Submission date
05/06/2009
Registration date
18/08/2009
Last edited
13/02/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Background and study aims
The Mental Health Commission of Canada is working with a national and five local research teams in Vancouver, Winnipeg, Toronto, Montreal and Moncton to conduct this study. The aims are to find out what kind of housing and support work best for people who are homeless and have mental health issues and to influence the government to create more long-term community-based housing and supports.

Who can participate?
Homeless or precariously housed adults aged 18 and older diagnosed with a serious mental disorder.

What does the study involve?
To find out which kind of supported housing works best, we are comparing people receiving Housing First with those in usual care. This means that those who agree to participate will be assigned at random to receive either Housing First (rent supplements and mental health supports from a case manager at one of two levels, assertive community treatment or intensive case management) or usual care (existing community services). All participants will be interviewed every 3 months over a period of two years and be asked to continue in a longer-term 4 year follow-up study. We ask participants to provide us with access to information about their use of health services, income assistance and any contacts with the justice system.

What are the possible benefits and risks of participating?
All participants get a cash honorarium (payment) for each interview. We make the interview as comfortable as possible to reduce the risk of personal questions creating distress. Those in the Housing First groups get supported housing through the study and have access to a minimum level of support and additional treatment if they choose to use it. Rent stipends and case management supports will be provided for the duration of the study when we will try to make sure that their housing is maintained. If they lose the housing for any reason, we will help them find another place to live and either continue to provide services/supports or locate alternative sources in the community. There is an equal chance that participants who agree to be in the study will not receive housing through the study. For those who do not get supported housing through the study, we let them know about housing and support through other sources.

Where is the study run from?
Centre for Addiction and Mental Health (Canada).

When is the study starting and how long is it expected to run for?
September 2009 to April 2013.

Who is funding the study?
Health Canada.

Who is the main contact?
Dr Paula Goering
paula_goering@camh.net

Study website

Contact information

Type

Scientific

Contact name

Dr Paula Goering

ORCID ID

http://orcid.org/0000-0002-2976-2127

Contact details

33 Russell Street
Toronto
M5S 2S1
Canada
+1 (0)416 979 6844
paula_goering@camh.net

Type

Scientific

Contact name

Dr Carol Adair

ORCID ID

http://orcid.org/0000-0001-5630-700X

Contact details

Departments of Psychiatry and Community Health Sciences
The University of Calgary
Faculty of Medicine
1215 – 39 Ave SW
Calgary
T2T 2K6
Canada
-
cadair@ucalgary.ca

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Multi-site pragmatic randomised controlled field trial of Housing First versus treatment as usual in mental health and homelessness

Acronym

Study hypothesis

What is the effectiveness, cost/benefit, and cost/effectiveness of Housing First in comparison to care as usual for homeless adults?

Ethics approval(s)

Centre for Addiction and Mental Health Research Ethics Board, 21/09/2009, ref: 252/2009

Study design

Multi-method multi-site unblinded randomised controlled field trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Other

Study type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Homelessness and serious mental illness

Intervention

Treatment: provision of rent supplements and case management or assertive community treatment for the duration of the study
Comparison: care as usual

Duration of intervention: Data collection will be ongoing from Sept 2009 to Feb 2013 with duration of intervention from 24 to 42 months.
Duration of follow-up: 2 years.

Intervention type

Other

Primary outcome measure

Housing stability, measured using the Tsemberis Residential Timeline Follow-back Inventory at 6, 12, 18 and 24 months

Secondary outcome measures

Quality of life, measured using the EQ-5D at 6, 12, 18 and 24 months

Overall study start date

01/09/2009

Overall study end date

01/04/2013

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Legal adult status
2. Absolute homelessness or precariously housed
3. Presence of a serious mental disorder
4. Aged 18 years and older, either sex

Participant type(s)

Other

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

2,225

Total final enrolment

2039

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/10/2009

Recruitment end date

01/07/2011

Locations

Countries of recruitment

Canada

Study participating centre

Centre for Addiction and Mental Health
Toronto
M5S 2S1
Canada

Study participating centre

Centre for Research on Inner City Health
St. Michael's Hospital
Toronto
-
Canada

Sponsor information

Organisation

Mental Health Commission of Canada (Canada)

Sponsor details

10301 Southport Lane SW
Calgary
T2W 1S7
Canada
-
awatson@mentalhealthcommission.ca

Sponsor type

Government

Website

http://www.mentalhealthcommissio.ca

ROR

https://ror.org/00hbkpf98

Funders

Funder type

Government

Funder name

Health Canada (Canada)

Alternative name(s)

Santé Canada

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Canada

Results and Publications

Publication and dissemination plan

A publications policy and plan, developed by a committee representing the project stakeholders, defined a set of core papers that will be written using the data from all sites. These include a paper describing the study methods as well as papers on how the Housing First programs were implemented and how well they worked at each level at one and two years. A process for coordinating author-initiated papers on a number of related topics is also in place. In addition, each site has a specific publication plan for their local papers.

Reports for policy and public audiences created throughout the project can be accessed at
http://mentalhealthcommission.ca/English/initiatives-and-projects/home

A National Film Board interactive documentary is at http://athome.nfb.ca/#/athome

Post project dissemination has included an interactive toolkit found at http://housingfirsttoolkit.ca

Data is stored at St. Michael's Hospital in Toronto and is available to external investigators who sign a Data Sharing and Use Agreement that stipulates the responsibilities associated with transfer of datasets. Dr. Carol Adair is the data access coordinator.

Intention to publish date

Individual participant data (IPD) sharing plan

Not provided at time of registration

IPD sharing plan summary

Stored in repository

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 14/11/2011 Yes No
Results article results 02/10/2012 Yes No
Results article childhood learning disability results 22/11/2012 Yes No
Results article results 01/06/2013 Yes No
Results article results 01/06/2013 Yes No
Other publications initial implementation 01/10/2013 Yes No
Results article cumulative childhood adversity results 12/04/2014 Yes No
Results article results 13/04/2014 Yes No
Results article discrimination results 07/09/2014 Yes No
Results article results 09/09/2014 Yes No
Results article results 14/12/2014 Yes No
Results article results 01/01/2015 Yes No
Results article results 23/02/2015 Yes No
Results article results 03/03/2015 Yes No
Results article results 01/05/2015 Yes No
Results article results 15/07/2015 Yes No
Results article results 29/09/2015 Yes No
Results article results 12/09/2016 Yes No
Results article results 21/10/2016 Yes No
Results article results 20/03/2018 Yes No
Results article results 12/07/2019 15/07/2019 Yes No
Results article results 02/08/2019 23/08/2019 Yes No
Results article results 22/08/2019 27/08/2019 Yes No
Results article results 01/11/2019 14/10/2019 Yes No
Results article dental results 30/03/2020 02/04/2020 Yes No
Results article retrospective analysis results 08/04/2019 15/04/2020 Yes No
Results article results 01/05/2019 13/07/2020 Yes No
Results article results 20/10/2020 28/09/2020 Yes No
Results article violence-related traumatic brain injury results 04/12/2020 07/12/2020 Yes No
Protocol article protocol for secondary data analysis 30/12/2020 04/01/2021 Yes No
Results article association of resiliance with quality of life results 04/03/2021 08/03/2021 Yes No
Results article 01/04/2021 19/04/2021 Yes No
Results article 01/06/2021 29/06/2021 Yes No
Results article 01/01/2021 12/07/2021 Yes No
Results article 25/08/2020 29/07/2021 Yes No
Results article Women experiencing homelessness and mental illness in a Housing First multi-site trial: Looking beyond housing to social outcomes and well-being 10/02/2023 13/02/2023 Yes No

Additional files

Editorial Notes

13/02/2023: Publication reference added. 29/07/2021: Publication reference added. 12/07/2021: Publication reference added. 29/06/2021: Publication reference added. 19/04/2021: Publication reference added. 08/03/2021: Publication reference added. 04/01/2021: Publication reference added. 07/12/2020: Publication reference added. 28/09/2020: Publication reference added. 13/07/2020: Publication reference added. 15/04/2020: Publication reference added. 02/04/2020: Publication reference added. 14/10/2019: Publication reference added. 27/08/2019: Publication reference added. 23/08/2019: Publication reference added. 15/07/2019: Publication reference and total final enrolment added. 22/03/2018: Publication reference added. 24/10/2016: Publication reference added. 14/09/2016: Publication reference added.