NCT07419282

Brief 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. 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
37mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Feb 2026Aug 2029

First Submitted

Initial submission to the registry

February 5, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

February 5, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

youthcoachemploymenthomelessnesstransitionsocioeconomic inclusionidentity capitalsocial capital

Outcome Measures

Primary Outcomes (5)

  • 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).

    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).

    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).

    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).

    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).

    Assessed at T4 (Month 18; end of intervention).

Secondary Outcomes (10)

  • Economic Capital: Employment

    Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).

  • Economic Capital: Education

    Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).

  • Economic Capital: Housing Security

    Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).

  • Economic Capital: Income

    Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).

  • Economic Capital: Food Insecurity

    Assessed at T1 (Baseline), T2 (Month 6), T3 (Month 12), T4 (Month 18), and T5 (Month 24).

  • +5 more secondary outcomes

Study Arms (1)

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

Behavioral: Wraparound Intervention

Interventions

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

Wraparound Intervention

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Study Officials

  • Naomi S Thulien, NP-PHC, PhD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naomi S Thulien, NP-PHC, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 19, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations