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NCT03772522: TIP

The Identity Project

Completed NA Results posted Last updated 22 June 2023
What this trial tests

NA trial testing dk Leadership in Youth in 27 participants. Completed in 6 August 2019.

Timeline
1 April 2018
Primary endpoint
6 August 2019
6 August 2019

Quick facts

Lead sponsorUnity Health Toronto
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment27
Start date1 April 2018
Primary completion6 August 2019
Estimated completion6 August 2019
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Unity Health Toronto — full company profile →

Who can join

Adults 18 to 26, any sex, with Youth or Homelessness. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale Primary · Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Assessed using Beck's Hopelessness Scale, a 20-item scale which measures motivation, expectations, and feelings about the future (internal consistency α = .93). The total scoring range is 0-20, with 0-3 = no or minimal hopelessness, 4-8 = mild hopelessness, 9-14 = moderate hopelessness- requires monitoring, and 15+ = severe hopelessness- suicide risk. Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of hopelessness. The change in scores over time will describe the general trajectory of hopelessness.

6-weeks pre-baseline
GroupValue95% CI
Immediate dk Leadership InterventionNA± NA
Delayed dk Leadership Intervention6.70± 4.08
Pooled Analysis of Immediate and Delayed Intervention GroupsNA± NA
Baseline (pre-intervention)
GroupValue95% CI
Immediate dk Leadership Intervention4.27± 3.28
Delayed dk Leadership Intervention6.55± 3.80
Pooled Analysis of Immediate and Delayed Intervention Groups5.59± 3.68
Immediately post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention2.63± 3.46
Delayed dk Leadership Intervention5.21± 4.01
Pooled Analysis of Immediate and Delayed Intervention Groups4.12± 3.92
3 Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention2.75± 2.71
Delayed dk Leadership Intervention5.55± 3.80
Pooled Analysis of Immediate and Delayed Intervention Groups4.36± 3.59
6 Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention1.75± 1.98
Delayed dk Leadership Intervention5.01± 3.57
Pooled Analysis of Immediate and Delayed Intervention Groups3.64± 3.37
9 Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention1.71± 1.70
Delayed dk Leadership Intervention5.00± 4.20
Pooled Analysis of Immediate and Delayed Intervention Groups3.72± 3.75
Mean Change From Baseline in Community Integration (Psychological and Physical) Scores as Measured by the Community Integration Scale (CIS) Primary · Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Assessed using the Community Integration Scale, an 11-item scale which measures behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. The CIS includes a physical subscale (with scores ranging from 0-7) and a psychological subscale (with scores ranging from 4-20). Higher scores indicate greater community integration. This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported. Participants' scores at baseline will be compared with their scores post-intervention to det

Physical sub-scale: 6-weeks pre-baseline
GroupValue95% CI
Immediate dk Leadership InterventionNA± NA
Delayed dk Leadership Intervention4.42± 2.12
Pooled Analysis of Immediate and Delayed Intervention GroupsNA± NA
Physical sub-scale: Baseline (pre-intervention)
GroupValue95% CI
Immediate dk Leadership Intervention2.50± 1.20
Delayed dk Leadership Intervention3.09± 2.30
Pooled Analysis of Immediate and Delayed Intervention Groups2.84± 1.89
Physical sub-scale: Immediately post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention3.89± 1.11
Delayed dk Leadership Intervention3.45± 1.86
Pooled Analysis of Immediate and Delayed Intervention Groups3.64± 1.57
Physical sub-scale: 3 Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention3.98± 2.37
Delayed dk Leadership Intervention3.55± 2.07
Pooled Analysis of Immediate and Delayed Intervention Groups3.73± 2.14
Physical sub-scale: 6 Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention3.75± 1.91
Delayed dk Leadership Intervention3.64± 1.50
Pooled Analysis of Immediate and Delayed Intervention Groups3.68± 1.63
Physical sub-scale: 9 Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention3.29± 2.36
Delayed dk Leadership Intervention3.45± 1.57
Pooled Analysis of Immediate and Delayed Intervention Groups3.39± 1.85
Psychological sub-scale: 6-weeks pre-baseline
GroupValue95% CI
Immediate dk Leadership InterventionNA± NA
Delayed dk Leadership Intervention12.9± 3.98
Pooled Analysis of Immediate and Delayed Intervention GroupsNA± NA
Psychological sub-scale: Baseline
GroupValue95% CI
Immediate dk Leadership Intervention11.63± 4.27
Delayed dk Leadership Intervention12.60± 3.91
Pooled Analysis of Immediate and Delayed Intervention Groups12.16± 3.98
Mean Change From Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS) Primary · Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Measured using the Social Connected Scale, a 20-item scale which measures belongingness - the degree to which people feel connected to others (internal consistency α = .92). Scores range from 20-120, with higher scores indicating greater social connectedness. Participants' scores at baseline will be compared with their scores post-intervention to detect changes in social connectedness. The change in scores over time will describe the general trajectory of social connectedness.

