Subnormal; Mental, SevereNCT01570712
Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France
A study testing HOUSING FIRST PROGRAM and traditional French services in people with Subnormal; Mental, Severe, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subnormal; Mental, Severe
- What is being tested?
- HOUSING FIRST PROGRAM and traditional French services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2011to Jun 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 18;
- who are absolutely homeless or precariously housed. Absolutely homeless is defined as having had no fixed place to stay for at least the past seven nights with little likelihood of finding a place in the coming month. Precariously housed is defined as being housed a in single room occupancy, rooming house, or hotel/motel as a primary residence AND in the past year having experienced two or more episodes of being absolutely homeless OR one episode of being absolutely homeless that lasted for more than four weeks in the preceding 12 months.
- living with schizophrenia or bipolar disorder (diagnosis of DSM-IV);
- with a sufficient understanding of written and spoken French to be able to provide informed consent and to participate to face-to-face interviews;
- affiliated to a social protection;
- who have lived in the city targeted for at least 6 months and willing to stand in the city during the 2 next years;
- with a global score measured on Multnomah Community Ability Scale (MCAS) (scale <=62 (high need criteria));
- hospitalized at least twice on the past 12 months OR held in prison on the past 24 months OR presenting substance or alcohol abuse or dependence (high need criteria).
Who cannot join
- being considered unable to provide informed consent;
- having dependent children;
- pregnancy;
- or a DSM-IV Axis I diagnosis other than schizophrenia or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study
As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.
- Conditions
- Subnormal; Mental, Severe
- Being tested
- HOUSING FIRST PROGRAM, traditional French services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOUSING FIRST PROGRAMOther
Realization of a psychosocial organic evaluation and a citizen;
- Support in the development and the maintenance of the housing;
- Support in the diverse steps (administrative, judicial, financiers, etc.);
- Support around addictions / alcohol;
- Supportin the family and social relations, in the environment of the person -to favor the occupational integration, by prioritizing the insertion in ordinary environment(middle)
- to favor the access and the preservation of the patient to the psychiatric and somatic care, to the devices and the departments favoring the social insertion and the integration.
traditional French servicesOther
The person will not receive from intervention of the team of site, but the person can resort(turn) without limitation to all the range of services said " about "common law " set up in the direction of the persons homeless persons, as well as to every type of care. She can too reach the housing and\or the restoring, but this by means of the existing devices
| Study group | Role | What they receive |
|---|---|---|
| Housing First Program | Experimental | Not described Receives: Other: HOUSING FIRST PROGRAM |
| traditional French services | Active comparator | Not described Receives: Other: traditional French services |
What is being measured
The primary outcome is the main question the study is designed to answer.
healthcare utilisation
hospitalizations, hospital days, and emergency department visits
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionMay 2016
- Study completionJun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Subnormal; Mental, SevereStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570712
- Sponsor's protocol ID
- 2011-A00668-33
- Other IDs
- 2011-12
- Status last verified
- Sep 2018
- First submitted
- 2 Apr 2012
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Loubiere S, Lemoine C, Boucekine M, Boyer L, Girard V, Tinland A, Auquier P; French Housing First Study Group. Housing First for homeless people with severe mental illness: extended 4-year follow-up and analysis of recovery and housing stability from the randomized Un Chez Soi d'Abord trial. Epidemiol Psychiatr Sci. 2022 Feb 7;31:e14. doi: 10.1017/S2045796022000026.
PubMed 35125129Tinland A, Loubiere S, Cantiello M, Boucekine M, Girard V, Taylor O, Auquier P. Mortality in homeless people enrolled in the French housing first randomized controlled trial: a secondary outcome analysis of predictors and causes of death. BMC Public Health. 2021 Jul 2;21(1):1294. doi: 10.1186/s12889-021-11310-w.
