<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/NCT03772522</url>
  </required_header>
  <id_info>
    <org_study_id>18-002</org_study_id>
    <nct_id>NCT03772522</nct_id>
  </id_info>
  <brief_title>The Identity Project</brief_title>
  <acronym>TIP</acronym>
  <official_title>The Identity Project: An Evaluation of an Identity Capital Intervention for Young People Transitioning Out of Homelessness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>dk Leadership</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Covenant House Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ontario Trillium Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Unity Health Toronto</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>
      Understanding how to create successful pathways out of homelessness is crucial. Thirty young&#xD;
      people (aged 18 - 26 years) who have transitioned out of homelessness within the past three&#xD;
      years will be offered scholarships to participate in a six week intervention that focuses on&#xD;
      building identity capital (sense of purpose and control, self-efficacy and self-esteem) and&#xD;
      providing career direction. The intervention will be designed and carried out by dk&#xD;
      Leadership - an established, highly successful leadership and counseling centre in Toronto&#xD;
      with a track record of significantly improving the life trajectories of teens and adults.&#xD;
      Importantly, study participants will be incorporated into the centre's current programming,&#xD;
      meaning the intervention will be held at a location not associated with homelessness. Study&#xD;
      participants will be collaboratively recruited by dk Leadership and Covenant House Toronto -&#xD;
      Canada's largest agency for street-involved and homeless youth.&#xD;
&#xD;
      This impact and process evaluation aims to address critical gaps in knowledge about&#xD;
      transition-related supports by asking whether and how an identity capital intervention&#xD;
      delivered outside the social service sector impacts the life-trajectories of formerly&#xD;
      homeless young people. Particular attention will be paid to whether this intervention shows&#xD;
      promise as an unconventional way to tackle poverty and improve social inclusion.&#xD;
&#xD;
      It is hypothesize that, for the primary quantitative outcome measures of hope, community&#xD;
      integration, social connectedness, and self-esteem:&#xD;
&#xD;
        1. Significant improvements in the mean scores of the intervention group compared to the&#xD;
           delayed intervention comparison group immediately post-intervention will be observed.&#xD;
&#xD;
        2. Significant improvements in the mean scores of both groups (intervention and delayed&#xD;
           intervention) immediately post-intervention will be observed.&#xD;
&#xD;
        3. These significant improvements will be sustained in both groups for at least three&#xD;
           months post-intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Young people comprise almost 20% of the homeless population in Canada. It is estimated&#xD;
      between 35,000 and 40,000 Canadian youth (aged 13 - 25 years) are homeless at some point&#xD;
      during the year and at least 6,000 on any given night. In Toronto, an estimated 1,000 - 2,000&#xD;
      youth find themselves searching for a place to sleep on any given night.&#xD;
&#xD;
      While a great deal is known about the risk factors associated with young people entering and&#xD;
      remaining entrenched in street life (e.g., intergenerational poverty, childhood abuse,&#xD;
      inadequate education, and limited employment opportunities), less is known much less about&#xD;
      how to facilitate and sustain transitions off the streets for youth experiencing&#xD;
      homelessness.&#xD;
&#xD;
      The scarcity of evidence on this issue means there are critical gaps in understanding how&#xD;
      best to help homeless young people move forward in life after they become housed. For&#xD;
      example, results from a recent longitudinal mixed method study of 51 formerly homeless youth&#xD;
      living in Toronto and Halifax - led by Dr. Sean Kidd and colleagues and one of the most&#xD;
      rigorous investigations to date - showed that obtaining stable housing did not necessarily&#xD;
      translate into a sense of belonging or connection to mainstream society. While study&#xD;
      participants demonstrated incredible commitment, the structural barriers they experienced&#xD;
      during the transition process (e.g., inadequate education and underemployment) led to fragile&#xD;
      identities (i.e., self-concept) as they experienced a significant decline in hope and a sense&#xD;
      of being 'stuck'. Youth described feeling unprepared for and overwhelmed by the realities&#xD;
      associated with the transition process, undermining their sense of belonging and confidence&#xD;
      in achieving larger life goals.&#xD;
&#xD;
      Building on the Kidd et al. study, Dr. Naomi Thulien (the lead investigator for this study)&#xD;
      spent 10 months following nine young people who had left the shelter system and moved into&#xD;
      market rent housing in Toronto. The study - believed to be the first of its kind - captured&#xD;
      the crucial role identity plays in the transition away from homelessness. Despite their&#xD;
      remarkable determination, study participants lacked sufficient identity capital -&#xD;
      conceptualized as a sense of purpose and control, self-efficacy, and self-esteem - to help&#xD;
      them press on in the face of significant structural inequities. Thulien asserts that failure&#xD;
      to understand and incorporate identity capital into transition-related supports may result in&#xD;
      a poor return on investment as these supports are likely to be ineffective, underutilized, or&#xD;
      rejected outright.&#xD;
&#xD;
      One notable identity-based intervention is a randomized controlled trial that targeted 264&#xD;
      eighth graders from high-poverty and high-unemployment neighborhoods in Detroit, Michigan.&#xD;
      Participants who attended the seven-week intervention aimed at aligning the students' current&#xD;
      identities with achievable positive adult identities, demonstrated improved outcomes on&#xD;
      measures pertaining to academics, mood, and behavior, which was sustained through the&#xD;
      two-year follow-up. The authors suggest brief identity-based interventions can have&#xD;
      significant effects on outcomes. Despite being suggested as a promising approach, the&#xD;
      investigators know of no other interventions (nationally or internationally) that are&#xD;
      specifically targeting the enhancement of identity capital for formerly homeless young&#xD;
      people. Given the limited evidence-based interventions for youth transitioning out of&#xD;
      homelessness, the investigators believe there is a critical need for evaluations that compare&#xD;
      findings based on different approaches, reflecting the diversity of the population and their&#xD;
      corresponding needs.&#xD;
&#xD;
      The proposed intervention is based on two premises: 1) identity is socially constructed and&#xD;
      malleable; and 2) people act in identity-congruent ways. Thus, the intervention aims to&#xD;
      change socially constructed life trajectories by providing identity-enhancing resources to&#xD;
      formerly homeless young people.&#xD;
&#xD;
      This impact and process evaluation aims to address critical gaps in the literature about&#xD;
      transition-related supports by asking whether and how an identity capital intervention&#xD;
      delivered outside the social service sector impacts the life-trajectories of formerly&#xD;
      homeless young people. Particular attention will be paid to whether this intervention shows&#xD;
      promise as an unconventional way to tackle poverty and improve social inclusion.&#xD;
&#xD;
      Specifically, this evaluation will investigate and disseminate important new knowledge on the&#xD;
      following outcomes&#xD;
&#xD;
        1. The impact of the intervention on measures of hope, community integration, social&#xD;
           connectedness, and self-esteem.&#xD;
&#xD;
        2. The effectiveness of the intervention to increase the number of young people in&#xD;
           education, employment, or training.&#xD;
&#xD;
        3. Understanding any practical challenges encountered during the intervention&#xD;
           implementation and how these challenges were resolved.&#xD;
&#xD;
        4. Understanding what young people found most beneficial about the intervention and their&#xD;
           suggestions for how it could be improved.&#xD;
&#xD;
      An impact and process evaluation utilizing a mixed method prospective cohort design with an&#xD;
      intervention and delayed intervention comparison group is the most appropriate because it:&#xD;
&#xD;
        1. Addresses the crucial need to understand and disseminate evidence regarding the impact&#xD;
           and process of interventions targeting homeless youth - both will help assess and inform&#xD;
           questions related to scalability.&#xD;
&#xD;
        2. Provides a more complete and synergistic utilization of data.&#xD;
&#xD;
        3. Balances scientific rigor with the ethical principle of fairness.&#xD;
&#xD;
      This evaluation is a mixed-methods design with a strong qualitative component. Quantitative&#xD;
      data collection will occur at six weeks pre-baseline (for the delayed intervention group&#xD;
      only), baseline (immediately pre-intervention), immediately post-intervention (one week),&#xD;
      three months post-intervention, six months post-intervention, and nine months&#xD;
      post-intervention. At each data collection period, participants will be asked whether they&#xD;
      are enrolled in education, employment, or training in the questionnaire. They will also be&#xD;
      asked about their housing status. Hope, community integration, social connectedness, and&#xD;
      self-esteem will be measured quantitatively using scales.&#xD;
&#xD;
      The frequencies, means and standard deviations will be calculated for all evaluation&#xD;
      variables. To address the question about the extent to which the outcome variables change&#xD;
      over time, independent t-tests will be conducted on the continuous variables (hope, community&#xD;
