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
About this trial
This is an interventional supportive care trial for Mental Health Disorder focused on measuring mental health, Housing First, homeless
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
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
NCT ID
NCT03622151
First Posted
July 18, 2018
Last Updated
September 29, 2018
Sponsor
Parc Sanitari Sant Joan de Déu
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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