PubMed 34215235Loubiere S, Tinland A, Taylor O, Loundou A, Girard V, Boyer L, Auquier P. Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study. Public Health. 2020 Aug;185:224-231. doi: 10.1016/j.puhe.2020.05.019. Epub 2020 Jul 14.
PubMed 32679400Fond G, Boyer L, Boucekine M, Girard V, Loubiere S, Lenoir C, Auquier P, Tinland A; French Housing First Study Group. Illness and drug modifiable factors associated with violent behavior in homeless people with severe mental illness: results from the French Housing First (FHF) program. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 2;90:92-96. doi: 10.1016/j.pnpbp.2018.11.006. Epub 2018 Nov 10.
PubMed 30423419Rhenter P, Tinland A, Grard J, Laval C, Mantovani J, Moreau D, Vidaud B, Greacen T, Auquier P, Girard V. Problems maintaining collaborative approaches with excluded populations in a randomised control trial: lessons learned implementing Housing First in France. Health Res Policy Syst. 2018 Apr 19;16(1):34. doi: 10.1186/s12961-018-0305-1.
PubMed 29673362Tinland A, Zemmour K, Auquier P, Boucekine M, Girard V, Loubiere S, Fond G, Boyer L; French Housing First Study Group. Homeless women with schizophrenia reported lower adherence to their medication than men: results from the French Housing First experience. Soc Psychiatry Psychiatr Epidemiol. 2017 Sep;52(9):1113-1122. doi: 10.1007/s00127-017-1411-z. Epub 2017 Jun 27.
PubMed 28656452Tinland A, Fortanier C, Girard V, Laval C, Videau B, Rhenter P, Greacen T, Falissard B, Apostolidis T, Lancon C, Boyer L, Auquier P. Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:309. doi: 10.1186/1745-6215-14-309.
PubMed 24063556
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the "Housing First Program" in Homeless Patients With Severe Mental Disorders in France: a Multicentric Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01570712
- Acronym / sponsor ID
- 2011-A00668-33
- Conditions
- Subnormal; Mental, Severe
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2019 (estimated)
- First posted
- 4 Apr 2012 (estimated)
- 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.
As mental health care shifted from state psychiatric hospitals to the community in France and western countries, the mental health system became inevitably involved in housing as it strove to meet the broader psychosocial needs of consumers. Simultaneously, as many consumers found themselves unable to find stable living in the community and struggling with addictions, they became a significant subgroup within a larger homeless population, which has received increasing policy attention over the past three decades. There are two distinct service models for adults who have severe mental illness and are homeless: the residential continuum model and the Housing First model.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Housing First Program | Experimental | Other: HOUSING FIRST PROGRAM |
| traditional French services | Active comparator | Other: traditional French services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- aged over 18;
- who are absolutely homeless or precariously housed. Absolutely homeless is defined as having had no fixed place to stay for at least the past seven nights with little likelihood of finding a place in the coming month. Precariously housed is defined as being housed a in single room occupancy, rooming house, or hotel/motel as a primary residence AND in the past year having experienced two or more episodes of being absolutely homeless OR one episode of being absolutely homeless that lasted for more than four weeks in the preceding 12 months.
