xml: <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/NCT05994612</url>
    </required_header>
    <id_info>
      <org_study_id>2023B0145</org_study_id>
      <nct_id>NCT05994612</nct_id>
    </id_info>
    <brief_title>Suicide Prevention for Substance Using Youth Experiencing Homelessness</brief_title>
    <official_title>Suicide Prevention for Substance Using Youth Experiencing Homelessness</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ohio State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Suicide is the leading cause of death among YEH and most youth do not access services that&#xD;
        may be available to them. Therefore, this study seeks to address this gap in the research&#xD;
        literature with the goal to identify an effective intervention that can be readily adopted by&#xD;
        communities that serve these youth. We will test the effects of outreach-worker delivered&#xD;
        Cognitive Therapy for Suicide Prevention (CTSP)+Services as Usual (SAU) versus SAU alone on&#xD;
        suicidal ideation (primary outcome), substance use and depressive symptoms (secondary&#xD;
        outcomes) at 3, 6, 9 and 12- months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        While research on substance using youth experiencing homelessness (YEH) is increasing, there&#xD;
        is a dearth of information regarding effective prevention interventions for these youth. This&#xD;
        is of significant concern because studies indicate that 66% to 89% of YEH have a mental&#xD;
        health disorder and 68% report at least one suicide attempt . In fact, suicide is the leading&#xD;
        cause of death among YEH. Among those who have attempted suicide, an average of 6.2 attempts&#xD;
        is reported, and lifetime suicidal ideation rates range from 14% to 66.5% with no clear&#xD;
        evidence of effective interventions for YEH. This study uses general cognitive theory,&#xD;
        complemented with concepts from two suicide specific theoretical models, to guide our&#xD;
        intervention and conceptual change model. The study goal is to test strategies to extend&#xD;
        delivery and uptake of a cognitive therapy intervention for YEH. Prior studies focus on&#xD;
        service-connected youth, but research suggests that most street living YEH do not access&#xD;
        services meant to assist them. Prior sampling limitations are overcome through engaging&#xD;
        service-disconnected youth in addition to service-connected youth through a local drop-in&#xD;
        center. As such, three hundred substance using YEH with recent suicidal ideation or a recent&#xD;
        suicide attempt will be randomly assigned to Cognitive Therapy for Suicide Prevention (CTSP)&#xD;
        + Services as Usual (SAU) (N=150) or to SAU alone (N=150). CTSP has previously shown efficacy&#xD;
        for YEH through a RCT pilot feasibility study. SAU includes outreach, advocacy and service&#xD;
        linkage which are typical services offered by agencies serving those experiencing&#xD;
        homelessness. Follow-up assessments will be conducted at 3, 6, 9 and 12-months post-baseline.&#xD;
        It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicidal&#xD;
        ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over&#xD;
        time compared to SAU alone, as well as improved risk and protective factors.&#xD;
        Theoretically-derived mediators will be tested to shed light on mechanisms associated with&#xD;
        change, and the moderating effects of sex, race, sexual orientation and baseline service&#xD;
        connection will be examined. In order to ease future dissemination of the intervention to&#xD;
        agencies serving YEH, the investigators will rigorously assess acceptability, feasibility,&#xD;
        fidelity and cost associated with the delivery of our intervention approach using a&#xD;
        mixed-methods approach. Ultimately, the goal of this research is to provide support for the&#xD;
        use of a suicide prevention intervention for substance using YEH that reduces premature&#xD;
        mortality, hospitalization, and loss of human capital and which can be easily adopted by&#xD;
        agencies serving YEH.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 30, 2029</completion_date>
    <primary_completion_date type="Anticipated">January 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W)</measure>
      <time_frame>baseline, 3, 6, 9 and 12 months</time_frame>
      <description>Change in suicidal ideation is measured using the Scale for Suicidal Ideation-Worst Point (SSI-W). Each item consists of three options, which are rated on a 3-point scale from 0 to 2, and each item is graded according to the intensity of the suicidality. Total scores are calculated by summing the 19 ratings, and these total scores can range from 0 to 38 with higher scores indicating worse severity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Depressive Symptoms: Beck Depression Inventory II</measure>
      <time_frame>baseline, 3, 6, 9 and 12 months</time_frame>
      <description>The Beck Depression Inventory II is a 21-item inventory that assesses the severity of depressive symptomatology. Each item is rated on a 0-3 scale with summary scores ranging between 0 and 63 and higher scores indicating higher depressive symptomatology.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Substance use: Form 90</measure>
