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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mental Health Disorder

Intervention / Treatment
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* Other: Primer la Llar program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 72 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group (housing first model program) and control group (treatment as usual).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.<br>|
| No Intervention: Control group<br>Treatment as usual: attention from the resources of the homeless network in Barcelona. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mental health, Housing First, homeless