<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/NCT02981420</url>
  </required_header>
  <id_info>
    <org_study_id>927079</org_study_id>
    <secondary_id>K23MH111606</secondary_id>
    <nct_id>NCT02981420</nct_id>
  </id_info>
  <brief_title>Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff</brief_title>
  <official_title>Implementing a Brief Suicide Intervention for High Risk Youth With Front-Line Juvenile Justice Staff</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A youth's contact with the juvenile justice system represents an opportune moment for suicide&#xD;
      screening and brief suicide intervention for indicated youth. This study will provide data on&#xD;
      the novel implementation of an evidence-based brief suicide intervention, safety planning,&#xD;
      administered by front-line juvenile court staff for suicidal court-involved non-incarcerated&#xD;
      youth. Data will inform the dissemination and implementation of suicide brief interventions&#xD;
      to be delivered by front-line staff at the time of mental health screening in the juvenile&#xD;
      justice system. The proposed study is consistent with the NIMH Strategic Plan by testing an&#xD;
      intervention for effectiveness in community settings (Strategy 3.3) and establishing a&#xD;
      research-practice partnership to improve D&amp;I of evidence-based MH services (4.2). The unique&#xD;
      service delivery by JJ court staff also supports the NIMH goals to develop innovative service&#xD;
      delivery models (Strategy 4.3) as well as validate a MH intervention for an underserved&#xD;
      population (Strategy 4.1). This proposal also addresses the Healthy People 2020 goals of&#xD;
      reducing suicide attempts (MHMD-2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Suicide and suicidal behaviors among youth in the United States represents a significant&#xD;
      public health problem. Youth involved in the juvenile justice system have a greater burden of&#xD;
      risk factors associated with suicide ideation and behaviors as compared to their non-justice&#xD;
      involved peers, placing these youth at greater risk for suicide. Thus, the overall goal of&#xD;
      this Mentored Patient-Oriented Research Career Development Award (K23) is to support the&#xD;
      applicant in developing the skills to launch an independent research program focused on the&#xD;
      dissemination and implementation of evidence-based interventions for court-involved&#xD;
      non-incarcerated (CINI) youth involved in the juvenile justice system to reduce psychiatric&#xD;
      morbidity. Specific training goals are: (1) engage in intensive clinical and research&#xD;
      training to increase my expertise in conducting brief interventions for adolescent suicide,&#xD;
      (2) develop expertise in dissemination and implementation strategies and research in the&#xD;
      juvenile justice system, (3) achieve skills in mixed-method research methodology including&#xD;
      design and analysis of studies to support causal inference when randomization is not&#xD;
      possible. The applicant will pursue these goals through a combination of mentoring,&#xD;
      didactics, and practical experience. Specific training goals for this 5-year-period will be&#xD;
      achieved under the mentorship of Drs. Anthony Spirito (Brown University), Marina Tolou-Shams&#xD;
      (UCSF), Gina Vincent (UMASS Medical School), and Peter Friedmann (Baystate Health). The&#xD;
      objective of the proposed research study is to 1) identify individual-, administrative-, and&#xD;
      system-level factors that promote or hinder uptake of a brief suicide intervention conducted&#xD;
      by front-line juvenile justice staff with CINI youth and 2) implement an evidence-based brief&#xD;
      intervention, safety planning, for suicidal CINI youth and evaluate its utility with these&#xD;
      youth. In the Treatment Adaptation phase, 12 juvenile justice stakeholders will be&#xD;
      interviewed pre- and post-intervention implementation, as well as 24 youth and 24 caregivers&#xD;
      3-months post-intervention, about the acceptability of the brief intervention in the juvenile&#xD;
      court setting. In the Treatment Trial phase, we will examine the effectiveness of a safety&#xD;
      planning intervention for indicated suicidal youth in reducing suicidal ideation, in reducing&#xD;
      suicidal events (suicide attempts as well as emergency evaluations and psychiatric&#xD;
      hospitalizations for suicidality), increased engagement in outpatient mental health&#xD;
      treatment, and improved youth motivation for treatment. CINI juveniles, ages 12-17, (N=100&#xD;
      for baseline (historical control) cohort; N=100 for efficacy trial; N=100 for alternative&#xD;
      causal design) and a caregiver will be recruited from the juvenile court to participate in&#xD;
      the current study. CINI juveniles in the efficacy trial will receive the evidenced-based&#xD;
      brief suicide intervention as part of standard of care and will be compared to historical&#xD;
      control and alternative causal design. Baseline data will be collected as part of routine&#xD;
      care. Youth and a caregiver will be re-assessed at 3 months subsequent to the juvenile's&#xD;
      initial court appointment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">May 2020</completion_date>
  <primary_completion_date type="Anticipated">May 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form</measure>
    <time_frame>3 months</time_frame>
    <description>Structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Suicide Ideation Questionnaire (SIQ) - Junior</measure>