      integration, social connectedness, and self-esteem) and chi-square tests on the categorical&#xD;
      variables (education, employment, training, and housing) to report on changes between: 1)&#xD;
      baseline and immediately post-intervention; 2) baseline and three months post-intervention;&#xD;
      3) baseline and six months post-intervention; and 4) baseline and nine months&#xD;
      post-intervention. To address the question about whether the intervention group demonstrates&#xD;
      a statistically significant difference in outcomes compared to no intervention, the outcome&#xD;
      variables between the intervention group and the delayed intervention group will be compared&#xD;
      six weeks after the baseline questionnaires (i.e., the intervention group will have just&#xD;
      completed the dk Leadership program and the delayed intervention group will not have started&#xD;
      it yet).&#xD;
&#xD;
      Qualitative measures are an important feature of this evaluation and will consist of: 1)&#xD;
      participant observation and 2) focus groups.&#xD;
&#xD;
      Over the six-week intervention period, the co-investigator will attend the weekly meetings as&#xD;
      an observer. She will do this with both the intervention and the delayed intervention group.&#xD;
      During these meetings, the investigator will take field notes, documenting her perceptions&#xD;
      about the way the workshops and group coaching sessions are being run, and how they are being&#xD;
      'taken up' by the young people in the intervention group.&#xD;
&#xD;
      Focus groups, will take place immediately (one week), three months, six months, and 9 months&#xD;
      post-intervention. Participants in the intervention and delayed intervention will be in&#xD;
      separate focus groups. The questions posed during the focus groups will be guided by the&#xD;
      evaluation objectives, but will be conversational and exploratory in nature with particular&#xD;
      attention to identity capital, life-trajectories, and social inclusion. It is anticipated&#xD;
      that the focus groups will last 60 - 90 minutes. All will be conducted by the co-investigator&#xD;
      at locations most convenient for the study participants, and will be audio recorded and&#xD;
      transcribed verbatim.&#xD;
&#xD;
      In keeping with the emergent, iterative nature of research using a qualitative design, data&#xD;
      analysis and interpretation will begin at the onset of the intervention. The handwritten&#xD;
      field notes from the participant observation sessions will be typed into Microsoft Word by&#xD;
      the co-investigator immediately after each biweekly meeting. The focus groups will be audio&#xD;
      recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data,&#xD;
      the transcriptionist will be instructed to note short responses, uncooperative tones, and&#xD;
      literal silence. Prior to each meeting with the participants, the co-investigator will&#xD;
      conduct a preliminary data analysis, reading the field notes multiple times, separating the&#xD;
      data into coded segments, making analytic memos beside large portions of the field notes or&#xD;
      transcripts, identifying emerging themes (and comparing/contrasting these between&#xD;
      participants), and complying new questions to ask the participants. Participants will be&#xD;
      asked for their perspectives on the emerging interpretations at each visit and these&#xD;
      perspectives will play a key role in helping shape the data analysis and help ensure the&#xD;
      trustworthiness of the data. The web-based application Dedoose39 will be utilized to assist&#xD;
      with sorting and coding the qualitative data.&#xD;
&#xD;
      Study participants may benefit from the opportunity to share with the co-investigator and&#xD;
      with each other about whether and how an identity-building intervention delivered outside the&#xD;
      social service sector impacts their life-trajectories. Additionally, participants may derive&#xD;
      satisfaction from knowing that their contributions will help advance understanding about how&#xD;
      best to design interventions that help tackle poverty and improve social inclusion for young&#xD;
      people transitioning out of homelessness.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">August 6, 2019</completion_date>
  <primary_completion_date type="Actual">August 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six-week intervention that focuses on building identity capital and providing career direction. The intervention will be designed and carried out by dk Leadership - an established, highly successful leadership and counseling centre in Toronto with a track record of significantly improving the life trajectories of teens and adults. Importantly, study participants will be incorporated into the centre's current programming, meaning the intervention will be held at a location not associated with homelessness. All of the participants will be invited to attend two focus groups, which will be conducted immediately post-intervention and at six months post-intervention. Each focus group will contain approximately 8 - 10 youth. Participants in the intervention and delayed intervention will be in separate focus groups.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale</measure>
    <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>Assessed using Beck's Hopelessness Scale, a 20-item scale which measures motivation, expectations, and feelings about the future (internal consistency α = .93). The total scoring range is 0-20, with 0-3 = no or minimal hopelessness, 4-8 = mild hopelessness, 9-14 = moderate hopelessness- requires monitoring, and 15+ = severe hopelessness- suicide risk.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of hopelessness. The change in scores over time will describe the general trajectory of hopelessness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Community Integration (Psychological and Physical) Scores as Measured by the Community Integration Scale (CIS)</measure>
    <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>Assessed using the Community Integration Scale, an 11-item scale which measures behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. The CIS includes a physical subscale (with scores ranging from 0-7) and a psychological subscale (with scores ranging from 4-20). Higher scores indicate greater community integration. This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of community integration. The change in scores over time will describe the general trajectory of community integration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS)</measure>
    <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>Measured using the Social Connected Scale, a 20-item scale which measures belongingness - the degree to which people feel connected to others (internal consistency α = .92). Scores range from 20-120, with higher scores indicating greater social connectedness.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in social connectedness. The change in scores over time will describe the general trajectory of social connectedness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Change From Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS)</measure>
    <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>Assessed using the Rosenberg Self-Esteem Scale, a 10-item scale which measures of global self-worth (internal consistency α = .77 - .88). Scores range from 0-30. A score of &lt;15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in self-esteem. The change in scores over time will describe the general trajectory of self-esteem.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Vocational Participation/Employment as Assessed by a Questionnaire From Baseline to 9-Months</measure>
    <time_frame>Assessed at baseline (immediately pre-intervention) and 9 months post-intervention</time_frame>
    <description>Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status, intensity of employment, and type of employment in the questionnaire. The change in the number of participants engaging in employment over time at the aggregate level will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire From Baseline to 9-Months</measure>
    <time_frame>Assessed at baseline (immediately pre-intervention) and 9 months post-intervention</time_frame>
    <description>Participants will be prompted to answer questions about their current educational pursuit, and type of schooling or training program in a questionnaire. The change in the number of participants engaging in education over time on the aggregate will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Themes Related to Change in Career Awareness Informed by Focus Groups With Participants</measure>
    <time_frame>60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>This outcome will describe the general trajectory of career awareness. Self-awareness, confidence, ability to articulate career goals, and understanding of how to achieve career goals will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Themes Related to Change in Knowledge and Use of Soft Skills Informed by Focus Groups With Participants</measure>
    <time_frame>60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>Acquirement of soft skills such as motivation, goal setting, self-discipline, and organization will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Themes Related to Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Focus Groups With Participants</measure>
    <time_frame>60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
    <description>In focus groups, youth will be prompted to discuss the strengths and drawbacks of conventional programs for youth transitioning out of homelessness. These evaluations will be compared to this intervention to determine what aspects of programs youth find most helpful, and which could be improved upon. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion.All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Youth</condition>
  <condition>Homelessness</condition>
  <arm_group>
    <arm_group_label>Immediate dk Leadership Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants allocated to the immediate intervention group are assessed for study outcomes immediately prior to the 6-week dk Leadership intervention and immediately after the intervention.&#xD;
Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks.&#xD;
After the delayed intervention group takes the intervention, the two groups are joined into a single arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed dk Leadership Intervention</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and immediately after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period.&#xD;
This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>dk Leadership</intervention_name>
    <description>Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The workshops and coaching sessions will be supplemented by on-line (e.g., podcasts) and print (e.g., workbooks) material. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group coaching sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
    <arm_group_label>Delayed dk Leadership Intervention</arm_group_label>
    <arm_group_label>Immediate dk Leadership Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18-26 years of age&#xD;
&#xD;
          -  Left homelessness within the last 3 years (youth living in supportive housing contexts&#xD;
             (e.g., transitional housing) will be considered to have left homelessness)&#xD;
&#xD;
          -  Currently not homeless (youth in supportive or transitional housing are eligible)&#xD;
&#xD;
          -  A concerted effort will be made to recruit young people facing additional&#xD;
             identity-related challenges like newcomer and racialized youth, Indigenous youth, and&#xD;
             youth who belong to the LGBTQ2S community.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not fluent in English&#xD;
&#xD;
          -  Cannot provide informed consent&#xD;
&#xD;
          -  Cannot commit to attending two full-day workshops and four half-day group coaching&#xD;
             sessions over the course of six weeks (missing more than one workshop and two coaching&#xD;
             sessions will disqualify participants from the study)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Naomi S Thulien</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Gaetz, S., Dej, E., Richter, T., &amp; Redman, M. (2016) The state of homelessness in Canada 2016. Toronto, ON: Canadian Observatory on Homelessness Press. Retrieved from http://www.homelesshub.ca/SOHC2016</citation>
  </reference>
  <reference>
    <citation>Gaetz, S., &amp; Redman, M. (2016). Federal investment in youth homelessness: Comparing Canada and the United States and a proposal for reinvestment. Canadian observatory on homelessness policy brief. Toronto, ON: The Homeless Hub Press. Retrieved from http://homelesshub.ca/sites/default/files/Policy_Brief.pdf</citation>
  </reference>
  <reference>
    <citation>Karabanow, J. (2008). Getting off the street: Exploring the process of young people's street exits. American Behavioral Scientist, 51(6), 772-788. doi:10.1177/0002764207311987</citation>
  </reference>
  <reference>
    <citation>Covenant House Toronto. (2016). Facts and stats. Retrieved from http://www.covenanthousetoronto.ca/homeless-youth/Facts-and-Stats</citation>
  </reference>
  <reference>
    <citation>Kidd, S.A., Frederick, T., Karabanow, J., Hughes, J., Naylor, T., &amp; Barbic, S. (2016). A mixed methods study of recently homeless youth efforts to sustain housing and stability. Child and Adolescent Social Work Journal, 33(3), 207-218. doi:10.1007/s10560-015-0424-2</citation>
  </reference>
  <reference>
    <citation>Mayock, P., O'Sullivan, E., &amp; Corr, M.L. (2011). Young people exiting homelessness: An exploration of process, meaning and definition. Housing Studies, 26(6), 803-826. doi:10.1080/02673037.2011.593131</citation>
  </reference>
  <reference>
    <citation>Brueckner, M., Green, M., &amp; Saggers, S. (2011). The trappings of home: Young homeless people's transitions towards independent living. Housing Studies, 26(1), 1-16. doi:10.1080/02673037.2010.512751</citation>
  </reference>
  <reference>
    <citation>Thulien NS, Gastaldo D, Hwang SW, McCay E. The elusive goal of social integration: A critical examination of the socio-economic and psychosocial consequences experienced by homeless young people who obtain housing. Can J Public Health. 2018 Feb;109(1):89-98. doi: 10.17269/s41997-018-0029-6.</citation>
    <PMID>29981071</PMID>
  </reference>
  <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>
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  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 23, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <results_first_submitted>April 9, 2020</results_first_submitted>
  <results_first_submitted_qc>May 5, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2020</results_first_posted>
  <last_update_submitted>June 20, 2023</last_update_submitted>
  <last_update_submitted_qc>June 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hopelessness</keyword>
  <keyword>Self Esteem</keyword>
  <keyword>Social Isolation</keyword>
  <keyword>Employment Status</keyword>
  <keyword>Education</keyword>
  <keyword>Housing Problems</keyword>
  <keyword>Identity, Social</keyword>
  <keyword>Self Efficacy</keyword>
  <keyword>Control Locus</keyword>
  <keyword>Poverty</keyword>
  <keyword>Youth</keyword>
  <keyword>Homelessness</keyword>
  <keyword>Homeless Youth</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/22/NCT03772522/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment took place between March, 2018 and September, 2018. Participants were collaboratively recruited by our community partner Covenant House Toronto, who referred youth to our research team.</recruitment_details>
      <pre_assignment_details>Although out recruitment goal was 26 youth, we exceeded that goal by recruiting 27 youth.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Immediate dk Leadership Intervention</title>
          <description>Participants allocated to the immediate intervention group are assessed for study outcomes immediately before and after the intervention.&#xD;
Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks. After the delayed intervention group takes the intervention, the two groups are joined into a single arm.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
        </group>
        <group group_id="P2">
          <title>Delayed dk Leadership Intervention</title>
          <description>Participants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period.&#xD;
This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Pre-intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </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>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Intervention</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</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>
          <title>Post-intervention Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </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="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>Immediate dk Leadership Intervention</title>
          <description>Participants allocated to the immediate intervention group are assessed for study outcomes immediately before and after the intervention.&#xD;
Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks. After the delayed intervention group takes the intervention, the two groups are joined into a single arm.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
        </group>
        <group group_id="B2">
          <title>Delayed dk Leadership Intervention</title>
          <description>Participants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period.&#xD;
This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</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="8"/>
            <count group_id="B2" value="11"/>
            <count group_id="B3" value="19"/>
          </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="22.5" spread="3.1"/>
                    <measurement group_id="B2" value="23.2" spread="1.3"/>
                    <measurement group_id="B3" value="22.9" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </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</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>Black/African Canadian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian (East Asian, South Asian, Middle Eastern)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Immigration Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Canadian Citizen</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Permanent Resident</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Refugee</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest Level of Education Obtained</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Less than high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completed high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some or complete post-secondary</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Social Assistance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not receiving social assistance</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployment benefit</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disability benefit</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pursuing Education, Employment or Training</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Currently pursuing EET</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not pursuing EET</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Living Situation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Market housing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Transitional housing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Social or subsidized housing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Living with family</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Monthly Rent</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>$0-$499</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$500-$999</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$1000+</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years Lived Apart from Family</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Attempts at Leaving Homelessness</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family Involvement with a Child Protection Agency</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lived in a Foster or Group Home</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Has Children</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale</title>
