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YouthNCT03277794

Generating Evidence for a Support Package to Stabilize Youth Trajectories Out of Homelessness

A study testing HOP-C and Transitional Case Management Only in people with Youth and Homelessness, run by Centre for Addiction and Mental Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This project builds upon initial proof of concept work examining the optimal set of supports for youth who have recently exited homelessness - an intervention comprised of mental health and peer supports alongside transitional case management. Read more about this study

Who is it for?
Ages 16 to 26 years
Conditions the study is for
Youth, Homelessness
What is being tested?
HOP-C and Transitional Case Management Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
1 siteCanada
Study dates
1 Apr 2017to 31 Dec 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 26 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • between the ages of 16 and 26
  • have obtained secure housing in a time period up to 12 months previously

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8

Other trials in Canada

About this study

Official title: Generating Evidence for a Comprehensive Support Package to Stabilize Youth Trajectories Out of Homelessness: A Tertiary Prevention Strategy

This project builds upon initial proof of concept work examining the optimal set of supports for youth who have recently exited homelessness - an intervention comprised of mental health and peer supports alongside transitional case management. This collaborative model will be tested as a proof-of-concept in Thunder Bay with Indigenous youth and a trial will be conducted in Toronto to optimize and determine the effectiveness of the existing model of support.

Read the detailed description

In response to the challenges outlined above, and with the support of a grant from the Ontario Ministry of Child and Youth Services, the investigators developed and tested a tertiary prevention strategy called the Housing Outreach Program Collaborative (HOP-C) which launched in the summer of 2015. In this approach the investigators focused on collaborations and interventions that have the greatest potential to be effective with this population. The investigators brought together partners from a number of sectors in the GTA and have tested a 3-pronged set of supports (intervention described in detail in the methods):

  • Transitional Case Management
  • Mental Health Interventions: Group, individual, family
  • Peer Support This is an intensive, 6-month critical time intervention - one that jointly addresses many points of vulnerability (mental health crises, housing instability, justice involvement) while fostering resilience and connection with resources in employment, education and training domains. It is unique in both content comprehensiveness and integrated process of delivery. Also important was the development of a collaborative and responsive partnering process, to facilitate effective organizational interfaces and seamless service integration so participants can experience a tailored and coherent set of supports. With CAMH, the Centre for Mindfulness Studies, Covenant House, LOFT, and SKETCH at the service level and the Wellesley Institute leading evaluation, the investigators have carefully attended to a collective impact framework.

This initiative has proven feasible and is demonstrating good outcomes - with excellent youth engagement, reports of lower social isolation, improved mental health, and engagement with resources, and spin-off benefits of closer collaboration between organizations. The investigators successfully met the target of youth engagement, with a total of 31 youth participating, minimal attrition (n=2), and the investigators observed no indications that HOP-C resulted in risk of any form, both with respect to the intervention itself and the mixed methods research methodology. This promising feasibility work formed the foundation from which the investigators were successful in obtaining a grant from the Local Poverty Reduction Fund to support the study described in this proposal.

Current Project Determine through a randomized trial in Toronto if the positive outcomes the investigators are observing are due solely or primarily to transitional case management and if the additional peer and mental health components are necessary.

Engaging in intensive, tertiary prevention shows clear promise in disrupting a cycle of poverty and marginalization at a critical time - if proven and scaled a key driver of chronic homelessness would be addressed.

Research Questions The objective of this two-part project is to examine the effectiveness and transferability of the Housing Outreach Program-Collaboration (HOP-C) transitional intervention. HOP-C has proven to be feasible with promising outcomes in the Toronto proof-of-concept work currently underway.

  1. Are the benefits of the complex HOP-C intervention with all components in place greater than transitional case management in isolation?
  • It is hypothesized that the full model will provide benefit in domains of housing stability, mental health, and quality of life that are significantly greater than case management alone.

The investigators have data in hand from their recent national work in the area which provides data on 'treatment as usual' or the outcomes that attend typically available supports. The proposed trial will unpack benefit and be essential in economic and viability arguments to be made going forward.

Conditions
Youth, Homelessness
Being tested
HOP-C, Transitional Case Management Only

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HOP-CBehavioural

    Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.

  • Transitional Case Management OnlyBehavioural

    Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.