- living with schizophrenia or bipolar disorder (diagnosis of DSM-IV);
- with a sufficient understanding of written and spoken French to be able to provide informed consent and to participate to face-to-face interviews;
- affiliated to a social protection;
Key exclusion criteria (4 listed)
- being considered unable to provide informed consent;
- having dependent children;
- pregnancy;
- or a DSM-IV Axis I diagnosis other than schizophrenia or bipolar disorder
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 |
|---|---|---|
| HOUSING FIRST PROGRAMRealization of a psychosocial organic evaluation and a citizen; * Support in the development and the maintenance of the housing; * Support in the diverse steps (administrative, judicial, financiers, etc.); * Support around addictions / alcohol; * Supportin the family and social relations, in the environment of the person -to favor the occupational integration, by prioritizing the insertion in ordinary environment(middle) * to favor the access and the preservation of the patient to the psychiatric and somatic care, to the devices and the departments favoring the social insertion and the integration. | Other | Housing First Program |
| traditional French servicesThe person will not receive from intervention of the team of site, but the person can resort(turn) without limitation to all the range of services said " about "common law " set up in the direction of the persons homeless persons, as well as to every type of care. She can too reach the housing and\or the restoring, but this by means of the existing devices | Other | traditional French services |
Primary outcome
healthcare utilisation
Time frame: 3 YEARS
hospitalizations, hospital days, and emergency department visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Derived from this study: PubMed 35125129Loubiere S, Lemoine C, Boucekine M, Boyer L, Girard V, Tinland A, Auquier P; French Housing First Study Group. Housing First for homeless people with severe mental illness: extended 4-year follow-up and analysis of recovery and housing stability from the randomized Un Chez Soi d'Abord trial. Epidemiol Psychiatr Sci. 2022 Feb 7;31:e14. doi: 10.1017/S2045796022000026.
- Derived from this study: PubMed 34215235Tinland A, Loubiere S, Cantiello M, Boucekine M, Girard V, Taylor O, Auquier P. Mortality in homeless people enrolled in the French housing first randomized controlled trial: a secondary outcome analysis of predictors and causes of death. BMC Public Health. 2021 Jul 2;21(1):1294. doi: 10.1186/s12889-021-11310-w.
- Derived from this study: PubMed 32679400Loubiere S, Tinland A, Taylor O, Loundou A, Girard V, Boyer L, Auquier P. Determinants of healthcare use by homeless people with schizophrenia or bipolar disorder: results from the French Housing First Study. Public Health. 2020 Aug;185:224-231. doi: 10.1016/j.puhe.2020.05.019. Epub 2020 Jul 14.
- Derived from this study: PubMed 30423419Fond G, Boyer L, Boucekine M, Girard V, Loubiere S, Lenoir C, Auquier P, Tinland A; French Housing First Study Group. Illness and drug modifiable factors associated with violent behavior in homeless people with severe mental illness: results from the French Housing First (FHF) program. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 2;90:92-96. doi: 10.1016/j.pnpbp.2018.11.006. Epub 2018 Nov 10.
- Derived from this study: PubMed 29673362Rhenter P, Tinland A, Grard J, Laval C, Mantovani J, Moreau D, Vidaud B, Greacen T, Auquier P, Girard V. Problems maintaining collaborative approaches with excluded populations in a randomised control trial: lessons learned implementing Housing First in France. Health Res Policy Syst. 2018 Apr 19;16(1):34. doi: 10.1186/s12961-018-0305-1.
- Derived from this study: PubMed 28656452Tinland A, Zemmour K, Auquier P, Boucekine M, Girard V, Loubiere S, Fond G, Boyer L; French Housing First Study Group. Homeless women with schizophrenia reported lower adherence to their medication than men: results from the French Housing First experience. Soc Psychiatry Psychiatr Epidemiol. 2017 Sep;52(9):1113-1122. doi: 10.1007/s00127-017-1411-z. Epub 2017 Jun 27.
- Derived from this study: PubMed 24063556Tinland A, Fortanier C, Girard V, Laval C, Videau B, Rhenter P, Greacen T, Falissard B, Apostolidis T, Lancon C, Boyer L, Auquier P. Evaluation of the Housing First program in patients with severe mental disorders in France: study protocol for a randomized controlled trial. Trials. 2013 Sep 24;14:309. doi: 10.1186/1745-6215-14-309.
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.
EMILIE GARRIDO PRADALIE study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HOUSING FIRST PROGRAM and traditional French services in people with Subnormal; Mental, Severe, 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 8 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Sep 2018. 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?
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?
healthcare utilisation (time frame: 3 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570712, which also lists 7 linked publications.
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 20 Sep 2018.