        <description>Assessed using Beck's Hopelessness Scale, a 20-item scale which measures motivation, expectations, and feelings about the future (internal consistency α = .93). The total scoring range is 0-20, with 0-3 = no or minimal hopelessness, 4-8 = mild hopelessness, 9-14 = moderate hopelessness- requires monitoring, and 15+ = severe hopelessness- suicide risk.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of hopelessness. The change in scores over time will describe the general trajectory of hopelessness.</description>
        <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate dk Leadership Intervention</title>
            <description>Participants receive the dk Leadership intervention immediately after their baseline interview.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O2">
            <title>Delayed dk Leadership Intervention</title>
            <description>Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. These timepoints include immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale</title>
          <description>Assessed using Beck's Hopelessness Scale, a 20-item scale which measures motivation, expectations, and feelings about the future (internal consistency α = .93). The total scoring range is 0-20, with 0-3 = no or minimal hopelessness, 4-8 = mild hopelessness, 9-14 = moderate hopelessness- requires monitoring, and 15+ = severe hopelessness- suicide risk.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of hopelessness. The change in scores over time will describe the general trajectory of hopelessness.</description>
          <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-weeks pre-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                    <measurement group_id="O2" value="6.70" spread="4.08"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (pre-intervention)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.27" spread="3.28"/>
                    <measurement group_id="O2" value="6.55" spread="3.80"/>
                    <measurement group_id="O3" value="5.59" spread="3.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediately post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="3.46"/>
                    <measurement group_id="O2" value="5.21" spread="4.01"/>
                    <measurement group_id="O3" value="4.12" spread="3.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="2.71"/>
                    <measurement group_id="O2" value="5.55" spread="3.80"/>
                    <measurement group_id="O3" value="4.36" spread="3.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.75" spread="1.98"/>
                    <measurement group_id="O2" value="5.01" spread="3.57"/>
                    <measurement group_id="O3" value="3.64" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.71" spread="1.70"/>
                    <measurement group_id="O2" value="5.00" spread="4.20"/>
                    <measurement group_id="O3" value="3.72" spread="3.75"/>
                  </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>Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.428</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.384</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of scores at baseline (pre-intervention) and immediately post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.058</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>-0.46</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of scores at baseline (pre-intervention) and 3-month post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.095</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>-0.40</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of scores at baseline (pre-intervention) and 6-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.005</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>-0.73</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of scores at baseline (pre-intervention) and 9-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.022</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>-0.60</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Community Integration (Psychological and Physical) Scores as Measured by the Community Integration Scale (CIS)</title>
        <description>Assessed using the Community Integration Scale, an 11-item scale which measures behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. The CIS includes a physical subscale (with scores ranging from 0-7) and a psychological subscale (with scores ranging from 4-20). Higher scores indicate greater community integration. This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of community integration. The change in scores over time will describe the general trajectory of community integration.</description>
        <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate dk Leadership Intervention</title>
            <description>Participants receive the dk Leadership intervention immediately after their baseline interview.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O2">
            <title>Delayed dk Leadership Intervention</title>
            <description>Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. Analyses were performed immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Community Integration (Psychological and Physical) Scores as Measured by the Community Integration Scale (CIS)</title>
          <description>Assessed using the Community Integration Scale, an 11-item scale which measures behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. The CIS includes a physical subscale (with scores ranging from 0-7) and a psychological subscale (with scores ranging from 4-20). Higher scores indicate greater community integration. This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of community integration. The change in scores over time will describe the general trajectory of community integration.</description>
          <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical sub-scale: 6-weeks pre-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                    <measurement group_id="O2" value="4.42" spread="2.12"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical sub-scale: Baseline (pre-intervention)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" spread="1.20"/>
                    <measurement group_id="O2" value="3.09" spread="2.30"/>
                    <measurement group_id="O3" value="2.84" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical sub-scale: Immediately post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.89" spread="1.11"/>
                    <measurement group_id="O2" value="3.45" spread="1.86"/>
                    <measurement group_id="O3" value="3.64" spread="1.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical sub-scale: 3 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.98" spread="2.37"/>
                    <measurement group_id="O2" value="3.55" spread="2.07"/>
                    <measurement group_id="O3" value="3.73" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical sub-scale: 6 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.75" spread="1.91"/>
                    <measurement group_id="O2" value="3.64" spread="1.50"/>
                    <measurement group_id="O3" value="3.68" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical sub-scale: 9 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.29" spread="2.36"/>
                    <measurement group_id="O2" value="3.45" spread="1.57"/>
                    <measurement group_id="O3" value="3.39" spread="1.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological sub-scale: 6-weeks pre-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                    <measurement group_id="O2" value="12.9" spread="3.98"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological sub-scale: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.63" spread="4.27"/>
                    <measurement group_id="O2" value="12.60" spread="3.91"/>
                    <measurement group_id="O3" value="12.16" spread="3.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological sub-scale: Imm. post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.88" spread="4.36"/>
                    <measurement group_id="O2" value="13.50" spread="4.25"/>
                    <measurement group_id="O3" value="12.79" spread="4.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological sub-scale:3 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.75" spread="2.82"/>
                    <measurement group_id="O2" value="13.09" spread="2.77"/>
                    <measurement group_id="O3" value="12.53" spread="2.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological sub-scale:6 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.00" spread="4.60"/>
                    <measurement group_id="O2" value="13.10" spread="3.53"/>
                    <measurement group_id="O3" value="12.21" spread="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychological sub-scale:9 Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.14" spread="4.06"/>
                    <measurement group_id="O2" value="12.45" spread="3.42"/>
                    <measurement group_id="O3" value="11.94" spread="3.62"/>
