Mental DisordersCoDiRCENCT02493088
Conduct Disorder in Prison: Search for Prospective and Retrospective Recurring and Contextual Elements
An observational study of Mental Disorders, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial summary
The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Antisocial personality recording of behavior and contextual elements
- How many people
- 11 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to Sep 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Study population: Individuals diagnosed with antisocial personality disorder have been chosen for this study due to their propensity of aberrant driving behaviors, including torts. Individuals detained in prison Rochefort and with a despcription fitting a psychopathic profile (impulsive, lack of empathy, repeated misconducts, repeat offenses ...) are informed of the study.
Who may be able to join
- Male
- Over 18
- Detention sentence in prison in Rochefort between March and August 2015
- Positive psychopathy score at PCL-R (Psychopathy Checklist-revised) test: score greater than or equal to 30
Who cannot join
- Chronic psychosis
- Bipolar disorder
- Women
- Minors,
- negative score at the PCL-R
- Subject under protection measure (curator or guardian)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passage à l'Acte en Maison d'arrêt : Recherche d'éléments Contextuels récurrents Prospectifs et rétrospectifs
The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. The French High Authority of Health (HAS) recommends to identify and prevent risk situations of violence and to develop research at this level. Some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. To our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date The investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. The investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.
Read the detailed description
This study aims at identifying elements that can provoke frustration and lead to aberrant driving behaviors. The question is whether there are triggers that occur more frequently for the same subject. If so, these specific contextual elements could be detected in order to prevent violent acts.
- Conditions
- Mental Disorders
- Being tested
- Antisocial personality recording of behavior and contextual elements
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antisocial personality recording of behavior and contextual elementsOther
aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
| Study group | Role | What they receive |
|---|---|---|
| Antisocial personality | Individuals Diagnosed with Antisocial Personality Disorder Receives: Other: Antisocial personality recording of behavior and contextual elements |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors.
Measured: 6 months
Secondary outcomes (2)
Percentage of Aberrant Driving Behaviors With Contextual Element Observed Before Aberrant Driving Behaviors
Collected contextual elements were :
- Disorders in the institution (with a caregiver, frustration with the rules)
- Difficulty / frustration with an inmate
- Difficulty / frustration with the entourage
- Consumption of alcohol or other toxic substances
- Steps in the judicial process (refusal of parole, reduction of sentence ...)
- Psychiatric symptoms: delirious, sleep disorders, nightmares The numerator for the percentage calculated is the number of aberrant driving behaviors with contextual element.
The denominator for the percentage calculated is the total number of aberrant driving behaviors (with and without contextual element)
Measured: 6 months
Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression)
Auto-aggressive: attempted suicide, any gesture of mutilation (scarification, punching in a wall, etc.) Aggressive: rixes with fellow inmates or prison staff, attempted homicides, sexual assaults, etc.
Other hetero transgression: Failure to comply with the rules of the institution, illegal entry of illicit objects into the establishment, consumption of toxic materials, destruction of property, etc.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Mental DisordersStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre PARRY, MD, Principal investigator, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493088
- Sponsor's protocol ID
- 2014P08040
- Acronym
- CoDiRCE
- Status last verified
- Mar 2017
- First submitted
- 6 Jul 2015
- Last updated
- 14 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Haute Autorité de Santé. Dangerosité psychiatrique : étude et évaluation des facteurs de risque de violence hétéro-agressive chez les personnes ayant des troubles schizophréniques ou des troubles de l'humeur. In: Service des bonnes pratiques professionnelles. Saint-Denis La Plaine: Service documentation - information des publics; 2011.
Quinsey VL, Harris GT, Rice ME, Cormier CA. Violent Offenders: Appraising and Managing Risk, Second Edition. American Psychological Association. Washington, DC, US 2006. 462 p.
Moulin V, Favard A-N.
Moulin V, Senon J-L. Évaluation de la dynamique criminelle et des processus qui sous-tendent l'agir infractionnel dans un cadre expertal, 2010.
Litinetskaia M. Dangerosité, délinquance et passage à l'acte : psychopathologie et prédictivité. Annales médico-psychologiques 170. 99-102; 2012.
Côté G. Vers une définition de la psychopathie. Pham TH & Côté. Villeneuve d'Ascq, France: Presse Universitaire du Septentrion; 2000. 240 p.
Balier C. Psychanalyse des comportements violents. Puf. Rouge LF. Paris1988
Gravier B. Violence et psychopathie. Psychiatrie légale et criminologie clinique. Issy-les-Moulineaux : Elsevier Masson, 2013. Les âges de la vie. ISBN : 978-2-294-73163-1; 2013.
Hare RD, Craigen D. Psychopathy and physiological activity in a mixed-motive game situation. Psychophysiology. 1974 Mar;11(2):197-206. doi: 10.1111/j.1469-8986.1974.tb00839.x. No abstract available.
PubMed 4821619Vanderstukken O. Troubles de l'attention et des fonctions executives chez les psychopathes. Université catholique de Louvain;1998.
Pham TH. [Psychometric evaluation of the Hare Psychopathy Questionnaire in a Belgian prison population]. Encephale. 1998 Sep-Oct;24(5):435-41. French.
PubMed 9850817Etude de Cote G, Sheilagh H, Toupin J. citée par Pham TH, Cote G. Psychopathie : Théorie et Recherche. Septentrion Presse Universitaire; 2000.
Sreenivasan S, Kirkish P, Eth S, Mintz J, Hwang S, Van Gorp W, Van Vort W. Predictors of recidivistic violence in criminally insane and civilly committed psychiatric inpatients. Int J Law Psychiatry. 1997 Spring;20(2):279-91. doi: 10.1016/s0160-2527(97)00008-3. No abstract available.
