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 (AILSI)

February 6, 2026 updated by: Assistance Publique Hopitaux De Marseille

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.

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 Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

169

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

      • Marseille, France, 13354
        • Service Epidémiologie et Economie de la Santé - AP-HM

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AILSI
place of respite with housing plus intensive follow-up
No Intervention: the standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of reincarceration, weighted by exposure time
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: François CREMIEUX, AP-HM

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)

February 2, 2022

Primary Completion (Estimated)

February 2, 2027

Study Completion (Estimated)

August 2, 2027

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 6, 2023

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-61

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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