Study groups in NCT03277794
Study groupRoleWhat they receive
Transitional Case Management OnlyActive comparatorParticipants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.
Receives: Behavioral: Transitional Case Management Only
Full HOP-C ServiceExperimentalService provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.
Receives: Behavioral: HOP-C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Housing

    Participants coded in a binary manner as having gained or sustained housing (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

    Measured: Change from Baseline to 6 months

  2. Employment/Education

    Participants coded in a binary manner as having gained or sustained education or employment (binary positive) or lost (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

    Measured: Change from baseline to 6 months

  3. Mental Health

    Participants coded in a binary manner as having gained or sustained mental health status without crises (binary positive) or experienced a crises that impacted major life domains (binary negative) based on assessment of the participant's trajectory from baseline to 6 months.

    Measured: Change from baseline to 6 months

  4. Housing Security Scale

    The Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from "strongly disagree" (minimum = 1) to "strongly agree" (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.

    Measured: Change from Baseline to 6 months

  5. Housing Security Scale (Subjective Housing Stability Subscale)

    The Housing Security Scale contains a 4 item subscale that measures subjective housing satisfaction and perception of housing stability (Frederick et al., 2014). Scores range from "strongly disagree" (minimum = 1) to "strongly agree" (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.

    Measured: Change from Baseline to 6 months

Secondary outcomes (9)
  1. Mental Health Continuum - Short Form

    Mental Health Continuum - Short Form assess mental health and addictions by measuring emotional, psychological and social well-being. It contains 14 items on a 6 point scale ranging from at minimum "never" (0) to, at maximum, "every day" (5). Higher scores indicate better outcomes. Range is 0-5 (means) with pre-post differences reported.

    Measured: Change from baseline to 6 month

  2. Cognitive and Affective Mindfulness Scale

    Cognitive and Affective Mindfulness Scale Revised was used to measure mindfulness and has demonstrated acceptable reliability (Feldman, Hayes, Kumar, Greeson, \& Laurenceau, 2007). It contains 10 items. The minimum score is "rarely/Not at all" (1) and the maximum score is "almost always" (4). Higher scores indicate better outcomes with a mean item range from 1-4 with pre-post mean change reported.

    Measured: Change from baseline to 6 months

  3. Community Integration Scale

    Behavioural and psychological aspects of community integration was examined using Community Integration Scale The scale contains 7 dichotomous questions with higher scores indicating greater community integration (better outcomes). Mean item range is 0-1 with mean change reported.

    Measured: Change from baseline to 6 months

  4. Community Integration Measure

    Behavioural and psychological aspects of community integration were examined using the Community Integration Measure. The measure contains 6 items scored on a 5 point scale ranging from, at minimum, "always disagree" (1) to, at maximum, "always agree" (5). Higher scores indicating better outcomes with an item mean range from 1-5 with mean pre-post differences reported.

    Measured: Change from baseline to 6 months

  5. Resilience Scale

    Resilience will be measured using the 10-item Resilience Scale. Each item score ranges from, at minimum, "Not true at all" (0) to, at maximum, "True nearly all the time" (4) with higher scores indicating better outcomes. Mean item range is from 0-4 with pre-post change in means reported.

    Measured: Change from baseline to 6 months

  6. Adults Hope Scale

    Adult Hope Scale, a cognitive measure of hope, was employed. This self-report questionnaire contains 8 questions that are each scored on an 8 point Likert scale with scores ranging from "Definitely False" to "Definitely True". Higher scores indicate better outcomes. Mean item range is minimum 1 to maximum 8 with pre-post mean differences reported.

    Measured: Change from baseline to 6 months

  7. GAIN Short Screener (CAMH Modified)

    Mental health (and addictions) was measured using the Global Assessment of Individual Needs Short Screener, which includes 22 items scored on a 5 point scale ranging from "never" (0) as the minimum score and "past month" (4) as the maximum score. Higher scores indicate worse outcomes. Mean item range is 0-4 with pre-post mean change reported.

    Measured: Change from baseline to 6 months

  8. Medical Outcomes Study (MOS) Social Support Survey

    We used a modified version of the Medical Outcomes Study Social Support Survey to measure social support. It is a 15-item 5-point Likert-type scale. The maximum score is "all of the time" (5) and the minimum score is "none of the time" (1). Higher score indicates better outcome. Item mean range is 1-5 with pre-post mean difference reported.

