Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-29 @ 5:38 AM
Study NCT ID:
NCT05781503
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2023-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transitioning Youth Out of Homelessness 2.0 (TYOH 2.0)
Sponsor:
Unity Health Toronto
Organization:
Study Overview
Official Title:
Transitioning Youth Out of Homelessness 2.0: a Pilot Randomized Controlled Trial of a Rent Subsidy and Identity Capital Intervention for Youth Exiting Homelessness
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction: This 12-month pilot randomized controlled trial (RCT) built on previous community-engaged work and explored whether portable rent subsidies and an intervention targeting identity capital (purpose, control, self-efficacy, and self-esteem) hold promise as a way to facilitate socioeconomic inclusion for youth (age 16 - 24 years) exiting homelessness and living in market rent housing in Ontario, Canada. All (n = 40) participants received rent subsidies; half were randomly assigned an identity capital intervention (co-designed leadership guide + coach).
Methods and analysis: This study employed a convergent mixed methods, two-arm parallel RCT, open-label design with 1:1 allocation embedded within a Community Based Participatory Action Research framework and underpinned by Critical Social Theory.
Specifically, the objectives and measures were:
1. Primary - to examine whether targeted economic and identity-based supports are a feasible and acceptable way to foster socioeconomic inclusion. Measures: recruitment/enrolment/dropout metrics; self-report composite checklists regarding intervention engagement; coaching session attendance; qualitative focus groups.
2. Secondary - to assess differences between targeted economic and identity-based supports (intervention group) and economic supports only (control group) at the 12-month primary endpoint with respect to self-reported socioeconomic inclusion measures of: 1) education, employment and training (EET); 2) housing security; and 3) identity capital. Measures: self-report composite EET checklist; self-report measures of housing security and identity capital.
3. Exploratory - to explore whether the estimated effect of the intervention differed by baseline variables or level of engagement with the intervention. Measures: select variables from the baseline demographic questionnaire; GAIN-Short Screener questionnaire for those in the intervention group.
Ethics and dissemination: This study received ethical approval from the Unity Health Toronto Research Ethics Board. The investigators will continue working alongside community partners - including youth with lived expertise - to disseminate findings broadly and in diverse formats.
Methods and analysis: This study employed a convergent mixed methods, two-arm parallel RCT, open-label design with 1:1 allocation embedded within a Community Based Participatory Action Research framework and underpinned by Critical Social Theory.
Specifically, the objectives and measures were:
1. Primary - to examine whether targeted economic and identity-based supports are a feasible and acceptable way to foster socioeconomic inclusion. Measures: recruitment/enrolment/dropout metrics; self-report composite checklists regarding intervention engagement; coaching session attendance; qualitative focus groups.
2. Secondary - to assess differences between targeted economic and identity-based supports (intervention group) and economic supports only (control group) at the 12-month primary endpoint with respect to self-reported socioeconomic inclusion measures of: 1) education, employment and training (EET); 2) housing security; and 3) identity capital. Measures: self-report composite EET checklist; self-report measures of housing security and identity capital.
3. Exploratory - to explore whether the estimated effect of the intervention differed by baseline variables or level of engagement with the intervention. Measures: select variables from the baseline demographic questionnaire; GAIN-Short Screener questionnaire for those in the intervention group.
Ethics and dissemination: This study received ethical approval from the Unity Health Toronto Research Ethics Board. The investigators will continue working alongside community partners - including youth with lived expertise - to disseminate findings broadly and in diverse formats.
Detailed Description:
The overarching aim of this mixed methods study was to determine the feasibility and acceptability of a strengths-based intervention focused on building identity capital, as a way to facilitate socioeconomic inclusion for youth (age 16 - 24 years) exiting homelessness and living in market rent housing.
Specifically, the objectives were to:
1. Primary - examine the feasibility and acceptability of a RCT of targeted economic and identity-based supports to foster socioeconomic inclusion.
2. Secondary - estimate the effect of adding identity-based supports to economic supports (intervention group) compared with economic supports alone (control group) at the 12-month endpoint with respect to self-reported proxy indicators of socioeconomic inclusion.
3. Exploratory - among the intervention group, explore whether the estimated effect of the intervention differs by baseline variables or level of engagement with the intervention.
This pilot study employed a convergent mixed methods (quantitative and qualitative data collected concurrently and the findings combined), two-arm parallel RCT (participants randomly assigned to either the intervention or control group), open-label (participants and research team aware of random assignment) design with 1:1 allocation (equal number of participants in each study arm) embedded within a CBPAR framework.