6-weeks pre-baseline
GroupValue95% CI
Immediate dk Leadership InterventionNA± NA
Delayed dk Leadership Intervention70.00± 10.10
Pooled Analysis of Immediate and Delayed Intervention GroupsNA± NA
Baseline (pre-intervention)
GroupValue95% CI
Immediate dk Leadership Intervention74.00± 13.37
Delayed dk Leadership Intervention71.00± 15.60
Pooled Analysis of Immediate and Delayed Intervention Groups72.26± 14.39
Immediately post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention75.75± 25.41
Delayed dk Leadership Intervention75.20± 14.60
Pooled Analysis of Immediate and Delayed Intervention Groups75.42± 19.23
3-Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention82.88± 20.79
Delayed dk Leadership Intervention75.27± 8.46
Pooled Analysis of Immediate and Delayed Intervention Groups78.47± 14.92
6-Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention84.38± 18.95
Delayed dk Leadership Intervention72.18± 12.36
Pooled Analysis of Immediate and Delayed Intervention Groups77.32± 16.21
9-Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention84.14± 14.81
Delayed dk Leadership Intervention73.26± 14.49
Pooled Analysis of Immediate and Delayed Intervention Groups77.49± 15.19
Mean Change From Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS) Primary · Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Assessed using the Rosenberg Self-Esteem Scale, a 10-item scale which measures of global self-worth (internal consistency α = .77 - .88). Scores range from 0-30. A score of \<15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem. Participants' scores at baseline will be compared with their scores post-intervention to detect changes in self-esteem. The change in scores over time will describe the general trajectory of self-esteem.

6-Weeks pre-baseline
GroupValue95% CI
Immediate dk Leadership InterventionNA± NA
Delayed dk Leadership Intervention17.70± 4.91
Pooled Analysis of Immediate and Delayed Intervention GroupsNA± NA
Baseline (pre-intervention)
GroupValue95% CI
Immediate dk Leadership Intervention16.66± 2.92
Delayed dk Leadership Intervention18.50± 6.09
Pooled Analysis of Immediate and Delayed Intervention Groups17.70± 4.97
Immediately post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention22.00± 4.87
Delayed dk Leadership Intervention19.20± 7.31
Pooled Analysis of Immediate and Delayed Intervention Groups20.37± 6.40
3-Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention21.00± 6.39
Delayed dk Leadership Intervention18.09± 5.11
Pooled Analysis of Immediate and Delayed Intervention Groups19.32± 5.71
6-Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention24.75± 5.23
Delayed dk Leadership Intervention19.18± 6.88
Pooled Analysis of Immediate and Delayed Intervention Groups21.53± 6.70
9-Months post-intervention
GroupValue95% CI
Immediate dk Leadership Intervention21.86± 4.98
Delayed dk Leadership Intervention19.00± 4.24
Pooled Analysis of Immediate and Delayed Intervention Groups20.11± 4.63
Change in Vocational Participation/Employment as Assessed by a Questionnaire From Baseline to 9-Months Secondary · Assessed at baseline (immediately pre-intervention) and 9 months post-intervention

Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status, intensity of employment, and type of employment in the questionnaire. The change in the number of participants engaging in employment over time at the aggregate level will be assessed.

