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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06425458
Other study ID # 24-072
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date August 2024

Study information

Verified date May 2024
Source Unity Health Toronto
Contact Naomi S Thulien, NP-PHC, PhD
Phone 416-360-4000
Email naomi.thulien@unityhealth.to
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 24 Years
Eligibility 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: - 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: - Enrolled in a program or study with similar features to the TYOH 2.5 leadership program.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Co-Designed Strengths-Based Leadership Program
Please see arm description.

Locations

Country Name City State
Canada Unity Health Toronto Toronto Ontario

Sponsors (4)

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

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Other 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. A baseline demographic questionnaire will be utilized (T1), session attendance will be tracked throughout the intervention (T1-T2), and focus group findings will be examined (T2).
The baseline demographic questionnaire is a 18-item self-report measure that 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; and food security.
Assessed at T1 (first day of intervention) and T2 (last day of intervention).
Primary Intervention feasibility and acceptability as assessed by recruitment/enrolment/attendance/dropout metrics. Quantitative measures consisting of recruitment/enrolment/attendance/dropout 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).
Session attendance and dropout rates will be tracked throughout the intervention (T1-T2).
Assessed at T0 (pre-intervention), T1 (first day of intervention) and T2 (last day of intervention).
Primary Intervention feasibility and acceptability as assessed by a composite program feedback questionnaire. This 4-item anonymous questionnaire will be used 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. Assessed at T2 (last day of intervention).
Primary Intervention feasibility and acceptability as informed by focus groups. Focus group discussions will explore intervention feasibility and acceptability (T2). Assessed at T2 (last day of intervention).
Secondary Change in self-reported measures of identity capital as assessed by the Multi-Measure Agentic Personality Scale (MAPS20). The MAPS20 is a 20-item validated self-report measure that 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; T1/T2). Assessed at T1 (first day of intervention) and T2 (last day of intervention).
Secondary Change in self-reported knowledge of program material as assessed by a composite knowledge assessment scale. The composite knowledge assessment scale is 16-item self-report measure that was developed for this study and explores domains related to self-leadership, such as: mindfulness; core values; purpose; goal setting; growth mindset; identity; and courage (T1/T2). Assessed at T1 (first day of intervention) and T2 (last day of intervention).
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