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Dissociation Investigation Study in Sex Offenders (DISSO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02949479
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : October 25, 2019
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief Summary:
Background: Adverse childhood experience have been described in sexual offenders but the link with the offence need to be further investigated. Investigators postulate that one of the clinical moderating factors could be dissociative experience, a consequence of these early adverse experiences reactivated during the offence. The purpose of the study is to estimate the prevalence of clinical dissociation during the offence in a male adult population referred to our center for a sexual offence and to explore its correlations with epidemiological and clinical data (personal, legal history, psychiatric comorbidities), clinical trauma and dissociation, prognosis estimates.

Condition or disease Intervention/treatment Phase
Sex Offenses Behavioral: Dissociation Investigation in Sex Offenders Not Applicable

Detailed Description:
The study will be proposed to the subjects after their usual clinical evaluation in the center for sexual offence and to extend this evaluation by a specific focus on childhood abuse and neglect trauma and dissociative history. After receiving complete information, the participants will sign the consent form and be referred to a unique on-site visit of approximately 2 hours long. During this visit, the participants will benefit from a psychiatric examination in search for clinical features of dissociation during the offence, lifetime dissociative experience, lifetime post-traumatic stress disorder; they will have to complete bioevaluation forms for dissociation (Dissociative Experience Scale) and childhood abuse and neglect (Childhood Experience of Care and Abuse). After this completion, they will benefit from a second part psychiatric examination, so as to complete the assessment and answer their questions if any.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Dissociative Experience During the Offence in Sex Offenders : Clinical and Prognosis Correlates
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Dissociation Investigation in Sex Offenders
The study will be proposed to the subjects after their usual clinical evaluation in the center for sexual offence, and to extend this evaluation by a specific focus on childhood abuse and neglect, trauma and dissociative history
Behavioral: Dissociation Investigation in Sex Offenders
prevalence of a clinical dissociative state during the offence; secondary : correlations of dissociation with childhood abuse or neglect, with significant lifetime dissociative experience, post traumatic stress disorder or dissociative disorder (DSM-5), violence and sexual estimated risk using actuarial and professional structured judgement tools




Primary Outcome Measures :
  1. point prevalence of clinical dissociation during the offence, assessed with the use of clinical examination (narrative and DSM-5 criteria) [ Time Frame: 3 years ]
    the presence of a clinical dissociative state will be assessed retrospectively with the use of clinical examination.


Secondary Outcome Measures :
  1. lifetime dissociation [ Time Frame: 3 years ]
    lifetime dissociation measured by the Dissociative Experience Scale

  2. childhood abuse or neglect [ Time Frame: 3 years ]
    Childhood abuse ant Neglect assessed by the Childhood Experience of Care and Abuse (CECA)

  3. psychiatric comorbidities [ Time Frame: 3 years ]
    psychiatric comorbidities

  4. prognosis issues [ Time Frame: 3 years ]
    risk assessment tools scoring



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male subject referred to the center for having committed a sexual offense; social insurance affiliation

Exclusion Criteria:

  • schizophrenia, mental retardation (IQ<70)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02949479


Contacts
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Contact: Mouchet-Mages Sabine, PH 0033437915309 sabine.mouchet-mages@ch-le-vinatier.fr
Contact: H Pham Thierry, Ph.D 003269646570 Thierry.phamhoang@umons.ac.be

Locations
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France
Centre Hospitalier Le Vinatier Recruiting
Bron, Rhône Alpes, France, 69678
Contact: MOUCHET MAGES SABINE    0033437915161    Sabine.MOUCHET-MAGES@ch-le-vinatier.fr   
Contact: VIAL VERONIQUE    0033437915531    veronique.vial@ch-le-vinatier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
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Principal Investigator: Mouchet-Mages Sabine, PH Centre Hospitalier Le Vinatier

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Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02949479    
Other Study ID Numbers: 2016-A01019-42
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: October 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital le Vinatier:
sex offenses