<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/NCT03016572</url>
  </required_header>
  <id_info>
    <org_study_id>16-886</org_study_id>
    <nct_id>NCT03016572</nct_id>
  </id_info>
  <brief_title>Promote Access to Stop Suicide: Comparison of Follow up Services for Youth at Risk for Suicide</brief_title>
  <acronym>PASS</acronym>
  <official_title>PASS (Promote Access to Stop Suicide): A Randomized Controlled Trial Comparing Enhanced Treatment as Usual, Crisis Center Follow up and Wraparound Services for Youth at Risk for Suicide</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Case Western Reserve University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Cleveland Clinic</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>
      This research study is designed to answer specific questions about new ways to provide&#xD;
      services for youth at-risk of suicide.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed project will be able to provide services to high-risk youth in Ohio. This&#xD;
      randomized controlled trial for youth discharged from inpatient psychiatric hospital will be&#xD;
      able to determine what combination of services is best suited to reduce subsequent suicide&#xD;
      attempts and re-hospitalization.&#xD;
&#xD;
      All youth (ages 10-18), that fit the inclusion criteria, will be recruited from the inpatient&#xD;
      unit at Fairview Youth Inpatient Unit. Patients will be consented, enrolled, and assigned to&#xD;
      group by the Research Coordinator working at the unit. The Methodologist/ Statistician will&#xD;
      generate a random allocation sequence using random number generator and communicate group&#xD;
      assignment to the Research Coordinator. There will not be any restriction on randomization.&#xD;
      The PI will be blinded to all group assignments.&#xD;
&#xD;
      The clinical research tools and screens that will be administered in this study include:&#xD;
      Columbia-Suicide Severity Rating Scale (C-SSRS), The Suicidal Ideation Questionnaire (SIQ),&#xD;
      The Adverse Childhood Experiences (ACEs), Ohio Scales, Children's Global Assessment Scale&#xD;
      (CGAS), Clinical Global Impressions (CGI-I).&#xD;
&#xD;
      The participants of the study will be seen by the child psychiatrist (Dr. Varkula) and the&#xD;
      research coordinator at the initial appointment, and a 6 month follow-up (Dr. Falcone). The&#xD;
      C-SSRS and the SIQ will be administered at the initial appointment and the follow-up&#xD;
      appointment. The study's research coordinator will be regulating the 3 month phone call and&#xD;
      scheduling the 6 month up visit and administering the Ohio Scales questionnaire with the&#xD;
      parents and/ or guardians of the child. There will also be a 12 month follow-up phone call&#xD;
      conducted by the research coordinator. During this time, the information for the C-SSRS&#xD;
      questionnaire, the SIQ, the Ohio Scales (for both the parent and the child), the CGI-I, and&#xD;
      the CGAS will be administered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 4, 2017</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of repeat suicide attempts in adolescents.</measure>
    <time_frame>up to 12 months post-discharge</time_frame>
    <description>Frequency of repeat suicide attempts during the 12 month follow up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency of readmissions after a suicide attempt in adolescents.</measure>
    <time_frame>up to 12 months post-discharge</time_frame>
    <description>Frequency of readmissions after a suicide attempt in adolescents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between service type and frequency of repeat suicide attempts in adolescents.</measure>
    <time_frame>up to 12 months post-discharge</time_frame>
    <description>Comparing the frequency of repeat suicide attempts in adolescents among the 3 service type treatment arms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between service type and frequency of readmissions after a suicide attempt in adolescents.</measure>
    <time_frame>up to 12 months post-discharge</time_frame>
    <description>Comparing the frequency of readmissions after a suicide attempt in adolescents among the 3 service type treatment arms.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Suicide</condition>
  <condition>Depressive Disorder, Major</condition>
  <condition>Anxiety Disorders</condition>
  <condition>Suicidal Ideation</condition>
  <condition>Suicidal Impulses</condition>
  <arm_group>
    <arm_group_label>Enhanced Treatment As Usual (E-TAU)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patient will be referred for regular (Standard of Care) outpatient psychiatry/ psychology services or continue with the services that they were receiving prior to admission. They will be followed up by calling patient families at 3 months (post their initial appointment) and at 12 months. They will also have 1 research visit at 6 months (with Dr. Falcone), which they will schedule during their 3 month follow-up call; the Suicide Ideation Questionnaire (SIQ) will be administered. The patients assigned to this group will also be receiving 10 caring follow-up post cards at the following weeks and months (post-discharge from the inpatient unit): 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 5 months, 7 months, 9 months, 12 months, and on the patient's birthday.