    Measured: Change from baseline to 6 month

  9. World Health Organization Quality of Life Scale - BREF

    The brief World Health Organization Quality of Life Scale - BREF contains 26 items, each scored from 1 to 5 with various labels for each score (e.g. 1= "very poor" for item 1 and 1= "very dissatisfied" for item 2). Higher scores indicate better outcomes with a mean item range of 1-5 with pre-post mean change reported.

    Measured: Change from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2017
  2. Study start1 Apr 2017
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03277794
Sponsor's protocol ID
02/06/2017
Status last verified
Feb 2021
First submitted
14 Aug 2017
Last updated
18 Mar 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Altena AM, Brilleslijper-Kater SN, Wolf JL. Effective interventions for homeless youth: a systematic review. Am J Prev Med. 2010 Jun;38(6):637-45. doi: 10.1016/j.amepre.2010.02.017.

    PubMed 20494240
  • Barber CC, Fonagy P, Fultz J, Simulinas M, Yates M. Homeless near a thousand homes: outcomes of homeless youth in a crisis shelter. Am J Orthopsychiatry. 2005 Jul;75(3):347-55. doi: 10.1037/0002-9432.75.3.347.

    PubMed 16060731
  • Boyatzis, R. E. (1998). Transforming Qualitative Information: Thematic Analysis and code Development. Thousand Oaks, California: Sage.

  • Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

    PubMed 12703651
  • Bryman, A. (2006). Integrating quantitative and qualitative research: How is it done? Qualitative Research, 6, 97-113.

  • Cloitre M, Courtois CA, Charuvastra A, Carapezza R, Stolbach BC, Green BL. Treatment of complex PTSD: results of the ISTSS expert clinician survey on best practices. J Trauma Stress. 2011 Dec;24(6):615-27. doi: 10.1002/jts.20697. Epub 2011 Dec 6.

    PubMed 22147449
  • Craig TK, Hodson S. Homeless youth in London: I. Childhood antecedents and psychiatric disorder. Psychol Med. 1998 Nov;28(6):1379-88. doi: 10.1017/s0033291798007351.

    PubMed 9854279
  • Research design: qualitative, quantitative and mixed methods approaches Research design: qualitative, quantitative and mixed methods approaches Creswell John W Sage 320 pound29 0761924426 0761924426 [Formula: see text]. Nurse Res. 2004 Sep 1;12(1):82-83. doi: 10.7748/nr.12.1.82.s2.

    PubMed 28718745
  • Frederick, T., Chwalek, M., Hughes, J., Karabanow, J., & Kidd, S.A. (2014). How stable is stable? Defining and measuring housing stability. Journal of Community Psychology, 42, 964-979*.

  • Gaetz, S., Donaldson, J., Richter, T., & Gulliver, T. (2013). The State of Homelessness in Canada - 2013. Toronto: Canadian Homeless Research Network Press.

  • Grabbe, L., Nguy, S. & Higgins, M. (2012). Spirituality development for homeless youth: A mindfulness meditation feasibility pilot. Journal of Child and Family Studies 21, 925-37.

  • Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.

    PubMed 16204405
  • Hurn J, Kneebone I, Cropley M. Goal setting as an outcome measure: A systematic review. Clin Rehabil. 2006 Sep;20(9):756-72. doi: 10.1177/0269215506070793.

    PubMed 17005500
  • Hwang SW, Kirst MJ, Chiu S, Tolomiczenko G, Kiss A, Cowan L, Levinson W. Multidimensional social support and the health of homeless individuals. J Urban Health. 2009 Sep;86(5):791-803. doi: 10.1007/s11524-009-9388-x. Epub 2009 Jul 23.

    PubMed 19629703
  • Karabanow J. (2004). Being Young and Homeless: Understanding how youth enter and exit street life. New York, NY. Peter Lang Publishing INC.

Questions about this trial

What is this clinical trial studying?

A study testing HOP-C and Transitional Case Management Only in people with Youth and Homelessness, 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 2 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 18 Mar 2021. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: Change from Baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03277794, which also lists 45 linked publications.

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 18 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.

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