Homeless PersonsNCT03779204
Effect of a Rent Subsidy and Mentoring on Youth Transitioning Out of Homelessness
A study testing Mentorship and Rent Subsidies in people with Homeless Persons, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Compared to the vast amount of literature about the risk factors associated with young people entering and becoming entrenched in homelessness, much less is known about how to facilitate and sustain transitions off the streets. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Homeless Persons
- What is being tested?
- Mentorship and Rent Subsidies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 28 Feb 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be between ages 18-26
- Left homelessness within the past year
- Living in market rent housing
- Plan on staying in or nearby the community in which they were recruited (Toronto, Hamilton, or St. Catharines) for the duration of the 24-month study
- Be willing to be matched with an adult mentor who has been screened and chosen by one of the community partners
Who cannot join
- In imminent danger of losing their housing (e.g., facing jail time or impending eviction)
- Enrolled in another study with enhanced financial and social supports
- Unable to provide free and informed consent
- Unable to communicate fluently in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transitioning Youth Out of Homelessness: A Mixed Methods Community-Based Pilot Randomized Controlled Trial of a Rent Subsidy and Mentoring Intervention in Three Canadian Cities
Compared to the vast amount of literature about the risk factors associated with young people entering and becoming entrenched in homelessness, much less is known about how to facilitate and sustain transitions off the streets.
Current evidence indicates that while structural supports such as subsidized housing and social service providers are important, these things alone are insufficient to help young people integrate into mainstream society. Connecting these young people with an adult who exhibits the relationship-based components of mentoring that young people value most (e.g., genuine interest in their well-being and belief in their ability to succeed, a non-judgmental attitude and a willingness to listen, the provision of advice, guidance, affirmation and encouragement) may be key to helping them move forward and integrate into the mainstream.
Read more
This intervention will provide 24 young people (ages 18-26) who have transitioned out of homelessness and into market rent housing within the past year with rent subsidies for 24 months. Half of the young people will be randomized to receive regular mentorship from an adult mentor, tasked with helping their mentee bridge the gap between homelessness and mainstream living.
It is hypothesized that, for the primary outcome measures of community integration and self-esteem:
- Better mean scores (community integration and self-esteem) in the participants who receive rent subsidies plus mentorship (intervention group) will be observed compared to the participants who receive rent subsidies only (control group) by the primary endpoint of 18 months of study participation.
It is hypothesized that, for the secondary outcome measures of social connectedness, hope, and academic and vocational participation:
- Better mean scores (social connectedness and hope) in the intervention group relative to participants in the control group will be observed by 18 months of study participation.
- Participants in the intervention group will be more likely than the control group to demonstrate sustained engagement in academic and vocational activities (education, employment, and/or skills training) by 18 months of study participation.
This pilot will be the first to test the impact of economic and social supports on meaningful social integration for formerly homeless young people living in market rent housing.
Read the detailed description
The overarching aim of this mixed methods study is to assess whether and how rent subsidies and mentorship influence social integration outcomes for formerly homeless young people living in market rent housing in three urban settings.
Specifically, the objectives of this study are to:
- Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) community integration (psychological and physical); and b) self-esteem at the primary endpoint of 18 months.
- Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) social connectedness; b) hope; and c) sustained academic and vocational participation at 18 months.
- Explore whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) income; b) perceived housing quality; c) psychiatric symptoms; and d) sense of engulfment at 18 months.
- Integrate qualitative data to facilitate a fuller understanding of the quantitative data and deepen understanding of what the study participants (young people and mentors) found most beneficial about the intervention and how it could be improved.
This study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a randomized controlled trial (RCT) and a community-based participatory action research (CBPAR) framework. A mixed methods RCT is appropriate given the complex explanatory pathways (i.e., social and behavioral processes that may act independently and interdependently) of this intervention. In addition, the qualitative data will provide insights on contextual factors that may impact the external validity of the findings. Most importantly, this design provides a crucial (and under utilized) youth-informed perspective on social integration.
