<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03277794</url>
  </required_header>
  <id_info>
    <org_study_id>02/06/2017</org_study_id>
    <nct_id>NCT03277794</nct_id>
  </id_info>
  <brief_title>Generating Evidence for a Support Package to Stabilize Youth Trajectories Out of Homelessness</brief_title>
  <official_title>Generating Evidence for a Comprehensive Support Package to Stabilize Youth Trajectories Out of Homelessness: A Tertiary Prevention Strategy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre for Addiction and Mental Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre for Addiction and Mental Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project builds upon initial proof of concept work examining the optimal set of supports&#xD;
      for youth who have recently exited homelessness - an intervention comprised of mental health&#xD;
      and peer supports alongside transitional case management. This collaborative model will be&#xD;
      tested as a proof-of-concept in Thunder Bay with Indigenous youth and a trial will be&#xD;
      conducted in Toronto to optimize and determine the effectiveness of the existing model of&#xD;
      support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In response to the challenges outlined above, and with the support of a grant from the&#xD;
      Ontario Ministry of Child and Youth Services, the investigators developed and tested a&#xD;
      tertiary prevention strategy called the Housing Outreach Program Collaborative (HOP-C) which&#xD;
      launched in the summer of 2015. In this approach the investigators focused on collaborations&#xD;
      and interventions that have the greatest potential to be effective with this population. The&#xD;
      investigators brought together partners from a number of sectors in the GTA and have tested a&#xD;
      3-pronged set of supports (intervention described in detail in the methods):&#xD;
&#xD;
        -  Transitional Case Management&#xD;
&#xD;
        -  Mental Health Interventions: Group, individual, family&#xD;
&#xD;
        -  Peer Support This is an intensive, 6-month critical time intervention - one that jointly&#xD;
           addresses many points of vulnerability (mental health crises, housing instability,&#xD;
           justice involvement) while fostering resilience and connection with resources in&#xD;
           employment, education and training domains. It is unique in both content&#xD;
           comprehensiveness and integrated process of delivery. Also important was the development&#xD;
           of a collaborative and responsive partnering process, to facilitate effective&#xD;
           organizational interfaces and seamless service integration so participants can&#xD;
           experience a tailored and coherent set of supports. With CAMH, the Centre for&#xD;
           Mindfulness Studies, Covenant House, LOFT, and SKETCH at the service level and the&#xD;
           Wellesley Institute leading evaluation, the investigators have carefully attended to a&#xD;
           collective impact framework.&#xD;
&#xD;
      This initiative has proven feasible and is demonstrating good outcomes - with excellent youth&#xD;
      engagement, reports of lower social isolation, improved mental health, and engagement with&#xD;
      resources, and spin-off benefits of closer collaboration between organizations. The&#xD;
      investigators successfully met the target of youth engagement, with a total of 31 youth&#xD;
      participating, minimal attrition (n=2), and the investigators observed no indications that&#xD;
      HOP-C resulted in risk of any form, both with respect to the intervention itself and the&#xD;
      mixed methods research methodology. This promising feasibility work formed the foundation&#xD;
      from which the investigators were successful in obtaining a grant from the Local Poverty&#xD;
      Reduction Fund to support the study described in this proposal.&#xD;
&#xD;
      Current Project Determine through a randomized trial in Toronto if the positive outcomes the&#xD;
      investigators are observing are due solely or primarily to transitional case management and&#xD;
      if the additional peer and mental health components are necessary.&#xD;
&#xD;
      Engaging in intensive, tertiary prevention shows clear promise in disrupting a cycle of&#xD;
      poverty and marginalization at a critical time - if proven and scaled a key driver of chronic&#xD;
      homelessness would be addressed.&#xD;
&#xD;
      Research Questions The objective of this two-part project is to examine the effectiveness and&#xD;
      transferability of the Housing Outreach Program-Collaboration (HOP-C) transitional&#xD;
      intervention. HOP-C has proven to be feasible with promising outcomes in the Toronto&#xD;
      proof-of-concept work currently underway.&#xD;
&#xD;
      1. Are the benefits of the complex HOP-C intervention with all components in place greater&#xD;
      than transitional case management in isolation?&#xD;
&#xD;
      • It is hypothesized that the full model will provide benefit in domains of housing&#xD;
      stability, mental health, and quality of life that are significantly greater than case&#xD;
      management alone.&#xD;
&#xD;
      The investigators have data in hand from their recent national work in the area which&#xD;
      provides data on 'treatment as usual' or the outcomes that attend typically available&#xD;
      supports. The proposed trial will unpack benefit and be essential in economic and viability&#xD;
      arguments to be made going forward.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Housing</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Employment/Education</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental Health</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Housing Security Scale</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>The Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from &quot;strongly disagree&quot; (minimum = 1) to &quot;strongly agree&quot; (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Housing Security Scale (Subjective Housing Stability Subscale)</measure>
    <time_frame>Change from Baseline to 6 months</time_frame>
    <description>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 &quot;strongly disagree&quot; (minimum = 1) to &quot;strongly agree&quot; (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mental Health Continuum - Short Form</measure>
    <time_frame>Change from baseline to 6 month</time_frame>