Baseline (pre-intervention)
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups3
Pooled Analysis of Immediate and Delayed Intervention Groups6
Pooled Analysis of Immediate and Delayed Intervention Groups10
9-Months post-intervention
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2
Pooled Analysis of Immediate and Delayed Intervention Groups5
Pooled Analysis of Immediate and Delayed Intervention Groups11
Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire From Baseline to 9-Months Secondary · Assessed at baseline (immediately pre-intervention) and 9 months post-intervention

Participants will be prompted to answer questions about their current educational pursuit, and type of schooling or training program in a questionnaire. The change in the number of participants engaging in education over time on the aggregate will be assessed.

Baseline (pre-intervention)
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups4
Pooled Analysis of Immediate and Delayed Intervention Groups4
Pooled Analysis of Immediate and Delayed Intervention Groups11
9-Months post-intervention
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups1
Pooled Analysis of Immediate and Delayed Intervention Groups7
Pooled Analysis of Immediate and Delayed Intervention Groups10
Number of Themes Related to Change in Career Awareness Informed by Focus Groups With Participants Secondary · 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

This outcome will describe the general trajectory of career awareness. Self-awareness, confidence, ability to articulate career goals, and understanding of how to achieve career goals will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbati

Themes
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2
Subthemes
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2
Number of Themes Related to Change in Knowledge and Use of Soft Skills Informed by Focus Groups With Participants Secondary · 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

Acquirement of soft skills such as motivation, goal setting, self-discipline, and organization will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis wi

Themes
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2
Subthemes
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2
Number of Themes Related to Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Focus Groups With Participants Secondary · 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention

In focus groups, youth will be prompted to discuss the strengths and drawbacks of conventional programs for youth transitioning out of homelessness. These evaluations will be compared to this intervention to determine what aspects of programs youth find most helpful, and which could be improved upon. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion.All will be conducted by the co-investigator at locations most conven

Themes
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2
Subthemes
GroupValue95% CI
Pooled Analysis of Immediate and Delayed Intervention Groups2

Sponsor's own description

Understanding how to create successful pathways out of homelessness is crucial. Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six week intervention that focuses on building identity capital (sense of purpose and control, self-efficacy and self-esteem) and providing career direction. The intervention will be designed and carried out by dk Leadership - an established, highly successful leadership and counseling centre in Toronto with a track record of significantly improving the life trajectories of teens and adults. Importantly, study participants will be incorporated into the centre's current programming, meaning the intervention will be held at a location not associated with homelessness. Study participants will be collaboratively recruited by dk Leadership and Covenant House Toronto - Canada's largest agency for street-involved and homeless youth. This impact and process evaluation aims to address critical gaps in knowledge about transition-related supports by asking whether and how an identity capital intervention delivered outside the social service sector impacts the life-trajectories of formerly homeless young people. Particular attention will be paid to whether this intervention shows promise as an unconventional way to tackle poverty and improve social inclusion. It is hypothesize that, for the primary quantitative outcome measures of hope, community integration, social connectedness, and self-esteem: 1. Significant improvements in the mean scores of the intervention group compared to the delayed intervention comparison group immediately post-intervention will be observed. 2. Significant improvements in the mean scores of both groups (intervention and delayed intervention) immediately post-intervention will be observed. 3. These significant improvements will be sustained in both groups for at least three months post-intervention.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Tackling exclusion: A pilot mixed method quasi-experimental identity capital intervention for young people exiting homelessness.
    Thulien NS, Wang A, Mathewson C, Wang R, et al · · 2021 · cited 6× · PMID 34415951 · DOI 10.1371/journal.pone.0256288

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03772522.

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