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU + Crisis Center (CC) Follow Up</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Frontline Services will be administering (at least 9) crisis intervention phone calls to the patients; more calls will be made if they feel it is necessary for the safety and health of the patient. Follow up calls will ask the patient questions about following up in the future, whether they have had thoughts about suicide, whether they are in imminent danger of suicide by the end of the call, and whether the patient is stable. At the end of the call, the patient will be asked to rate their suicidality on a scale of 1 to 10.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAU + CC Follow Up + Wraparound Services</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will be linked with a care coordinator through Tapestry services. Wraparound is an intensive, individualized care coordination and treatment planning process that involves all of the important people in a child's life to work together to make the child successful in school, at home and in the community.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Follow-Up Calls, Questionnaires</description>
    <arm_group_label>Enhanced Treatment As Usual (E-TAU)</arm_group_label>
    <arm_group_label>TAU + CC Follow Up + Wraparound Services</arm_group_label>
    <arm_group_label>TAU + Crisis Center (CC) Follow Up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Crisis Intervention</intervention_name>
    <description>Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.</description>
    <arm_group_label>TAU + CC Follow Up + Wraparound Services</arm_group_label>
    <arm_group_label>TAU + Crisis Center (CC) Follow Up</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wraparound Services</intervention_name>
    <description>Tapestry will be assigning case management services for participants randomized into the third arm of the study.</description>
    <arm_group_label>TAU + CC Follow Up + Wraparound Services</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients (ages 10-18 years) admitted to the Cleveland Clinic Inpatient Child and&#xD;
             Adolescent psychiatry unit after a suicide ideation, behavior, or attempt.&#xD;
&#xD;
          -  This can be defined by any intentional, nonfatal self-injury, regardless of medical&#xD;
             lethality, will be consider a suicide attempt if intent to die was indicated.&#xD;
&#xD;
          -  Signed consent by the adult patient (18 years) or by a first-degree relative or a&#xD;
             guardian (for children) at the time of enrollment in the study, and assent by the&#xD;
             children as soon as is feasible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known history of autistic spectrum disorder, non-verbal patients and&#xD;
             moderate or severe mental retardation (IQ less than 70 and those patients in special&#xD;
             education full time), patients with substance dependency and patients with&#xD;
             schizophrenia.&#xD;
&#xD;
          -  Patients who are enrolled in case management will also be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatiana Falcone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Fairview Hospital</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brent DA, Oquendo M, Birmaher B, Greenhill L, Kolko D, Stanley B, Zelazny J, Brodsky B, Firinciogullari S, Ellis SP, Mann JJ. Peripubertal suicide attempts in offspring of suicide attempters with siblings concordant for suicidal behavior. Am J Psychiatry. 2003 Aug;160(8):1486-93. doi: 10.1176/appi.ajp.160.8.1486.</citation>
    <PMID>12900312</PMID>
  </reference>
  <reference>
    <citation>Gould MS, Greenberg T, Velting DM, Shaffer D. Youth suicide risk and preventive interventions: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):386-405. doi: 10.1097/01.CHI.0000046821.95464.CF.</citation>
    <PMID>12649626</PMID>
  </reference>
  <reference>
    <citation>Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.</citation>
    <PMID>23303463</PMID>
  </reference>
  <reference>
    <citation>Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13.</citation>
    <PMID>25444653</PMID>
  </reference>
  <reference>
    <citation>Gould MS, Kalafat J, Harrismunfakh JL, Kleinman M. An evaluation of crisis hotline outcomes. Part 2: Suicidal callers. Suicide Life Threat Behav. 2007 Jun;37(3):338-52. doi: 10.1521/suli.2007.37.3.338.</citation>
    <PMID>17579545</PMID>
  </reference>
  <reference>
    <citation>Busch KA, Fawcett J, Jacobs DG. Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003 Jan;64(1):14-9. doi: 10.4088/jcp.v64n0105.</citation>
    <PMID>12590618</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Tatiana Falcone, MD</investigator_full_name>
    <investigator_title>Tatiana Falcone M.D.</investigator_title>
  </responsible_party>
  <keyword>Suicide</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Intervention</keyword>
  <keyword>Crisis</keyword>
  <keyword>Follow-Up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicidal Ideation</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03016572
org study id: 16-886
nct id: NCT03016572
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This research study is designed to answer specific questions about new ways to provide
      services for youth at-risk of suicide.
