<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03762356</url>
  </required_header>
  <id_info>
    <org_study_id>BournemouthU</org_study_id>
    <nct_id>NCT03762356</nct_id>
  </id_info>
  <brief_title>Questionnaire About Individual's Insight/Awareness of Risk of Violence</brief_title>
  <official_title>What Factors Are Important When Assessing an Individual's Insight/Awareness of Their Own Violence Risk?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bournemouth University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dorset HealthCare University NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bournemouth University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of this questionnaire is to gather the views of qualified clinicians on what&#xD;
      factors contribute to an individual's insight or awareness into their own violent behaviours.&#xD;
      The questionnaire will also explore what type of tool would be useful to develop for use in&#xD;
      clinical practice to aid effective risk assessment and management. Brief demographic&#xD;
      information will also be gathered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite insight into violence being a factor regularly addressed by professionals in the&#xD;
      assessment of future violence occurring research on this concept is sparse. Research instead&#xD;
      tends to focus specifically on insight into violence specifically in relation to&#xD;
      schizophrenia rather than more broadly in forensic and other clinical settings. What evidence&#xD;
      there is suggests that developing an individual's insight or awareness of their own risk of&#xD;
      violence is a key factor in reducing the likelihood of them engaging in further acts of&#xD;
      violence. Being able to appropriately assess this is key and appears to currently be&#xD;
      inconsistent between professionals.&#xD;
&#xD;
      In this study, therefore, a questionnaire will be disseminated to professionals working in&#xD;
      secure care or a forensic community setting in order to gather their views on what factors&#xD;
      contribute to an individual's insight or awareness into their own violent behaviours.&#xD;
&#xD;
      All clinicians/professionals who are currently employed and qualified as an Offender Manager,&#xD;
      Offender Supervisor, Psychologist, Nurse, Social Worker, Occupational Therapist,&#xD;
      Psychiatrist, Prison Officer currently working in a secure care or forensic community setting&#xD;
      will be eligible to participate. Individuals with the appropriate qualifications working&#xD;
      within private practice in the UK will also be eligible to participate. Those working outside&#xD;
      the UK will not be eligible to participate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study did not receive final approval however it was decided to not pursue.&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 2020</start_date>
  <completion_date type="Anticipated">February 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Questionnaire responses that measure levels of insight or awareness of violence</measure>
    <time_frame>10 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <enrollment type="Actual">0</enrollment>
  <condition>Risk Behavior, Health</condition>
  <condition>Violence</condition>
  <condition>Risk Behavior</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Employed as a qualified as a Psychologist, Nurse, Social Worker, Occupational Therapist,&#xD;
        Psychiatrist, Prison Officer or Offender Manager currently working in a secure care or&#xD;
        forensic community setting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Employed as a qualified as a Psychologist, Nurse, Social Worker, Occupational&#xD;
             Therapist, Psychiatrist, Prison Officer or Offender Manager currently working in a&#xD;
             secure care or forensic community setting.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those working solely in private practice outside of organisations and those who work&#xD;
             outside the UK, are not eligible to participate&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joe Lowenstein, BSc MSc DClinPsy</last_name>
    <role>Study Chair</role>
    <affiliation>Chief Investigator</affiliation>
  </overall_official>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 3, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Insight</keyword>
  <keyword>Awareness</keyword>
  <keyword>Violence</keyword>
  <keyword>Professional views</keyword>
  <keyword>Risk to others</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03762356
org study id: BournemouthU
nct id: NCT03762356
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Other
measure: Questionnaire responses that measure levels of insight or awareness of violence
time frame: 10 minutes
description: 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.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joe Lowenstein, BSc MSc DClinPsy
role: Study Chair
affiliation: Chief Investigator
responsible party type: Sponsor
sharing ipd: No