Homeless PersonsPhase 2/3NCT04755361
Examining the Effectiveness of a Critical Time Intervention to Stabilize Trajectories Out of Homelessness for Youth
A Phase 2/3 study testing Housing Outreach Project Collaboration (HOP-C) in people with Homeless Persons, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Homeless Persons
- What is being tested?
- Housing Outreach Project Collaboration (HOP-C)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 31 Jan 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 1) Has transitioned to a residence outside of Toronto or plans to do so within the coming year.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Homeless Persons
- Being tested
- Housing Outreach Project Collaboration (HOP-C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Housing Outreach Project Collaboration (HOP-C)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Housing Outreach Project - Collaboration (HOP-C) + Treatment as Usual | Experimental | The treatment condition is HOP-C plus treatment as usual (TAU). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Every 6 months after baseline up to 18 months.
Secondary outcomes (5)
Mental Health Crises
The secondary outcome is an assessment of mental health crises, operationalized as nights spent in hospital during the assessment time period for any mental health and/or addiction problem. More nights spent indicate worse outcomes.
Measured: Every 6 months after baseline up to 18 months.
Self-reported Mental Health
Self-reported Mental Health will be operationalized as (i) participant ratings on the Colorado Symptom Index which is a 15-item measure of psychiatric symptoms measured on a 5 point scale. Higher scores indicate greater distress.
Measured: Every 6 months after baseline up to 18 months.
Quality of Life
Quality of Life will be measured using the World Health Organization Quality of Life Scale - Bref: WHO QOL Bref, which is a 24 item scale that captures: Physical health with 7 items, psychological health with 6 items, social relationships with 3 items, and environmental health with 8 items. Higher scores indicate better outcomes.
Measured: Every 6 months after baseline up to 18 months.
Resilience
Resilience will be assessed using the Connor-Davidson Resilience Scale. Respondents rate 10 items on a 5-point Likert scale, ranging from 0 (not true at all) to 4 (true nearly all the time). Each item has a minimum score of 0 and a maximum score of 4. A higher score indicates higher resilience.
Measured: Every 6 months after baseline up to 18 months.
Subjective housing stability
Subjective housing stability will be assessed with the Housing Security Scale - Version 2 (HSSV2). It is a 21 item scale designed for youth homelessness populations to assess housing stability with higher scores indicating greater stability.
Measured: Every 6 months after baseline up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Sep 2021
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homeless PersonsStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- LOFT Community Services, Covenant House Toronto, Wellesley Institute
- Responsible party
- Principal investigator, Sean Kidd, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755361
- Sponsor's protocol ID
- 162/2020
- Status last verified
- Apr 2026
- First submitted
- 11 Feb 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to provide de-identified data to other researchers after analyses are complete.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of a Critical Time Intervention to Stabilize Trajectories Out of Homelessness for Youth
- ClinicalTrials.gov ID
- NCT04755361
- Acronym / sponsor ID
- 162/2020
- Conditions
- Homeless Persons
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- LOFT Community Services, Covenant House Toronto, Wellesley Institute
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Housing Outreach Project - Collaboration (HOP-C) + Treatment as Usual | Experimental | Behavioral: Housing Outreach Project Collaboration (HOP-C)The treatment condition is HOP-C plus treatment as usual (TAU). |
| 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. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Has transitioned to a residence outside of Toronto or plans to do so within the coming year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Housing Outreach Project Collaboration (HOP-C)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. | Behavioural | Housing Outreach Project - Collaboration (HOP-C) + Treatment as Usual |
Primary outcome
Housing Stability
Time frame: Every 6 months after baseline up to 18 months.
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.
Education and Vocational Engagement
Time frame: Every 6 months after baseline up to 18 months.
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.
5 secondary outcomes
Mental Health Crises
Time frame: Every 6 months after baseline up to 18 months.
Self-reported Mental Health
Time frame: Every 6 months after baseline up to 18 months.
Quality of Life
Time frame: Every 6 months after baseline up to 18 months.
Resilience
Time frame: Every 6 months after baseline up to 18 months.
Subjective housing stability
Time frame: Every 6 months after baseline up to 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- More details on the HOP-C program of work.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The plan is to provide de-identified data to other researchers after analyses are complete.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Housing Outreach Project Collaboration (HOP-C) in people with Homeless Persons, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Housing Stability (time frame: Every 6 months after baseline up to 18 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.