison establishment which has aims that overlap with PIT, e.g. it is designed to address their distress or self-harm via a talking therapy approach or they are booked to start an overlapping therapy during the 12-week study period
- •2. The participant lacks capacity to consent to research participation. This assessment will be made by experienced researchers in collaboration with prison staff and healthcare staff and will be based on the principles behind the Mental Capacity Act (2005).
- •3. The participant is too distressed/unwell to participate in research. This decision will be based on consultation with Safer Custody/healthcare staff. For example, women who are at a very high risk of suicide may be excluded as they will be too distressed to engage effectively with therapy.
- •4. The participant currently poses a high risk to the researchers or the therapists. This criterion is only for people who pose an imminent risk of violence which would mean that the researchers/therapists are in danger of physical harm. People will be assessed based on their current risk rather than their past behaviours. Assessment will be made by the Safer Custody and OMU team in consultation with the researchers and mental health in-reach. Once the risk has subsided women may be eligible to participate if they fit the other criteria.
- •For staff participating in the qualitative follow-up:
- •Staff with no experience working with women involved in the intervention
- •Previous exclusion criteria:
- •For women participating in the randomised controlled trial and qualitative follow up:
- •1. Women who lack capacity to consent to research participation will be excluded from the research. This assessment will be made by experienced researchers in collaboration with prison staff and healthcare staff and will be based on the principles behind the Mental Capacity Act (2005).
- •2. Women who are too distressed/unwell to participate in research will also be excluded. This decision will be based on consultation with Safer Custody/healthcare staff. For example, women who are at a very high risk of suicide may be excluded as they will be too distressed to engage effectively with therapy.
- •3. Women who have less than 8 weeks left in prison will also be excluded as they will be unable to complete the entire course of treatment.
- •4. Women who currently pose a high risk to the researchers or the therapists will also be excluded from the research. This criterion is only for people who pose an imminent risk of violence which would mean that the researchers/therapists are in danger of physical harm. People will be assessed based on their current risk rather than their past behaviours. Assessment will be made by the Safer Custody team in consultation with the researchers and mental health in-reach. Once the risk has subsided women may be eligible to participate if they fit the other criteria.
- •5. Women will be excluded if they are already involved in another psychological intervention within the prison establishment that has aims which overlap with PIT, e.g. it is designed to address their distress or self-harm via a talking therapy approach.
- •For staff participating in the qualitative follow-up:
- •Staff with no experience working with women involved in the intervention
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