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

Primary Purpose

Mental Health Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Primer la Llar program
Sponsored by
Parc Sanitari Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Health Disorder focused on measuring mental health, Housing First, homeless

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group

    Arm Description

    Primer la Llar Program (housing first model): to live in permanent and individual housing and receiving weekly visits from a multidisciplinary team.

    Treatment as usual: attention from the resources of the homeless network in Barcelona.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    Number of participants with a drug abuse problem assessed by questionnaire on drug abuse
    Increase or decrease on drug abuse in both groups

    Full Information

    First Posted
    July 18, 2018
    Last Updated
    September 29, 2018
    Sponsor
    Parc Sanitari Sant Joan de Déu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03622151
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    January 2017 (Actual)
    Study Completion Date
    May 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Parc Sanitari Sant Joan de Déu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Disorder
    Keywords
    mental health, Housing First, homeless

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Intervention group (housing first model program) and control group (treatment as usual).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Primer la Llar Program (housing first model): to live in permanent and individual housing and receiving weekly visits from a multidisciplinary team.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Treatment as usual: attention from the resources of the homeless network in Barcelona.
    Intervention Type
    Other
    Intervention Name(s)
    Primer la Llar program
    Intervention Description
    Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.
    Primary Outcome Measure Information:
    Title
    Prevalence and gravity of psychotic symptoms in both groups
    Description
    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.
    Time Frame
    Up to 21 months
    Title
    Prevalence and gravity of anxious symptoms in both groups
    Description
    HARS scale (Hamilton Anxiety Rating Scale). Total range:0-56. Higher values represent a worse outcome.
    Time Frame
    Up to 21 months
    Title
    Prevalence and gravity of depressive symptoms in both groups
    Description
    HDRS scale (Hamilton Depression Rating Scale). Total range: 0-52. Higher values represent a worse outcome.
    Time Frame
    Up to 21 months.
    Secondary Outcome Measure Information:
    Title
    Changes in number of visits to the emergency room/health center/specialist doctors
    Description
    To see if there are increases or decreases in use of general and specific health services; questionnaire on use of services.
    Time Frame
    Up to 21 months
    Title
    Basic skills of daily life
    Description
    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.
    Time Frame
    Up to 21 months
    Title
    Sociodemographic and psychopathological description of both groups
    Description
    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.
    Time Frame
    Up to 21 months
    Title
    Number of participants with an alcohol abuse problem assessed by Audit test
    Description
    Changes in alcohol abuse in both groups Audit test (0-40). Higher value reports worse outcome.
    Time Frame
    Up to 21 months
    Title
    Number of participants with a drug abuse problem assessed by questionnaire on drug abuse
    Description
    Increase or decrease on drug abuse in both groups
    Time Frame
    Up to 21 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Josep Maria Haro Abad
    Organizational Affiliation
    Parc Sanitari Sant Joan de Déu
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    25639993
    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.
    Results Reference
    background
    PubMed Identifier
    26634243
    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.
    Results Reference
    background
    PubMed Identifier
    29558927
    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.
    Results Reference
    background
    PubMed Identifier
    24176253
    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.
    Results Reference
    background
    PubMed Identifier
    25734732
    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.
    Results Reference
    background

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

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