    <description>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 &quot;never&quot; (0) to, at maximum, &quot;every day&quot; (5). Higher scores indicate better outcomes. Range is 0-5 (means) with pre-post differences reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive and Affective Mindfulness Scale</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>Cognitive and Affective Mindfulness Scale Revised was used to measure mindfulness and has demonstrated acceptable reliability (Feldman, Hayes, Kumar, Greeson, &amp; Laurenceau, 2007). It contains 10 items. The minimum score is &quot;rarely/Not at all&quot; (1) and the maximum score is &quot;almost always&quot; (4). Higher scores indicate better outcomes with a mean item range from 1-4 with pre-post mean change reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Integration Scale</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Community Integration Measure</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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, &quot;always disagree&quot; (1) to, at maximum, &quot;always agree&quot; (5). Higher scores indicating better outcomes with an item mean range from 1-5 with mean pre-post differences reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resilience Scale</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>Resilience will be measured using the 10-item Resilience Scale. Each item score ranges from, at minimum, &quot;Not true at all&quot; (0) to, at maximum, &quot;True nearly all the time&quot; (4) with higher scores indicating better outcomes. Mean item range is from 0-4 with pre-post change in means reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adults Hope Scale</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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 &quot;Definitely False&quot; to &quot;Definitely True&quot;. Higher scores indicate better outcomes. Mean item range is minimum 1 to maximum 8 with pre-post mean differences reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GAIN Short Screener (CAMH Modified)</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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 &quot;never&quot; (0) as the minimum score and &quot;past month&quot; (4) as the maximum score. Higher scores indicate worse outcomes. Mean item range is 0-4 with pre-post mean change reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study (MOS) Social Support Survey</measure>
    <time_frame>Change from baseline to 6 month</time_frame>
    <description>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 &quot;all of the time&quot; (5) and the minimum score is &quot;none of the time&quot; (1). Higher score indicates better outcome. Item mean range is 1-5 with pre-post mean difference reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life Scale - BREF</measure>
    <time_frame>Change from baseline to 6 months</time_frame>
    <description>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= &quot;very poor&quot; for item 1 and 1= &quot;very dissatisfied&quot; for item 2). Higher scores indicate better outcomes with a mean item range of 1-5 with pre-post mean change reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Youth</condition>
  <condition>Homelessness</condition>
  <arm_group>
    <arm_group_label>Transitional Case Management Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Full HOP-C Service</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>HOP-C</intervention_name>
    <description>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.</description>
    <arm_group_label>Full HOP-C Service</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Transitional Case Management Only</intervention_name>
    <description>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.</description>
    <arm_group_label>Transitional Case Management Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between the ages of 16 and 26&#xD;
&#xD;
          -  have obtained secure housing in a time period up to 12 months previously&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sean A Kidd, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre for Addiction and Mental Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.camh.ca/en/research/Pages/research.aspx</url>
    <description>Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teaching hospital.</description>
  </link>
  <reference>
    <citation>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.</citation>
    <PMID>20494240</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16060731</PMID>
  </reference>
  <reference>
    <citation>Boyatzis, R. E. (1998). Transforming Qualitative Information: Thematic Analysis and code Development. Thousand Oaks, California: Sage.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12703651</PMID>
  </reference>
  <reference>
    <citation>Bryman, A. (2006). Integrating quantitative and qualitative research: How is it done? Qualitative Research, 6, 97-113.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22147449</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9854279</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28718745</PMID>
  </reference>
  <reference>
    <citation>Frederick, T., Chwalek, M., Hughes, J., Karabanow, J., &amp; Kidd, S.A. (2014). How stable is stable? Defining and measuring housing stability. Journal of Community Psychology, 42, 964-979*.</citation>
  </reference>
  <reference>
    <citation>Gaetz, S., Donaldson, J., Richter, T., &amp; Gulliver, T. (2013). The State of Homelessness in Canada - 2013. Toronto: Canadian Homeless Research Network Press.</citation>
  </reference>
  <reference>
    <citation>Grabbe, L., Nguy, S. &amp; Higgins, M. (2012). Spirituality development for homeless youth: A mindfulness meditation feasibility pilot. Journal of Child and Family Studies 21, 925-37.</citation>
  </reference>
  <reference>
    <citation>Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.</citation>
    <PMID>16204405</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17005500</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19629703</PMID>
  </reference>
  <reference>
    <citation>Karabanow J. (2004). Being Young and Homeless: Understanding how youth enter and exit street life. New York, NY. Peter Lang Publishing INC.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Karabanow, J. (2008). Getting off the Street: Exploring Young People's Street Exits. American Behavioral Scientist, 51, 772-788.</citation>
  </reference>
  <reference>
    <citation>Kerrigan D, Johnson K, Stewart M, Magyari T, Hutton N, Ellen JM, Sibinga EM. Perceptions, experiences, and shifts in perspective occurring among urban youth participating in a mindfulness-based stress reduction program. Complement Ther Clin Pract. 2011 May;17(2):96-101. doi: 10.1016/j.ctcp.2010.08.003. Epub 2010 Sep 16.</citation>
    <PMID>21457899</PMID>
  </reference>
  <reference>