The study will be conducted in three Canadian cities: Toronto, Ontario (pop. 2.8 million); Hamilton, Ontario (pop. 552,000); and St. Catharines, Ontario (pop. 133,000). All of the study participants (n = 24) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as a part of the intervention. This study includes funding for the rent subsidies and will be paid directly to the landlords by the community partners. St. Michael's Hospital will establish a service provider agreement with each of the community partners for this purpose. Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners.
The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. To facilitate more of an organic, natural mentor-mentee relationship, the mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. For example, they will not be mandated to attend shelter-based social events. Instead, mentors will be encouraged to initiate activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus, touring a local library, or visiting the mentor's place of employment during business hours). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.
Community partners will match all participants with an outreach worker (already employed by each agency) who will communicate regularly with the research team, help ensure the rent subsidies are being distributed appropriately, maintain an ongoing relationship with the study participants, and monitor for 'red flags' in participants matched in mentor-mentee relationships (e.g., mentee reluctant to meet with their mentor). Matching all of the study participants with a worker will also help ensure that everyone is receiving a fairly equal level of social support from community partners, making it easier for the research team to discern whether the outcomes of interest are more likely attributable to mentorship rather than to varied levels of agency-based support. Moreover, a review of services and interventions designed to reduce "problem behaviors" (e.g., substance use and risky sexual practices) among street-involved and homeless young people (ages 12 - 24) found that researchers who had strong relationships with outreach workers and the community had more effective interventions and lower attrition rates than those who did not.
Following the baseline interview, participants at each of the three study sites (Toronto (n=12), Hamilton (n=6), and St. Catharine's (n=6)) will be randomized using block randomization to either the intervention (rent subsidies plus mentoring) or control (rent subsidies only) group. Randomization will be balanced by site based on random block sizes of two and four. The advantage of using block randomization is to uniformly distribute participants into treatment groups within each site. Because small block sizes may increase the risk of guessing the allocation procedure and subsequently introducing bias into the enrolment procedure, random block sizes will be used to avoid this potential selection bias. A unique randomization schedule will be produced for each site using SAS. A research coordinator not affiliated with the study will be the only person with access to the randomization schedule. The research coordinator will prepare sealed, opaque and sequentially numbered envelopes with the randomization results of participants. After assessing for eligibility and obtaining consent of each participant, research personnel responsible for enrolling participants will open the next randomization envelope from the sequentially ordered randomization envelope file to obtain the participant's randomized group assignment.
Quantitative data will be collected at six points in time over the course of 30 months: baseline, month six, month 12, month 18, month 24, and month 30. Qualitative measures are an important feature of this study and will consist of: 1) semi-structured individual interviews (study participants) and 2) focus groups (mentors). At baseline, twelve participants (six from each arm of the study) will be invited to participate in six semi-structured individual interviews, which will take place at the same time as the quantitative data collection: baseline, month six, month 12, month 18, month 24, and month 30. Participants will be purposively selected with a goal of having input from each of the three communities and a fairly equal gender and ethno-racial representation. All of the mentors (n = 12) will be invited to participate in two focus groups, which will take place at month 12 and month 24.
All analyses will be performed using the intention-to-treat principle; that is, all participants will be included and analyzed in the groups they were originally randomized. Baseline characteristics of the intervention and control groups will be summarized using descriptive statistics (i.e., mean, standard deviation, median and interquartile range for continuous variables, and frequencies and proportions for categorical variables). The descriptive statistics for outcomes at each study time point will be calculated, and differences in trajectories from baseline to 30 months follow-up between intervention and control groups using scatterplots and box-plots will be explored. Differences with 95% confidence intervals in continuous outcomes at 18 months (psychological community integration, self-esteem, social connectedness, hope, perceived housing quality, psychiatric symptoms, and sense of engulfment) between participants who received rent subsidies plus mentorship and participants who only received rent subsidies will be estimated using Analysis of Covariance (i.e., linear regression models), including an indicator of intervention group and the baseline value of the outcome. Regression diagnostics will be performed and analyses using the non-parametric Wilcoxon rank-sum test will be repeated if there are extreme outliers or influential observations. Groups will be compared with respect to count outcomes at 18 months (physical community integration) using graphical tools and the non-parametric Wilcoxon rank-sum test. For binary outcomes at 18 months (sustained academic and vocational participation, and income above low income cut-off ), differences in proportions with 95% confidence intervals will be estimated and tested using the chi-square or Fisher's exact test. Given the small sample size of this pilot randomized trial, all results will be interpreted with caution and with the intention of generating data and hypotheses for conducting a larger trial.