                  </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>Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the physical component of the CIS.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.002</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>1.792</param_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>Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks) for the psychological component of the CIS.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.923</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.047</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (physical component) scores at baseline (pre-intervention) and immediately post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.18</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.60</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (psychological component) scores at baseline (pre-intervention) and immediately post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.388</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.20</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (physical component) scores at baseline (pre-intervention) and 3-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.037</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.52</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 3-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.688</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.09</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (physical component) scores at baseline (pre-intervention) and 6-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.038</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.51</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 6-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.956</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.01</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (physical component) scores at baseline (pre-intervention) and 9-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.197</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.32</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of CIS (psychological component) scores at baseline (pre-intervention) and 9-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.762</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>-0.07</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS)</title>
        <description>Measured using the Social Connected Scale, a 20-item scale which measures belongingness - the degree to which people feel connected to others (internal consistency α = .92). Scores range from 20-120, with higher scores indicating greater social connectedness.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in social connectedness. The change in scores over time will describe the general trajectory of social connectedness.</description>
        <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate dk Leadership Intervention</title>
            <description>Participants receive the dk Leadership intervention immediately after their baseline interview.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O2">
            <title>Delayed dk Leadership Intervention</title>
            <description>Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. Analyses were performed immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS)</title>
          <description>Measured using the Social Connected Scale, a 20-item scale which measures belongingness - the degree to which people feel connected to others (internal consistency α = .92). Scores range from 20-120, with higher scores indicating greater social connectedness.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in social connectedness. The change in scores over time will describe the general trajectory of social connectedness.</description>
          <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-weeks pre-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                    <measurement group_id="O2" value="70.00" spread="10.10"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data wasn't taken for the immediate intervention group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (pre-intervention)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.00" spread="13.37"/>
                    <measurement group_id="O2" value="71.00" spread="15.60"/>
                    <measurement group_id="O3" value="72.26" spread="14.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediately post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.75" spread="25.41"/>
                    <measurement group_id="O2" value="75.20" spread="14.60"/>
                    <measurement group_id="O3" value="75.42" spread="19.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.88" spread="20.79"/>
                    <measurement group_id="O2" value="75.27" spread="8.46"/>
                    <measurement group_id="O3" value="78.47" spread="14.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.38" spread="18.95"/>
                    <measurement group_id="O2" value="72.18" spread="12.36"/>
                    <measurement group_id="O3" value="77.32" spread="16.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.14" spread="14.81"/>
                    <measurement group_id="O2" value="73.26" spread="14.49"/>
                    <measurement group_id="O3" value="77.49" spread="15.19"/>
                  </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>Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.834</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.101</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of SCS scores at baseline (pre-intervention) and immediately post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.417</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.19</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of SCS scores at baseline (pre-intervention) and 3-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.087</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.42</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of SCS scores at baseline (pre-intervention) and 6-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.168</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.33</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of SCS scores at baseline (pre-intervention) and 9-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.133</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.37</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Change From Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS)</title>
        <description>Assessed using the Rosenberg Self-Esteem Scale, a 10-item scale which measures of global self-worth (internal consistency α = .77 - .88). Scores range from 0-30. A score of &lt;15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in self-esteem. The change in scores over time will describe the general trajectory of self-esteem.</description>
        <time_frame>Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
        <group_list>
          <group group_id="O1">
            <title>Immediate dk Leadership Intervention</title>
            <description>Participants receive the dk Leadership intervention immediately after their baseline interview.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O2">
            <title>Delayed dk Leadership Intervention</title>
            <description>Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
          </group>
          <group group_id="O3">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>After both groups had received the dk Leadership intervention, analyses for the immediate and delayed intervention groups were pooled for subsequent analyses. Analyses were performed immediately post-intervention, 3-months post-intervention, 6-months post-intervention and 9-months post-intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS)</title>
          <description>Assessed using the Rosenberg Self-Esteem Scale, a 10-item scale which measures of global self-worth (internal consistency α = .77 - .88). Scores range from 0-30. A score of &lt;15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.&#xD;
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in self-esteem. The change in scores over time will describe the general trajectory of self-esteem.</description>
          <population>1 participant in the delayed intervention group missed the 6-week delay period and joined immediately pre-intervention.Thus, the number of participants at 6-weeks pre-baseline is 10 rather than 11.&#xD;
1 participant was lost to follow-up at the 9-month follow-up. Thus the number of participants in the immediate intervention group was 7 rather than 8.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>6-Weeks pre-baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data wasn't collected for the immediate intervention group at this timepoint.</measurement>
                    <measurement group_id="O2" value="17.70" spread="4.91"/>
                    <measurement group_id="O3" value="NA" spread="NA">Data wasn't collected for the immediate intervention group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline (pre-intervention)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.66" spread="2.92"/>
                    <measurement group_id="O2" value="18.50" spread="6.09"/>
                    <measurement group_id="O3" value="17.70" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Immediately post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.00" spread="4.87"/>
                    <measurement group_id="O2" value="19.20" spread="7.31"/>
                    <measurement group_id="O3" value="20.37" spread="6.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.00" spread="6.39"/>
                    <measurement group_id="O2" value="18.09" spread="5.11"/>
                    <measurement group_id="O3" value="19.32" spread="5.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.75" spread="5.23"/>
                    <measurement group_id="O2" value="19.18" spread="6.88"/>
                    <measurement group_id="O3" value="21.53" spread="6.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="11"/>
                    <count group_id="O3" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.86" spread="4.98"/>
                    <measurement group_id="O2" value="19.00" spread="4.24"/>
                    <measurement group_id="O3" value="20.11" spread="4.63"/>
                  </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>Change in score in the immediate intervention group (after receiving the intervention for 6 weeks) compared to that of the delayed intervention group (after receiving no intervention for 6 weeks).</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>1.161</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of RSS scores at baseline (pre-intervention) and immediately post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.014</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.62</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of RSS scores at baseline (pre-intervention) and 3-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.217</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.29</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of RSS scores at baseline (pre-intervention) and 6-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.71</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Comparison of RSS scores at baseline (pre-intervention) and 9-months post-intervention.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.039</p_value>
