HomelessnessSEED CHANGENCT07419282
Supporting Social & Economic Equity, Disrupting Cycles of Homelessness, And Nurturing Growth & Empowerment
A study testing Wraparound Intervention in people with Homelessness and Youth, run by Unity Health Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Homelessness, Youth
- What is being tested?
- Wraparound Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18 - 24 years
- Experienced homelessness (defined as unstable/time-limited housing arrangements like shelter stays, foster care, or couch surfing) for at least seven consecutive days 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Unity Health Toronto
Toronto, Ontario, M5B 1W8
Naomi S Thulien, NP-PHC, PhD, 416-360-4000, naomi.thulien@unityhealth.to
About this study
Official title: 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?)
Read more
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
- Conditions
- Homelessness, Youth
- Being tested
- Wraparound Intervention
- Keywords
- youth, coach, employment, homelessness, transition, socioeconomic inclusion, identity capital, social capital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wraparound InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Wraparound Intervention | Experimental | Young people transitioning away from homelessness 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 Receives: Behavioral: Wraparound Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability: Recruitment, Enrolment, and Dropout Metrics
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).
Measured: 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
Employment placement engagement is defined as the length of time participants remain in their job placement (self-reported).
Measured: Assessed at T4 (Month 18; end of intervention).
Feasibility and Acceptability: Coaching Engagement
Coaching Engagement is defined as the proportion of total possible coaching sessions (max. 36) that a participant attends (reported by coaches).
Measured: Assessed at T4 (Month 18; end of intervention).
Feasibility and Acceptability: Group Program Engagement
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).
Measured: Assessed at T4 (Month 18; end of intervention).
Feasibility and Acceptability: Community Connections Worker Engagement
Community Connections Worker Engagement is defined as the total number of sessions a participant attends with their Community Connections Worker (reported by workers).
Measured: Assessed at T4 (Month 18; end of intervention).
Secondary outcomes (10)
Economic Capital: Employment
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Education
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Housing Security
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Income
Income is self-reported; participants are asked their average monthly income (including income from their job placement, additional jobs, and social assistance).
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Food Insecurity
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?
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Social Capital: Social Connectedness
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Social Capital: Social Support
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Identity Capital: Self-Esteem
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Identity Capital: Hope
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Identity Capital: Self-Efficacy
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.
Measured: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start25 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HomelessnessStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Covenant House Toronto, StepStones for Youth, Resource Association for Teens
- Responsible party
- Sponsor
- Investigators
- Naomi S Thulien, NP-PHC, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419282
- Sponsor's protocol ID
- 25-126
- Acronym
- SEED CHANGE
- Status last verified
- Jun 2026
- First submitted
- 5 Feb 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07419282
- Acronym / sponsor ID
- SEED CHANGE / 25-126
- Conditions
- Homelessness, Youth
- Keywords
- youth, coach, employment, homelessness, transition, socioeconomic inclusion, identity capital, social capital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Covenant House Toronto, StepStones for Youth, Resource Association for Teens
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wraparound Intervention | Experimental | Behavioral: Wraparound InterventionYoung people transitioning away from homelessness 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 |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged 18 - 24 years
- Experienced homelessness (defined as unstable/time-limited housing arrangements like shelter stays, foster care, or couch surfing) for at least seven consecutive days 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)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wraparound InterventionAn 18-month wraparound intervention including the following supports: * Job Placement * Housing Stabilization Funds * Grocery Supplements * Community Connections Worker * Coaching * Tools for Intentional Living Program | Behavioural | Wraparound Intervention |
Primary outcome
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).
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).
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).
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).
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).
10 secondary outcomes
Economic Capital: Employment
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Education
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Housing Security
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Income
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Economic Capital: Food Insecurity
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Social Capital: Social Connectedness
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Social Capital: Social Support
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Identity Capital: Self-Esteem
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Identity Capital: Hope
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Identity Capital: Self-Efficacy
Time frame: Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naomi S Thulien, NP-PHC, PhD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wraparound Intervention in people with Homelessness and Youth, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naomi S Thulien, NP-PHC, PhD (416-360-4000, naomi.thulien@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.