- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05013996
Impact of a Structured Clinical Assessment MIDSA, Its Feedback and Support for Change on Commitment to Care of Perpetrators of Sexual Offenses (EV-AICS)
November 18, 2025 updated by: University Hospital, Tours
Impact d'un Bilan Clinique structuré (MIDSA), de sa Restitution et de l'Accompagnement au Changement Sur l'Engagement Dans le Soin (évalué Par l'échelle URICA) d'Auteurs d'Infraction à caractère Sexuel : Essai contrôlé randomisé Multicentrique en Ouvert
Evaluate the effectiveness of an intervention including the clinical assessment carried out with the (Multidimensional Inventory of Development, Sex, and Aggression) MIDSA and the review of the results with the professional in charge of the subject on the adherence and commitment to the care of the sexual offenders.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The intervention of MIDSA (Multidimensional Inventory of Development, Sex, and Aggression), a multidimensional investigation tool for issues related to sexuality and violence, could be prove very useful by providing AICS patients as well as the professionals who take care of them with a complete clinical assessment which enlightens the patient on his psychopathological functioning and / or his disorders, and which guides the care through the axes of intervention to be implemented in response to the criminological and non-criminological needs of the patient.
This should allow the latter a better awareness (awareness) of his difficulties in the relationship with the other, facilitate his adherence to care, obtain a better commitment on his part in the process of change and consequently, bring him change their lifestyle and gradually adopt proactive attitudes and behavior that ultimately reduce the risk of recidivism of sexual and general violence.
However, recourse to MIDSA as a "change operator" in a patient's trajectory is only possible if it is accompanied by a resumption of his clinical assessment by a professional who supports the change process by strengthening his motivation to change their criminal behavior.
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
-
Lille, France, 59000
- CHRU Lille - URSAVS Lille
-
Lyon, France, 69000
- CH LE Vinatier - Service de Psychiatrie Légale
-
Montpellier, France, 34000
- CHU Montpellier Lapeyronie - CRIAVS Languedoc-Roussillon
-
Poitiers, France, 86000
- CHU Poitiers Henri Laborit - CRIAVS - CMP Espace Vienne - SMPR
-
Tours, France, 37044
- CHRU Tours - UC3P
-
-
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
Description
Inclusion Criteria:
- Adult male patients
- Express written consent of the participant after receiving the study information
- Subject making contact or being taken in charge by a psychiatric service (even an addictology service or by liberal practitioners in connection with psychiatry), a CRIAVS or a care unit dedicated to the care of perpetrators of a sexual offense (AICS) ;
For a problem of sexual violence such as sexual harassment, assault and rape of adult women (including marital rape), incest, pedophilic or hebephilic acts, sexual sadism, exhibition, voyeurism, frotteurism, use and possession of child pornography or addiction sexual.
- Affiliated to a social security scheme
Exclusion Criteria:
- Maximum stage (maintenance phase) listed on the URICA scale
- Poor understanding of the French language;
- Patient imprisoned, under legal protection, under guardianship or curatorship
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Patients randomized to the experimental (MIDSA groupe) will be treated according to the usual methods of each of the centers (CMP / CRIAVS / private practitioners, etc.) completed with the Multidimensional Inventory of Development, Sex, and Aggression-MIDSA groupe Multidimensional Inventory of Development, Sex, and Aggression-inventory tool.
|
Multidimensional Inventory of Development, Sex, and Aggression
|
|
Active Comparator: Control
Patients randomized to the control group will be treated according to the usual methods of each of the participating centers (CMP / CRIAVS / private practitioners, etc.).
