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Mental Health DisorderNCT03622151

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

A study testing Primer la Llar program in people with Mental Health Disorder, run by Parc Sanitari Sant Joan de Déu.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 72 years
Conditions the study is for
Mental Health Disorder
What is being tested?
Primer la Llar program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
No sites listed yet
Study dates
Jan 2016to May 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

About this study

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).

Read the 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.

Being tested
Primer la Llar program
Keywords
mental health, Housing First, homeless
Medical subject headings
Mental Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Primer la Llar programOther

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

Study groups in NCT03622151
Study groupRoleWhat they receive
Intervention groupExperimentalPrimer la Llar Program (housing first model): to live in permanent and individual housing and receiving weekly visits from a multidisciplinary team.
Receives: Other: Primer la Llar program
Control groupNo interventionTreatment as usual: attention from the resources of the homeless network in Barcelona.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 21 months

  2. 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.

    Measured: Up to 21 months

  3. 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.

    Measured: Up to 21 months.

Secondary outcomes (5)

  1. 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.

    Measured: Up to 21 months

  2. 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.

    Measured: Up to 21 months

  3. 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.

    Measured: Up to 21 months

  4. 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.

    Measured: Up to 21 months

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

    Increase or decrease on drug abuse in both groups

    Measured: Up to 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2018
  2. Study startJan 2016
  3. Primary completionJan 2017
  4. Study completionMay 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Intervention group (housing first model program) and control group (treatment as usual).
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03622151
Sponsor's protocol ID
PIC-130-15
Status last verified
Sep 2018
First submitted
18 Jul 2018
Last updated
2 Oct 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25639993

  • 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.

    PubMed 26634243

  • 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.

    PubMed 29558927

  • 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.

    PubMed 24176253

  • 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.

    PubMed 25734732

Questions about this trial

What is this clinical trial studying?

A study testing Primer la Llar program in people with Mental Health Disorder, run by Parc Sanitari Sant Joan de Déu.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence and gravity of psychotic symptoms in both groups (time frame: Up to 21 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03622151, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.

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