CClinicalTrials.gg
CompletedNCT06425458Updated Sep 15, 2025Results posted

Transitioning Youth Out of Homelessness 2.5 (TYOH 2.5)

An interventional study of Co-Designed Strengths-Based Leadership Program in Homelessness and Youth, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 16 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Unity Health Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
16 Years to 24 Years
Sex
All
01

Study summary

The idea for this study came from the research team's current study called Transitioning Youth Out of Homelessness (TYOH) 2.0, which provides coaching and a leadership guide to youth transitioning out of homelessness. Based on feedback from youth and coaches involved in that study, the research team plans to make small changes to the leadership guide and see if it works better as an in-person, four-week leadership program.

All participants in this study will be invited to attend an in-person, four-week leadership program. There will be two programs running at the same time: one in St. Catharines and one in Toronto. The goal is to have 15 participants in each program.

The main purpose of the study is to learn what participants think of the program. The second purpose is to see if there are changes in identity capital (feeling a sense of purpose and confidence in achieving goals) and knowledge about things that are covered in the program, when the research team compares participants' answers at the beginning and at the end of the program.

Read the detailed description

This project builds on the research team's current community-based randomized clinical trial (Transitioning Youth Out of Homelessness 2.0) utilizing coaching and a co-designed leadership guide to target identity capital (purpose, control, self-efficacy, and self-esteem) for youth transitioning out of homelessness (all participants are also receiving rent subsidies). Based on preliminary feedback from study youth and coaches involved in the intervention arm, the research team will modify the leadership guide and pilot it in the form of an in-person, four-week leadership program (vs. independent learning in the current study).

The overarching objective of this mixed methods pilot project is to co-develop and test a strengths-based leadership program targeting identity capital for youth (16-24 years of age) transitioning out of homelessness. Specifically, the objectives are to:

  1. Modify the leadership guide being used in the research team's current study so it can be delivered as an in-person leadership program.
  2. Co-develop and pilot a four-week, strengths-based leadership program for young people transitioning out of homelessness.
  3. Determine the feasibility and acceptability of the leadership guide when delivered as a four-week, in-person program (as opposed to independent learning in the current study).
  4. Examine whether self-reported measures of identity capital and knowledge of program material show improvement immediately post-program compared to baseline.
  5. Explore whether there are differences in outcomes by sub-groups (e.g., gender, age, identification as 2SLGBTQ+, child welfare involvement) and/or program participation levels.

If this modified delivery of the leadership guide shows promise, the research team plans to incorporate it into a national scale-up alongside rent subsidies and coaching.

02

Conditions studied

  • Homelessness
  • Youth

Keywords

  • Identity Capital
  • Youth
  • Coach
  • Self-Efficacy
  • Self-Esteem
  • Control
  • Purpose
  • Socioeconomic Inclusion
  • Homelessness
  • Transition
03

In context

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligible young people aged 16-24 years who have transitioned out of homelessness (e.g., no longer living in a shelter or couch surfing), defined as 3 consecutive months within the past 12 months, will be identified by community partners (note: for the purpose of this study, youth living in foster care will be considered homeless).

This age mandate was chosen because this is the age group served by the community partners. The research team has chosen to target the first year of exiting homelessness because collective experience has shown that this can be a particularly precarious time for youth in terms of mental health challenges and risk of (re)experiencing homelessness (even if youth have attempted exits in the past).

Inclusion criteria

Inclusion Criteria:

  • Be able to provide free and informed consent.
  • Be able to understand English (leadership program and data collection will be conducted in English).
  • Have experienced homelessness (e.g., unstable housing arrangements including shelter stays, foster care, and couch surfing) for 3 consecutive months in the past 12 months.
  • Be able to consistently attend the four-week leadership program.

Exclusion criteria

Exclusion Criteria:

  • Enrolled in a program or study with similar features to the TYOH 2.5 leadership program.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Co-Designed Strengths-Based Leadership Program

    Young people transitioning out of homelessness will attend a four-week, strengths-based leadership program. Two four-week leadership programs (15 youth per program) will be led by coaches from the research team's current TYOH 2.0 study with youth advisors participating as paid leadership interns.

    Behavioral: Co-Designed Strengths-Based Leadership Program

Interventions

  • BehavioralCo-Designed Strengths-Based Leadership Program

    Please see arm description.

06

What researchers measure

Primary outcomes

  1. Intervention Feasibility and Acceptability (Assessed by Recruitment/Enrolment/Completion Metrics)

    Quantitative measures consisting of recruitment/enrolment/completion metrics will be utilized. The recruitment rate will be estimated as the proportion of contacted individuals who express interest in participating in the study (T0). The enrolment rate will be calculated as the proportion of recruited individuals who are eligible and consent to participate in the study (T0). Participants were considered to have completed the study if they attended the final program session and completed final data collection (T2).

