<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/NCT03300596</url>
  </required_header>
  <id_info>
    <org_study_id>RSRB00069554</org_study_id>
    <nct_id>NCT03300596</nct_id>
  </id_info>
  <brief_title>Brief New Treatment for Suicide Attempts</brief_title>
  <official_title>Suicidal Adults With Alcohol or Drug Use Problems: A New Hospital-based Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</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>
      Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at&#xD;
      high risk for reattempt. This treatment development study adapts a promising outpatient&#xD;
      intervention to prevent suicide reattempt in order to administer it during hospitalization to&#xD;
      individuals with alcohol and drug use problems, and to test the adapted intervention in a&#xD;
      pilot randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 12, 2018</start_date>
  <completion_date type="Actual">September 15, 2020</completion_date>
  <primary_completion_date type="Actual">September 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>suicide reattempt</measure>
    <time_frame>6 months</time_frame>
    <description>number who reattempt suicide</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Suicide, Attempted</condition>
  <condition>Drug Use</condition>
  <condition>Alcohol; Use, Problem</condition>
  <arm_group>
    <arm_group_label>brief intervention to prevent suicide attempt</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief intervention to prevent suicide attempt</intervention_name>
    <description>A patient-centered, 3-session intervention that calls for videotaping the narrative story of a patient's suicide attempt, in his/her own words (session 1); reviewing segments of the tape to arrive at a shared understanding of the attempt and the sequence of events that led to it (session 2); and using this information, along with a homework task completed by the patient in-between sessions, in order to develop a collaborative, comprehensive written safety plan that addresses the patient's unique vulnerabilities (session 3).</description>
    <arm_group_label>brief intervention to prevent suicide attempt</arm_group_label>
    <other_name>Modification of the Attempted Suicide Short Intervention Program (ASSIP)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced treatment as usual</intervention_name>
    <description>Safety procedures' control intervention. For these procedures we will share summary results of the research assessments regarding suicidal thoughts, suicidal behaviors, alcohol and drug use and related problems, and depressive symptoms with appropriate hospital clinical staff. We will also arrange to send this information, with participants' permission, to their ongoing therapist or treatment program and, if none exists, to the therapist or program to which they are being referred. In this regard, the research assessment protocol serves a dual function of helping with additional monitoring of high-risk patients in addition to providing data for the study.</description>
    <arm_group_label>standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  suicide attempt within one week of hospitalization with acknowledgment of some intent&#xD;
             to die using a standard item&#xD;
&#xD;
          -  problematic alcohol or drug use as determined by score &gt;8 on Alcohol Use Disorders&#xD;
             Identification Test, AUDIT or &gt;3 on the 10-item version of the Drug Abuse Screening&#xD;
             Test, DAST-10&#xD;
&#xD;
          -  admission to hospital&#xD;
&#xD;
          -  residence within 40 miles of Strong Memorial Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  under age 18&#xD;
&#xD;
          -  treated in ED, CPEP, or observation unit only&#xD;
&#xD;
          -  unable to communicate with the researcher in English&#xD;
&#xD;
          -  unable to comprehend the nature of the study&#xD;
&#xD;
          -  participation untenable from a medical (e.g., intubated), psychiatric (e.g., florid&#xD;
             psychosis), or behavioral (e.g., refusing to speak with staff) standpoint&#xD;
&#xD;
          -  short hospital length of stay, ruling out administering three sessions of the therapy&#xD;
             prior to discharge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>September 15, 2020</last_update_submitted>
  <last_update_submitted_qc>September 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Kenneth Conner</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
    <mesh_term>Suicide, Attempted</mesh_term>
    <mesh_term>Alcohol Drinking</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/NCT03300596
org study id: RSRB00069554
nct id: NCT03300596
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Individuals with alcohol or drug use problems who are hospitalized for suicide attempt are at
      high risk for reattempt. This treatment development study adapts a promising outpatient
      intervention to prevent suicide reattempt in order to administer it during hospitalization to
      individuals with alcohol and drug use problems, and to test the adapted intervention in a
      pilot randomized controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: suicide reattempt
time frame: 6 months
description: number who reattempt suicide
arm group label: brief intervention to prevent suicide attempt
arm group type: Experimental
description: Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
arm group label: standard of care
arm group type: Other
description: Individuals presenting to hospital following a suicide attempt who are age 18-plus and screen positive for alcohol or drug use problem
intervention type: Behavioral
intervention name: Brief intervention to prevent suicide attempt
description: A patient-centered, 3-session intervention that calls for videotaping the narrative story of a patient's suicide attempt, in his/her own words (session 1); reviewing segments of the tape to arrive at a shared understanding of the attempt and the sequence of events that led to it (session 2); and using this information, along with a homework task completed by the patient in-between sessions, in order to develop a collaborative, comprehensive written safety plan that addresses the patient's unique vulnerabilities (session 3).
arm group label: brief intervention to prevent suicide attempt
other name: Modification of the Attempted Suicide Short Intervention Program (ASSIP)
intervention type: Behavioral
intervention name: Enhanced treatment as usual
description: Safety procedures' control intervention. For these procedures we will share summary results of the research assessments regarding suicidal thoughts, suicidal behaviors, alcohol and drug use and related problems, and depressive symptoms with appropriate hospital clinical staff. We will also arrange to send this information, with participants' permission, to their ongoing therapist or treatment program and, if none exists, to the therapist or program to which they are being referred. In this regard, the research assessment protocol serves a dual function of helping with additional monitoring of high-risk patients in addition to providing data for the study.
arm group label: standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Kenneth Conner
investigator title: Professor
mesh term: Suicide
mesh term: Suicide, Attempted
mesh term: Alcohol Drinking
sharing ipd: No