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NCT04755361

Examining the Effectiveness of a Critical Time Intervention to Stabilize Trajectories Out of Homelessness for Youth

Completed Phase 2, PHASE3 Last updated 15 April 2026
What this trial tests

Phase 2, PHASE3 trial testing Housing Outreach Project Collaboration (HOP-C) in Homeless Persons in 108 participants. Completed in 31 January 2026.

Timeline
1 September 2021
Primary endpoint
31 January 2026
31 January 2026

Quick facts

Lead sponsorCentre for Addiction and Mental Health
PhasePhase 2, PHASE3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment108
Start date1 September 2021
Primary completion31 January 2026
Estimated completion31 January 2026
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Centre for Addiction and Mental Health — full company profile →

Who can join

Adults 16 to 25, any sex, with Homeless Persons. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Problem Statement: This proposal addresses the problem of youth not being adequately supported as they attempt to transition out of homelessness. This problem leads to frequent cycling in and out of homelessness, protracted periods of homelessness, and increased exposure to an array of serious risks to health and wellbeing. This is not just an issue of housing. While adequate housing is necessary to youth exiting homelessness it is not, in and of itself, sufficient to ensure success in sustaining housing nor flourishing as a result of housing. Objective: This proposal tests a complex, critical time intervention for youth in transition out of homelessness. This intervention, which is team-based and comprised of integrated case management, peer support, and mental health supports, has proven feasible in pilot and feasibility trials. Its objective is to stabilize housing trajectories and improve outcomes in major life domains. Specific Aims: The primary aim of this study is to determine if the provision of 1 year of the critical time intervention HOP-C can improve the outcomes of youth who have transitioned into stable housing in the past 6 months. It is hypothesized that, compared with treatment as usual, housing, employment, education, and mental health outcomes will be significantly better for youth who receive HOP-C and that these gains will be sustained. Changes in quality of life, social supports, and psychological wellbeing will be explored as secondary outcomes. Partners: This study builds on a partnership between the Centre for Addiction and Mental Health (research capability, mental health service expertise) and two established Toronto service providers focusing on homeless youth populations (Covenant House - Toronto; LOFT Community Services). Study Design: This study is a single blind, randomized controlled trial comparing the outcomes of the transitional intervention described above with typical supports provided in the community. Assessments will be conducted at baseline, mid-point (6 months), post-intervention (1 year), and at 6 months follow up. Implications: From a trial design perspective, the proposed study would provide evidence supporting a rationale for future trials and wide implementation. Pending positive outcomes, this would flow into multisite trial and implementation grant applications and further collaborations with others working within Canada and elsewhere. More broadly, this line of investigation has synergy with the increasingly larger and better-organized movements towards addressing homelessness in Canada. These efforts have included At Home/Chez soi - the largest study to date of housing first and Making the Shift, an NCE-funded collaborative effort towards ending youth homelessness in Canada. Collectively, these developments (in which the applicants are substantively involved), present the opportunity for both scaling the critical time intervention proposed here and its ultimately being combined with other approaches (e.g., housing first, family reunification, support in transitions from protection and justice systems). Such systems-oriented strategies, girded by evidence, hold the greatest promise for ameliorating the problem of youth homelessness and homelessness overall in Canada.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing