<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779204</url>
  </required_header>
  <id_info>
    <org_study_id>18-251</org_study_id>
    <nct_id>NCT03779204</nct_id>
  </id_info>
  <brief_title>Effect of a Rent Subsidy and Mentoring on Youth Transitioning Out of Homelessness</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covenant House Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Living Rock Ministries</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Resource Association for Teens (RAFT)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Compared to the vast amount of literature about the risk factors associated with young people&#xD;
      entering and becoming entrenched in homelessness, much less is known about how to facilitate&#xD;
      and sustain transitions off the streets.&#xD;
&#xD;
      Current evidence indicates that while structural supports such as subsidized housing and&#xD;
      social service providers are important, these things alone are insufficient to help young&#xD;
      people integrate into mainstream society. Connecting these young people with an adult who&#xD;
      exhibits the relationship-based components of mentoring that young people value most (e.g.,&#xD;
      genuine interest in their well-being and belief in their ability to succeed, a non-judgmental&#xD;
      attitude and a willingness to listen, the provision of advice, guidance, affirmation and&#xD;
      encouragement) may be key to helping them move forward and integrate into the mainstream.&#xD;
&#xD;
      This intervention will provide 24 young people (ages 18-26) who have transitioned out of&#xD;
      homelessness and into market rent housing within the past year with rent subsidies for 24&#xD;
      months. Half of the young people will be randomized to receive regular mentorship from an&#xD;
      adult mentor, tasked with helping their mentee bridge the gap between homelessness and&#xD;
      mainstream living.&#xD;
&#xD;
      It is hypothesized that, for the primary outcome measures of community integration and&#xD;
      self-esteem:&#xD;
&#xD;
      1. Better mean scores (community integration and self-esteem) in the participants who receive&#xD;
      rent subsidies plus mentorship (intervention group) will be observed compared to the&#xD;
      participants who receive rent subsidies only (control group) by the primary endpoint of 18&#xD;
      months of study participation.&#xD;
&#xD;
      It is hypothesized that, for the secondary outcome measures of social connectedness, hope,&#xD;
      and academic and vocational participation:&#xD;
&#xD;
        1. Better mean scores (social connectedness and hope) in the intervention group relative to&#xD;
           participants in the control group will be observed by 18 months of study participation.&#xD;
&#xD;
        2. Participants in the intervention group will be more likely than the control group to&#xD;
           demonstrate sustained engagement in academic and vocational activities (education,&#xD;
           employment, and/or skills training) by 18 months of study participation.&#xD;
&#xD;
      This pilot will be the first to test the impact of economic and social supports on meaningful&#xD;
      social integration for formerly homeless young people living in market rent housing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching aim of this mixed methods study is to assess whether and how rent subsidies&#xD;
      and mentorship influence social integration outcomes for formerly homeless young people&#xD;
      living in market rent housing in three urban settings.&#xD;
&#xD;
      Specifically, the objectives of this study are to:&#xD;
&#xD;
        1. Determine whether rent subsidies plus mentorship results in better social integration&#xD;
           outcomes than only receiving rent subsidies with respect to: a) community integration&#xD;
           (psychological and physical); and b) self-esteem at the primary endpoint of 18 months.&#xD;
&#xD;
        2. Determine whether rent subsidies plus mentorship results in better social integration&#xD;
           outcomes than only receiving rent subsidies with respect to: a) social connectedness; b)&#xD;
           hope; and c) sustained academic and vocational participation at 18 months.&#xD;
&#xD;
        3. Explore whether rent subsidies plus mentorship results in better social integration&#xD;
           outcomes than only receiving rent subsidies with respect to: a) income; b) perceived&#xD;
           housing quality; c) psychiatric symptoms; and d) sense of engulfment at 18 months.&#xD;
&#xD;
        4. Integrate qualitative data to facilitate a fuller understanding of the quantitative data&#xD;
           and deepen understanding of what the study participants (young people and mentors) found&#xD;
           most beneficial about the intervention and how it could be improved.&#xD;
&#xD;
      This study will employ a convergent mixed methods design (i.e., quantitative and qualitative&#xD;
      data are collected concurrently, and the findings combined) embedded within a randomized&#xD;
      controlled trial (RCT) and a community-based participatory action research (CBPAR) framework.&#xD;
      A mixed methods RCT is appropriate given the complex explanatory pathways (i.e., social and&#xD;
      behavioral processes that may act independently and interdependently) of this intervention.&#xD;
      In addition, the qualitative data will provide insights on contextual factors that may impact&#xD;
      the external validity of the findings. Most importantly, this design provides a crucial (and&#xD;
      under utilized) youth-informed perspective on social integration.&#xD;
&#xD;
      The study will be conducted in three Canadian cities: Toronto, Ontario (pop. 2.8 million);&#xD;
      Hamilton, Ontario (pop. 552,000); and St. Catharines, Ontario (pop. 133,000). All of the&#xD;