    <citation>Kidd SA, Scrimenti K. Evaluating child and youth homelessness. Eval Rev. 2004 Aug;28(4):325-41. doi: 10.1177/0193841X04264820.</citation>
    <PMID>15245623</PMID>
  </reference>
  <reference>
    <citation>Kidd, S.A. (2006). Factors precipitating suicidality among homeless youth: A quantitative follow-up. Youth &amp; Society, 37, 393-422.</citation>
  </reference>
  <reference>
    <citation>Kidd, S.A., &amp; Davidson, L. (2007). &quot;You have to adapt because you have no other choice.&quot;: The stories of strength and resilience of 208 homeless youth in New York City and Toronto. Journal of Community Psychology, 35, 219-238.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22302217</PMID>
  </reference>
  <reference>
    <citation>Kidd, S.A., Frederick, T., Karabanow, J.,Hughes, J., &amp; 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.</citation>
  </reference>
  <reference>
    <citation>Linehan, M. (2014). DBT Skills Training Manual Second Edition. New York: The Guilford Press.</citation>
  </reference>
  <reference>
    <citation>Milburn NG, Rice E, Rotheram-Borus MJ, Mallett S, Rosenthal D, Batterham P, May SJ, Witkin A, Duan N. Adolescents Exiting Homelessness Over Two Years: The Risk Amplification and Abatement Model. J Res Adolesc. 2009 Dec 1;19(4):762-785. doi: 10.1111/j.1532-7795.2009.00610.x.</citation>
    <PMID>25067896</PMID>
  </reference>
  <reference>
    <citation>Public Health Agency of Canada. (2006). Street Youth in Canada. www.publichealth.gc.ca/sti</citation>
  </reference>
  <reference>
    <citation>Rew L, Horner SD. Personal strengths of homeless adolescents living in a high-risk environment. ANS Adv Nurs Sci. 2003 Apr-Jun;26(2):90-101. doi: 10.1097/00012272-200304000-00002.</citation>
    <PMID>12795538</PMID>
  </reference>
  <reference>
    <citation>Rosenthal D, Rotheram-Borus MJ, Batterham P, Mallett S, Rice E, Milburn NG. Housing stability over two years and HIV risk among newly homeless youth. AIDS Behav. 2007 Nov;11(6):831-41. doi: 10.1007/s10461-007-9235-6. Epub 2007 May 12.</citation>
    <PMID>17497219</PMID>
  </reference>
  <reference>
    <citation>Roy E, Haley N, Leclerc P, Sochanski B, Boudreau JF, Boivin JF. Mortality in a cohort of street youth in Montreal. JAMA. 2004 Aug 4;292(5):569-74. doi: 10.1001/jama.292.5.569.</citation>
    <PMID>15292082</PMID>
  </reference>
  <reference>
    <citation>Roy E, Haley N, Boudreau JF, Leclerc P, Boivin JF. The challenge of understanding mortality changes among street youth. J Urban Health. 2010 Jan;87(1):95-101. doi: 10.1007/s11524-009-9397-9. Epub 2009 Dec 29.</citation>
    <PMID>20039140</PMID>
  </reference>
  <reference>
    <citation>Roy E, Robert M, Fournier L, Vaillancourt E, Vandermeerschen J, Boivin JF. Residential trajectories of street youth-the Montreal Cohort Study. J Urban Health. 2014 Oct;91(5):1019-31. doi: 10.1007/s11524-013-9860-5.</citation>
    <PMID>24515932</PMID>
  </reference>
  <reference>
    <citation>Rush B, Castel S, Brands B, Toneatto T, Veldhuizen S. Validation and comparison of diagnostic accuracy of four screening tools for mental disorders in people seeking treatment for substance use disorders. J Subst Abuse Treat. 2013 Apr;44(4):375-83. doi: 10.1016/j.jsat.2012.08.221. Epub 2012 Oct 23.</citation>
    <PMID>23098381</PMID>
  </reference>
  <reference>
    <citation>Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.</citation>
    <PMID>7899572</PMID>
  </reference>
  <reference>
    <citation>Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.</citation>
    <PMID>2035047</PMID>
  </reference>
  <reference>
    <citation>Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.</citation>
    <PMID>15085902</PMID>
  </reference>
  <reference>
    <citation>Slesnick N, Kang MJ, Bonomi AE, Prestopnik JL. Six- and twelve-month outcomes among homeless youth accessing therapy and case management services through an urban drop-in center. Health Serv Res. 2008 Feb;43(1 Pt 1):211-29. doi: 10.1111/j.1475-6773.2007.00755.x.</citation>
    <PMID>18211526</PMID>
  </reference>
  <reference>
    <citation>Slesnick N, Bartle-Haring S, Dashora P, Kang MJ, Aukward E. Predictors of Homelessness Among Street Living Youth. J Youth Adolesc. 2008;37(4):465-474. doi: 10.1007/s10964-007-9188-0.</citation>
    <PMID>18584069</PMID>
  </reference>
  <reference>
    <citation>Slesnick N, Dashora P, Letcher A, Erdem G, Serovich J. A Review of Services and Interventions for Runaway and Homeless Youth: Moving Forward. Child Youth Serv Rev. 2009 Jul;31(7):732-742. doi: 10.1016/j.childyouth.2009.01.006.</citation>
    <PMID>20161294</PMID>
  </reference>
  <reference>
    <citation>Snyder CR, Harris C, Anderson JR, Holleran SA, Irving LM, Sigmon ST, Yoshinobu L, Gibb J, Langelle C, Harney P. The will and the ways: development and validation of an individual-differences measure of hope. J Pers Soc Psychol. 1991 Apr;60(4):570-85. doi: 10.1037//0022-3514.60.4.570.</citation>
    <PMID>2037968</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24725374</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22098772</PMID>
  </reference>
  <reference>
    <citation>Unesco. (2014, July 4). Street Children. Retrieved from: http://www.unesco.org/new/en/social-and-human-sciences/themes/fight-against-discrimination/education-of-children-in-need/street-children/.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>Yalom, I.D. &amp; Leszcz, M. (2005). The Theory &amp; Practice of Group Psychotherapy, 5th ed. N.Y.: Basic Books.</citation>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <results_first_submitted>August 11, 2020</results_first_submitted>
  <results_first_submitted_qc>February 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 23, 2021</results_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre for Addiction and Mental Health</investigator_affiliation>
    <investigator_full_name>Sean Kidd</investigator_full_name>
    <investigator_title>Clinician Scientist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03277794/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 29, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/94/NCT03277794/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transitional Case Management Only</title>
          <description>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.&#xD;
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.</description>
        </group>
        <group group_id="P2">
          <title>Full HOP-C Service</title>
          <description>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.&#xD;
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.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrew due to high acuity</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transitional Case Management Only</title>