Given the emergent, iterative nature of research using a qualitative design, data analysis and interpretation will begin immediately after the first qualitative data generation session (at baseline). The semi-structured individual interviews and focus groups will be audio recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data, the transcriptionist will be instructed to note short responses, uncooperative tones, and literal silence. Prior to each subsequent qualitative data generation session, members of the research team will conduct a preliminary data analysis, reading the interview transcripts multiple times, separating the data into coded segments, making analytic memos beside sections of the transcripts, identifying emerging themes (and comparing/contrasting these between respondents), and compiling new questions. Those participating in the individual interviews and the focus groups will be asked for their perspectives on the emerging interpretations at each visit and these perspectives will play a key role in helping shape the data analysis and help ensure the trustworthiness of the data. The web-based application Dedoose will be utilized to assist with sorting and coding the qualitative data.
In keeping with CBPAR methodology, disseminating evidence with community partners is key in building community capacity and improving the lives of the young people participating in this study. Moreover, given the use of Critical Social Theory, the study findings will not only be presented, but will also be used to expose and explicate the relational processes (e.g., subjective experience of low socioeconomic position and low social class) that may be preventing formerly homeless young people from achieving meaningful social integration. With an emphasis on 'actionable' data, the findings will be disseminated broadly to both academic and community-based audiences in a variety of formats ranging from scientific journal papers to oral presentations.
- Conditions
- Homeless Persons
- Being tested
- Mentorship, Rent Subsidies
- Keywords
- Social Isolation, Self-Esteem, Hope, Psychiatric Problem, Education, Employment, Income, Housing Problems, Identity, Social, Youth, Rent Subsidy, Mentorship
- Medical subject headings
- Social Isolation, Social Identification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentorshipBehavioural
The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.
Rent SubsidiesBehavioural
Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Rent subsidies + Mentorship | Experimental | Participants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners. Receives: Behavioral: Mentorship; Behavioral: Rent Subsidies |
| Rent subsidies only | Active comparator | Participants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship. Receives: Behavioral: Rent Subsidies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community Integration Scale Score at 18 Months
This outcome is a measure of behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. This will be measured using the Community Integration Scale (CIS), an 11-item scale. The CIS includes a psychological subscale (possible score range is from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total score range is 0-7, 0 being low physical community integration, and 7 being high integration). Only the psychological subscale has been reported here.
Measured: Change from baseline to 18 months
Rosenberg Self-Esteem Scale Score at 18 Months
This outcome is a measure of global self-worth and will be measured using the Rosenberg Self-Esteem Scale, a 10-item scale, internal consistency α = .77 - .88. The total scoring range is 0-30, a score of <15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.
Measured: Change from baseline to 18 months.
Secondary outcomes (3)
Social Connectedness Scale Score at 18 Months
This outcome is a measure of belongingness - the degree to which people feel connected to others. It is measured using the Social Connected Scale, a 20-item scale, internal consistency α = .92. The total scoring range is 20-120, 20 being low social connectedness and 120 being high social connectedness.
Measured: Change from baseline to 18 months.