            <method>t-test, 2 sided</method>
            <param_type>Cohen's d (effect size)</param_type>
            <param_value>0.53</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Vocational Participation/Employment as Assessed by a Questionnaire From Baseline to 9-Months</title>
        <description>Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status, intensity of employment, and type of employment in the questionnaire. The change in the number of participants engaging in employment over time at the aggregate level will be assessed.</description>
        <time_frame>Assessed at baseline (immediately pre-intervention) and 9 months post-intervention</time_frame>
        <population>1 participant was lost to follow-up at the 9-month data collection period. Thus, the number of participants analyzed at 9-months is 18 rather than 19.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>Data for the immediate and delayed intervention groups were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vocational Participation/Employment as Assessed by a Questionnaire From Baseline to 9-Months</title>
          <description>Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status, intensity of employment, and type of employment in the questionnaire. The change in the number of participants engaging in employment over time at the aggregate level will be assessed.</description>
          <population>1 participant was lost to follow-up at the 9-month data collection period. Thus, the number of participants analyzed at 9-months is 18 rather than 19.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-intervention)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Full-time (&gt;=30 hours/week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Part-time (&lt;30 hours/week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Full-time (&gt;=30 hours/week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Part-time (&lt;30 hours/week)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unemployed</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire From Baseline to 9-Months</title>
        <description>Participants will be prompted to answer questions about their current educational pursuit, and type of schooling or training program in a questionnaire. The change in the number of participants engaging in education over time on the aggregate will be assessed.</description>
        <time_frame>Assessed at baseline (immediately pre-intervention) and 9 months post-intervention</time_frame>
        <population>1 participant was lost to follow-up at the 9-month data collection period. Thus, the number of participants analyzed at 9-months is 18 rather than 19.</population>
        <group_list>
          <group group_id="O1">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>Data for the immediate and delayed intervention groups were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire From Baseline to 9-Months</title>
          <description>Participants will be prompted to answer questions about their current educational pursuit, and type of schooling or training program in a questionnaire. The change in the number of participants engaging in education over time on the aggregate will be assessed.</description>
          <population>1 participant was lost to follow-up at the 9-month data collection period. Thus, the number of participants analyzed at 9-months is 18 rather than 19.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-intervention)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Secondary education</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-secondary education</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not pursuing education</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9-Months post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Secondary education</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Post-secondary education</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not pursuing education</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Themes Related to Change in Career Awareness Informed by Focus Groups With Participants</title>
        <description>This outcome will describe the general trajectory of career awareness. Self-awareness, confidence, ability to articulate career goals, and understanding of how to achieve career goals will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
        <time_frame>60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>Data for the immediate and delayed intervention groups were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Themes Related to Change in Career Awareness Informed by Focus Groups With Participants</title>
          <description>This outcome will describe the general trajectory of career awareness. Self-awareness, confidence, ability to articulate career goals, and understanding of how to achieve career goals will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
          <units>Key themes identified</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Themes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subthemes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Themes Related to Change in Knowledge and Use of Soft Skills Informed by Focus Groups With Participants</title>
        <description>Acquirement of soft skills such as motivation, goal setting, self-discipline, and organization will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
        <time_frame>60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>Data for the immediate and delayed intervention groups were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Themes Related to Change in Knowledge and Use of Soft Skills Informed by Focus Groups With Participants</title>
          <description>Acquirement of soft skills such as motivation, goal setting, self-discipline, and organization will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
          <units>Key themes identified</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Themes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subthemes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Themes Related to Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Focus Groups With Participants</title>
        <description>In focus groups, youth will be prompted to discuss the strengths and drawbacks of conventional programs for youth transitioning out of homelessness. These evaluations will be compared to this intervention to determine what aspects of programs youth find most helpful, and which could be improved upon. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion.All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
        <time_frame>60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pooled Analysis of Immediate and Delayed Intervention Groups</title>
            <description>Data for the immediate and delayed intervention groups were pooled.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Themes Related to Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Focus Groups With Participants</title>
          <description>In focus groups, youth will be prompted to discuss the strengths and drawbacks of conventional programs for youth transitioning out of homelessness. These evaluations will be compared to this intervention to determine what aspects of programs youth find most helpful, and which could be improved upon. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion.All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.</description>
          <units>Key themes identified</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Themes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Subthemes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from the time participants were enrolled to the end of the 9-month follow-up period. This was roughly 1 year for each participant.</time_frame>
      <desc>Our intervention was an identity-based intervention that proposed little risk to participants; thus no study-related adverse events were observed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Immediate dk Leadership Intervention</title>
          <description>Participants receive the dk Leadership intervention immediately after their baseline interview.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</description>
        </group>
        <group group_id="E2">
          <title>Delayed dk Leadership Intervention</title>
          <description>Participants allocated to this arm are followed for 6 weeks after enrolment with no intervention; they then receive the dk Leadership intervention.&#xD;
dk Leadership: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.</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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </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="8"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>A limitation is that the small sample size means the findings are unable to be generalized to young people in other contexts.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Naomi Thulien</name_or_title>
      <organization>MAP Centre for Urban Health Solutions, Unity Health Toronto</organization>
      <phone>647-460-0781</phone>
      <email>ThulienN@mcmaster.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/NCT03772522
org study id: 18-002
nct id: NCT03772522
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Understanding how to create successful pathways out of homelessness is crucial. Thirty young
      people (aged 18 - 26 years) who have transitioned out of homelessness within the past three
      years will be offered scholarships to participate in a six week intervention that focuses on
      building identity capital (sense of purpose and control, self-efficacy and self-esteem) and
      providing career direction. The intervention will be designed and carried out by dk
      Leadership - an established, highly successful leadership and counseling centre in Toronto
      with a track record of significantly improving the life trajectories of teens and adults.
      Importantly, study participants will be incorporated into the centre's current programming,
      meaning the intervention will be held at a location not associated with homelessness. Study
      participants will be collaboratively recruited by dk Leadership and Covenant House Toronto -
      Canada's largest agency for street-involved and homeless youth.

      This impact and process evaluation aims to address critical gaps in knowledge about
      transition-related supports by asking whether and how an identity capital intervention
      delivered outside the social service sector impacts the life-trajectories of formerly
      homeless young people. Particular attention will be paid to whether this intervention shows
      promise as an unconventional way to tackle poverty and improve social inclusion.

      It is hypothesize that, for the primary quantitative outcome measures of hope, community
      integration, social connectedness, and self-esteem:

        1. Significant improvements in the mean scores of the intervention group compared to the
           delayed intervention comparison group immediately post-intervention will be observed.

        2. Significant improvements in the mean scores of both groups (intervention and delayed
           intervention) immediately post-intervention will be observed.

        3. These significant improvements will be sustained in both groups for at least three
           months post-intervention.
Young people comprise almost 20% of the homeless population in Canada. It is estimated
      between 35,000 and 40,000 Canadian youth (aged 13 - 25 years) are homeless at some point
      during the year and at least 6,000 on any given night. In Toronto, an estimated 1,000 - 2,000
      youth find themselves searching for a place to sleep on any given night.

      While a great deal is known about the risk factors associated with young people entering and
      remaining entrenched in street life (e.g., intergenerational poverty, childhood abuse,
      inadequate education, and limited employment opportunities), less is known much less about
      how to facilitate and sustain transitions off the streets for youth experiencing
      homelessness.

      The scarcity of evidence on this issue means there are critical gaps in understanding how
      best to help homeless young people move forward in life after they become housed. For
      example, results from a recent longitudinal mixed method study of 51 formerly homeless youth
      living in Toronto and Halifax - led by Dr. Sean Kidd and colleagues and one of the most
      rigorous investigations to date - showed that obtaining stable housing did not necessarily
      translate into a sense of belonging or connection to mainstream society. While study
      participants demonstrated incredible commitment, the structural barriers they experienced
      during the transition process (e.g., inadequate education and underemployment) led to fragile
      identities (i.e., self-concept) as they experienced a significant decline in hope and a sense
      of being 'stuck'. Youth described feeling unprepared for and overwhelmed by the realities
      associated with the transition process, undermining their sense of belonging and confidence
      in achieving larger life goals.

      Building on the Kidd et al. study, Dr. Naomi Thulien (the lead investigator for this study)
      spent 10 months following nine young people who had left the shelter system and moved into
      market rent housing in Toronto. The study - believed to be the first of its kind - captured
      the crucial role identity plays in the transition away from homelessness. Despite their
      remarkable determination, study participants lacked sufficient identity capital -
      conceptualized as a sense of purpose and control, self-efficacy, and self-esteem - to help
      them press on in the face of significant structural inequities. Thulien asserts that failure
      to understand and incorporate identity capital into transition-related supports may result in
      a poor return on investment as these supports are likely to be ineffective, underutilized, or
      rejected outright.

      One notable identity-based intervention is a randomized controlled trial that targeted 264
      eighth graders from high-poverty and high-unemployment neighborhoods in Detroit, Michigan.
      Participants who attended the seven-week intervention aimed at aligning the students' current
      identities with achievable positive adult identities, demonstrated improved outcomes on
      measures pertaining to academics, mood, and behavior, which was sustained through the
      two-year follow-up. The authors suggest brief identity-based interventions can have
      significant effects on outcomes. Despite being suggested as a promising approach, the
      investigators know of no other interventions (nationally or internationally) that are
      specifically targeting the enhancement of identity capital for formerly homeless young
      people. Given the limited evidence-based interventions for youth transitioning out of
      homelessness, the investigators believe there is a critical need for evaluations that compare
      findings based on different approaches, reflecting the diversity of the population and their
      corresponding needs.

      The proposed intervention is based on two premises: 1) identity is socially constructed and
      malleable; and 2) people act in identity-congruent ways. Thus, the intervention aims to
      change socially constructed life trajectories by providing identity-enhancing resources to
      formerly homeless young people.

      This impact and process evaluation aims to address critical gaps in the literature about
      transition-related supports by asking whether and how an identity capital intervention
      delivered outside the social service sector impacts the life-trajectories of formerly
      homeless young people. Particular attention will be paid to whether this intervention shows
      promise as an unconventional way to tackle poverty and improve social inclusion.

      Specifically, this evaluation will investigate and disseminate important new knowledge on the
      following outcomes

        1. The impact of the intervention on measures of hope, community integration, social
           connectedness, and self-esteem.

        2. The effectiveness of the intervention to increase the number of young people in
           education, employment, or training.

        3. Understanding any practical challenges encountered during the intervention
           implementation and how these challenges were resolved.

        4. Understanding what young people found most beneficial about the intervention and their
           suggestions for how it could be improved.

      An impact and process evaluation utilizing a mixed method prospective cohort design with an
      intervention and delayed intervention comparison group is the most appropriate because it:

        1. Addresses the crucial need to understand and disseminate evidence regarding the impact
           and process of interventions targeting homeless youth - both will help assess and inform
           questions related to scalability.

        2. Provides a more complete and synergistic utilization of data.

        3. Balances scientific rigor with the ethical principle of fairness.

      This evaluation is a mixed-methods design with a strong qualitative component. Quantitative
      data collection will occur at six weeks pre-baseline (for the delayed intervention group
      only), baseline (immediately pre-intervention), immediately post-intervention (one week),
      three months post-intervention, six months post-intervention, and nine months
      post-intervention. At each data collection period, participants will be asked whether they
      are enrolled in education, employment, or training in the questionnaire. They will also be
      asked about their housing status. Hope, community integration, social connectedness, and
      self-esteem will be measured quantitatively using scales.

      The frequencies, means and standard deviations will be calculated for all evaluation
      variables. To address the question about the extent to which the outcome variables change
      over time, independent t-tests will be conducted on the continuous variables (hope, community
      integration, social connectedness, and self-esteem) and chi-square tests on the categorical
      variables (education, employment, training, and housing) to report on changes between: 1)
      baseline and immediately post-intervention; 2) baseline and three months post-intervention;
      3) baseline and six months post-intervention; and 4) baseline and nine months
      post-intervention. To address the question about whether the intervention group demonstrates
      a statistically significant difference in outcomes compared to no intervention, the outcome
      variables between the intervention group and the delayed intervention group will be compared
      six weeks after the baseline questionnaires (i.e., the intervention group will have just
      completed the dk Leadership program and the delayed intervention group will not have started
      it yet).

      Qualitative measures are an important feature of this evaluation and will consist of: 1)
      participant observation and 2) focus groups.

      Over the six-week intervention period, the co-investigator will attend the weekly meetings as
      an observer. She will do this with both the intervention and the delayed intervention group.
      During these meetings, the investigator will take field notes, documenting her perceptions
      about the way the workshops and group coaching sessions are being run, and how they are being
      'taken up' by the young people in the intervention group.

      Focus groups, will take place immediately (one week), three months, six months, and 9 months
      post-intervention. Participants in the intervention and delayed intervention will be in
      separate focus groups. The questions posed during the focus groups will be guided by the
      evaluation objectives, but will be conversational and exploratory in nature with particular
      attention to identity capital, life-trajectories, and social inclusion. It is anticipated
      that the focus groups will last 60 - 90 minutes. All will be conducted by the co-investigator
      at locations most convenient for the study participants, and will be audio recorded and
      transcribed verbatim.

      In keeping with the emergent, iterative nature of research using a qualitative design, data
      analysis and interpretation will begin at the onset of the intervention. The handwritten
      field notes from the participant observation sessions will be typed into Microsoft Word by
      the co-investigator immediately after each biweekly meeting. The focus groups will be audio
      recorded and transcribed verbatim. In order to conduct a more nuanced analysis of the data,
      the transcriptionist will be instructed to note short responses, uncooperative tones, and
      literal silence. Prior to each meeting with the participants, the co-investigator will
      conduct a preliminary data analysis, reading the field notes multiple times, separating the
      data into coded segments, making analytic memos beside large portions of the field notes or
      transcripts, identifying emerging themes (and comparing/contrasting these between
      participants), and complying new questions to ask the participants. Participants will be
      asked for their perspectives on the emerging interpretations at each visit and these
      perspectives will play a key role in helping shape the data analysis and help ensure the
      trustworthiness of the data. The web-based application Dedoose39 will be utilized to assist
      with sorting and coding the qualitative data.