    Time frame: Assessed at T0 (pre-intervention), T1 (first day of intervention) and T2 (last day of intervention).

  2. Intervention Feasibility and Acceptability (Assessed by Program Attendance)

    Program attendance was calculated as the percentage of total possible leadership program sessions attended (maximum 8 sessions).

    Time frame: Assessed at T2 (last day of intervention).

  3. Intervention Feasibility and Acceptability (Assessed by Program Feedback Questionnaire)

    This 4-item anonymous questionnaire was developed for this study to collect information about participants' view of the leadership program, the impact of the program on them, and their view of the individuals running the program.

    Time frame: Assessed at T2 (last day of intervention).

  4. Intervention Feasibility and Acceptability (Informed by Focus Groups)

    Focus group discussions (at T2) with program participants primarily centered around intervention acceptability but also explored the impact of the intervention on identity capital (e.g., sense of purpose and control) and socioeconomic inclusion (e.g., connection to broader social networks). Qualitative data analysis was conducted using reflexive thematic analysis with a critical social theoretical lens. During analysis, focus group transcripts were coded and codes were organized in a code book, clustered into categories, and eventually synthesized into key themes and sub-themes.

    Time frame: Assessed at T2 (last day of intervention).

Secondary outcomes

  1. Pre-post Intervention Change in Identity Capital (Assessed by Multi-Measure Agentic Personality Scale)

    The Multi-Measure Agentic Personality Scale (MAPS20) is a 20-item validated self-report measure that explores domains related to identity capital. The MAPS20 contains the following sub-scales: Self-Esteem; Purpose in Life; Internal Locus of Control; Self-Efficacy/Ego Strength. Each subscale has a score range of 5-30, with higher scores indicating greater identity capital.

    Time frame: Assessed at T1 (first day of intervention) and T2 (last day of intervention).

  2. Pre-post Intervention Change in Knowledge of Program Material

    The composite knowledge assessment scale is 16-item self-report measure that was developed for this study and explores concepts from the program curriculum, such as: mindfulness; core values; purpose; goal setting; growth mindset; identity; and courage. Reported values represent the percentage of participants who answered the question correctly (i.e., agreeing with a correct statement or disagreeing with an incorrect statement).

    Time frame: Assessed at T1 (first day of intervention) and T2 (last day of intervention).

07

Results

Posted Sep 15, 2025
Limitations and caveats
This is a feasibility and acceptability study and thus not adequately powered to detect a significant difference in quantitative self-report measures; results must be interpreted with caution. All young people will be connected to urban-based social service agencies in the province of Ontario; other youth populations may differ. Quantitative instruments are based on self-reports and thus subject to social desirability bias.

Participant flow

Participant flow — Overall Study
MilestoneLeadership Program
Started25
Completed18
Not completed7
Withdrew: Removed by study team2
Withdrew: Lost to follow-up5

Outcome measures

PrimaryIntervention Feasibility and Acceptability (Assessed by Recruitment/Enrolment/Completion Metrics)

Quantitative measures consisting of recruitment/enrolment/completion metrics will be utilized. The recruitment rate will be estimated as the proportion of contacted individuals who express interest in participating in the study (T0). The enrolment rate will be calculated as the proportion of recruited individuals who are eligible and consent to participate in the study (T0). Participants were considered to have completed the study if they attended the final program session and completed final data collection (T2).

Time frame:
Assessed at T0 (pre-intervention), T1 (first day of intervention) and T2 (last day of intervention).
Reported as:
Count of participants · Participants
Intervention Feasibility and Acceptability (Assessed by Recruitment/Enrolment/Completion Metrics)
ParticipantsLeadership Program
Screened35
Enrolled25
Completed Study18
PrimaryIntervention Feasibility and Acceptability (Assessed by Program Attendance)

Program attendance was calculated as the percentage of total possible leadership program sessions attended (maximum 8 sessions).

Time frame:
Assessed at T2 (last day of intervention).
Reported as:
Mean · Percent of sessions attended
Intervention Feasibility and Acceptability (Assessed by Program Attendance)
Percent of sessions attendedLeadership Program
Intervention Feasibility and Acceptability (Assessed by Program Attendance)75.5 ± 20.9
PrimaryIntervention Feasibility and Acceptability (Assessed by Program Feedback Questionnaire)

This 4-item anonymous questionnaire was developed for this study to collect information about participants' view of the leadership program, the impact of the program on them, and their view of the individuals running the program.