          <description>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.</description>
        </group>
        <group group_id="B2">
          <title>Full HOP-C Service</title>
          <description>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.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="65"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.74" spread="2.03"/>
                    <measurement group_id="B2" value="21.76" spread="2.14"/>
                    <measurement group_id="B3" value="21.75" spread="2.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White - North American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black - African</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black - Caribbean</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other/Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexual Orientation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Heterosexual</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bi-Sexual</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer not to answer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other/Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Some High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Completed High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Transitional Program</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other/Not Specified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Homelessness - Lifetime Length</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>6-12 Months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-2 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-3 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3+ years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>NEET - Not in Employment, Education or Training</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Housing</title>
        <description>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.</description>
        <time_frame>Change from Baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Housing</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.354</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.28</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.89</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.465</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.95</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Employment/Education</title>
        <description>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.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Employment/Education</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.159</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.59</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.200</p_value>
            <method>Regression, Linear</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.30</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.64</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mental Health</title>
        <description>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.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Mental Health</title>
          <description>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.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.121</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.74</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Full HOP-C Service (Treatment) vs. Transitional Case Management Only (Control)</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.134</p_value>
            <method>Regression, Logistic</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>3.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Housing Security Scale</title>
        <description>The Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from &quot;strongly disagree&quot; (minimum = 1) to &quot;strongly agree&quot; (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.</description>
        <time_frame>Change from Baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Housing Security Scale</title>
          <description>The Housing Security Scale contains 12 items on a 5 point likert scale (Frederick et al., 2014). Scores range from &quot;strongly disagree&quot; (minimum = 1) to &quot;strongly agree&quot; (maximum = 5). Higher scores indicate better outcomes. Mean item range is 1-5 with pre-post difference reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.017" spread="0.129"/>
                    <measurement group_id="O2" value="0.153" spread="0.098"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.899</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.128</p_value>
            <p_value_desc>Unadjusted</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Housing Security Scale (Subjective Housing Stability Subscale)</title>
        <description>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 &quot;strongly disagree&quot; (minimum = 1) to &quot;strongly agree&quot; (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.</description>
        <time_frame>Change from Baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Housing Security Scale (Subjective Housing Stability Subscale)</title>
          <description>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 &quot;strongly disagree&quot; (minimum = 1) to &quot;strongly agree&quot; (maximum = 5). Higher scores indicate better outcomes with a mean range of 1-5 with pre-post change reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.259" spread="0.196"/>
                    <measurement group_id="O2" value="0.422" spread="0.167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.198</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.017</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mental Health Continuum - Short Form</title>
        <description>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 &quot;never&quot; (0) to, at maximum, &quot;every day&quot; (5). Higher scores indicate better outcomes. Range is 0-5 (means) with pre-post differences reported.</description>
        <time_frame>Change from baseline to 6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Mental Health Continuum - Short Form</title>
          <description>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 &quot;never&quot; (0) to, at maximum, &quot;every day&quot; (5). Higher scores indicate better outcomes. Range is 0-5 (means) with pre-post differences reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.276" spread="0.157"/>
                    <measurement group_id="O2" value="0.077" spread="0.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.091</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.591</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cognitive and Affective Mindfulness Scale</title>