      <time_frame>baseline, 3, 6, 9 and 12 months</time_frame>
      <description>Frequency of substance use is measured using the Form-90, a semi-structured questionnaire that uses the timeline follow-back method. Form yields percentage of days in the prior 90 days using alcohol and drugs.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Suicide Prevention</condition>
    <arm_group>
      <arm_group_label>Cognitive Therapy for Suicide Prevention + Services as Usual</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with 9 optional booster sessions + services as usual (SAU) received by the community.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Services as Usual</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Therapy for Suicide Prevention</intervention_name>
      <description>10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions</description>
      <arm_group_label>Cognitive Therapy for Suicide Prevention + Services as Usual</arm_group_label>
      <other_name>CTSP</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Services as Usual</intervention_name>
      <description>Participants will receive services that they would normally receive in the community.</description>
      <arm_group_label>Cognitive Therapy for Suicide Prevention + Services as Usual</arm_group_label>
      <arm_group_label>Services as Usual</arm_group_label>
      <other_name>SAU</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  15-24 years&#xD;
  &#xD;
            -  SSI-W score &gt; 4 or at least one suicide attempt in prior 12 months&#xD;
  &#xD;
            -  Meets criteria for homelessness&#xD;
  &#xD;
            -  At least four uses of alcohol/drugs in prior 30 days&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Youth requires psychiatric hospitalization&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>24 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Natasha Slesnick</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Natasha Slesnick, PhD</last_name>
      <phone>6142478469</phone>
      <email>slesnick.5@osu.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicide</mesh_term>
      <mesh_term>Suicide Prevention</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will share results from surveys after de-identification through the Inter-University Consortium for Political and Social Research (ICPSR), an NIH funded data repository, within one year of completion of data collection (see https://www.icpsr.umich.edu/icpsrweb/). Submitted data will conform with relevant data and terminology standards.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>one year after project close-out.</ipd_time_frame>
      <ipd_access_criteria>Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) for secondary study/data analysis purposes and with study PI approval.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05994612
  org study id: 2023B0145
  nct id: NCT05994612
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Suicide is the leading cause of death among YEH and most youth do not access services that
        may be available to them. Therefore, this study seeks to address this gap in the research
        literature with the goal to identify an effective intervention that can be readily adopted by
        communities that serve these youth. We will test the effects of outreach-worker delivered
        Cognitive Therapy for Suicide Prevention (CTSP)+Services as Usual (SAU) versus SAU alone on
        suicidal ideation (primary outcome), substance use and depressive symptoms (secondary
        outcomes) at 3, 6, 9 and 12- months.
  While research on substance using youth experiencing homelessness (YEH) is increasing, there
        is a dearth of information regarding effective prevention interventions for these youth. This
        is of significant concern because studies indicate that 66% to 89% of YEH have a mental
        health disorder and 68% report at least one suicide attempt . In fact, suicide is the leading
        cause of death among YEH. Among those who have attempted suicide, an average of 6.2 attempts
        is reported, and lifetime suicidal ideation rates range from 14% to 66.5% with no clear
        evidence of effective interventions for YEH. This study uses general cognitive theory,
        complemented with concepts from two suicide specific theoretical models, to guide our
        intervention and conceptual change model. The study goal is to test strategies to extend
        delivery and uptake of a cognitive therapy intervention for YEH. Prior studies focus on
        service-connected youth, but research suggests that most street living YEH do not access
        services meant to assist them. Prior sampling limitations are overcome through engaging
        service-disconnected youth in addition to service-connected youth through a local drop-in
        center. As such, three hundred substance using YEH with recent suicidal ideation or a recent
        suicide attempt will be randomly assigned to Cognitive Therapy for Suicide Prevention (CTSP)
        + Services as Usual (SAU) (N=150) or to SAU alone (N=150). CTSP has previously shown efficacy
        for YEH through a RCT pilot feasibility study. SAU includes outreach, advocacy and service
        linkage which are typical services offered by agencies serving those experiencing
        homelessness. Follow-up assessments will be conducted at 3, 6, 9 and 12-months post-baseline.