      Study participants may benefit from the opportunity to share with the co-investigator and
      with each other about whether and how an identity-building intervention delivered outside the
      social service sector impacts their life-trajectories. Additionally, participants may derive
      satisfaction from knowing that their contributions will help advance understanding about how
      best to design interventions that help tackle poverty and improve social inclusion for young
      people transitioning out of homelessness.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Thirty young people (aged 18 - 26 years) who have transitioned out of homelessness within the past three years will be offered scholarships to participate in a six-week intervention that focuses on building identity capital and providing career direction. The intervention will be designed and carried out by dk Leadership - an established, highly successful leadership and counseling centre in Toronto with a track record of significantly improving the life trajectories of teens and adults. Importantly, study participants will be incorporated into the centre's current programming, meaning the intervention will be held at a location not associated with homelessness. All of the participants will be invited to attend two focus groups, which will be conducted immediately post-intervention and at six months post-intervention. Each focus group will contain approximately 8 - 10 youth. Participants in the intervention and delayed intervention will be in separate focus groups.
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change From Baseline in Hopelessness as Measured by the Beck Hopelessness Scale
time frame: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: Assessed using Beck's Hopelessness Scale, a 20-item scale which measures motivation, expectations, and feelings about the future (internal consistency α = .93). The total scoring range is 0-20, with 0-3 = no or minimal hopelessness, 4-8 = mild hopelessness, 9-14 = moderate hopelessness- requires monitoring, and 15+ = severe hopelessness- suicide risk.
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of hopelessness. The change in scores over time will describe the general trajectory of hopelessness.
measure: Mean Change From Baseline in Community Integration (Psychological and Physical) Scores as Measured by the Community Integration Scale (CIS)
time frame: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: Assessed using the Community Integration Scale, an 11-item scale which measures behavioural (e.g., participation in activities) and psychological (e.g., sense of belonging) aspects of community integration. The CIS includes a physical subscale (with scores ranging from 0-7) and a psychological subscale (with scores ranging from 4-20). Higher scores indicate greater community integration. This scale was used extensively in the Chez Soi/At Home study, but psychometric properties have yet to be reported.
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in levels of community integration. The change in scores over time will describe the general trajectory of community integration.
measure: Mean Change From Baseline in Social Connectedness Scores as Measured by the Social Connectedness Scale (SCS)
time frame: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: Measured using the Social Connected Scale, a 20-item scale which measures belongingness - the degree to which people feel connected to others (internal consistency α = .92). Scores range from 20-120, with higher scores indicating greater social connectedness.
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in social connectedness. The change in scores over time will describe the general trajectory of social connectedness.
measure: Mean Change From Baseline in Self-esteem Scores as Measured by the Rosenberg Self-Esteem Scale (RSS)
time frame: Assessed at 6 weeks pre-baseline (for the delayed intervention group only), at baseline (immediately pre-intervention), immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: Assessed using the Rosenberg Self-Esteem Scale, a 10-item scale which measures of global self-worth (internal consistency α = .77 - .88). Scores range from 0-30. A score of <15 is categorized as low self-esteem, and 15-30 is categorized as normal self-esteem.
Participants' scores at baseline will be compared with their scores post-intervention to detect changes in self-esteem. The change in scores over time will describe the general trajectory of self-esteem.
measure: Change in Vocational Participation/Employment as Assessed by a Questionnaire From Baseline to 9-Months
time frame: Assessed at baseline (immediately pre-intervention) and 9 months post-intervention
description: Acquirement of meaningful employment will be assessed. Participants will be prompted to answer questions about their current employment status, intensity of employment, and type of employment in the questionnaire. The change in the number of participants engaging in employment over time at the aggregate level will be assessed.
measure: Change in Academic Participation/Educational Attainment as Assessed by a Questionnaire From Baseline to 9-Months
time frame: Assessed at baseline (immediately pre-intervention) and 9 months post-intervention
description: Participants will be prompted to answer questions about their current educational pursuit, and type of schooling or training program in a questionnaire. The change in the number of participants engaging in education over time on the aggregate will be assessed.
measure: Number of Themes Related to Change in Career Awareness Informed by Focus Groups With Participants
time frame: 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: This outcome will describe the general trajectory of career awareness. Self-awareness, confidence, ability to articulate career goals, and understanding of how to achieve career goals will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.
measure: Number of Themes Related to Change in Knowledge and Use of Soft Skills Informed by Focus Groups With Participants
time frame: 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: Acquirement of soft skills such as motivation, goal setting, self-discipline, and organization will be assessed in focus groups. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion. All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.
measure: Number of Themes Related to Participant Perspectives of Intervention Barriers and Facilitators, as Informed by Focus Groups With Participants
time frame: 60 - 90 minute focus groups at each of the following timepoints: immediately post-intervention, 3 months post-intervention, 6 months post-intervention, and 9 months post-intervention
description: In focus groups, youth will be prompted to discuss the strengths and drawbacks of conventional programs for youth transitioning out of homelessness. These evaluations will be compared to this intervention to determine what aspects of programs youth find most helpful, and which could be improved upon. The questions posed during the focus groups will be guided by the evaluation objectives, but will be conversational and exploratory in nature with particular attention to identity capital, life-trajectories, and social inclusion.All will be conducted by the co-investigator at locations most convenient for the study participants, and will be audio recorded and transcribed verbatim. All focus groups will be analyzed together; the themes identified from the analysis will be presented as one data entry.
arm group label: Immediate dk Leadership Intervention
arm group type: Experimental
description: Participants allocated to the immediate intervention group are assessed for study outcomes immediately prior to the 6-week dk Leadership intervention and immediately after the intervention.
Outcomes measured immediately post-intervention are compared with participants who have not received the intervention during the 6 weeks.
After the delayed intervention group takes the intervention, the two groups are joined into a single arm.
arm group label: Delayed dk Leadership Intervention
arm group type: Placebo Comparator
description: Participants allocated to this arm receive 6 weeks of no intervention. Outcomes are measured immediately before and immediately after the 6 week period. The change in outcomes are compared with participants who have received the intervention during the 6 week period.
This group then receives the same dk Leadership intervention; after this point, the two groups are joined into a single arm for subsequent analyses.
intervention type: Behavioral
intervention name: dk Leadership
description: Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The workshops and coaching sessions will be supplemented by on-line (e.g., podcasts) and print (e.g., workbooks) material. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group coaching sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.
arm group label: Delayed dk Leadership Intervention
arm group label: Immediate dk Leadership Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi S Thulien
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
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responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: A limitation is that the small sample size means the findings are unable to be generalized to young people in other contexts.
point of contact: 