The study was conducted collaboratively with four community partners who serve youth who are experiencing or have experienced homelessness: 1) Covenant House Toronto (Toronto, ON); 2) Living Rock (Hamilton, ON); 3) The RAFT (St. Catharines, ON); and 4) StepStones for Youth (Toronto, ON). Study participants were recruited from the cities in which our community partners are located: Toronto, ON (Greater Toronto Area population 6.7 million); Hamilton, ON (population 785,000); and St. Catharines, ON (St. Catharines-Niagara population 416,000).
Youth in both arms (n = 40) were provided monthly rent subsidies ($700.00 CAD/month Hamilton and St. Catharines; $800.00 CAD/month Toronto) for 12 months, which was paid directly to landlords and facilitated by our community partners. Youth randomized to the intervention group (n = 20) were also provided a co-designed leadership guide and assigned a study coach. The control group (n = 20) was offered the co-designed leadership guide at the end of the study.
The strengths-based leadership guide - Finding Home: A Guide for Youth in Transition - was co-designed with 12 youth who had experienced homelessness, including youth who participated in TYOH 1.0. The Leadership Guide contained 12 chapters with the overarching aim of enhancing identity capital along with providing strategies to achieve participant-identified goals. Each chapter contained four activities (e.g., self-reflection exercise or listening to a podcast). While the guide was designed for individual study, it was also meant to serve as a reference point for individual and group discussions with the study coaches.
The role of the coach was to speak with youth about how to draw on internal resources to help orient them toward their preferred future. This role was different from case management or mentorship in that a specific coaching methodology (Brief Solution-Focused Coaching) was utilized to walk alongside youth as they developed strategies to reach self-defined goals. Each coach was instructed to devote 2.5 days/week to the intervention and was given a caseload of 9-11 youth. The coaches were instructed to meet individually with each youth on their caseload every two weeks and collectively with the rest of the youth in their group every month.
Questionnaires were completed at baseline. four-, eight-, and 12-months post-randomization. Quantitative analysis was performed using the intention-to-treat principle; that is, all participants were included and analyzed in the groups they were originally randomized. Baseline characteristics of the intervention and control groups were summarized using descriptive statistics (i.e., mean, standard deviation, median and interquartile range for continuous variables, and frequencies and proportions for categorical variables).
Primary outcomes were analyzed by estimating the recruitment rate as the proportion of contacted individuals who expressed interest in participating in the study. The enrollment rate was calculated as the proportion of recruited individuals who were eligible and consented to participate in the study. Dropout rates were separately calculated for intervention and control groups at the end of the study as the 1 - proportion of randomized participants who completed the study at 12 months. Exact (Clopper-Pearson) 95% confidence limits were also calculated.
Secondary outcomes were analyzed by calculating descriptive statistics at each study time point and exploring differences in trajectories from baseline to 12 months follow-up between intervention and control groups using scatterplots and box-plots. Adjusted mean group differences with 95% confidence intervals in continuous outcomes at 12 months (housing security and identity capital) between participants who received the intervention and control participants were estimated using analysis of covariance (i.e., linear regression models), including an indicator of intervention group and the baseline value of the outcome, adjusting for site. We performed regression diagnostics and repeated analyses using the non-parametric Wilcoxon rank-sum test if there were extreme outliers or influential observations.
Exploratory sub-group analysis was conducted considering only the intervention group and stratifying the primary outcomes by selected baseline demographics (for example, gender) or severity levels of components of the Global Appraisal of Individual Needs Short Screener (GAIN-SS) V.3.0.2. We also calculated the correlation between secondary outcomes and the level of engagement with the intervention measured as the percentage of class sessions attended out of a maximum of 24 over the 12-month period. Spearman correlation and Spearman partial correlation coefficients were calculated.
Focus groups with those in the intervention group was conducted at four-, eight-, and 12-months post-randomization. Focus group questions primarily centred around intervention acceptability but also explored the impact of the intervention on identity capital and socioeconomic inclusion (e.g., connection to broader social networks). Analysis began during and after the first data generation session, meaning the questions asked evolved over time based on our preliminary interpretations of the data.
Working alongside community partners to disseminate findings with the aim of highlighting sociostructural inequities, building community capacity, and improving the lives of the youth we serve is fundamental to this work. We anticipate disseminating our findings broadly to community-based and academic audiences in a variety of formats ranging from oral presentations to scientific journal papers.
Specifically, the objectives were to:
1. Primary - examine the feasibility and acceptability of a RCT of targeted economic and identity-based supports to foster socioeconomic inclusion.
2. Secondary - estimate the effect of adding identity-based supports to economic supports (intervention group) compared with economic supports alone (control group) at the 12-month endpoint with respect to self-reported proxy indicators of socioeconomic inclusion.
3. Exploratory - among the intervention group, explore whether the estimated effect of the intervention differs by baseline variables or level of engagement with the intervention.