Beck Hopelessness Scale Score at 18 Months
This outcome is a measure of motivation, expectations, and feelings about the future and will be measured using Beck's Hopelessness Scale, a 20-item scale, internal consistency α = .93. The total scoring range is 0-20, 0-3 = None or minimal, 4-8 = Mild, 9-14 = Moderate - requires monitoring, 15+ = Severe - suicide risk.
Measured: Change from baseline to 18 months.
Academic/Vocational Participation as Assessed by a Questionnaire at 18 Months
Participant engagement with school or a training program will be assessed. Participants will be prompted to answer questions about their current educational pursuit every 6 months in a questionnaire, including whether the individual is pursuing education, and the type of education.
Measured: Change from baseline to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start28 Feb 2019
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (66)Papers the sponsor has linked to this study.
- Other trials for Homeless PersonsStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a RCT and a CBPAR framework. 24 participants will be assessed for eligibility, and then randomized into 1 of 2 arms using covariate adaptive randomization. 12 are allocated to the intervention group (rent subsidies + mentoring), while 12 are allocated to the control group (rent subsidies only). Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners. Mentors are selected and matched through one-on-one interviews with someone in a leadership role within the organization. A common mentoring guide will be used for all sites; these booklets cover information ranging from ideal mentor characteristics to mentor code of conduct.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Covenant House Toronto, Living Rock Ministries, Resource Association for Teens
- Responsible party
- Sponsor
- Investigators
- Naomi S Thulien, RN, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779204
- Sponsor's protocol ID
- 18-251
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2018
- Last updated
- 13 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Altena AM, Brilleslijper-Kater SN, Wolf JL. Effective interventions for homeless youth: a systematic review. Am J Prev Med. 2010 Jun;38(6):637-45. doi: 10.1016/j.amepre.2010.02.017.
PubMed 20494240Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.
PubMed 4436473Brueckner, M., Green, M., & Saggers, S. (2011). The trappings of home: Young homeless people's transitions towards independent living. Housing Studies, 26(1), 1-16. doi:10.1080/02673037.2010.512751.
Chenail. R. J., St. Goerge, S., Wulff, D., & Cooper, R. (2012). Action research: The methodologies. In P. L. Munhall (Ed.), Nursing research: A qualitative perspective (5th ed.) (pp. 455-470). Sudbury, MS: Jones & Bartlett.
Ciarolo, J. A., Edwards, D. W., Kiresuk, T. J., Newman, F. L., & Brown, T. R. (1981). Colorado symptom index. Washington, DC: National Institute of Mental Health.
Coren E, Hossain R, Pardo Pardo J, Bakker B. Interventions for promoting reintegration and reducing harmful behaviour and lifestyles in street-connected children and young people. Cochrane Database Syst Rev. 2016 Jan 13;2016(1):CD009823. doi: 10.1002/14651858.CD009823.pub3.
PubMed 26760047Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
PubMed 18824488Creswell, J.W. (2014). Research design: Qualitative, quantitative, and mixed method approaches (4th ed.). Thousand Oaks, CA: Sage.
Creswell, J.W., & Plano Clark, V.L. (2018). Designing and conducting mixed methods research (3rd ed.). Thousand Oaks, CA: Sage.
Dang MT, Miller E. Characteristics of natural mentoring relationships from the perspectives of homeless youth. J Child Adolesc Psychiatr Nurs. 2013 Nov;26(4):246-53. doi: 10.1111/jcap.12038. Epub 2013 Jun 14.
PubMed 24180604Denzin, N.K., & Lincoln, Y.S. (2011). The SAGE handbook of qualitative research. Thousand Oaks, CA: SAGE Publications Inc.
Eakin JM, Mykhalovskiy E. Reframing the evaluation of qualitative health research: reflections on a review of appraisal guidelines in the health sciences. J Eval Clin Pract. 2003 May;9(2):187-94. doi: 10.1046/j.1365-2753.2003.00392.x.
PubMed 12787182Farquhar MC, Ewing G, Booth S. Using mixed methods to develop and evaluate complex interventions in palliative care research. Palliat Med. 2011 Dec;25(8):748-57. doi: 10.1177/0269216311417919. Epub 2011 Aug 1.
