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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05781503
Other study ID # 22-230
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date February 28, 2024

Study information

Verified date July 2023
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: This 12-month pilot randomized controlled trial (RCT) builds on previous community-engaged work and explores 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 will receive rent subsidies; half will be randomly assigned an identity capital intervention (co-designed leadership guide + coach). Methods and analysis: This study will employ 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 are: 1. Primary - 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; qualitative focus groups. 2. Secondary - 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 - explore whether variables at baseline (e.g., participant demographics such as gender or global assessment of individual needs [GAIN]) suggest the intervention may be more feasible and acceptable for certain groups of young people. Measures: select variables from the baseline demographic; GAIN-Short Screener questionnaires 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date February 28, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility Eligible young people ages 16 - 24 years who have left homelessness within the past 12 months and are currently living or planning to live in market rent housing will be identified by the community partners. This age mandate was chosen because this is the age group served by the community partners. The investigators have chosen to target the first year of exiting homelessness because their collective experience has shown that this is a particularly precarious time for youth in terms of mental health challenges and risk of returning to homelessness. Inclusion Criteria: - Be able to provide free and informed consent. - Be able to understand English (intervention and data collection will be conducted in English). - Have experienced homelessness (e.g., all non-parental and unstable housing arrangements including shelter stays, couch surfing, and time-limited housing) in the past 12 months. - Be willing to actively participate in the intervention (co-designed leadership program + coach) if randomized to this arm. Exclusion Criteria: - In imminent danger of losing their housing and not able to utilize the rent subsidy to sustain market rent housing. - Currently receiving rent subsidies. - Enrolled in a program or study with similar features to the TYOH 2.0 intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Identity Capital Intervention (Coach + Co-designed Leadership Guide)
Young people randomized to the intervention group will engage in a co-designed leadership guide with their assigned coach. The co-designed leadership guide contains 12 chapters with the overarching aim of enhancing identity capital along with providing strategies to achieve participant-identified goals. Each chapter contains four activities (e.g., self-reflection exercise or listening to a podcast). Ideally, youth will complete one chapter every month. Each young person in this group will meet individually with their coach every two weeks and with a larger group of 10 youth participants and their coach every month.
Other:
Monthly Rent Subsidies
All study participants will receive a monthly rent subsidy ($800 for those living in Toronto; $700 for those living in St. Catharine's or Hamilton due to differences in cost of living) for 12 months.

Locations

Country Name City State
Canada Unity Health Toronto Toronto Ontario

Sponsors (5)

Lead Sponsor Collaborator
Unity Health Toronto Covenant House Toronto, Living Rock Youth Resources, StepStones for Youth, The Resource Association for Teens (RAFT)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Subgroup feasibility and acceptability as measured by the Baseline Demographic Questionnaire. This 17-item self-report measure was developed for this study and explores domains related to: age; gender; race/ethnicity; sexual orientation; immigration status; child welfare involvement; homelessness entrenchment; education; social support; financial support; physical health support; mental health support; food security. Assessed at baseline.
Other Subgroup feasibility and acceptability as measured by the GAIN Short Screener (GAIN-SS). This 23-item validated self-report measure explores: internalizing disorders (e.g., anxiety/depression); externalizing disorders (e.g., impulsivity/disruptive conduct; substance disorders (e.g., illicit drug/alcohol abuse); and crime and violence (e.g., illegal activities/fighting). Score range: 0-23; higher scores (symptoms) indicate higher probability of a mental health diagnosis and likely benefit of further assessment/intervention (internal consistency a = .96). Assessed at baseline.
Primary Change in intervention feasibility and acceptability as assessed by recruitment/enrolment/dropout metrics from baseline to 12-months. To examine intervention feasibility and acceptability, quantitative measures consisting of recruitment/enrolment/dropout metrics will be utilized. Recruitment rate will be estimated as the proportion of contacted individuals who express interest in participating in the study. The enrollment rate will be calculated as the proportion of recruited individuals who are eligible and consent to participate in the study. Dropout rates will be 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 will also be calculated. Assessed at baseline and 12-months.
Primary Change in intervention feasibility and acceptability as assessed by the Intervention Engagement Questionnaire from 4-months to 12-months. This five-item self-report measure was developed for this study and explores engagement with the co-designed leadership guide and coaching (administered only to intervention participants). Higher scores indicate greater engagement. Assessed at 4-months, 8-months, and 12-months.
Primary Intervention feasibility and acceptability as informed by focus groups from 4-months to 12-months. Focus group questions will explore intervention feasibility and acceptability. Assessed at 4-months, 8-months, and 12-months.
Secondary Change in employment, education, and training as assessed by a questionnaire from baseline to 12-months. This five-item self-report measure was developed for this study and explores engagement in education (secondary or post-secondary), employment (full- or part-time; formal and informal), and training (paid or unpaid apprenticeship). Assessed at baseline and 12-months.
Secondary Mean change from baseline in housing security as measured by the Housing Security Scale at 12-months. This 20-item self-report measure explores domains related to: housing need; subjective stability; safety net; threats to stability. Score range: 20-120; higher scores indicate more housing security (internal consistency for subjective stability sub-scale a = 0.71; other sub-scales have not been validated). Assessed at baseline, 4-months, 8-months, and 12-months.
Secondary Mean change from baseline in identity capital as measured by the Multi-Measure Agentic Personal Scale (MAPS20) at 12-months. This 20-item validated self-report measure explores domains related to identity capital: self-esteem; purpose in life; internal locus of control; self-efficacy/ego strength. Score range: 20-120; score of less than 71 indicates risk/vulnerability of being overwhelmed by any adverse circumstances (internal consistency of four sub-scales a = .61-.75). Assessed at baseline, 4-months, 8-months, and 12-months.
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