        <description>Cognitive and Affective Mindfulness Scale Revised was used to measure mindfulness and has demonstrated acceptable reliability (Feldman, Hayes, Kumar, Greeson, &amp; Laurenceau, 2007). It contains 10 items. The minimum score is &quot;rarely/Not at all&quot; (1) and the maximum score is &quot;almost always&quot; (4). Higher scores indicate better outcomes with a mean item range from 1-4 with pre-post mean change reported.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Cognitive and Affective Mindfulness Scale</title>
          <description>Cognitive and Affective Mindfulness Scale Revised was used to measure mindfulness and has demonstrated acceptable reliability (Feldman, Hayes, Kumar, Greeson, &amp; Laurenceau, 2007). It contains 10 items. The minimum score is &quot;rarely/Not at all&quot; (1) and the maximum score is &quot;almost always&quot; (4). Higher scores indicate better outcomes with a mean item range from 1-4 with pre-post mean change reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.226" spread="0.099"/>
                    <measurement group_id="O2" value="0.176" spread="0.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.030</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.005</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Community Integration Scale</title>
        <description>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.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Community Integration Scale</title>
          <description>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.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.108" spread="0.075"/>
                    <measurement group_id="O2" value="0.008" spread="0.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.163</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.865</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Community Integration Measure</title>
        <description>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, &quot;always disagree&quot; (1) to, at maximum, &quot;always agree&quot; (5). Higher scores indicating better outcomes with an item mean range from 1-5 with mean pre-post differences reported.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Community Integration Measure</title>
          <description>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, &quot;always disagree&quot; (1) to, at maximum, &quot;always agree&quot; (5). Higher scores indicating better outcomes with an item mean range from 1-5 with mean pre-post differences reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.239"/>
                    <measurement group_id="O2" value="-0.051" spread="0.163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.980</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.758</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Resilience Scale</title>
        <description>Resilience will be measured using the 10-item Resilience Scale. Each item score ranges from, at minimum, &quot;Not true at all&quot; (0) to, at maximum, &quot;True nearly all the time&quot; (4) with higher scores indicating better outcomes. Mean item range is from 0-4 with pre-post change in means reported.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Resilience Scale</title>
          <description>Resilience will be measured using the 10-item Resilience Scale. Each item score ranges from, at minimum, &quot;Not true at all&quot; (0) to, at maximum, &quot;True nearly all the time&quot; (4) with higher scores indicating better outcomes. Mean item range is from 0-4 with pre-post change in means reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.252" spread="0.159"/>
                    <measurement group_id="O2" value="0.093" spread="0.065"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.124</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.168</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adults Hope Scale</title>
        <description>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 &quot;Definitely False&quot; to &quot;Definitely True&quot;. Higher scores indicate better outcomes. Mean item range is minimum 1 to maximum 8 with pre-post mean differences reported.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Adults Hope Scale</title>
          <description>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 &quot;Definitely False&quot; to &quot;Definitely True&quot;. Higher scores indicate better outcomes. Mean item range is minimum 1 to maximum 8 with pre-post mean differences reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.218" spread="0.276"/>
                    <measurement group_id="O2" value="-0.038" spread="0.099"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.436</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.706</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GAIN Short Screener (CAMH Modified)</title>
        <description>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 &quot;never&quot; (0) as the minimum score and &quot;past month&quot; (4) as the maximum score. Higher scores indicate worse outcomes. Mean item range is 0-4 with pre-post mean change reported.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>GAIN Short Screener (CAMH Modified)</title>
          <description>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 &quot;never&quot; (0) as the minimum score and &quot;past month&quot; (4) as the maximum score. Higher scores indicate worse outcomes. Mean item range is 0-4 with pre-post mean change reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Internalizing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.124" spread="0.236"/>
                    <measurement group_id="O2" value="-0.265" spread="0.191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Externalizing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.151" spread="0.15"/>
                    <measurement group_id="O2" value="-0.212" spread="0.171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Substance Use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.308" spread="0.184"/>
                    <measurement group_id="O2" value="-0.291" spread="0.147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Internalizing</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.604</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Internalizing</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.177</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Externalizing</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.325</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Externalizing</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.227</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Substance Use</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.106</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Substance Use</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.058</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Medical Outcomes Study (MOS) Social Support Survey</title>