      study participants (n = 24) will receive rent subsidies (ranging from $400 - $500/month) for&#xD;
      24 months as a part of the intervention. This study includes funding for the rent subsidies&#xD;
      and will be paid directly to the landlords by the community partners. St. Michael's Hospital&#xD;
      will establish a service provider agreement with each of the community partners for this&#xD;
      purpose. Participants in the intervention group (n = 12) will be matched with an adult mentor&#xD;
      recruited by one of the community partners.&#xD;
&#xD;
      The mentors will be encouraged to incorporate the key relationship-based components of&#xD;
      natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream&#xD;
      integration. To facilitate more of an organic, natural mentor-mentee relationship, the&#xD;
      mentors will have more flexibility than a typical formal mentorship program in the types of&#xD;
      activities they pursue with their mentees. For example, they will not be mandated to attend&#xD;
      shelter-based social events. Instead, mentors will be encouraged to initiate activities that&#xD;
      direct their mentees away from the shelter system (and their old identities as homeless&#xD;
      youth) and toward the mainstream (e.g., meeting for coffee at a local university campus,&#xD;
      touring a local library, or visiting the mentor's place of employment during business hours).&#xD;
      All of the mentors will meet monthly with their mentees for two years. In addition, the&#xD;
      mentor will be encouraged to touch base with their mentee via phone or text message every&#xD;
      week. If a mentor is unable to continue their role and there are at least six months left in&#xD;
      the study, the study participant will be matched with a new mentor.&#xD;
&#xD;
      Community partners will match all participants with an outreach worker (already employed by&#xD;
      each agency) who will communicate regularly with the research team, help ensure the rent&#xD;
      subsidies are being distributed appropriately, maintain an ongoing relationship with the&#xD;
      study participants, and monitor for 'red flags' in participants matched in mentor-mentee&#xD;
      relationships (e.g., mentee reluctant to meet with their mentor). Matching all of the study&#xD;
      participants with a worker will also help ensure that everyone is receiving a fairly equal&#xD;
      level of social support from community partners, making it easier for the research team to&#xD;
      discern whether the outcomes of interest are more likely attributable to mentorship rather&#xD;
      than to varied levels of agency-based support. Moreover, a review of services and&#xD;
      interventions designed to reduce &quot;problem behaviors&quot; (e.g., substance use and risky sexual&#xD;
      practices) among street-involved and homeless young people (ages 12 - 24) found that&#xD;
      researchers who had strong relationships with outreach workers and the community had more&#xD;
      effective interventions and lower attrition rates than those who did not.&#xD;
&#xD;
      Following the baseline interview, participants at each of the three study sites (Toronto&#xD;
      (n=12), Hamilton (n=6), and St. Catharine's (n=6)) will be randomized using block&#xD;
      randomization to either the intervention (rent subsidies plus mentoring) or control (rent&#xD;
      subsidies only) group. Randomization will be balanced by site based on random block sizes of&#xD;
      two and four. The advantage of using block randomization is to uniformly distribute&#xD;
      participants into treatment groups within each site. Because small block sizes may increase&#xD;
      the risk of guessing the allocation procedure and subsequently introducing bias into the&#xD;
      enrolment procedure, random block sizes will be used to avoid this potential selection bias.&#xD;
      A unique randomization schedule will be produced for each site using SAS. A research&#xD;
      coordinator not affiliated with the study will be the only person with access to the&#xD;
      randomization schedule. The research coordinator will prepare sealed, opaque and sequentially&#xD;
      numbered envelopes with the randomization results of participants. After assessing for&#xD;
      eligibility and obtaining consent of each participant, research personnel responsible for&#xD;
      enrolling participants will open the next randomization envelope from the sequentially&#xD;
      ordered randomization envelope file to obtain the participant's randomized group assignment.&#xD;
&#xD;
      Quantitative data will be collected at six points in time over the course of 30 months:&#xD;
      baseline, month six, month 12, month 18, month 24, and month 30. Qualitative measures are an&#xD;
      important feature of this study and will consist of: 1) semi-structured individual interviews&#xD;
      (study participants) and 2) focus groups (mentors). At baseline, twelve participants (six&#xD;
      from each arm of the study) will be invited to participate in six semi-structured individual&#xD;
      interviews, which will take place at the same time as the quantitative data collection:&#xD;
      baseline, month six, month 12, month 18, month 24, and month 30. Participants will be&#xD;
      purposively selected with a goal of having input from each of the three communities and a&#xD;
      fairly equal gender and ethno-racial representation. All of the mentors (n = 12) will be&#xD;
      invited to participate in two focus groups, which will take place at month 12 and month 24.&#xD;
&#xD;
      All analyses will be performed using the intention-to-treat principle; that is, all&#xD;
      participants will be included and analyzed in the groups they were originally randomized.&#xD;
      Baseline characteristics of the intervention and control groups will be summarized using&#xD;
