Offense, SexEV-AICSNCT05013996
Impact of a Structured Clinical Assessment MIDSA, Its Feedback and Support for Change on Commitment to Care of Perpetrators of Sexual Offenses
A study testing MIDSA and Usual methods of evaluation in people with Offense, Sex, run by University Hospital, Tours at 5 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Offense, Sex
- What is being tested?
- MIDSA and Usual methods of evaluation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesFrance
- Study dates
- 20 Jan 2022to 14 Jan 2025
- 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
- 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
Who cannot join
- Maximum stage (maintenance phase) listed on the URICA scale
- Poor understanding of the French language;
- Patient imprisoned, under legal protection, under guardianship or curatorship
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHRU Lille - URSAVS Lille
Lille, 59000
CH LE Vinatier - Service de Psychiatrie Légale
Lyon, 69000
CHU Montpellier Lapeyronie - CRIAVS Languedoc-Roussillon
Montpellier, 34000
CHU Poitiers Henri Laborit - CRIAVS - CMP Espace Vienne - SMPR
Poitiers, 86000
CHRU Tours - UC3P
Tours, 37044
About this study
Official title: 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.
Read the 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.
- Conditions
- Offense, Sex
- Being tested
- MIDSA, Usual methods of evaluation
- Keywords
- sexual offenders;MIDSA
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIDSABehavioural
Multidimensional Inventory of Development, Sex, and Aggression
Usual methods of evaluationBehavioural
Usual methods of evaluation of each of the participating centers (CMP / CRIAVS / private practitioners, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: MIDSA |
| Control | Active comparator | 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.). Receives: Behavioral: Usual methods of evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in behavior
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
Measured: up to 6 months
Secondary outcomes (6)
Assessment of the risk for sexual violence (RSVP)
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
Measured: up to 1 year
Assessment of the risk of violence (in general) and the risk factors of the sexual offenders
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);
Measured: up to 1 year
Assessment of the multidimensional self-esteem assessment (SEI)
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;
Measured: up to 1 year
Quality of life assessment
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.
Measured: up to 1 year
Assessment of social desirability will be carried out by the MCSDS
The assessment of social desirability will be carried out by the Marlow-Crowne Social Desirability Scale (MCSDS) through its brief version of 20 items
Measured: up to 1 year
Assessment of Risk factors and protective factors against violence
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))
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start20 Jan 2022
- Primary completion14 Jan 2025
- Study completion14 Jan 2025
Why it stopped: 10 patients out of 152 expected over 3 years of inclusion. There are many reasons for this failure (staff recruitment, duration of MIDSA..).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Offense, SexStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label multicenter randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert COURTOIS, MD-PhD, Study director, University Hospital of TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013996
- Sponsor's protocol ID
- EV-AICS (DR190059)
- Other IDs
- 2020-A02628-31, DR190059
- Acronym
- EV-AICS
- Status last verified
- Nov 2025
- First submitted
- 3 Jun 2021
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05013996
- Acronym / sponsor ID
- EV-AICS / EV-AICS (DR190059)
- Conditions
- Offense, Sex
- Keywords
- sexual offenders;MIDSA
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 10 patients out of 152 expected over 3 years of inclusion. There are many reasons for this failure (staff recruitment, duration of MIDSA..).
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 14 Jan 2025 (actual)
- Study completion
- 14 Jan 2025 (actual)
- First posted
- 20 Aug 2021 (actual)
- 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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label multicenter randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MIDSAPatients 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. |
| Control | Active comparator | Behavioral: Usual methods of evaluationPatients randomized to the control group will be treated according to the usual methods of each of the participating centers (CMP / CRIAVS / private practitioners, etc.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Maximum stage (maintenance phase) listed on the URICA scale
- Poor understanding of the French language;
- Patient imprisoned, under legal protection, under guardianship or curatorship
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 |
|---|---|---|
| MIDSAMultidimensional Inventory of Development, Sex, and Aggression | Behavioural | Intervention |
| Usual methods of evaluationUsual methods of evaluation of each of the participating centers (CMP / CRIAVS / private practitioners, etc.). | Behavioural | Control |
Primary outcome
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
6 secondary outcomes
Assessment of the risk for sexual violence (RSVP)
Time frame: 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
Assessment of the multidimensional self-esteem assessment (SEI)
Time frame: up to 1 year
Quality of life assessment
Time frame: up to 1 year
Assessment of social desirability will be carried out by the MCSDS
Time frame: up to 1 year
Assessment of Risk factors and protective factors against violence
Time frame: up to 1 year
Results and safety
The study was stopped early (reason given: 10 patients out of 152 expected over 3 years of inclusion. There are many reasons for this failure (staff recruitment, duration of MIDSA..).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Offense, Sex
Recruiting
Rigorous Evaluation of the READY to Stand Curriculum to Prevent the Commercial Sexual Exploitation of Children
Sex Trafficking, Sex Crimes
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.
Robert COURTOIS, MD-PhD study director
University Hospital of TOURS
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIDSA and Usual methods of evaluation in people with Offense, Sex, run by University Hospital, Tours at 5 sites 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 5 inclusion and 3 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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: 10 patients out of 152 expected over 3 years of inclusion. There are many reasons for this failure (staff recruitment, duration of MIDSA..).). 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?
Change in behavior (time frame: up to 6 months). 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 24 Nov 2025.