Time frame:
Assessed at T2 (last day of intervention).
Reported as:
Count of participants · Participants
Intervention Feasibility and Acceptability (Assessed by Program Feedback Questionnaire)
ParticipantsLeadership Program
I would recommend this program to my friends or other youth I know with similar experiences. — Strongly disagree0
I would recommend this program to my friends or other youth I know with similar experiences. — Disagree0
I would recommend this program to my friends or other youth I know with similar experiences. — Slightly disagree0
I would recommend this program to my friends or other youth I know with similar experiences. — Slightly agree1
I would recommend this program to my friends or other youth I know with similar experiences. — Agree8
I would recommend this program to my friends or other youth I know with similar experiences. — Strongly agree9
The coaches and staff were knowledgeable about the program material. — Strongly disagree0
The coaches and staff were knowledgeable about the program material. — Disagree0
The coaches and staff were knowledgeable about the program material. — Slightly disagree0
The coaches and staff were knowledgeable about the program material. — Slightly agree0
The coaches and staff were knowledgeable about the program material. — Agree8
The coaches and staff were knowledgeable about the program material. — Strongly agree10
The coaches and staff were effective facilitators. — Strongly disagree0
The coaches and staff were effective facilitators. — Disagree0
The coaches and staff were effective facilitators. — Slightly disagree1
The coaches and staff were effective facilitators. — Slightly agree0
The coaches and staff were effective facilitators. — Agree7
The coaches and staff were effective facilitators. — Strongly agree10
Participating in this program has made a difference in my day-to-day life. — Strongly disagree0
Participating in this program has made a difference in my day-to-day life. — Disagree1
Participating in this program has made a difference in my day-to-day life. — Slightly disagree0
Participating in this program has made a difference in my day-to-day life. — Slightly agree2
Participating in this program has made a difference in my day-to-day life. — Agree5
Participating in this program has made a difference in my day-to-day life. — Strongly agree10
PrimaryIntervention Feasibility and Acceptability (Informed by Focus Groups)

Focus group discussions (at T2) with program participants primarily centered around intervention acceptability but also explored the impact of the intervention on identity capital (e.g., sense of purpose and control) and socioeconomic inclusion (e.g., connection to broader social networks). Qualitative data analysis was conducted using reflexive thematic analysis with a critical social theoretical lens. During analysis, focus group transcripts were coded and codes were organized in a code book, clustered into categories, and eventually synthesized into key themes and sub-themes.

Time frame:
Assessed at T2 (last day of intervention).
Reported as:
Number · Themes
Intervention Feasibility and Acceptability (Informed by Focus Groups)
ThemesLeadership Program
Key Themes3
Sub-themes7
SecondaryPre-post Intervention Change in Identity Capital (Assessed by Multi-Measure Agentic Personality Scale)

The Multi-Measure Agentic Personality Scale (MAPS20) is a 20-item validated self-report measure that explores domains related to identity capital. The MAPS20 contains the following sub-scales: Self-Esteem; Purpose in Life; Internal Locus of Control; Self-Efficacy/Ego Strength. Each subscale has a score range of 5-30, with higher scores indicating greater identity capital.

Time frame:
Assessed at T1 (first day of intervention) and T2 (last day of intervention).
Reported as:
Mean · Score on a Scale
Pre-post Intervention Change in Identity Capital (Assessed by Multi-Measure Agentic Personality Scale)
Score on a ScaleLeadership Program
Self-Esteem (T1)20.3 ± 4.0
Purpose in Life (T1)18.8 ± 4.8
Locus of Control (T1)20.8 ± 2.9
Self-Efficacy (T1)20.6 ± 4.0
Self-Esteem (T2)21.9 ± 4.4
Purpose in Life (T2)20.2 ± 5.4
Locus of Control (T2)20.6 ± 3.8
Self-Efficacy (T2)19.0 ± 4.2
Statistical analysis
  • Leadership Program · t-test, 2 sided · p = 0.0011 (Threshold for statistical significance: P \<= 0.05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.)
  • Leadership Program · t-test, 2 sided · p = 0.0719 (Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.)
  • Leadership Program · t-test, 2 sided · p = 0.7991 (Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.)
  • Leadership Program · t-test, 2 sided · p = 0.2208 (Threshold for statistical significance: P \<= .05. As this was an exploratory analysis only, p-values were not adjusted for multiple comparisons.)
  • Leadership Program · Spearman partial correlation coefficient: 0.37
  • Leadership Program · Spearman partial correlation coefficient: -0.29
  • Leadership Program · Spearman partial correlation coefficient: -0.58
  • Leadership Program · Spearman partial correlation coefficient: -0.14
SecondaryPre-post Intervention Change in Knowledge of Program Material

The composite knowledge assessment scale is 16-item self-report measure that was developed for this study and explores concepts from the program curriculum, such as: mindfulness; core values; purpose; goal setting; growth mindset; identity; and courage. Reported values represent the percentage of participants who answered the question correctly (i.e., agreeing with a correct statement or disagreeing with an incorrect statement).