        <description>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 &quot;all of the time&quot; (5) and the minimum score is &quot;none of the time&quot; (1). Higher score indicates better outcome. Item mean range is 1-5 with pre-post mean difference reported.</description>
        <time_frame>Change from baseline to 6 month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>Medical Outcomes Study (MOS) Social Support Survey</title>
          <description>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 &quot;all of the time&quot; (5) and the minimum score is &quot;none of the time&quot; (1). Higher score indicates better outcome. Item mean range is 1-5 with pre-post mean difference reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Emotional Supports</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.043" spread="0.247"/>
                    <measurement group_id="O2" value="0.174" spread="0.196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tangible Supports</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.110" spread="0.264"/>
                    <measurement group_id="O2" value="-0.003" spread="0.194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Affectionate Supports</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.115" spread="0.297"/>
                    <measurement group_id="O2" value="0.333" spread="0.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Emotional Supports</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.862</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Emotional Supports</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.382</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Tangible Supports</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.680</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Tangible Supports</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.988</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Affectionate</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.701</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Affectionate</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.154</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>World Health Organization Quality of Life Scale - BREF</title>
        <description>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= &quot;very poor&quot; for item 1 and 1= &quot;very dissatisfied&quot; for item 2). Higher scores indicate better outcomes with a mean item range of 1-5 with pre-post mean change reported.</description>
        <time_frame>Change from baseline to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transitional Case Management Only</title>
            <description>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.</description>
          </group>
          <group group_id="O2">
            <title>Full HOP-C Service</title>
            <description>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.</description>
          </group>
        </group_list>
        <measure>
          <title>World Health Organization Quality of Life Scale - BREF</title>
          <description>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= &quot;very poor&quot; for item 1 and 1= &quot;very dissatisfied&quot; for item 2). Higher scores indicate better outcomes with a mean item range of 1-5 with pre-post mean change reported.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical Health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.201" spread="0.552"/>
                    <measurement group_id="O2" value="0.717" spread="0.484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.117" spread="0.432"/>
                    <measurement group_id="O2" value="0.086" spread="0.355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Social</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.308" spread="0.869"/>
                    <measurement group_id="O2" value="0.099" spread="0.376"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Environment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.124" spread="0.596"/>
                    <measurement group_id="O2" value="0.843" spread="0.407"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Physical Health</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.719</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Physical Health</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.150</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Psychological</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.789</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Psychological</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.811</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Social</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.726</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Social</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.795</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Environment</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.837</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Environment</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.048</p_value>
            <p_value_desc>Unadjusted.</p_value_desc>
            <method>Regression, Linear</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Transitional Case Management Only</title>
          <description>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.&#xD;
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.</description>
        </group>
        <group group_id="E2">
          <title>Full HOP-C Service</title>
          <description>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.&#xD;
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.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="34"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Variability in youth service need resulting in variable effectiveness of treatment. In attempt to normalize the control group, it became less generalizable. RCT challenges with engagement and trust.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Sean Kidd</name_or_title>
      <organization>Centre for Addiction and Mental Health</organization>
      <phone>416-535-8501 ext 36295</phone>
      <email>sean.kidd@camh.ca</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277794
org study id: 02/06/2017
nct id: NCT03277794
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Housing
time frame: Change from Baseline to 6 months
description: 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.