PubMed 9178068Méry B. Diplôme Inter-Universitaire de psychiatrie criminelle et médicolégale. "Organisation du système pénitentiaire " ; Mars 2014.
Hare RD, Neumann CN. The PCL-R Assessment of Psychopathy: Development, Structural Properties, and New Directions. C. Patrick ed. New York: Guilford; 2006.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passage à l'Acte en Maison d'arrêt : Recherche d'éléments Contextuels récurrents Prospectifs et rétrospectifs
- ClinicalTrials.gov ID
- NCT02493088
- Acronym / sponsor ID
- CoDiRCE / 2014P08040
- Conditions
- Mental Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prediction of dangerousness remains a delicate subject, relevant in current psychiatry. Scalable psychopathological elements identified in schizophrenia and mood disorders are considered as most at risk for crime committing. The French High Authority of Health (HAS) recommends to identify and prevent risk situations of violence and to develop research at this level. Some authors have worked on criminal career and became interested in risk factors for aberrant driving behaviors but also in environmental or clinical elements accompanying these phases. To our knowledge, no specific study about contextual elements before misconduct and which could lead to aberrant driving behaviors among individuals diagnosed with antisocial personality disorder has been described to date The investigators propose to follow individuals diagnosed with antisocial personality disorder in prison during 6 months in order to list their conduct disorders and contextual elements upstream of these misconducts. The investigators will also study the effect of contextual factors related to judicial steps on the appearance of aberrant driving behaviors.
Detailed description
This study aims at identifying elements that can provoke frustration and lead to aberrant driving behaviors. The question is whether there are triggers that occur more frequently for the same subject. If so, these specific contextual elements could be detected in order to prevent violent acts.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antisocial personality | – | Other: Antisocial personality recording of behavior and contextual elementsIndividuals Diagnosed with Antisocial Personality Disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals diagnosed with antisocial personality disorder have been chosen for this study due to their propensity of aberrant driving behaviors, including torts. Individuals detained in prison Rochefort and with a despcription fitting a psychopathic profile (impulsive, lack of empathy, repeated misconducts, repeat offenses ...) are informed of the study.
Key inclusion criteria (4 listed)
- Male
- Over 18
- Detention sentence in prison in Rochefort between March and August 2015
- Positive psychopathy score at PCL-R (Psychopathy Checklist-revised) test: score greater than or equal to 30
Key exclusion criteria (7 listed)
- Chronic psychosis
- Bipolar disorder
- Women
- Minors,
- negative score at the PCL-R
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antisocial personality recording of behavior and contextual elementsaberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study | Other | Antisocial personality |
Primary outcome
The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors.
Time frame: 6 months
2 secondary outcomes
Percentage of Aberrant Driving Behaviors With Contextual Element Observed Before Aberrant Driving Behaviors
Time frame: 6 months
Number of Observed Situations Per Type of Aberrant Driving Behavior (Auto-aggressive, Aggressive or Other Hetero Transgression)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundHaute Autorité de Santé. Dangerosité psychiatrique : étude et évaluation des facteurs de risque de violence hétéro-agressive chez les personnes ayant des troubles schizophréniques ou des troubles de l'humeur. In: Service des bonnes pratiques professionnelles. Saint-Denis La Plaine: Service documentation - information des publics; 2011.
- BackgroundQuinsey VL, Harris GT, Rice ME, Cormier CA. Violent Offenders: Appraising and Managing Risk, Second Edition. American Psychological Association. Washington, DC, US 2006. 462 p.
- BackgroundMoulin V, Favard A-N.
- BackgroundMoulin V, Senon J-L. Évaluation de la dynamique criminelle et des processus qui sous-tendent l'agir infractionnel dans un cadre expertal, 2010.
- BackgroundLitinetskaia M. Dangerosité, délinquance et passage à l'acte : psychopathologie et prédictivité. Annales médico-psychologiques 170. 99-102; 2012.
- BackgroundCôté G. Vers une définition de la psychopathie. Pham TH & Côté. Villeneuve d'Ascq, France: Presse Universitaire du Septentrion; 2000. 240 p.
- BackgroundBalier C. Psychanalyse des comportements violents. Puf. Rouge LF. Paris1988
- BackgroundGravier B. Violence et psychopathie. Psychiatrie légale et criminologie clinique. Issy-les-Moulineaux : Elsevier Masson, 2013. Les âges de la vie. ISBN : 978-2-294-73163-1; 2013.
- Background: PubMed 4821619Hare RD, Craigen D. Psychopathy and physiological activity in a mixed-motive game situation. Psychophysiology. 1974 Mar;11(2):197-206. doi: 10.1111/j.1469-8986.1974.tb00839.x. No abstract available.
- BackgroundVanderstukken O. Troubles de l'attention et des fonctions executives chez les psychopathes. Université catholique de Louvain;1998.
- Background: PubMed 9850817Pham TH. [Psychometric evaluation of the Hare Psychopathy Questionnaire in a Belgian prison population]. Encephale. 1998 Sep-Oct;24(5):435-41. French.
- BackgroundEtude de Cote G, Sheilagh H, Toupin J. citée par Pham TH, Cote G. Psychopathie : Théorie et Recherche. Septentrion Presse Universitaire; 2000.
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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.
Pierre PARRY, MD principal investigator
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Disorders, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Individuals Diagnosed With Antisocial Personality Disorder in Rochefort Prison With Aberrant Driving Behaviors. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02493088, which also lists 20 linked publications.
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 14 Apr 2017.