Time frame:
Assessed at T1 (first day of intervention) and T2 (last day of intervention).
Reported as:
Number · Percentage of participants
Pre-post Intervention Change in Knowledge of Program Material
Percentage of participantsLeadership Program
I am confident about my ability to be in the driver's seat in my "car of life." (T1)76.0
I can name at least one strategy that I consistently use to help me accomplish my daily tasks. (T1)88.0
It is more important to focus on what you want to achieve than who you wish to become. (T1)40.0
I have a good understanding of how my brain becomes anxious. (T1)87.5
I am confident in my purpose and why it is important in my life. (T1)80.0
People who believe they are worthy of love/belonging have an easier time showing vulnerability. (T1)100.0
I am not very confident about knowing how to get my "wise mind" in control. (T1)52.0
I have a good understanding of how to create an environment that helps me achieve my goals. (T1)84.0
I have a hard time naming things around me that have contributed to my habits. (T1)56.0
I am confident that I have the knowledge/skills to "speak back" to feelings of shame. (T1)76.0
I can easily name my core values. (T1)84.0
When creating a new habit (e.g., exercising) it is important to stop while it still feels good. (T1)41.7
Your intelligence is something very basic about you that you can't change very much. (T1)72.0
It is more important to strive for excellence than perfection. (T1)84.0
You need to connect with others before you can connect with yourself. (T1)62.5
Interdependence is an important part of self-leadership. (T1)87.5
I am confident about my ability to be in the driver's seat in my "car of life." (T2)83.3
I can name at least one strategy that I consistently use to help me accomplish my daily tasks. (T2)94.4
It is more important to focus on what you want to achieve than who you wish to become. (T2)29.4
I have a good understanding of how my brain becomes anxious. (T2)100.0
I am confident in my purpose and why it is important in my life. (T2)94.4
People who believe they are worthy of love/belonging have an easier time showing vulnerability. (T2)83.3
I am not very confident about knowing how to get my "wise mind" in control. (T2)55.6
I have a good understanding of how to create an environment that helps me achieve my goals. (T2)88.9
I have a hard time naming things around me that have contributed to my habits. (T2)83.3
I am confident that I have the knowledge/skills to "speak back" to feelings of shame. (T2)82.4
I can easily name my core values. (T2)100.0
When creating a new habit (e.g., exercising) it is important to stop while it still feels good. (T2)72.2
Your intelligence is something very basic about you that you can't change very much. (T2)32.2
It is more important to strive for excellence than perfection. (T2)94.4
You need to connect with others before you can connect with yourself. (T2)77.8
Interdependence is an important part of self-leadership. (T2)88.9

Adverse events

Collected over 4 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Leadership Program0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Leadership Program
Age — 16-18 years6
Age — 19-21 years10
Age — 22-24 years9
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Leadership Program
Gender — Boy/Man7
Gender — Girl/Woman16
Gender — Non-binary2
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Leadership Program
Race/Ethnicity — White7
Race/Ethnicity — Black5
Race/Ethnicity — Mixed8
Race/Ethnicity — Other5
Sexual Orientation
Sexual Orientation(Participants)Leadership Program
Queer/gay/lesbian/bisexual/pansexual/questioning9
Straight/heterosexual15
Did not specify1
Immigration Status
Immigration Status(Participants)Leadership Program
Canadian Citizen19
Permanent Resident5
Refugee1
Child Welfare Involvement
Child Welfare Involvement(Participants)Leadership Program
Yes16
No9
Age First Homeless
Age First Homeless(Participants)Leadership Program
Before the age of 102
10-12 years of age0
13-15 years of age7
16-18 years of age10
19-21 years of age6
22-25 years of age0
Attempts to Live on Own After Being Homeless
Attempts to Live on Own After Being Homeless(Participants)Leadership Program
1-212
3-411
5 or more2

10 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Unity Health Toronto
    Toronto, Ontario, Canada
09

References and documents

Publications

  • Côté, J. (2016). The identity capital model: A handbook of theory, methods, and findings.

Study documents

  • Protocol and statistical analysis plan · May 27, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06425458
Lead sponsor
Unity Health Toronto
Collaborators
Covenant House Toronto, StepStones for Youth, Resource Association for Teens
Responsible party
Sponsor
First posted
May 22, 2024
Start date
Jun 11, 2024
Primary completion
Aug 9, 2024
Completion
Aug 9, 2024
Results posted
Sep 15, 2025
Last update
Sep 15, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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