PubMed 21807749Fletcher, R.H., Fletcher, S.W., & Fletcher, G.S. (2014). Clinical epidemiology: The essentials (5th ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
Frederick, T., Chwalek, M., Hughes, J., Karabanow, J., & Kidd, S. (2014). How stable is stable? Defining and measuring housing stability. Journal of Community Psychology, 42(8), 964- 979. doi:10.1002/jcop.21665.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning Youth Out of Homelessness: A Mixed Methods Community-Based Pilot Randomized Controlled Trial of a Rent Subsidy and Mentoring Intervention in Three Canadian Cities
- ClinicalTrials.gov ID
- NCT03779204
- Acronym / sponsor ID
- 18-251
- Conditions
- Homeless Persons
- Keywords
- Social Isolation, Self-Esteem, Hope, Psychiatric Problem, Education, Employment, Income, Housing Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Covenant House Toronto, Living Rock Ministries, Resource Association for Teens
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 13 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compared to the vast amount of literature about the risk factors associated with young people entering and becoming entrenched in homelessness, much less is known about how to facilitate and sustain transitions off the streets.
Current evidence indicates that while structural supports such as subsidized housing and social service providers are important, these things alone are insufficient to help young people integrate into mainstream society. Connecting these young people with an adult who exhibits the relationship-based components of mentoring that young people value most (e.g., genuine interest in their well-being and belief in their ability to succeed, a non-judgmental attitude and a willingness to listen, the provision of advice, guidance, affirmation and encouragement) may be key to helping them move forward and integrate into the mainstream.
This intervention will provide 24 young people (ages 18-26) who have transitioned out of homelessness and into market rent housing within the past year with rent subsidies for 24 months. Half of the young people will be randomized to receive regular mentorship from an adult mentor, tasked with helping their mentee bridge the gap between homelessness and mainstream living.
It is hypothesized that, for the primary outcome measures of community integration and self-esteem:
- Better mean scores (community integration and self-esteem) in the participants who receive rent subsidies plus mentorship (intervention group) will be observed compared to the participants who receive rent subsidies only (control group) by the primary endpoint of 18 months of study participation.
It is hypothesized that, for the secondary outcome measures of social connectedness, hope, and academic and vocational participation:
- Better mean scores (social connectedness and hope) in the intervention group relative to participants in the control group will be observed by 18 months of study participation.
- Participants in the intervention group will be more likely than the control group to demonstrate sustained engagement in academic and vocational activities (education, employment, and/or skills training) by 18 months of study participation.
This pilot will be the first to test the impact of economic and social supports on meaningful social integration for formerly homeless young people living in market rent housing.
Detailed description
The overarching aim of this mixed methods study is to assess whether and how rent subsidies and mentorship influence social integration outcomes for formerly homeless young people living in market rent housing in three urban settings.
Specifically, the objectives of this study are to:
- Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) community integration (psychological and physical); and b) self-esteem at the primary endpoint of 18 months.
- Determine whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) social connectedness; b) hope; and c) sustained academic and vocational participation at 18 months.
- Explore whether rent subsidies plus mentorship results in better social integration outcomes than only receiving rent subsidies with respect to: a) income; b) perceived housing quality; c) psychiatric symptoms; and d) sense of engulfment at 18 months.
- Integrate qualitative data to facilitate a fuller understanding of the quantitative data and deepen understanding of what the study participants (young people and mentors) found most beneficial about the intervention and how it could be improved.
This study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a randomized controlled trial (RCT) and a community-based participatory action research (CBPAR) framework. A mixed methods RCT is appropriate given the complex explanatory pathways (i.e., social and behavioral processes that may act independently and interdependently) of this intervention. In addition, the qualitative data will provide insights on contextual factors that may impact the external validity of the findings. Most importantly, this design provides a crucial (and under utilized) youth-informed perspective on social integration.
The study will be conducted in three Canadian cities: Toronto, Ontario (pop. 2.8 million); Hamilton, Ontario (pop. 552,000); and St. Catharines, Ontario (pop. 133,000). All of the study participants (n = 24) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as a part of the intervention. This study includes funding for the rent subsidies and will be paid directly to the landlords by the community partners. St. Michael's Hospital will establish a service provider agreement with each of the community partners for this purpose. Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners.
The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. To facilitate more of an organic, natural mentor-mentee relationship, the mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. For example, they will not be mandated to attend shelter-based social events. Instead, mentors will be encouraged to initiate activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus, touring a local library, or visiting the mentor's place of employment during business hours). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.
Community partners will match all participants with an outreach worker (already employed by each agency) who will communicate regularly with the research team, help ensure the rent subsidies are being distributed appropriately, maintain an ongoing relationship with the study participants, and monitor for 'red flags' in participants matched in mentor-mentee relationships (e.g., mentee reluctant to meet with their mentor). Matching all of the study participants with a worker will also help ensure that everyone is receiving a fairly equal level of social support from community partners, making it easier for the research team to discern whether the outcomes of interest are more likely attributable to mentorship rather than to varied levels of agency-based support. Moreover, a review of services and interventions designed to reduce "problem behaviors" (e.g., substance use and risky sexual practices) among street-involved and homeless young people (ages 12 - 24) found that researchers who had strong relationships with outreach workers and the community had more effective interventions and lower attrition rates than those who did not.
Following the baseline interview, participants at each of the three study sites (Toronto (n=12), Hamilton (n=6), and St. Catharine's (n=6)) will be randomized using block randomization to either the intervention (rent subsidies plus mentoring) or control (rent subsidies only) group. Randomization will be balanced by site based on random block sizes of two and four. The advantage of using block randomization is to uniformly distribute participants into treatment groups within each site. Because small block sizes may increase the risk of guessing the allocation procedure and subsequently introducing bias into the enrolment procedure, random block sizes will be used to avoid this potential selection bias. A unique randomization schedule will be produced for each site using SAS. A research coordinator not affiliated with the study will be the only person with access to the randomization schedule. The research coordinator will prepare sealed, opaque and sequentially numbered envelopes with the randomization results of participants. After assessing for eligibility and obtaining consent of each participant, research personnel responsible for enrolling participants will open the next randomization envelope from the sequentially ordered randomization envelope file to obtain the participant's randomized group assignment.
Quantitative data will be collected at six points in time over the course of 30 months: baseline, month six, month 12, month 18, month 24, and month 30. Qualitative measures are an important feature of this study and will consist of: 1) semi-structured individual interviews (study participants) and 2) focus groups (mentors). At baseline, twelve participants (six from each arm of the study) will be invited to participate in six semi-structured individual interviews, which will take place at the same time as the quantitative data collection: baseline, month six, month 12, month 18, month 24, and month 30. Participants will be purposively selected with a goal of having input from each of the three communities and a fairly equal gender and ethno-racial representation. All of the mentors (n = 12) will be invited to participate in two focus groups, which will take place at month 12 and month 24.
All analyses will be performed using the intention-to-treat principle; that is, all participants will be included and analyzed in the groups they were originally randomized. Baseline characteristics of the intervention and control groups will be summarized using descriptive statistics (i.e., mean, standard deviation, median and interquartile range for continuous variables, and frequencies and proportions for categorical variables). The descriptive statistics for outcomes at each study time point will be calculated, and differences in trajectories from baseline to 30 months follow-up between intervention and control groups using scatterplots and box-plots will be explored. Differences with 95% confidence intervals in continuous outcomes at 18 months (psychological community integration, self-esteem, social connectedness, hope, perceived housing quality, psychiatric symptoms, and sense of engulfment) between participants who received rent subsidies plus mentorship and participants who only received rent subsidies will be estimated using Analysis of Covariance (i.e., linear regression models), including an indicator of intervention group and the baseline value of the outcome. Regression diagnostics will be performed and analyses using the non-parametric Wilcoxon rank-sum test will be repeated if there are extreme outliers or influential observations. Groups will be compared with respect to count outcomes at 18 months (physical community integration) using graphical tools and the non-parametric Wilcoxon rank-sum test. For binary outcomes at 18 months (sustained academic and vocational participation, and income above low income cut-off ), differences in proportions with 95% confidence intervals will be estimated and tested using the chi-square or Fisher's exact test. Given the small sample size of this pilot randomized trial, all results will be interpreted with caution and with the intention of generating data and hypotheses for conducting a larger trial.
