- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277794
Generating Evidence for a Support Package to Stabilize Youth Trajectories Out of Homelessness
Generating Evidence for a Comprehensive Support Package to Stabilize Youth Trajectories Out of Homelessness: A Tertiary Prevention Strategy
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5T 1R8
- Centre for Addiction and Mental Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between the ages of 16 and 26
- have obtained secure housing in a time period up to 12 months previously
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Transitional Case Management Only
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.
|
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.
|
EXPERIMENTAL: Full HOP-C Service
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Housing
Time Frame: Change from Baseline to 6 months
|
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.
|
Change from Baseline to 6 months
|
Employment/Education
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Mental Health
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Housing Security Scale
Time Frame: Change from Baseline to 6 months
|
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.
|
Change from Baseline to 6 months
|
Housing Security Scale (Subjective Housing Stability Subscale)
Time Frame: Change from Baseline to 6 months
|
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.
|
Change from Baseline to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Health Continuum - Short Form
Time Frame: Change from baseline to 6 month
|
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.
|
Change from baseline to 6 month
|
Cognitive and Affective Mindfulness Scale
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Community Integration Scale
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Community Integration Measure
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Resilience Scale
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Adults Hope Scale
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
GAIN Short Screener (CAMH Modified)
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Medical Outcomes Study (MOS) Social Support Survey
Time Frame: Change from baseline to 6 month
|
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.
|
Change from baseline to 6 month
|
World Health Organization Quality of Life Scale - BREF
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
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- Karabanow J. (2004). Being Young and Homeless: Understanding how youth enter and exit street life. New York, NY. Peter Lang Publishing INC.
- Karabanow, J., Hopkins, S., Kisely, S., Parker, J., Hughes, J., Gahagan, J., and Campbell, LA. (2007). Can You Be healthy on the Street?: Exploring the Health Experiences of Halifax Street Youth. The Canadian Journal of Urban Research, 16, 12-32.
- Karabanow, J. (2008). Getting off the Street: Exploring Young People's Street Exits. American Behavioral Scientist, 51, 772-788.
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- Kidd SA, Scrimenti K. Evaluating child and youth homelessness. Eval Rev. 2004 Aug;28(4):325-41. doi: 10.1177/0193841X04264820.
- Kidd, S.A. (2006). Factors precipitating suicidality among homeless youth: A quantitative follow-up. Youth & Society, 37, 393-422.
- Kidd, S.A., & Davidson, L. (2007). "You have to adapt because you have no other choice.": The stories of strength and resilience of 208 homeless youth in New York City and Toronto. Journal of Community Psychology, 35, 219-238.
- Kidd S. Invited commentary: seeking a coherent strategy in our response to homeless and street-involved youth: a historical review and suggested future directions. J Youth Adolesc. 2012 May;41(5):533-43. doi: 10.1007/s10964-012-9743-1.
- Kidd, S.A., Frederick, T., Karabanow, J.,Hughes, J., & Barbic, S. (2016). A mixed methods of recently homeless youth efforts to sustain housing and stability. Child and Adolescent Social Work Journal, 33, 207-218.
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- Stergiopoulos V, Gozdzik A, O'Campo P, Holtby AR, Jeyaratnam J, Tsemberis S. Housing First: exploring participants' early support needs. BMC Health Serv Res. 2014 Apr 13;14:167. doi: 10.1186/1472-6963-14-167.
- Tevendale HD, Comulada WS, Lightfoot MA. Finding shelter: two-year housing trajectories among homeless youth. J Adolesc Health. 2011 Dec;49(6):615-20. doi: 10.1016/j.jadohealth.2011.04.021.
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- Wagnild G.M. The Resilience Scale user's guide for the US English version of the Resilience Scale and the 14- Item Resilience Scale (RS-14). Worden, MT: The Resilience Center. 2010.
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- Kidd SA, Vitopoulos N, Frederick T, Leon S, Wang W, Mushquash C, McKenzie K. Trialing the feasibility of a critical time intervention for youth transitioning out of homelessness. Am J Orthopsychiatry. 2020;90(5):535-545. doi: 10.1037/ort0000454. Epub 2020 Apr 20.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 02/06/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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