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

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.

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

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.

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