The proposed project will be able to provide services to high-risk youth in Ohio. This
      randomized controlled trial for youth discharged from inpatient psychiatric hospital will be
      able to determine what combination of services is best suited to reduce subsequent suicide
      attempts and re-hospitalization.

      All youth (ages 10-18), that fit the inclusion criteria, will be recruited from the inpatient
      unit at Fairview Youth Inpatient Unit. Patients will be consented, enrolled, and assigned to
      group by the Research Coordinator working at the unit. The Methodologist/ Statistician will
      generate a random allocation sequence using random number generator and communicate group
      assignment to the Research Coordinator. There will not be any restriction on randomization.
      The PI will be blinded to all group assignments.

      The clinical research tools and screens that will be administered in this study include:
      Columbia-Suicide Severity Rating Scale (C-SSRS), The Suicidal Ideation Questionnaire (SIQ),
      The Adverse Childhood Experiences (ACEs), Ohio Scales, Children's Global Assessment Scale
      (CGAS), Clinical Global Impressions (CGI-I).

      The participants of the study will be seen by the child psychiatrist (Dr. Varkula) and the
      research coordinator at the initial appointment, and a 6 month follow-up (Dr. Falcone). The
      C-SSRS and the SIQ will be administered at the initial appointment and the follow-up
      appointment. The study's research coordinator will be regulating the 3 month phone call and
      scheduling the 6 month up visit and administering the Ohio Scales questionnaire with the
      parents and/ or guardians of the child. There will also be a 12 month follow-up phone call
      conducted by the research coordinator. During this time, the information for the C-SSRS
      questionnaire, the SIQ, the Ohio Scales (for both the parent and the child), the CGI-I, and
      the CGAS will be administered.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
measure: Frequency of repeat suicide attempts in adolescents.
time frame: up to 12 months post-discharge
description: Frequency of repeat suicide attempts during the 12 month follow up
measure: Frequency of readmissions after a suicide attempt in adolescents.
time frame: up to 12 months post-discharge
description: Frequency of readmissions after a suicide attempt in adolescents
measure: Relation between service type and frequency of repeat suicide attempts in adolescents.
time frame: up to 12 months post-discharge
description: Comparing the frequency of repeat suicide attempts in adolescents among the 3 service type treatment arms.
measure: Relation between service type and frequency of readmissions after a suicide attempt in adolescents.
time frame: up to 12 months post-discharge
description: Comparing the frequency of readmissions after a suicide attempt in adolescents among the 3 service type treatment arms.
arm group label: Enhanced Treatment As Usual (E-TAU)
arm group type: Experimental
description: The patient will be referred for regular (Standard of Care) outpatient psychiatry/ psychology services or continue with the services that they were receiving prior to admission. They will be followed up by calling patient families at 3 months (post their initial appointment) and at 12 months. They will also have 1 research visit at 6 months (with Dr. Falcone), which they will schedule during their 3 month follow-up call; the Suicide Ideation Questionnaire (SIQ) will be administered. The patients assigned to this group will also be receiving 10 caring follow-up post cards at the following weeks and months (post-discharge from the inpatient unit): 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 5 months, 7 months, 9 months, 12 months, and on the patient's birthday.
arm group label: TAU + Crisis Center (CC) Follow Up
arm group type: Experimental
description: Frontline Services will be administering (at least 9) crisis intervention phone calls to the patients; more calls will be made if they feel it is necessary for the safety and health of the patient. Follow up calls will ask the patient questions about following up in the future, whether they have had thoughts about suicide, whether they are in imminent danger of suicide by the end of the call, and whether the patient is stable. At the end of the call, the patient will be asked to rate their suicidality on a scale of 1 to 10.
arm group label: TAU + CC Follow Up + Wraparound Services
arm group type: Experimental
description: This group will be linked with a care coordinator through Tapestry services. Wraparound is an intensive, individualized care coordination and treatment planning process that involves all of the important people in a child's life to work together to make the child successful in school, at home and in the community.
intervention type: Behavioral
intervention name: Standard of Care
description: Follow-Up Calls, Questionnaires
arm group label: Enhanced Treatment As Usual (E-TAU)
arm group label: TAU + CC Follow Up + Wraparound Services
arm group label: TAU + Crisis Center (CC) Follow Up
intervention type: Behavioral
intervention name: Crisis Intervention
description: Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.
arm group label: TAU + CC Follow Up + Wraparound Services
arm group label: TAU + Crisis Center (CC) Follow Up
intervention type: Behavioral
intervention name: Wraparound Services
description: Tapestry will be assigning case management services for participants randomized into the third arm of the study.
arm group label: TAU + CC Follow Up + Wraparound Services
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Tatiana Falcone, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
citation: Brent DA, Oquendo M, Birmaher B, Greenhill L, Kolko D, Stanley B, Zelazny J, Brodsky B, Firinciogullari S, Ellis SP, Mann JJ. Peripubertal suicide attempts in offspring of suicide attempters with siblings concordant for suicidal behavior. Am J Psychiatry. 2003 Aug;160(8):1486-93. doi: 10.1176/appi.ajp.160.8.1486.
PMID: 12900312
citation: Gould MS, Greenberg T, Velting DM, Shaffer D. Youth suicide risk and preventive interventions: a review of the past 10 years. J Am Acad Child Adolesc Psychiatry. 2003 Apr;42(4):386-405. doi: 10.1097/01.CHI.0000046821.95464.CF.
PMID: 12649626
citation: Nock MK, Green JG, Hwang I, McLaughlin KA, Sampson NA, Zaslavsky AM, Kessler RC. Prevalence, correlates, and treatment of lifetime suicidal behavior among adolescents: results from the National Comorbidity Survey Replication Adolescent Supplement. JAMA Psychiatry. 2013 Mar;70(3):300-10. doi: 10.1001/2013.jamapsychiatry.55.
PMID: 23303463
citation: Torio CM, Encinosa W, Berdahl T, McCormick MC, Simpson LA. Annual report on health care for children and youth in the United States: national estimates of cost, utilization and expenditures for children with mental health conditions. Acad Pediatr. 2015 Jan-Feb;15(1):19-35. doi: 10.1016/j.acap.2014.07.007. Epub 2014 Nov 13.
PMID: 25444653
citation: Gould MS, Kalafat J, Harrismunfakh JL, Kleinman M. An evaluation of crisis hotline outcomes. Part 2: Suicidal callers. Suicide Life Threat Behav. 2007 Jun;37(3):338-52. doi: 10.1521/suli.2007.37.3.338.
PMID: 17579545
citation: Busch KA, Fawcett J, Jacobs DG. Clinical correlates of inpatient suicide. J Clin Psychiatry. 2003 Jan;64(1):14-9. doi: 10.4088/jcp.v64n0105.
PMID: 12590618
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Tatiana Falcone, MD
investigator title: Tatiana Falcone M.D.
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
mesh term: Suicide
mesh term: Suicidal Ideation
mesh term: Depressive Disorder, Major
sharing ipd: No