Clinical trial NCT03622151: Homeless Population and Mental Health: Impact of Primer la Llar Program
Official title: Homeless Population and Mental Health: Impact of Primer la Llar Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Keywords: mental health
Housing First
homeless
Lead sponsor: Parc Sanitari Sant Joan de Déu
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group (housing first model program) and control group (treatment as usual).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main goal is to evaluate the impact of the Primer La Llar housing program for the homeless population on the mental health of the participants.

The hypothesis is that the housing program, which follows Housing first model, for the homeless population has a positive impact on the mental health of the participants, compared to the group that does not receive the intervention -treatment as usual group (meaning the "positive impact" a lower score on the symptomatology scales and lower toxic intake in the group receiving the intervention).

Detailed description: The specific objectives are:

Identify the socio-demographic and clinical characteristics of the participants.

Compare the severity of psychiatric symptoms and improvement among the participants in the intervention group and the control group (depressive, anxious, psychotic or manic symptomatology, depending on the case).

Compare the consumption of alcohol and drugs among the participants of both groups.

Compare the basic daily life skills among the participants in both groups, as well as the improvement of them in the experimental group.

Compare the use of services and between the participants of the intervention group and the control group.

Intervention group receives entry to the program (which means individual and permanent housing without previous requirements such as abstinence, compliance with treatment or sobriety.

Control group receives treatment as usual, as they are users of homeless population network of Barcelona.

Eligibility criteria: Inclusion Criteria:

* Single people, adults (exceptionally sentimental couples, friends with positive support relationship for both).
* Long life on the street (minimum 1 year staying overnight on the street) and / or accommodation centers without linking, using them in a timely manner in the last year.
* Social needs concurrent to the lack of housing: mental illness and / or drug abuse.
* Functional autonomy for daily life.
* Have regular economic income or possibility of obtaining them.
* Sign informed consent form.

Exclusion Criteria:

* language barrier
* severe neurological or organic pathology
* severe dementia
* alcoholic dementia Wernicke Korsakoff

Primary outcomes:
measure: Prevalence and gravity of psychotic symptoms in both groups
timeFrame: Up to 21 months
measure: Prevalence and gravity of anxious symptoms in both groups
timeFrame: Up to 21 months
measure: Prevalence and gravity of depressive symptoms in both groups
timeFrame: Up to 21 months.
Secondary outcomes:
measure: Changes in number of visits to the emergency room/health center/specialist doctors
timeFrame: Up to 21 months
measure: Basic skills of daily life
timeFrame: Up to 21 months
measure: Sociodemographic and psychopathological description of both groups
timeFrame: Up to 21 months
measure: Number of participants with an alcohol abuse problem assessed by Audit test
timeFrame: Up to 21 months
measure: Number of participants with a drug abuse problem assessed by questionnaire on drug abuse
timeFrame: Up to 21 months
Other outcomes:
Locations:
Study officials:
affiliation: Parc Sanitari Sant Joan de Déu
name: Josep Maria Haro Abad
role: STUDY_DIRECTOR
References:
citation: Aubry T, Tsemberis S, Adair CE, Veldhuizen S, Streiner D, Latimer E, Sareen J, Patterson M, McGarvey K, Kopp B, Hume C, Goering P. One-year outcomes of a randomized controlled trial of housing first with ACT in five Canadian cities. Psychiatr Serv. 2015 May 1;66(5):463-9. doi: 10.1176/appi.ps.201400167. Epub 2015 Feb 2.
citation: Henwood BF, Byrne T, Scriber B. Examining mortality among formerly homeless adults enrolled in Housing First: An observational study. BMC Public Health. 2015 Dec 4;15:1209. doi: 10.1186/s12889-015-2552-1.
citation: Kerman N, Sylvestre J, Aubry T, Distasio J. The effects of housing stability on service use among homeless adults with mental illness in a randomized controlled trial of housing first. BMC Health Serv Res. 2018 Mar 20;18(1):190. doi: 10.1186/s12913-018-3028-7.
citation: Somers JM, Patterson ML, Moniruzzaman A, Currie L, Rezansoff SN, Palepu A, Fryer K. Vancouver At Home: pragmatic randomized trials investigating Housing First for homeless and mentally ill adults. Trials. 2013 Nov 1;14:365. doi: 10.1186/1745-6215-14-365.
citation: Stergiopoulos V, Hwang SW, Gozdzik A, Nisenbaum R, Latimer E, Rabouin D, Adair CE, Bourque J, Connelly J, Frankish J, Katz LY, Mason K, Misir V, O'Brien K, Sareen J, Schutz CG, Singer A, Streiner DL, Vasiliadis HM, Goering PN; At Home/Chez Soi Investigators. Effect of scattered-site housing using rent supplements and intensive case management on housing stability among homeless adults with mental illness: a randomized trial. JAMA. 2015 Mar 3;313(9):905-15. doi: 10.1001/jama.2015.1163.