      descriptive statistics (i.e., mean, standard deviation, median and interquartile range for&#xD;
      continuous variables, and frequencies and proportions for categorical variables). The&#xD;
      descriptive statistics for outcomes at each study time point will be calculated, and&#xD;
      differences in trajectories from baseline to 30 months follow-up between intervention and&#xD;
      control groups using scatterplots and box-plots will be explored. Differences with 95%&#xD;
      confidence intervals in continuous outcomes at 18 months (psychological community&#xD;
      integration, self-esteem, social connectedness, hope, perceived housing quality, psychiatric&#xD;
      symptoms, and sense of engulfment) between participants who received rent subsidies plus&#xD;
      mentorship and participants who only received rent subsidies will be estimated using Analysis&#xD;
      of Covariance (i.e., linear regression models), including an indicator of intervention group&#xD;
      and the baseline value of the outcome. Regression diagnostics will be performed and analyses&#xD;
      using the non-parametric Wilcoxon rank-sum test will be repeated if there are extreme&#xD;
      outliers or influential observations. Groups will be compared with respect to count outcomes&#xD;
      at 18 months (physical community integration) using graphical tools and the non-parametric&#xD;
      Wilcoxon rank-sum test. For binary outcomes at 18 months (sustained academic and vocational&#xD;
      participation, and income above low income cut-off ), differences in proportions with 95%&#xD;
      confidence intervals will be estimated and tested using the chi-square or Fisher's exact&#xD;
      test. Given the small sample size of this pilot randomized trial, all results will be&#xD;
      interpreted with caution and with the intention of generating data and hypotheses for&#xD;
      conducting a larger trial.&#xD;
&#xD;
      Given the emergent, iterative nature of research using a qualitative design, data analysis&#xD;
      and interpretation will begin immediately after the first qualitative data generation session&#xD;
      (at baseline). The semi-structured individual interviews and focus groups will be audio&#xD;
      recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data,&#xD;
      the transcriptionist will be instructed to note short responses, uncooperative tones, and&#xD;
      literal silence. Prior to each subsequent qualitative data generation session, members of the&#xD;
      research team will conduct a preliminary data analysis, reading the interview transcripts&#xD;
      multiple times, separating the data into coded segments, making analytic memos beside&#xD;
      sections of the transcripts, identifying emerging themes (and comparing/contrasting these&#xD;
      between respondents), and compiling new questions. Those participating in the individual&#xD;
      interviews and the focus groups will be asked for their perspectives on the emerging&#xD;
      interpretations at each visit and these perspectives will play a key role in helping shape&#xD;
      the data analysis and help ensure the trustworthiness of the data. The web-based application&#xD;
      Dedoose will be utilized to assist with sorting and coding the qualitative data.&#xD;
&#xD;
      In keeping with CBPAR methodology, disseminating evidence with community partners is key in&#xD;
      building community capacity and improving the lives of the young people participating in this&#xD;
      study. Moreover, given the use of Critical Social Theory, the study findings will not only be&#xD;
      presented, but will also be used to expose and explicate the relational processes (e.g.,&#xD;
      subjective experience of low socioeconomic position and low social class) that may be&#xD;
      preventing formerly homeless young people from achieving meaningful social integration. With&#xD;
      an emphasis on 'actionable' data, the findings will be disseminated broadly to both academic&#xD;
      and community-based audiences in a variety of formats ranging from scientific journal papers&#xD;
      to oral presentations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2019</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change from Baseline in Community integration (psychological and physical) Scores as Measured by the Community Integration Scale (CIS) at 18 Months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>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, an 11-item scale. The CIS includes a psychological subscale (scores possible range from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total scoring range is 0-7, 0 being low physical community integration, and 7 being high integration). This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.&#xD;
This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change from Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS) at 18 Months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>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 &lt;15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change from Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS) at 18 Months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change from Baseline in Hope as Measured by the Beck Hopelessness Scale at 18 Months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire at 18 Months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Vocational Participation/Employment as Assessed by a Questionnaire at 18 months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status every 6 months in the questionnaire, including whether they are employed, the type of employment, and the intensity of the employment (hours per month). This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean Change from Baseline in Engulfment Scores as Measured by the Modified Engulfment Scale (ES) at 18 months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>This is an exploratory outcome. This outcome is a measure of the degree to which an individual's self-concept is defined by their experience of homelessness. It will be assessed using the Modified Engulfment Scale, a 30-item scale, internal consistency α = .91. The total scoring range is 30-150, 30 being low engulfment, 150 being high engulfment.&#xD;