This pilot study employed a convergent mixed methods (quantitative and qualitative data collected concurrently and the findings combined), two-arm parallel RCT (participants randomly assigned to either the intervention or control group), open-label (participants and research team aware of random assignment) design with 1:1 allocation (equal number of participants in each study arm) embedded within a CBPAR framework.
The study was conducted collaboratively with four community partners who serve youth who are experiencing or have experienced homelessness: 1) Covenant House Toronto (Toronto, ON); 2) Living Rock (Hamilton, ON); 3) The RAFT (St. Catharines, ON); and 4) StepStones for Youth (Toronto, ON). Study participants were recruited from the cities in which our community partners are located: Toronto, ON (Greater Toronto Area population 6.7 million); Hamilton, ON (population 785,000); and St. Catharines, ON (St. Catharines-Niagara population 416,000).
Youth in both arms (n = 40) were provided monthly rent subsidies ($700.00 CAD/month Hamilton and St. Catharines; $800.00 CAD/month Toronto) for 12 months, which was paid directly to landlords and facilitated by our community partners. Youth randomized to the intervention group (n = 20) were also provided a co-designed leadership guide and assigned a study coach. The control group (n = 20) was offered the co-designed leadership guide at the end of the study.
The strengths-based leadership guide - Finding Home: A Guide for Youth in Transition - was co-designed with 12 youth who had experienced homelessness, including youth who participated in TYOH 1.0. The Leadership Guide contained 12 chapters with the overarching aim of enhancing identity capital along with providing strategies to achieve participant-identified goals. Each chapter contained four activities (e.g., self-reflection exercise or listening to a podcast). While the guide was designed for individual study, it was also meant to serve as a reference point for individual and group discussions with the study coaches.
The role of the coach was to speak with youth about how to draw on internal resources to help orient them toward their preferred future. This role was different from case management or mentorship in that a specific coaching methodology (Brief Solution-Focused Coaching) was utilized to walk alongside youth as they developed strategies to reach self-defined goals. Each coach was instructed to devote 2.5 days/week to the intervention and was given a caseload of 9-11 youth. The coaches were instructed to meet individually with each youth on their caseload every two weeks and collectively with the rest of the youth in their group every month.
Questionnaires were completed at baseline. four-, eight-, and 12-months post-randomization. Quantitative analysis was performed using the intention-to-treat principle; that is, all participants were included and analyzed in the groups they were originally randomized. Baseline characteristics of the intervention and control groups were summarized using descriptive statistics (i.e., mean, standard deviation, median and interquartile range for continuous variables, and frequencies and proportions for categorical variables).
Primary outcomes were analyzed by estimating the recruitment rate as the proportion of contacted individuals who expressed interest in participating in the study. The enrollment rate was calculated as the proportion of recruited individuals who were eligible and consented to participate in the study. Dropout rates were separately calculated for intervention and control groups at the end of the study as the 1 - proportion of randomized participants who completed the study at 12 months. Exact (Clopper-Pearson) 95% confidence limits were also calculated.
Secondary outcomes were analyzed by calculating descriptive statistics at each study time point and exploring differences in trajectories from baseline to 12 months follow-up between intervention and control groups using scatterplots and box-plots. Adjusted mean group differences with 95% confidence intervals in continuous outcomes at 12 months (housing security and identity capital) between participants who received the intervention and control participants were estimated using analysis of covariance (i.e., linear regression models), including an indicator of intervention group and the baseline value of the outcome, adjusting for site. We performed regression diagnostics and repeated analyses using the non-parametric Wilcoxon rank-sum test if there were extreme outliers or influential observations.
Exploratory sub-group analysis was conducted considering only the intervention group and stratifying the primary outcomes by selected baseline demographics (for example, gender) or severity levels of components of the Global Appraisal of Individual Needs Short Screener (GAIN-SS) V.3.0.2. We also calculated the correlation between secondary outcomes and the level of engagement with the intervention measured as the percentage of class sessions attended out of a maximum of 24 over the 12-month period. Spearman correlation and Spearman partial correlation coefficients were calculated.
Focus groups with those in the intervention group was conducted at four-, eight-, and 12-months post-randomization. Focus group questions primarily centred around intervention acceptability but also explored the impact of the intervention on identity capital and socioeconomic inclusion (e.g., connection to broader social networks). Analysis began during and after the first data generation session, meaning the questions asked evolved over time based on our preliminary interpretations of the data.
Working alongside community partners to disseminate findings with the aim of highlighting sociostructural inequities, building community capacity, and improving the lives of the youth we serve is fundamental to this work. We anticipate disseminating our findings broadly to community-based and academic audiences in a variety of formats ranging from oral presentations to scientific journal papers.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: