Research demonstration projects in mental health and homelessness

ISRCTN	ISRCTN42520374
DOI	https://doi.org/10.1186/ISRCTN42520374
Secondary identifying numbers	N/A

Submission date: 05/06/2009
Registration date: 18/08/2009
Last edited: 07/08/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Paula Goering
Scientific

33 Russell Street
Toronto
M5S 2S1
Canada

ORCID ID	0000-0002-2976-2127
Phone	+1 (0)416 979 6844
Email	paula_goering@camh.net

Dr Carol Adair
Scientific

Departments of Psychiatry and Community Health Sciences
The University of Calgary, Faculty of Medicine
1215 – 39 Ave SW
Calgary
T2T 2K6
Canada

ORCID ID	0000-0001-5630-700X
Email	cadair@ucalgary.ca

Study information

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
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Multi-site pragmatic randomised controlled field trial of Housing First versus treatment as usual in mental health and homelessness
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/04/2013

Eligibility

Participant type(s)	Other
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	2,225
Total final enrolment	2039
Key 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
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/10/2009
Date of final enrolment	01/07/2011

Locations

Countries of recruitment

Canada

Study participating centres

Centre for Addiction and Mental Health

Toronto
M5S 2S1
Canada

Centre for Research on Inner City Health

St. Michael's Hospital
Toronto
-
Canada

Sponsor information

Mental Health Commission of Canada (Canada)
Government

10301 Southport Lane SW
Calgary
T2W 1S7
Canada

Email	awatson@mentalhealthcommission.ca
Website	http://www.mentalhealthcommissio.ca
"ROR"	https://ror.org/00hbkpf98

Funders

Funder type

Government

Health Canada (Canada)
Government organisation / National government

Alternative name(s): Santé Canada
Location: Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
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.
IPD sharing plan	Not provided at time of registration

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
Other publications	Association of housing and support interventions with mortality among individuals experiencing homelessness and mental illnesses secondary analysis	01/07/2025	07/08/2025	Yes	No

Editorial Notes

07/08/2025: Publication reference added.
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.