NCT04755361

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2021

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 16, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

4.4 years

First QC Date

February 11, 2021

Last Update Submit

April 10, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Housing Stability

    Housing stability will be assessed using the Residential Time Line Follow-back (RTLFB) inventory. This tool will be used to calculate the percentage of days spent stably housed during each 6-month assessment period - the number of days housed divided by the total number of days. Higher percentages indicate better outcomes.

    Every 6 months after baseline up to 18 months.

  • Education and Vocational Engagement

    Education and vocational engagement will be pooled and assessed using the Residential Time Line Follow-back (RTLFB) inventory. This tool will be used to calculate the percentage of days spent engaged in education or vocational activities during each 6-month assessment period - the number of days engaged divided by the total number of days. Higher percentages indicate better outcomes.

    Every 6 months after baseline up to 18 months.

Secondary Outcomes (5)

  • Mental Health Crises

    Every 6 months after baseline up to 18 months.

  • Self-reported Mental Health

    Every 6 months after baseline up to 18 months.

  • Quality of Life

    Every 6 months after baseline up to 18 months.

  • Resilience

    Every 6 months after baseline up to 18 months.

  • Subjective housing stability

    Every 6 months after baseline up to 18 months.

Study Arms (2)

Housing Outreach Project - Collaboration (HOP-C) + Treatment as Usual

EXPERIMENTAL

The treatment condition is HOP-C plus treatment as usual (TAU).

Behavioral: Housing Outreach Project Collaboration (HOP-C)

Treatment As Usual

NO INTERVENTION

TAU for this population reflects the standard array of services accessed by transitional youth populations. Most will have some contact with a youth worker with ranging focus and intensity (none likely to receive case management at HOP-C intensity), and very few will have any routine contact with other professionals or peer support. They may have some sporadic access to skills development programs and primary healthcare providers with mental health and addictions needs addressed primarily through emergency services at times of crisis.

Interventions

HOP-C has several components: HOP-C Case management is outreach-based (emphasizing community and home contacts) and participant goal-driven, providing coaching and skill building in key functional domains and assistance with navigating various systems (justice, housing, employment, health, education). The mental health component has two parts. One is a weekly, 90-minute, mental health and wellness-oriented group. The group acts, for most, as a stepped care approach, with members moving on to access individual psychotherapy as needed. Peer support is provided by youth with a history of lived experience of homelessness who have successfully achieved housing stability and progress in major life domains. Peers receive extensive training and are formally hired into these roles with their being 2-3 peers on the team.

Housing Outreach Project - Collaboration (HOP-C) + Treatment as Usual

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants will be aged 16-25 (service mandate of participating organizations and captures the age span of youth transitioning from homelessness - in previous studies mean age ranged from 21-22).
  • All participants will have experienced at least 6 months of homelessness defined as being a lack of fixed, regular, and adequate housing across their lifetime.
  • Participants will have been in stable housing for between 1 day and 6 months. This period has characterized the transitional experience in previous research14. Stable housing is a housing arrangement that either (i) involves an individual holding a lease, (ii) is a supported housing arrangement with a tenure of 12+ months, or (iii) involves the person residing with a family member wherein the individual and service provider attest to stability. These broad criteria are necessary due to the diversity of housing arrangements into which youth transition.
  • Proficiency in English.

You may not qualify if:

  • \) Has transitioned to a residence outside of Toronto or plans to do so within the coming year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

Location

Related Links

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

February 11, 2021

First Posted

February 16, 2021

Study Start

September 1, 2021

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The plan is to provide de-identified data to other researchers after analyses are complete.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Pending
Access Criteria
Pending

Locations