## Protocol Section
### Identification Module
**NCT ID:** NCT02949479

**Acronym:** DISSO

**Brief Title:** Dissociation Investigation Study in Sex Offenders

**Official Title:** Dissociative Experience During the Offence in Sex Offenders : Clinical and Prognosis Correlates

#### Organization Study ID Info
**ID:** 2016-A01019-42
#### Organization
**Class:** OTHER
**Full Name:** Hôpital le Vinatier
### Status Module
#### Completion Date
**Date:** 2021-12-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-01-27

**Type:** ACTUAL

**Last Update Submit Date:** 2022-01-26

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2021-09-21

**Type:** ACTUAL

#### Start Date
**Date:** 2017-03-29

**Type:** ACTUAL

**Status Verified Date:** 2021-12

#### Study First Post Date
**Date:** 2016-10-31
**Type:** ESTIMATED
**Study First Submit Date:** 2016-10-05
**Study First Submit QC Date:** 2016-10-27
**Why Stopped:** STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hôpital le Vinatier

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Sex Offenses

**Keywords:**

- sex offenses

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 30

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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

**Intervention Names:**

- Behavioral: Dissociation Investigation in Sex Offenders

**Label:** Dissociation Investigation in Sex Offenders

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dissociation Investigation in Sex Offenders

**Description:** 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

**Name:** Dissociation Investigation in Sex Offenders

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** the presence of a clinical dissociative state will be assessed retrospectively with the use of clinical examination.

**Measure:** point prevalence of clinical dissociation during the offence, assessed with the use of clinical examination (narrative and DSM-5 criteria)

**Time Frame:** 3 years

#### Secondary Outcomes

**Description:** lifetime dissociation measured by the Dissociative Experience Scale

**Measure:** lifetime dissociation

**Time Frame:** 3 years

**Description:** Childhood abuse ant Neglect assessed by the Childhood Experience of Care and Abuse (CECA)

**Measure:** childhood abuse or neglect

**Time Frame:** 3 years

**Description:** psychiatric comorbidities

**Measure:** psychiatric comorbidities

**Time Frame:** 3 years

**Description:** risk assessment tools scoring

**Measure:** prognosis issues

**Time Frame:** 3 years

### Eligibility Module

**Eligibility 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)

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bron

**Country:** France

**Facility:** Centre Hospitalier Le Vinatier

**State:** Rhône Alpes

**Zip:** 69678

#### Overall Officials

**Official 1:**

**Affiliation:** Centre Hospitalier le Vinatier

**Name:** Mouchet-Mages Sabine, PH

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