measure: Employment/Education
time frame: Change from baseline to 6 months
description: 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.
measure: Mental Health
time frame: Change from baseline to 6 months
description: 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.
measure: Housing Security Scale
time frame: Change from Baseline to 6 months
description: 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.
measure: Housing Security Scale (Subjective Housing Stability Subscale)
time frame: Change from Baseline to 6 months
description: 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.
measure: Mental Health Continuum - Short Form
time frame: Change from baseline to 6 month
description: 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.
measure: Cognitive and Affective Mindfulness Scale
time frame: Change from baseline to 6 months
description: 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.
measure: Community Integration Scale
time frame: Change from baseline to 6 months
description: 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.
measure: Community Integration Measure
time frame: Change from baseline to 6 months
description: 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.
measure: Resilience Scale
time frame: Change from baseline to 6 months
description: 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.
measure: Adults Hope Scale
time frame: Change from baseline to 6 months
description: 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.
measure: GAIN Short Screener (CAMH Modified)
time frame: Change from baseline to 6 months
description: 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.
measure: Medical Outcomes Study (MOS) Social Support Survey
time frame: Change from baseline to 6 month
description: 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.
measure: World Health Organization Quality of Life Scale - BREF
time frame: Change from baseline to 6 months
description: 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.
arm group label: Transitional Case Management Only
arm group type: Active Comparator
description: 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.
arm group label: Full HOP-C Service
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: HOP-C
description: 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.
arm group label: Full HOP-C Service
intervention type: Behavioral
intervention name: Transitional Case Management Only
description: 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.
arm group label: Transitional Case Management Only
criteria: 
gender: All
minimum age: 16 Years
maximum age: 26 Years
healthy volunteers: No
last name: Sean A Kidd, Phd
role: Principal Investigator
affiliation: Centre for Addiction and Mental Health
facility: 
country: Canada
url: http://www.camh.ca/en/research/Pages/research.aspx
description: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teaching hospital.
citation: 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.
PMID: 20494240
citation: 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.
PMID: 16060731
citation: Boyatzis, R. E. (1998). Transforming Qualitative Information: Thematic Analysis and code Development. Thousand Oaks, California: Sage.
citation: 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.
PMID: 12703651
citation: Bryman, A. (2006). Integrating quantitative and qualitative research: How is it done? Qualitative Research, 6, 97-113.
citation: 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.
PMID: 22147449
citation: 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.
PMID: 9854279
citation: 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.
PMID: 28718745
citation: 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*.
citation: Gaetz, S., Donaldson, J., Richter, T., & Gulliver, T. (2013). The State of Homelessness in Canada - 2013. Toronto: Canadian Homeless Research Network Press.
citation: 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.
citation: Hsieh HF, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res. 2005 Nov;15(9):1277-88. doi: 10.1177/1049732305276687.
PMID: 16204405
citation: 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.
PMID: 17005500
citation: 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.
PMID: 19629703
citation: Karabanow J. (2004). Being Young and Homeless: Understanding how youth enter and exit street life. New York, NY. Peter Lang Publishing INC.
citation: 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.
citation: Karabanow, J. (2008). Getting off the Street: Exploring Young People's Street Exits. American Behavioral Scientist, 51, 772-788.
citation: Kerrigan D, Johnson K, Stewart M, Magyari T, Hutton N, Ellen JM, Sibinga EM. Perceptions, experiences, and shifts in perspective occurring among urban youth participating in a mindfulness-based stress reduction program. Complement Ther Clin Pract. 2011 May;17(2):96-101. doi: 10.1016/j.ctcp.2010.08.003. Epub 2010 Sep 16.
PMID: 21457899
citation: Kidd SA, Scrimenti K. Evaluating child and youth homelessness. Eval Rev. 2004 Aug;28(4):325-41. doi: 10.1177/0193841X04264820.
PMID: 15245623
citation: Kidd, S.A. (2006). Factors precipitating suicidality among homeless youth: A quantitative follow-up. Youth & Society, 37, 393-422.
citation: 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.
citation: 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.
PMID: 22302217
citation: 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.
citation: Linehan, M. (2014). DBT Skills Training Manual Second Edition. New York: The Guilford Press.
citation: Milburn NG, Rice E, Rotheram-Borus MJ, Mallett S, Rosenthal D, Batterham P, May SJ, Witkin A, Duan N. Adolescents Exiting Homelessness Over Two Years: The Risk Amplification and Abatement Model. J Res Adolesc. 2009 Dec 1;19(4):762-785. doi: 10.1111/j.1532-7795.2009.00610.x.
