- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07419282
Supporting Social & Economic Equity, Disrupting Cycles of Homelessness, And Nurturing Growth & Empowerment (SEED CHANGE)
Supporting Social & Economic Equity, Disrupting Cycles of Homelessness, And Nurturing Growth & Empowerment (SEED CHANGE): A Mixed Methods Quasi-experimental Trial of Economic, Social, and Identity Capital Supports for Youth Transitioning Out of Homelessness in Ontario, Canada
The goal of the SEED CHANGE pilot study is to co-design and test a wraparound intervention for young people transitioning away from homelessness. This study will provide information about the types of supports these young people need to live meaningful and thriving lives, and the best ways to deliver these supports. The main questions it aims to answer are:
- Is the wraparound intervention feasible? (i.e., Will young people engage in the study and supports?)
- Is the wraparound intervention acceptable? (i.e., Do young people find the supports satisfactory and/or beneficial?)
Participants will engage in an 18-month wraparound intervention including the following supports:
- Job Placement
- Housing Stabilization Funds
- Grocery Supplements
- Community Connections Worker
- Coaching
- Tools for Intentional Living Program
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Naomi S Thulien, NP-PHC, PhD
- Phone Number: 416-360-4000
- Email: naomi.thulien@unityhealth.to
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- Recruiting
- Unity Health Toronto
-
Contact:
- Naomi S Thulien, NP-PHC, PhD
- Phone Number: 416-360-4000
- Email: naomi.thulien@unityhealth.to
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 - 24 years
- Experienced homelessness (defined as unstable/time-limited housing arrangements like shelter stays, foster care, or couch surfing) for at least four consecutive weeks in the past year
- Living in market rent housing (defined as non-subsidized housing, inclusive of both formal and informal rental agreements) in the Greater Toronto Area or Niagara Region for at least one month preceding study start
- Willing to actively participate in all components of the intervention
- Able to legally work in Canada (includes having a valid Social Insurance Number)
- Able to provide free and informed consent
- Able to understand English well enough to give consent and participate in the intervention and data collection
Exclusion Criteria:
- In imminent danger of losing their housing (e.g., facing eviction)
- Planning to move out of the Greater Toronto Area or Niagara Region in the next 18 months
- Employed full-time or enrolled in an education or training program that requires a long-term (>4 weeks) full-time work placement (coinciding with the duration of the study intervention)
- Receiving rent subsidies (does not include shelter allowance through social welfare programs such as Ontario Works or the Ontario Disability Support Program)
- Enrolled in a program or study with features similar to the SEED CHANGE intervention (e.g., 1:1 coaching, supported employment, group program targeting identity/social capital)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Wraparound Intervention
Young people transitioning away from homelessness will engage in an 18-month wraparound intervention including the following supports:
|
An 18-month wraparound intervention including the following supports:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility and Acceptability: Recruitment, Enrolment, and Dropout Metrics
Time Frame: Recruitment and enrolment metrics are assessed at T0 (Baseline; pre-intervention). Dropout metrics are assessed at T4 (Month 18; end of intervention).
|
Recruitment, enrolment, and dropout metrics were documented by the research team. The recruitment total is the total number of individuals who express interest in participating in the study. The enrolment total is the total number of recruited individuals who are eligible and consent to participate in the study. The dropout total is the total number of enrolled participants who drop out during the study. Participants are considered to have dropped out of the study if they explicitly request to withdraw from the study, or cease participating in all intervention and research activities (i.e., no contact). |
Recruitment and enrolment metrics are assessed at T0 (Baseline; pre-intervention). Dropout metrics are assessed at T4 (Month 18; end of intervention).
|
|
Feasibility and Acceptability: Employment Placement Engagement
Time Frame: Assessed at T4 (Month 18; end of intervention).
|
Employment placement engagement is defined as the length of time participants remain in their job placement (self-reported).
|
Assessed at T4 (Month 18; end of intervention).
|
|
Feasibility and Acceptability: Coaching Engagement
Time Frame: Assessed at T4 (Month 18; end of intervention).
|
Coaching Engagement is defined as the proportion of total possible coaching sessions (max.
36) that a participant attends (reported by coaches).
|
Assessed at T4 (Month 18; end of intervention).
|
|
Feasibility and Acceptability: Group Program Engagement
Time Frame: Assessed at T4 (Month 18; end of intervention).
|
Group Program Engagement is defined as the proportion of total possible Tools for Intentional Living program sessions that a participant attends (reported by program facilitators).
|
Assessed at T4 (Month 18; end of intervention).
|
|
Feasibility and Acceptability: Community Connections Worker Engagement
Time Frame: Assessed at T4 (Month 18; end of intervention).
|
Community Connections Worker Engagement is defined as the total number of sessions a participant attends with their Community Connections Worker (reported by workers).
|
Assessed at T4 (Month 18; end of intervention).
|
|
Economic Capital: Food Insecurity
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Food insecurity is self-reported; participants are asked three yes/no questions about their food insecurity in the past six months. A participant is deemed food insecure if they answer affirmative to one or more of the questions. The questions are: Did you ever worry that your food would run out before you had money to buy more? Did you ever cut the size of your meals or skip meals because you did not have enough money for food? Were you ever hungry but did not eat because you could not afford enough food? |
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Economic Capital: Employment
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Employment is assessed by self-report; participants are asked whether they are currently working (in their study job placement or elsewhere).
Employment rate will be reported as the number of participants who are currently employed.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
|
Economic Capital: Education
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Education and training is assessed by self-report; participants are asked whether they are currently attending secondary or post-secondary classes or participating in a training/trades program.
Education rate will be reported as the number of participants who are currently in an education or training program.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
|
Economic Capital: Housing Security
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Housing security is assessed using the Housing Security Scale V.3. This 19-item self-report measure explores domains related to: housing need; subjective stability; safety net; threats to stability. Housing need is a 2-item composite dichotomous indicator (Yes=presence of housing need [i.e., poor housing security]). Subjective Stability is a 5-item subscale (range 5-30); higher scores indicate greater housing security. Safety Net is a 3-item subscale (range 3-18); higher scores indicate greater housing security. Threats to Stability is a 7-item subscale (range 3-18); higher scores indicate poorer housing security. Two additional items assessing Housing History are reported separately and are not part of any subscale. |
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
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Economic Capital: Income
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Income is self-reported; participants are asked their average monthly income (including income from their job placement, additional jobs, and social assistance).
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
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Social Capital: Social Connectedness
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Social connectedness is assessed using the Social Connectedness Scale - Revised.
This 20-item self-report measure examines an individual's sense of belonging and connection with others.
Higher scores indicate stronger perceived social connectedness.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
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Social Capital: Social Support
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
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Social support is assessed using the Medical Outcomes Study (MOS) Social Support Survey.
This 19-item self-report measure examines perceived social support across multiple dimensions, such as emotional support, tangible support, and affectionate support.
Higher scores reflect greater perceived support.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
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Identity Capital: Self-Esteem
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Self-esteem is assessed using the Rosenberg Self-Esteem Scale.
This 10-item self-report measure examines positive and negative feelings about oneself.
Higher scores indicate higher levels of self-esteem.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
|
Identity Capital: Hope
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Hope is assessed using the Beck Hopelessness Scale.
This 20-item self-report measure explores an individual's expectations about the future.
Higher scores indicate greater hopelessness.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
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Identity Capital: Self-Efficacy
Time Frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Self-efficacy is assessed using the Generalized Self-Efficacy Scale.
This 10-item self-report measure assesses an individual's belief in their ability to cope with demands and unexpected situations.
Higher scores indicate greater self-efficacy.
|
Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), and T4 (Month 18).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Naomi S Thulien, NP-PHC, PhD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 25-126
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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