Given the emergent, iterative nature of research using a qualitative design, data analysis and interpretation will begin immediately after the first qualitative data generation session (at baseline). The semi-structured individual interviews and focus groups will be audio recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data, the transcriptionist will be instructed to note short responses, uncooperative tones, and literal silence. Prior to each subsequent qualitative data generation session, members of the research team will conduct a preliminary data analysis, reading the interview transcripts multiple times, separating the data into coded segments, making analytic memos beside sections of the transcripts, identifying emerging themes (and comparing/contrasting these between respondents), and compiling new questions. Those participating in the individual interviews and the focus groups will be asked for their perspectives on the emerging interpretations at each visit and these perspectives will play a key role in helping shape the data analysis and help ensure the trustworthiness of the data. The web-based application Dedoose will be utilized to assist with sorting and coding the qualitative data.
In keeping with CBPAR methodology, disseminating evidence with community partners is key in building community capacity and improving the lives of the young people participating in this study. Moreover, given the use of Critical Social Theory, the study findings will not only be presented, but will also be used to expose and explicate the relational processes (e.g., subjective experience of low socioeconomic position and low social class) that may be preventing formerly homeless young people from achieving meaningful social integration. With an emphasis on 'actionable' data, the findings will be disseminated broadly to both academic and community-based audiences in a variety of formats ranging from scientific journal papers to oral presentations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will employ a convergent mixed methods design (i.e., quantitative and qualitative data are collected concurrently, and the findings combined) embedded within a RCT and a CBPAR framework. 24 participants will be assessed for eligibility, and then randomized into 1 of 2 arms using covariate adaptive randomization. 12 are allocated to the intervention group (rent subsidies + mentoring), while 12 are allocated to the control group (rent subsidies only). Participants in the intervention group (n = 12) will be matched with an adult mentor recruited by one of the community partners. Mentors are selected and matched through one-on-one interviews with someone in a leadership role within the organization. A common mentoring guide will be used for all sites; these booklets cover information ranging from ideal mentor characteristics to mentor code of conduct.
| Arm | Type | Receives |
|---|---|---|
| Rent subsidies + Mentorship | Experimental | Behavioral: Mentorship, Behavioral: Rent SubsidiesParticipants in this arm (n = 13) will receive rent subsidies (ranging from $400 - $500/month) for 24 months as part of the intervention and be matched with an adult mentor recruited by one of the community partners. |
| Rent subsidies only | Active comparator | Behavioral: Rent SubsidiesParticipants in this arm (n = 11) will receive rent subsidies only (ranging from $400 - $500/month) for 24 months as part of the comparator group intervention. This group will not receive mentorship. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Be between ages 18-26
- Left homelessness within the past year
- Living in market rent housing
- Plan on staying in or nearby the community in which they were recruited (Toronto, Hamilton, or St. Catharines) for the duration of the 24-month study
- Be willing to be matched with an adult mentor who has been screened and chosen by one of the community partners
Key exclusion criteria (4 listed)
- In imminent danger of losing their housing (e.g., facing jail time or impending eviction)
- Enrolled in another study with enhanced financial and social supports
- Unable to provide free and informed consent
- Unable to communicate fluently in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MentorshipThe mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor. | Behavioural | Rent subsidies + Mentorship |
| Rent SubsidiesParticipants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months. | Behavioural | Rent subsidies + Mentorship, Rent subsidies only |
Primary outcome
Community Integration Scale Score at 18 Months
Time frame: Change from baseline to 18 months
This outcome is a measure of behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. This will be measured using the Community Integration Scale (CIS), an 11-item scale. The CIS includes a psychological subscale (possible score range is from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total score range is 0-7, 0 being low physical community integration, and 7 being high integration). Only the psychological subscale has been reported here.
