Sex OffensesDISSONCT02949479
Dissociation Investigation Study in Sex Offenders
A study testing Dissociation Investigation in Sex Offenders in people with Sex Offenses, run by Hôpital le Vinatier at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Sex Offenses
- What is being tested?
- Dissociation Investigation in Sex Offenders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2017to 10 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- male subject referred to the center for having committed a sexual offense; social insurance affiliation
Who cannot join
- schizophrenia, mental retardation (IQ<70)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Sex Offenses
- Being tested
- Dissociation Investigation in Sex Offenders
- Keywords
- sex offenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissociation Investigation in Sex OffendersBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Dissociation Investigation in Sex Offenders | Other | 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 Receives: Behavioral: Dissociation Investigation in Sex Offenders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (4)
lifetime dissociation
lifetime dissociation measured by the Dissociative Experience Scale
Measured: 3 years
childhood abuse or neglect
Childhood abuse ant Neglect assessed by the Childhood Experience of Care and Abuse (CECA)
Measured: 3 years
psychiatric comorbidities
psychiatric comorbidities
Measured: 3 years
prognosis issues
risk assessment tools scoring
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start29 Mar 2017
- Primary completion21 Sep 2021
- Study completion10 Dec 2021
Why it stopped: STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sex OffensesStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouchet-Mages Sabine, PH, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949479
- Sponsor's protocol ID
- 2016-A01019-42
- Acronym
- DISSO
- Status last verified
- Dec 2021
- First submitted
- 5 Oct 2016
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissociative Experience During the Offence in Sex Offenders : Clinical and Prognosis Correlates
- ClinicalTrials.gov ID
- NCT02949479
- Acronym / sponsor ID
- DISSO / 2016-A01019-42
- Conditions
- Sex Offenses
- Keywords
- sex offenses
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 31 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dissociation Investigation in Sex Offenders | Other | Behavioral: Dissociation Investigation in Sex OffendersThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male subject referred to the center for having committed a sexual offense; social insurance affiliation
Key exclusion criteria (1 listed)
- schizophrenia, mental retardation (IQ<70)
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 |
|---|---|---|
| Dissociation Investigation in Sex Offendersprevalence 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 | Behavioural | Dissociation Investigation in Sex Offenders |
Primary outcome
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.
4 secondary outcomes
lifetime dissociation
Time frame: 3 years
childhood abuse or neglect
Time frame: 3 years
psychiatric comorbidities
Time frame: 3 years
prognosis issues
Time frame: 3 years
Results and safety
The study was stopped early (reason given: STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Sex Offenses
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
RecruitingObservational study
Epidemiology of French Sexual Offenders. A Cross-sectional Study
Psychiatric Disorder
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.
Mouchet-Mages Sabine, PH principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissociation Investigation in Sex Offenders in people with Sex Offenses, run by Hôpital le Vinatier 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Jan 2022. 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?
The study was stopped early (reason given: STUDY INVESTIGATORS HAVE LEFT THE INSTITUTION, THE DEPARTMENT NO LONGER HAS TIME TO INCLUDE). Results are not available in the source record.
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?
point prevalence of clinical dissociation during the offence, assessed with the use of clinical examination (narrative and DSM-5 criteria) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2022.