PMID: 25067896
citation: Public Health Agency of Canada. (2006). Street Youth in Canada. www.publichealth.gc.ca/sti
citation: Rew L, Horner SD. Personal strengths of homeless adolescents living in a high-risk environment. ANS Adv Nurs Sci. 2003 Apr-Jun;26(2):90-101. doi: 10.1097/00012272-200304000-00002.
PMID: 12795538
citation: Rosenthal D, Rotheram-Borus MJ, Batterham P, Mallett S, Rice E, Milburn NG. Housing stability over two years and HIV risk among newly homeless youth. AIDS Behav. 2007 Nov;11(6):831-41. doi: 10.1007/s10461-007-9235-6. Epub 2007 May 12.
PMID: 17497219
citation: Roy E, Haley N, Leclerc P, Sochanski B, Boudreau JF, Boivin JF. Mortality in a cohort of street youth in Montreal. JAMA. 2004 Aug 4;292(5):569-74. doi: 10.1001/jama.292.5.569.
PMID: 15292082
citation: Roy E, Haley N, Boudreau JF, Leclerc P, Boivin JF. The challenge of understanding mortality changes among street youth. J Urban Health. 2010 Jan;87(1):95-101. doi: 10.1007/s11524-009-9397-9. Epub 2009 Dec 29.
PMID: 20039140
citation: Roy E, Robert M, Fournier L, Vaillancourt E, Vandermeerschen J, Boivin JF. Residential trajectories of street youth-the Montreal Cohort Study. J Urban Health. 2014 Oct;91(5):1019-31. doi: 10.1007/s11524-013-9860-5.
PMID: 24515932
citation: Rush B, Castel S, Brands B, Toneatto T, Veldhuizen S. Validation and comparison of diagnostic accuracy of four screening tools for mental disorders in people seeking treatment for substance use disorders. J Subst Abuse Treat. 2013 Apr;44(4):375-83. doi: 10.1016/j.jsat.2012.08.221. Epub 2012 Oct 23.
PMID: 23098381
citation: Sandelowski M. Sample size in qualitative research. Res Nurs Health. 1995 Apr;18(2):179-83. doi: 10.1002/nur.4770180211.
PMID: 7899572
citation: Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
PMID: 2035047
citation: Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
PMID: 15085902
citation: Slesnick N, Kang MJ, Bonomi AE, Prestopnik JL. Six- and twelve-month outcomes among homeless youth accessing therapy and case management services through an urban drop-in center. Health Serv Res. 2008 Feb;43(1 Pt 1):211-29. doi: 10.1111/j.1475-6773.2007.00755.x.
PMID: 18211526
citation: Slesnick N, Bartle-Haring S, Dashora P, Kang MJ, Aukward E. Predictors of Homelessness Among Street Living Youth. J Youth Adolesc. 2008;37(4):465-474. doi: 10.1007/s10964-007-9188-0.
PMID: 18584069
citation: Slesnick N, Dashora P, Letcher A, Erdem G, Serovich J. A Review of Services and Interventions for Runaway and Homeless Youth: Moving Forward. Child Youth Serv Rev. 2009 Jul;31(7):732-742. doi: 10.1016/j.childyouth.2009.01.006.
PMID: 20161294
citation: Snyder CR, Harris C, Anderson JR, Holleran SA, Irving LM, Sigmon ST, Yoshinobu L, Gibb J, Langelle C, Harney P. The will and the ways: development and validation of an individual-differences measure of hope. J Pers Soc Psychol. 1991 Apr;60(4):570-85. doi: 10.1037//0022-3514.60.4.570.
PMID: 2037968
citation: 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.
PMID: 24725374
citation: 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.
PMID: 22098772
citation: Unesco. (2014, July 4). Street Children. Retrieved from: http://www.unesco.org/new/en/social-and-human-sciences/themes/fight-against-discrimination/education-of-children-in-need/street-children/.
citation: 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.
citation: Yalom, I.D. & Leszcz, M. (2005). The Theory & Practice of Group Psychotherapy, 5th ed. N.Y.: Basic Books.
responsible party type: Principal Investigator
investigator affiliation: Centre for Addiction and Mental Health
investigator full name: Sean Kidd
investigator title: Clinician Scientist
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Variability in youth service need resulting in variable effectiveness of treatment. In attempt to normalize the control group, it became less generalizable. RCT challenges with engagement and trust.
point of contact: 