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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03277794
Other study ID # 02/06/2017
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2017
Est. completion date December 31, 2018

Study information

Verified date February 2021
Source Centre for Addiction and Mental Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 16 Years to 26 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HOP-C
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 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.

Locations

Country Name City State
Canada Centre for Addiction and Mental Health Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

References & Publications (44)

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

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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.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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* Note: There are 44 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline to 6 months
Primary 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. Change from baseline to 6 months
Primary 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. Change from baseline to 6 months
Primary 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. Change from Baseline to 6 months
Primary 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. Change from Baseline to 6 months
Secondary 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. Change from baseline to 6 month
Secondary 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. Change from baseline to 6 months
Secondary 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. Change from baseline to 6 months
Secondary 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. Change from baseline to 6 months
Secondary 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. Change from baseline to 6 months
Secondary 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. Change from baseline to 6 months
Secondary 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. Change from baseline to 6 months
Secondary 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. Change from baseline to 6 month
Secondary 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. Change from baseline to 6 months
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