Severe Psychiatric DisorderAILSINCT06025006
Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team for Homeless People With Severe Psychiatric Disorders Referred to Referral Procedures : AILSI Program
A study testing alternative to incarceration in people with Severe Psychiatric Disorder, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
People who are homeless with severe psychiatric disorders have to negotiate discontinuous mental health care pathways including high use of emergency departement and enforced hospitalisation, poor access to ambulatory care, poor access to common rights services and a greater risk of incarceration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Psychiatric Disorder
- What is being tested?
- alternative to incarceration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteFrance
- Study dates
- 2 Feb 2022to 2 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Being defered in referral procedures to the Public Prosecutor's department of Marseille
- Being homeless (ETHOS 1 to 8.3)
- Presenting a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR
- Having health coverage
- Having signed an informed consent to participate in the study
- Having declared to want to stay in the area at least 18 months after inclusion in the study.
Who cannot join
- Less than 18 years old;
- Do not have any criteria for ETHOS 1 to 8.3 classification
- Do not present a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR
- Presenting cognitive impairment that limits comprehension,
- Being under guardianship,
- Do not have health coverage
- Having refused to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site
Service Epidémiologie et Economie de la Santé - AP-HM
Marseille, 13354
About this study
Official title: Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team (AILSI Program) for People Who Are Homeless With Severe Psychiatric Disorders and Referred to Referral Procedures, in Comparison With Usual Services: a Randomized Controlled Trial
People who are homeless with severe psychiatric disorders have to negotiate discontinuous mental health care pathways including high use of emergency departement and enforced hospitalisation, poor access to ambulatory care, poor access to common rights services and a greater risk of incarceration.
In order to reduce morbidity, improve social integration and outpatient care for people with severe psychiatric disorders and multiple factors of social vulnerability, the concept of therapeutic jurisprudence has led to the emergence of mental health courts in Anglo-Saxon nations. These courts aim to condition alternatives to incarceration through community-based intensive care (assertive community treatment-ACT). ACT Teams offer direct access to housing without any prerequisite of treatment or abstinence. This model of community-based intensive care tends to demonstrate medical and legal effectiveness while being associated with greater care acceptability by patients. In France, very little data exists on the subject.
Read more
Médecins du Monde (NGO), in collaboration with the Public Prosecutor's department of Marseille, proposes the implementation of the AILSI strategy for people who homeless with severe psychiatric disorders and referred to referral procedures. The research unit EA 3279 - CEReSS is in charge of the independent evaluation of this innovative intervention.
This is an randomized coontrolled study, with two groups: AILSI group (intervention) and TAU group (usual services). A total of 169 patients will be included (80 in the AILSI group / 89 in the TAU group).
The main objective is to evaluate the effectiveness of the innovative program (AILSI) compared to usual services by assessing the duration of reincarceration at 18 months in each group, weighted by exposure time.
. Duration of inclusion: 39 months; Duration of follow-up: 18 months; Total duration of the study: 60 months.
Both quantitative and qualitative analyses will be conducted to address overall outcomes. Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations.
- Conditions
- Severe Psychiatric Disorder
- Being tested
- alternative to incarceration
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alternative to incarcerationOther
place of respite with housing plus intensive follow-up
| Study group | Role | What they receive |
|---|---|---|
| AILSI | Experimental | Not described Receives: Other: alternative to incarceration |
| the standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of reincarceration, weighted by exposure time
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start2 Feb 2022
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025006
- Sponsor's protocol ID
- 2018-61
- Acronym
- AILSI
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2019
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Alternative to Incarceration by Housing and Support by Assertive Community Treatment Team (AILSI Program) for People Who Are Homeless With Severe Psychiatric Disorders and Referred to Referral Procedures, in Comparison With Usual Services: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06025006
- Acronym / sponsor ID
- AILSI / 2018-61
- Conditions
- Severe Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Aug 2027 (estimated)
- First posted
- 6 Sep 2023 (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.
People who are homeless with severe psychiatric disorders have to negotiate discontinuous mental health care pathways including high use of emergency departement and enforced hospitalisation, poor access to ambulatory care, poor access to common rights services and a greater risk of incarceration.
In order to reduce morbidity, improve social integration and outpatient care for people with severe psychiatric disorders and multiple factors of social vulnerability, the concept of therapeutic jurisprudence has led to the emergence of mental health courts in Anglo-Saxon nations. These courts aim to condition alternatives to incarceration through community-based intensive care (assertive community treatment-ACT). ACT Teams offer direct access to housing without any prerequisite of treatment or abstinence. This model of community-based intensive care tends to demonstrate medical and legal effectiveness while being associated with greater care acceptability by patients. In France, very little data exists on the subject.
Médecins du Monde (NGO), in collaboration with the Public Prosecutor's department of Marseille, proposes the implementation of the AILSI strategy for people who homeless with severe psychiatric disorders and referred to referral procedures. The research unit EA 3279 - CEReSS is in charge of the independent evaluation of this innovative intervention.
This is an randomized coontrolled study, with two groups: AILSI group (intervention) and TAU group (usual services). A total of 169 patients will be included (80 in the AILSI group / 89 in the TAU group).
The main objective is to evaluate the effectiveness of the innovative program (AILSI) compared to usual services by assessing the duration of reincarceration at 18 months in each group, weighted by exposure time.
. Duration of inclusion: 39 months; Duration of follow-up: 18 months; Total duration of the study: 60 months.
Both quantitative and qualitative analyses will be conducted to address overall outcomes. Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AILSI | Experimental | Other: alternative to incarceration |
| the standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old
- Being defered in referral procedures to the Public Prosecutor's department of Marseille
- Being homeless (ETHOS 1 to 8.3)
- Presenting a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR
- Having health coverage
Key exclusion criteria (7 listed)
- Less than 18 years old;
- Do not have any criteria for ETHOS 1 to 8.3 classification
- Do not present a diagnosis of a severe psychiatric disorder as defined by DSM-IV-TR
- Presenting cognitive impairment that limits comprehension,
- Being under guardianship,
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 |
|---|---|---|
| alternative to incarcerationplace of respite with housing plus intensive follow-up | Other | AILSI |
Primary outcome
Duration of reincarceration, weighted by exposure time
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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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.
François CREMIEUX study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alternative to incarceration in people with Severe Psychiatric Disorder, run by Assistance Publique Hopitaux De Marseille 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Duration of reincarceration, weighted by exposure time (time frame: 18 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 10 Feb 2026.