Homeless Population and Mental Health: Impact of Primer la Llar Program

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).

Study Overview

• Status: Completed
• Conditions: Mental Health Disorder
• Intervention / Treatment: Other: Primer la Llar program

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.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Primer la Llar Program (housing first model): to live in permanent and individual housing and receiving weekly visits from a multidisciplinary team.	Other: Primer la Llar program; Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.
No Intervention: Control group; Treatment as usual: attention from the resources of the homeless network in Barcelona.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and gravity of psychotic symptoms in both groups	PANSS scale (Positive And Negative Syndrome Scale). Subscales: 1. PANSS-P-Positive (7 ítems): range 7-49 (minimum and maximum scores) 2. PANSS-N-Negative (7 ítems). Range: 7-49. 3. PANSS-PG- general psychopathology (16 ítems). Range: 16-112. Higher values represent a worse outcome. Subscales are summed to compute a total score.	Up to 21 months
Prevalence and gravity of anxious symptoms in both groups	HARS scale (Hamilton Anxiety Rating Scale). Total range:0-56. Higher values represent a worse outcome.	Up to 21 months
Prevalence and gravity of depressive symptoms in both groups	HDRS scale (Hamilton Depression Rating Scale). Total range: 0-52. Higher values represent a worse outcome.	Up to 21 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in number of visits to the emergency room/health center/specialist doctors	To see if there are increases or decreases in use of general and specific health services; questionnaire on use of services.	Up to 21 months
Basic skills of daily life	BELS scale (Basic everyday living skills). Range subscales: self-care (0-40) domestic skills (0-28) community skills (0-16) and activity and social relations (0-20). Higher value reports better outcome. Subescales are summed to compute a total score.	Up to 21 months
Sociodemographic and psychopathological description of both groups	Number of participants from each country, average age, number of men and women, number of participants with a problem of substance abuse or mental health, etc. Assessed by a questionnaire about clinical and socio-demographic items.	Up to 21 months
Number of participants with an alcohol abuse problem assessed by Audit test	Changes in alcohol abuse in both groups Audit test (0-40). Higher value reports worse outcome.	Up to 21 months
Number of participants with a drug abuse problem assessed by questionnaire on drug abuse	Increase or decrease on drug abuse in both groups	Up to 21 months

Collaborators and Investigators

• Sponsor: Parc Sanitari Sant Joan de Déu
• Investigators: Study Director: Josep Maria Haro Abad, Parc Sanitari Sant Joan de Déu

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 4, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 29, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: mental health; homeless; Housing First
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: PIC-130-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No