ISRCTN ISRCTN42520374
DOI https://doi.org/10.1186/ISRCTN42520374
Protocol serial number N/A
Sponsor Mental Health Commission of Canada (Canada)
Funder Health Canada (Canada)
Submission date
05/06/2009
Registration date
18/08/2009
Last edited
04/09/2025
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 logoORCID 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 logoORCID ID 0000-0001-5630-700X
Email cadair@ucalgary.ca

Study information

Primary study designInterventional
Study designMulti-method multi-site unblinded randomised controlled field trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleMulti-site pragmatic randomised controlled field trial of Housing First versus treatment as usual in mental health and homelessness
Study objectivesWhat 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) studiedHomelessness and serious mental illness
InterventionTreatment: 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date01/04/2013

Eligibility

Participant type(s)Other
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration2225
Total final enrolment2039
Key inclusion criteria1. 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 criteriaDoes not meet inclusion criteria
Date of first enrolment01/10/2009
Date of final enrolment01/07/2011

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summary
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
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
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
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
Results article 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
Results article 03/09/2025 04/09/2025 Yes No
Protocol article 14/11/2011 Yes No
Protocol article protocol for secondary data analysis 30/12/2020 04/01/2021 Yes No
Other publications initial implementation 01/10/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

04/09/2025: Publication reference added.
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.