    <time_frame>3 months</time_frame>
    <description>assesses the frequency of suicidal ideation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child and Adolescent Services Assessment</measure>
    <time_frame>3 months</time_frame>
    <description>parent report of utilization of MH services and operationalized as a composite score of suicide attempts and emergency interventions for acute suicidality assessed by the Child and Adolescent Services Assessment (CASA)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment Attendance</measure>
    <time_frame>3 months</time_frame>
    <description>Attendance at first treatment appointment and total number of treatment sessions attended will be collected by contacting each juveniles' treatment provider at the 3-month follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recidivism</measure>
    <time_frame>3 months</time_frame>
    <description>Collateral data gathered from court database). Juveniles' recidivism rates (e.g., new arrests), description of related charges (e.g., substance-related, property) and time detained/incarcerated</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Suicide and Self Harm</condition>
  <arm_group>
    <arm_group_label>Pre-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Pre-intervention baseline comparison</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Safety Planning</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regression discontinuity</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subthreshold no intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Safety planning</intervention_name>
    <description>Safety Planning Intervention. This brief one-session intervention, based on cognitive behavioral principles, is designed to help individuals identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of suicidal behavior. In youth who also report nonsuicidal self-injurious behavior (NSSI), the safety plan will address both suicidal and nonsuicidal behavior. The plan helps youth identify possible triggers to SI/crisis including self-monitoring of suicidal thoughts, feelings, and behaviors; advance planning to remove lethal means; determine distress tolerance/emotion regulation skills that may be helpful; identify accessible social supports to target hopelessness/sense of isolation; reinforce the commitment to seek treatment; and, how and where to access emergency care.</description>
    <arm_group_label>Safety Planning</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Court-involved non-incarcerated (CINI) youth,&#xD;
&#xD;
          -  ages 12-17&#xD;
&#xD;
          -  Legal guardian available to consent for juvenile's participation,&#xD;
&#xD;
          -  Juvenile is English speaking, and&#xD;
&#xD;
          -  Juvenile flags in the caution or warning range of the MAYSI-2.&#xD;
&#xD;
        Inclusion for second cohort:&#xD;
&#xD;
          -  Court-involved non-incarcerated (CINI) youth,&#xD;
&#xD;
          -  ages 12-17&#xD;
&#xD;
          -  Legal guardian available to consent for juvenile's participation,&#xD;
&#xD;
          -  Juvenile is English speaking, and&#xD;
&#xD;
          -  Juvenile does not flag in the caution or warning range of the MAYSI-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  observable cognitive, developmental delays, or psychosis that would interfere with&#xD;
             completing consent, assessment or intervention, and&#xD;
&#xD;
          -  Juvenile meets hospital level of care for imminent suicide risk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathleen Kemp, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>RIH/Brown University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathleen Kemp, Ph.D.</last_name>
    <phone>4017938269</phone>
    <email>kkemp@lifespan.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rhode Island Family Court</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Kemp, Ph.D.</last_name>
      <phone>203-619-1692</phone>
      <email>kkemp@lifespan.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>March 2, 2017</last_update_submitted>
  <last_update_submitted_qc>March 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2017</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>Self-Injurious Behavior</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/NCT02981420
org study id: 927079
secondary id: K23MH111606
nct id: NCT02981420
lead sponsor: 
collaborator: 
has dmc: No
A youth's contact with the juvenile justice system represents an opportune moment for suicide
      screening and brief suicide intervention for indicated youth. This study will provide data on
      the novel implementation of an evidence-based brief suicide intervention, safety planning,
      administered by front-line juvenile court staff for suicidal court-involved non-incarcerated
      youth. Data will inform the dissemination and implementation of suicide brief interventions
      to be delivered by front-line staff at the time of mental health screening in the juvenile
      justice system. The proposed study is consistent with the NIMH Strategic Plan by testing an
      intervention for effectiveness in community settings (Strategy 3.3) and establishing a
      research-practice partnership to improve D&I of evidence-based MH services (4.2). The unique
      service delivery by JJ court staff also supports the NIMH goals to develop innovative service
      delivery models (Strategy 4.3) as well as validate a MH intervention for an underserved
      population (Strategy 4.1). This proposal also addresses the Healthy People 2020 goals of
      reducing suicide attempts (MHMD-2).
