- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025006
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)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Marseille, France, 13354
- Service Epidémiologie et Economie de la Santé - AP-HM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Investigators
- Study Director: François CREMIEUX, AP-HM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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