The scale was adapted for use in this study, substituting &quot;experience of homelessness&quot; for &quot;illness&quot;.&#xD;
This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Change from Baseline in Psychiatric Symptoms as Measured by the Modified Colorado Symptom Index (CSI) at 18 months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>This is an exploratory outcome; it is the measurement of the presence and frequency of psychiatric symptoms experienced in the past month. Measured using the Modified Colorado Symptom Index, a 14-item questionnaire, internal consistency α = .90 - .92. The total scoring range is 0-56, 0 being a low frequency of psychiatric symptoms, and 56 being a high frequency of psychiatric symptoms. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Income as Assessed by a Questionnaire at 18 months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>This is an exploratory outcome. Participants will be prompted to answer questions about their current income every 6 months in a questionnaire. This outcome is assessed using a repeated measures analysis and changes in income will be assessed for change over time at the aggregate level. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Change from Baseline in Perceived Housing Quality as Measured by the Perceived Housing Quality Scale (PHQS) at 18 months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>This is an exploratory outcome and is assessed by participant perception of housing choice and quality. Measured using the Perceived Housing Quality Scale.This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported. It has been shortened it from 10 items (Chez Soi/At Home) to seven relevant items. The total scoring range is 7-35, 7 being very dissatisfied with current housing quality, and 35 being very satisfied with housing quality. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Interviews with Participants and Focus Groups with Case Workers at 18 months</measure>
    <time_frame>Assessed every 6 months for 30 months, after introduction of the mentor to the participant</time_frame>
    <description>This is an exploratory outcome. Through interviews and focus groups, youth will be able to indicate what aspects of the program they found most effective. Understanding of the strengths and weaknesses of the intervention is expected to increase over time.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Homeless Persons</condition>
  <arm_group>
    <arm_group_label>Rent subsidies + Mentorship</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm (n = 12) 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rent subsidies only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in this arm (n = 12) 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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mentorship</intervention_name>
    <description>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.</description>
    <arm_group_label>Rent subsidies + Mentorship</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Rent Subsidies</intervention_name>
    <description>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.</description>
    <arm_group_label>Rent subsidies + Mentorship</arm_group_label>
    <arm_group_label>Rent subsidies only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be between ages 18-26&#xD;
&#xD;
          -  Left homelessness within the past year&#xD;
&#xD;
          -  Living in market rent housing&#xD;
&#xD;
          -  Plan on staying in or nearby the community in which they were recruited (Toronto,&#xD;
             Hamilton, or St. Catharines) for the duration of the 24-month study&#xD;
&#xD;
          -  Be willing to be matched with an adult mentor who has been screened and chosen by one&#xD;
             of the community partners&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  In imminent danger of losing their housing (e.g., facing jail time or impending&#xD;
             eviction)&#xD;
&#xD;
          -  Enrolled in another study with enhanced financial and social supports&#xD;
&#xD;
          -  Unable to provide free and informed consent&#xD;
&#xD;
          -  Unable to communicate fluently in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi S Thulien, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20494240</PMID>
  </reference>
  <reference>
    <citation>Beck 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.</citation>
    <PMID>4436473</PMID>
  </reference>
  <reference>
    <citation>Brueckner, M., Green, M., &amp; 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.</citation>
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  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>September 1, 2022</last_update_submitted>
  <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Social Isolation</keyword>
  <keyword>Self-Esteem</keyword>
  <keyword>Hope</keyword>
  <keyword>Psychiatric Problem</keyword>
  <keyword>Education</keyword>
  <keyword>Employment</keyword>
  <keyword>Income</keyword>
  <keyword>Housing Problems</keyword>
  <keyword>Identity, Social</keyword>
  <keyword>Youth</keyword>
  <keyword>Rent Subsidy</keyword>
  <keyword>Mentorship</keyword>
  <pending_results>
    <submitted>March 22, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779204
org study id: 18-251
nct id: NCT03779204
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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:

      1. 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:

        1. 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.