|
Usual methods of evaluation of each of the participating centers (CMP / CRIAVS / private practitioners, etc.).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in behavior
Time Frame: up to 6 months
|
Change in behavior (awareness of its difficulties, commitment to care, motivation to abandon the previous lifestyle, etc.) and with reference to the transtheoretical model of stage change, it will be measured using the University of Rhode Island Change Assessment (URICA) by the rate of patients with a stage of change at Month 6 higher than that observed at D0
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of the risk for sexual violence (RSVP)
Time Frame: up to 1 year
|
The risk assessment for sexual violence will be performed by the Risk for Sexual Violence Protocol (RSVP; Hart et al., 2003);cut-off score: 0-44 (lowrisk); score: 45-132 moderate to high risk
|
up to 1 year
|
|
Assessment of the risk of violence (in general) and the risk factors of the sexual offenders
Time Frame: up to 1 year
|
The assessment of the risk of violence (in general) and the risk factors of the sexual offenders will be carried out from the Level of Service Inventory / Case Management Inventory (LS / CMI; Andrews , Bonta, & Wormith, 2000; Guay, 2008);
|
up to 1 year
|
|
Assessment of the multidimensional self-esteem assessment (SEI)
Time Frame: up to 1 year
|
The multidimensional self-esteem assessment will be carried out by the Self-Esteem Inventory (SEI; Coopersmith, 1981) with 4 dimensions: general, social, family and professional self-esteem;
|
up to 1 year
|
|
Quality of life assessment
Time Frame: up to 1 year
|
The quality of life assessment will be carried out by the World Health Organization Quality Of Life (WHOQOL-brief); Leplege, Reveillere, Ecosse, Caria, & Riviere, 2000; The WHOQOL Group, 1998) around four dimensions: physical health, psychological health, social relations and the environment.
|
up to 1 year
|
|
Assessment of social desirability will be carried out by the MCSDS
Time Frame: up to 1 year
|
The assessment of social desirability will be carried out by the Marlow-Crowne Social Desirability Scale (MCSDS) through its brief version of 20 items
|
up to 1 year
|
|
Assessment of Risk factors and protective factors against violence
Time Frame: up to 1 year
|
Risk factors and protective factors against violence are assessed through a semi-structured interview (for assessment of Risk for Sexual Violence Protocol (RSVP), Level of Service Inventory/Case Management Inventory (LS / CMI) and Structured Assessment of Protective Factors (SAPROF))
|
up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert COURTOIS, MD-PhD, University hospital of Tours
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)
January 20, 2022
Primary Completion (Actual)
January 14, 2025
Study Completion (Actual)
January 14, 2025
Study Registration Dates
First Submitted
June 3, 2021
First Submitted That Met QC Criteria
August 12, 2021
First Posted (Actual)
August 20, 2021
Study Record Updates
Last Update Posted (Actual)
November 24, 2025
Last Update Submitted That Met QC Criteria
November 18, 2025
Last Verified
November 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV-AICS (DR190059)
- 2020-A02628-31 (Registry Identifier: Id-RCB-ANSM-France)
- DR190059 (Other Identifier: Sponsor Reg n°)
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
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.
Clinical Trials on Offense, Sex
-
University of Nebraska LincolnCenters for Disease Control and Prevention; The Set Me Free Project; Des Moines...CompletedSexual Violence | Sex Trafficking | Child Abuse, Sexual | Sex Crimes | Commercial Sex | Sex OffenseUnited States
-
University of MichiganRecruitingSexual Violence | Sex Trafficking | Child Abuse, Sexual | Sex Crimes | Commercial Sex | Sex OffenseUnited States
-
University Hospital, MontpellierRecruiting
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteCompletedUnsafe Sex | Unprotected SexUnited States
-
The University of Hong KongCompletedAdolescent Behavior | Behavior, Sex | Sex, UnsafeHong Kong
-
North Carolina Agriculture & Technical State UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Not yet recruitingSexual Assault | Condomless SexUnited States
-
ARCAGY/ GINECO GROUPRoche Pharma AGCompleted
-
Erin RowellAnn & Robert H Lurie Children's Hospital of ChicagoRecruitingDisorders of Sex Development | Disorder of Sex Development, 46,XY | DSD, 46,XY | DSD, Ovotesticular | DSD, Sex Chromosome | Disorder of Sex Development, 46,Xy, Cbx2-RelatedUnited States
-
Rong ZhangRecruiting
-
Chinese University of Hong KongRecruiting