Rosenberg Self-Esteem Scale Score at 18 Months
Time frame: Change from baseline to 18 months.
This outcome is a measure of global self-worth and will be measured using the Rosenberg Self-Esteem Scale, a 10-item scale, internal consistency α = .77 - .88. The total scoring range is 0-30, a score of <15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.
3 secondary outcomes
Social Connectedness Scale Score at 18 Months
Time frame: Change from baseline to 18 months.
Beck Hopelessness Scale Score at 18 Months
Time frame: Change from baseline to 18 months.
Academic/Vocational Participation as Assessed by a Questionnaire at 18 Months
Time frame: Change from baseline to 18 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20494240Altena AM, Brilleslijper-Kater SN, Wolf JL. Effective interventions for homeless youth: a systematic review. Am J Prev Med. 2010 Jun;38(6):637-45. doi: 10.1016/j.amepre.2010.02.017.
- Background: PubMed 4436473Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.
- BackgroundBrueckner, M., Green, M., & Saggers, S. (2011). The trappings of home: Young homeless people's transitions towards independent living. Housing Studies, 26(1), 1-16. doi:10.1080/02673037.2010.512751.
- BackgroundChenail. R. J., St. Goerge, S., Wulff, D., & Cooper, R. (2012). Action research: The methodologies. In P. L. Munhall (Ed.), Nursing research: A qualitative perspective (5th ed.) (pp. 455-470). Sudbury, MS: Jones & Bartlett.
- BackgroundCiarolo, J. A., Edwards, D. W., Kiresuk, T. J., Newman, F. L., & Brown, T. R. (1981). Colorado symptom index. Washington, DC: National Institute of Mental Health.
- Background: PubMed 26760047Coren E, Hossain R, Pardo Pardo J, Bakker B. Interventions for promoting reintegration and reducing harmful behaviour and lifestyles in street-connected children and young people. Cochrane Database Syst Rev. 2016 Jan 13;2016(1):CD009823. doi: 10.1002/14651858.CD009823.pub3.
- Background: PubMed 18824488Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
- BackgroundCreswell, J.W. (2014). Research design: Qualitative, quantitative, and mixed method approaches (4th ed.). Thousand Oaks, CA: Sage.
- BackgroundCreswell, J.W., & Plano Clark, V.L. (2018). Designing and conducting mixed methods research (3rd ed.). Thousand Oaks, CA: Sage.
- Background: PubMed 24180604Dang MT, Miller E. Characteristics of natural mentoring relationships from the perspectives of homeless youth. J Child Adolesc Psychiatr Nurs. 2013 Nov;26(4):246-53. doi: 10.1111/jcap.12038. Epub 2013 Jun 14.
- BackgroundDenzin, N.K., & Lincoln, Y.S. (2011). The SAGE handbook of qualitative research. Thousand Oaks, CA: SAGE Publications Inc.
- Background: PubMed 12787182Eakin JM, Mykhalovskiy E. Reframing the evaluation of qualitative health research: reflections on a review of appraisal guidelines in the health sciences. J Eval Clin Pract. 2003 May;9(2):187-94. doi: 10.1046/j.1365-2753.2003.00392.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi S Thulien, RN, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentorship and Rent Subsidies in people with Homeless Persons, run by Unity Health Toronto at 1 site in Canada.
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 5 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 13 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Community Integration Scale Score at 18 Months (time frame: Change from baseline to 18 months). The study lists 2 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 NCT03779204, which also lists 66 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 13 Jan 2025.