- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02949479
Dissociation Investigation Study in Sex Offenders (DISSO)
January 26, 2022 updated by: Hôpital le Vinatier
Dissociative Experience During the Offence in Sex Offenders : Clinical and Prognosis Correlates
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhône Alpes
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Bron, Rhône Alpes, France, 69678
- Centre Hospitalier Le Vinatier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male subject referred to the center for having committed a sexual offense; social insurance affiliation
Exclusion Criteria:
- schizophrenia, mental retardation (IQ<70)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
lifetime dissociation
Time Frame: 3 years
|
lifetime dissociation measured by the Dissociative Experience Scale
|
3 years
|
childhood abuse or neglect
Time Frame: 3 years
|
Childhood abuse ant Neglect assessed by the Childhood Experience of Care and Abuse (CECA)
|
3 years
|
psychiatric comorbidities
Time Frame: 3 years
|
psychiatric comorbidities
|
3 years
|
prognosis issues
Time Frame: 3 years
|
risk assessment tools scoring
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mouchet-Mages Sabine, PH, Centre Hospitalier Le Vinatier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 29, 2017
Primary Completion (Actual)
September 21, 2021
Study Completion (Actual)
December 10, 2021
Study Registration Dates
First Submitted
October 5, 2016
First Submitted That Met QC Criteria
October 27, 2016
First Posted (Estimate)
October 31, 2016
Study Record Updates
Last Update Posted (Actual)
January 27, 2022
Last Update Submitted That Met QC Criteria
January 26, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2016-A01019-42
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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