NCT03622151

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
Last Updated

October 2, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

July 18, 2018

Last Update Submit

September 29, 2018

Conditions

Keywords

mental healthHousing Firsthomeless

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Changes in number of visits to the emergency room/health center/specialist doctors

    Up to 21 months

  • Basic skills of daily life

    Up to 21 months

  • Sociodemographic and psychopathological description of both groups

    Up to 21 months

  • Number of participants with an alcohol abuse problem assessed by Audit test

    Up to 21 months

  • Number of participants with a drug abuse problem assessed by questionnaire on drug abuse

    Up to 21 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.

Intervention group

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 25639993BACKGROUND
  • 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.

    PMID: 26634243BACKGROUND
  • 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.

    PMID: 29558927BACKGROUND
  • 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.

    PMID: 24176253BACKGROUND
  • 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.

    PMID: 25734732BACKGROUND

MeSH Terms

Conditions

Mental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Josep Maria Haro Abad

    Parc Sanitari Sant Joan de Déu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention group (housing first model program) and control group (treatment as usual).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mental Health Nurse

Study Record Dates

First Submitted

July 18, 2018

First Posted

August 9, 2018

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

May 1, 2018

Last Updated

October 2, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share