Suicide and suicidal behaviors among youth in the United States represents a significant
      public health problem. Youth involved in the juvenile justice system have a greater burden of
      risk factors associated with suicide ideation and behaviors as compared to their non-justice
      involved peers, placing these youth at greater risk for suicide. Thus, the overall goal of
      this Mentored Patient-Oriented Research Career Development Award (K23) is to support the
      applicant in developing the skills to launch an independent research program focused on the
      dissemination and implementation of evidence-based interventions for court-involved
      non-incarcerated (CINI) youth involved in the juvenile justice system to reduce psychiatric
      morbidity. Specific training goals are: (1) engage in intensive clinical and research
      training to increase my expertise in conducting brief interventions for adolescent suicide,
      (2) develop expertise in dissemination and implementation strategies and research in the
      juvenile justice system, (3) achieve skills in mixed-method research methodology including
      design and analysis of studies to support causal inference when randomization is not
      possible. The applicant will pursue these goals through a combination of mentoring,
      didactics, and practical experience. Specific training goals for this 5-year-period will be
      achieved under the mentorship of Drs. Anthony Spirito (Brown University), Marina Tolou-Shams
      (UCSF), Gina Vincent (UMASS Medical School), and Peter Friedmann (Baystate Health). The
      objective of the proposed research study is to 1) identify individual-, administrative-, and
      system-level factors that promote or hinder uptake of a brief suicide intervention conducted
      by front-line juvenile justice staff with CINI youth and 2) implement an evidence-based brief
      intervention, safety planning, for suicidal CINI youth and evaluate its utility with these
      youth. In the Treatment Adaptation phase, 12 juvenile justice stakeholders will be
      interviewed pre- and post-intervention implementation, as well as 24 youth and 24 caregivers
      3-months post-intervention, about the acceptability of the brief intervention in the juvenile
      court setting. In the Treatment Trial phase, we will examine the effectiveness of a safety
      planning intervention for indicated suicidal youth in reducing suicidal ideation, in reducing
      suicidal events (suicide attempts as well as emergency evaluations and psychiatric
      hospitalizations for suicidality), increased engagement in outpatient mental health
      treatment, and improved youth motivation for treatment. CINI juveniles, ages 12-17, (N=100
      for baseline (historical control) cohort; N=100 for efficacy trial; N=100 for alternative
      causal design) and a caregiver will be recruited from the juvenile court to participate in
      the current study. CINI juveniles in the efficacy trial will receive the evidenced-based
      brief suicide intervention as part of standard of care and will be compared to historical
      control and alternative causal design. Baseline data will be collected as part of routine
      care. Youth and a caregiver will be re-assessed at 3 months subsequent to the juvenile's
      initial court appointment.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Self-Injurious Thoughts and Behaviors Interview 2.0 (SITBI 2.0) Short Form
time frame: 3 months
description: Structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors
measure: Suicide Ideation Questionnaire (SIQ) - Junior
time frame: 3 months
description: assesses the frequency of suicidal ideation
measure: Child and Adolescent Services Assessment
time frame: 3 months
description: parent report of utilization of MH services and operationalized as a composite score of suicide attempts and emergency interventions for acute suicidality assessed by the Child and Adolescent Services Assessment (CASA)
measure: Treatment Attendance
time frame: 3 months
description: Attendance at first treatment appointment and total number of treatment sessions attended will be collected by contacting each juveniles' treatment provider at the 3-month follow-up
measure: Recidivism
time frame: 3 months
description: Collateral data gathered from court database). Juveniles' recidivism rates (e.g., new arrests), description of related charges (e.g., substance-related, property) and time detained/incarcerated
arm group label: Pre-intervention
arm group type: No Intervention
description: Pre-intervention baseline comparison
arm group label: Safety Planning
arm group type: Experimental
description: Intervention group
arm group label: Regression discontinuity
arm group type: No Intervention
description: Subthreshold no intervention
intervention type: Behavioral
intervention name: Safety planning
description: Safety Planning Intervention. This brief one-session intervention, based on cognitive behavioral principles, is designed to help individuals identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of suicidal behavior. In youth who also report nonsuicidal self-injurious behavior (NSSI), the safety plan will address both suicidal and nonsuicidal behavior. The plan helps youth identify possible triggers to SI/crisis including self-monitoring of suicidal thoughts, feelings, and behaviors; advance planning to remove lethal means; determine distress tolerance/emotion regulation skills that may be helpful; identify accessible social supports to target hopelessness/sense of isolation; reinforce the commitment to seek treatment; and, how and where to access emergency care.
arm group label: Safety Planning
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kathleen Kemp, Ph.D.
role: Principal Investigator
affiliation: RIH/Brown University
last name: Kathleen Kemp, Ph.D.
phone: 4017938269
email: kkemp@lifespan.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
mesh term: Self-Injurious Behavior
sharing ipd: No