Homeless Persons Clinical Trial
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
NCT number | NCT03779204 |
Other study ID # | 18-251 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 28, 2019 |
Est. completion date | March 31, 2022 |
Verified date | September 2022 |
Source | Unity Health Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 26 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | St. Michael's Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Unity Health Toronto | Covenant House Toronto, The Living Rock Ministries, The Resource Association for Teens (RAFT) |
Canada,
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* Note: There are 63 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mean Change from Baseline in Engulfment Scores as Measured by the Modified Engulfment Scale (ES) at 18 months | 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 a = .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. |
Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Other | Mean Change from Baseline in Psychiatric Symptoms as Measured by the Modified Colorado Symptom Index (CSI) at 18 months | 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 a = .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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Other | Change in Income as Assessed by a Questionnaire at 18 months | 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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Other | Mean Change from Baseline in Perceived Housing Quality as Measured by the Perceived Housing Quality Scale (PHQS) at 18 months | 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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Other | Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Interviews with Participants and Focus Groups with Case Workers at 18 months | 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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Primary | Mean Change from Baseline in Community integration (psychological and physical) Scores as Measured by the Community Integration Scale (CIS) 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, 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. |
Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Primary | Mean Change from Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS) 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 a = .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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Secondary | Mean Change from Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS) 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 a = .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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Secondary | Mean Change from Baseline in Hope as Measured by the Beck Hopelessness Scale 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 a = .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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Secondary | Change in Academic Participation/Educational Attainment 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. This outcome is assessed for change at 18 months, and the overall trajectory described over 30 months. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant | |
Secondary | Change in Vocational Participation/Employment as Assessed by a Questionnaire at 18 months | 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. | Assessed every 6 months for 30 months, after introduction of the mentor to the participant |
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