Risk Behavior, HealthNCT03762356
Questionnaire About Individual's Insight/Awareness of Risk of Violence
An observational study of Risk Behavior, Health and Violence, run by Bournemouth University.
Trial summary
The overall aim of this questionnaire is to gather the views of qualified clinicians on what factors contribute to an individual's insight or awareness into their own violent behaviours. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Behavior, Health, Violence, Risk Behavior
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to 1 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Employed as a qualified as a Psychologist, Nurse, Social Worker, Occupational Therapist, Psychiatrist, Prison Officer or Offender Manager currently working in a secure care or forensic community setting
Who may be able to join
- Employed as a qualified as a Psychologist, Nurse, Social Worker, Occupational Therapist, Psychiatrist, Prison Officer or Offender Manager currently working in a secure care or forensic community setting.
Who cannot join
- Those working solely in private practice outside of organisations and those who work outside the UK, are not eligible to participate
About this study
Official title: What Factors Are Important When Assessing an Individual's Insight/Awareness of Their Own Violence Risk?
The overall aim of this questionnaire is to gather the views of qualified clinicians on what factors contribute to an individual's insight or awareness into their own violent behaviours. The questionnaire will also explore what type of tool would be useful to develop for use in clinical practice to aid effective risk assessment and management. Brief demographic information will also be gathered.
Read the detailed description
Despite insight into violence being a factor regularly addressed by professionals in the assessment of future violence occurring research on this concept is sparse. Research instead tends to focus specifically on insight into violence specifically in relation to schizophrenia rather than more broadly in forensic and other clinical settings. What evidence there is suggests that developing an individual's insight or awareness of their own risk of violence is a key factor in reducing the likelihood of them engaging in further acts of violence. Being able to appropriately assess this is key and appears to currently be inconsistent between professionals.
In this study, therefore, a questionnaire will be disseminated to professionals working in secure care or a forensic community setting in order to gather their views on what factors contribute to an individual's insight or awareness into their own violent behaviours.
All clinicians/professionals who are currently employed and qualified as an Offender Manager, Offender Supervisor, Psychologist, Nurse, Social Worker, Occupational Therapist, Psychiatrist, Prison Officer currently working in a secure care or forensic community setting will be eligible to participate. Individuals with the appropriate qualifications working within private practice in the UK will also be eligible to participate. Those working outside the UK will not be eligible to participate.
- Conditions
- Risk Behavior, Health, Violence, Risk Behavior
- Keywords
- Insight, Awareness, Violence, Professional views, Risk to others
- Medical subject headings
- Health Risk Behaviors, Risk-Taking
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire responses that measure levels of insight or awareness of violence
Online survey responses as to range of factors identified by clinicians, a consensus on a format of insight tool and to have sufficient information to be able to devise an insight tool that measures level of insight or awareness of violence.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study startSep 2020 (estimated)
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Why it stopped: Study did not receive final approval however it was decided to not pursue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Behavior, HealthStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bournemouth University
- Sponsor type
- University, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Joe Lowenstein, BSc MSc DClinPsy, Study chair, Chief Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03762356
- Sponsor's protocol ID
- BournemouthU
- Status last verified
- Oct 2020
- First submitted
- 3 Oct 2018
- Last updated
- 30 Oct 2020
- 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 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Factors Are Important When Assessing an Individual's Insight/Awareness of Their Own Violence Risk?
- ClinicalTrials.gov ID
- NCT03762356
- Acronym / sponsor ID
- BournemouthU
- Conditions
- Risk Behavior, Health, Violence, Risk Behavior
- Keywords
- Insight, Awareness, Violence, Professional views, Risk to others
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study did not receive final approval however it was decided to not pursue.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bournemouth UniversityUniversity, hospital or other
- Collaborators
- Dorset HealthCare University NHS Foundation Trust
- Study start
- Sep 2020 (estimated)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 3 Dec 2018 (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.
The overall aim of this questionnaire is to gather the views of qualified clinicians on what factors contribute to an individual's insight or awareness into their own violent behaviours. The questionnaire will also explore what type of tool would be useful to develop for use in clinical practice to aid effective risk assessment and management. Brief demographic information will also be gathered.
Detailed description
Despite insight into violence being a factor regularly addressed by professionals in the assessment of future violence occurring research on this concept is sparse. Research instead tends to focus specifically on insight into violence specifically in relation to schizophrenia rather than more broadly in forensic and other clinical settings. What evidence there is suggests that developing an individual's insight or awareness of their own risk of violence is a key factor in reducing the likelihood of them engaging in further acts of violence. Being able to appropriately assess this is key and appears to currently be inconsistent between professionals.
In this study, therefore, a questionnaire will be disseminated to professionals working in secure care or a forensic community setting in order to gather their views on what factors contribute to an individual's insight or awareness into their own violent behaviours.
All clinicians/professionals who are currently employed and qualified as an Offender Manager, Offender Supervisor, Psychologist, Nurse, Social Worker, Occupational Therapist, Psychiatrist, Prison Officer currently working in a secure care or forensic community setting will be eligible to participate. Individuals with the appropriate qualifications working within private practice in the UK will also be eligible to participate. Those working outside the UK will not be eligible to participate.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Employed as a qualified as a Psychologist, Nurse, Social Worker, Occupational Therapist, Psychiatrist, Prison Officer or Offender Manager currently working in a secure care or forensic community setting
Key inclusion criteria (1 listed)
- Employed as a qualified as a Psychologist, Nurse, Social Worker, Occupational Therapist, Psychiatrist, Prison Officer or Offender Manager currently working in a secure care or forensic community setting.
Key exclusion criteria (1 listed)
- Those working solely in private practice outside of organisations and those who work outside the UK, are not eligible to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Questionnaire responses that measure levels of insight or awareness of violence
Time frame: 10 minutes
Online survey responses as to range of factors identified by clinicians, a consensus on a format of insight tool and to have sufficient information to be able to devise an insight tool that measures level of insight or awareness of violence.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- 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.
Joe Lowenstein, BSc MSc DClinPsy study chair
Chief Investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Behavior, Health and Violence, run by Bournemouth University.
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 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: withdrawn, as of the sponsor's last update on 30 Oct 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Questionnaire responses that measure levels of insight or awareness of violence (time frame: 10 minutes). 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 30 Oct 2020.