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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02949479
Other study ID # 2016-A01019-42
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 29, 2017
Est. completion date December 10, 2021

Study information

Verified date December 2021
Source Hôpital le Vinatier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date December 10, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Centre Hospitalier Le Vinatier Bron Rhône Alpes

Sponsors (1)

Lead Sponsor Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary point prevalence of clinical dissociation during the offence, assessed with the use of clinical examination (narrative and DSM-5 criteria) the presence of a clinical dissociative state will be assessed retrospectively with the use of clinical examination. 3 years
Secondary lifetime dissociation lifetime dissociation measured by the Dissociative Experience Scale 3 years
Secondary childhood abuse or neglect Childhood abuse ant Neglect assessed by the Childhood Experience of Care and Abuse (CECA) 3 years
Secondary psychiatric comorbidities psychiatric comorbidities 3 years
Secondary prognosis issues risk assessment tools scoring 3 years
See also
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