        2. 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.
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:

        1. 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.

        2. 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.

        3. 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.

        4. 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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change from Baseline in Community integration (psychological and physical) Scores as Measured by the Community Integration Scale (CIS) at 18 Months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: 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, an 11-item scale. The CIS includes a psychological subscale (scores possible range from 4-20, 4 being low psychological community integration and 20 being high integration), and a physical subscale (total scoring range is 0-7, 0 being low physical community integration, and 7 being high integration). This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.
This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Mean Change from Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS) at 18 Months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: 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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Mean Change from Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS) at 18 Months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: 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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Mean Change from Baseline in Hope as Measured by the Beck Hopelessness Scale at 18 Months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: 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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire at 18 Months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: 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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Change in Vocational Participation/Employment as Assessed by a Questionnaire at 18 months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status every 6 months in the questionnaire, including whether they are employed, the type of employment, and the intensity of the employment (hours per month). This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Mean Change from Baseline in Engulfment Scores as Measured by the Modified Engulfment Scale (ES) at 18 months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: This is an exploratory outcome. This outcome is a measure of the degree to which an individual's self-concept is defined by their experience of homelessness. It will be assessed using the Modified Engulfment Scale, a 30-item scale, internal consistency α = .91. The total scoring range is 30-150, 30 being low engulfment, 150 being high engulfment.
The scale was adapted for use in this study, substituting "experience of homelessness" for "illness".
This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Mean Change from Baseline in Psychiatric Symptoms as Measured by the Modified Colorado Symptom Index (CSI) at 18 months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: This is an exploratory outcome; it is the measurement of the presence and frequency of psychiatric symptoms experienced in the past month. Measured using the Modified Colorado Symptom Index, a 14-item questionnaire, internal consistency α = .90 - .92. The total scoring range is 0-56, 0 being a low frequency of psychiatric symptoms, and 56 being a high frequency of psychiatric symptoms. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Change in Income as Assessed by a Questionnaire at 18 months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: This is an exploratory outcome. Participants will be prompted to answer questions about their current income every 6 months in a questionnaire. This outcome is assessed using a repeated measures analysis and changes in income will be assessed for change over time at the aggregate level. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Mean Change from Baseline in Perceived Housing Quality as Measured by the Perceived Housing Quality Scale (PHQS) at 18 months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: This is an exploratory outcome and is assessed by participant perception of housing choice and quality. Measured using the Perceived Housing Quality Scale.This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported. It has been shortened it from 10 items (Chez Soi/At Home) to seven relevant items. The total scoring range is 7-35, 7 being very dissatisfied with current housing quality, and 35 being very satisfied with housing quality. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months.
measure: Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Interviews with Participants and Focus Groups with Case Workers at 18 months
time frame: Assessed every 6 months for 30 months, after introduction of the mentor to the participant
description: This is an exploratory outcome. Through interviews and focus groups, youth will be able to indicate what aspects of the program they found most effective. Understanding of the strengths and weaknesses of the intervention is expected to increase over time.
arm group label: Rent subsidies + Mentorship
arm group type: Experimental
description: Participants in this arm (n = 12) 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.
arm group label: Rent subsidies only
arm group type: Active Comparator
description: Participants in this arm (n = 12) 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.
intervention type: Behavioral
intervention name: Mentorship
description: 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.
arm group label: Rent subsidies + Mentorship
intervention type: Behavioral
intervention name: Rent Subsidies
description: 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.
arm group label: Rent subsidies + Mentorship
arm group label: Rent subsidies only
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi S Thulien, RN, PhD
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
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responsible party type: Sponsor
submitted: March 22, 2023