        It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicidal
        ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over
        time compared to SAU alone, as well as improved risk and protective factors.
        Theoretically-derived mediators will be tested to shed light on mechanisms associated with
        change, and the moderating effects of sex, race, sexual orientation and baseline service
        connection will be examined. In order to ease future dissemination of the intervention to
        agencies serving YEH, the investigators will rigorously assess acceptability, feasibility,
        fidelity and cost associated with the delivery of our intervention approach using a
        mixed-methods approach. Ultimately, the goal of this research is to provide support for the
        use of a suicide prevention intervention for substance using YEH that reduces premature
        mortality, hospitalization, and loss of human capital and which can be easily adopted by
        agencies serving YEH.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Suicidal Ideation: Scale for Suicidal Ideation-Worst Point (SSI-W)
  time frame: baseline, 3, 6, 9 and 12 months
  description: Change in suicidal ideation is measured using the Scale for Suicidal Ideation-Worst Point (SSI-W). Each item consists of three options, which are rated on a 3-point scale from 0 to 2, and each item is graded according to the intensity of the suicidality. Total scores are calculated by summing the 19 ratings, and these total scores can range from 0 to 38 with higher scores indicating worse severity.
  measure: Depressive Symptoms: Beck Depression Inventory II
  time frame: baseline, 3, 6, 9 and 12 months
  description: The Beck Depression Inventory II is a 21-item inventory that assesses the severity of depressive symptomatology. Each item is rated on a 0-3 scale with summary scores ranging between 0 and 63 and higher scores indicating higher depressive symptomatology.
  measure: Substance use: Form 90
  time frame: baseline, 3, 6, 9 and 12 months
  description: Frequency of substance use is measured using the Form-90, a semi-structured questionnaire that uses the timeline follow-back method. Form yields percentage of days in the prior 90 days using alcohol and drugs.
  arm group label: Cognitive Therapy for Suicide Prevention + Services as Usual
  arm group type: Experimental
  description: 10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with 9 optional booster sessions + services as usual (SAU) received by the community.
  arm group label: Services as Usual
  arm group type: Active Comparator
  description: Services as Usual involves utilizing Strengths-Based Outreach and Advocacy to link youth to community services for a period of 6 months.
  intervention type: Behavioral
  intervention name: Cognitive Therapy for Suicide Prevention
  description: 10 sessions of cognitive therapy for suicide prevention plus 9 optional booster sessions
  arm group label: Cognitive Therapy for Suicide Prevention + Services as Usual
  other name: CTSP
  intervention type: Behavioral
  intervention name: Services as Usual
  description: Participants will receive services that they would normally receive in the community.
  arm group label: Cognitive Therapy for Suicide Prevention + Services as Usual
  arm group label: Services as Usual
  other name: SAU
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 24 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Natasha Slesnick
  role: Principal Investigator
  affiliation: Ohio State University
  last name: Natasha Slesnick, PhD
  phone: 6142478469
  email: slesnick.5@osu.edu
  responsible party type: Sponsor
  mesh term: Suicide
  mesh term: Suicide Prevention
  sharing ipd: Yes
  ipd description: We will share results from surveys after de-identification through the Inter-University Consortium for Political and Social Research (ICPSR), an NIH funded data repository, within one year of completion of data collection (see https://www.icpsr.umich.edu/icpsrweb/). Submitted data will conform with relevant data and terminology standards.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: one year after project close-out.
  ipd access criteria: Data will be shared with investigators working under an institution with a Federal Wide Assurance (FWA) for secondary study/data analysis purposes and with study PI approval.