<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/NCT04404322</url>
  </required_header>
  <id_info>
    <org_study_id>17-0634 RMC</org_study_id>
    <nct_id>NCT04404322</nct_id>
  </id_info>
  <brief_title>Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)</brief_title>
  <official_title>Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</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>
      To address the critical need in crisis intervention for children and adolescents at suicidal&#xD;
      risk the investigators developed an ultra-brief acute crisis intervention, based on&#xD;
      Interpersonal Psychotherapy (IPT). The current adaptation of IPT-A is comprised of five&#xD;
      weekly sessions, followed by monthly follow-up caring email contacts to the patients and&#xD;
      their parents, over a period of three months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, suicidal behaviors have shown substantial increase worldwide. This trend is&#xD;
      also prominent in Israel and has led to a dramatic increase in mental health treatment demand&#xD;
      resulting in long wait times and low treatment acceptance rate. To address the critical need&#xD;
      in crisis intervention for children and adolescents at suicidal risk, the investigators&#xD;
      developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy&#xD;
      (IPT). IPT is an evidence-based intervention for various psychopathologies among different&#xD;
      age groups. The current adaptation of IPT-A is comprised of five weekly sessions, followed by&#xD;
      monthly follow-up caring email contacts to the patients and their parents, over a period of&#xD;
      three months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 17, 2018</start_date>
  <completion_date type="Anticipated">April 17, 2024</completion_date>
  <primary_completion_date type="Anticipated">April 17, 2022</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>Factorial Assignment</intervention_model>
    <intervention_model_description>Patients are referred to SCMC depression and suicide clinic through the ER, outpatient providers or are self-referred. They undergo an initial evaluation and risk assessment. Following initial evaluation, each subject is assigned to one of three study groups, based on clinical considerations. In this stratified randomization system, the most serious acute cases are generally referred to our ultra-short crisis intervention (IPT- A SCI) and the rest are randomized to either one of the three groups: IPT- A SCI, Treatment as usual (TAU) and waiting list (WL). All participants and their parents complete the questionnaires via a secure electronic interface, with the aid of a trained research assistant. Treatment drop-out rates, thus far, seem low and stand at about 11% for the IPT-A SCI and at about 16% for patients who receive TAU.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Suicide Ideation</measure>
    <time_frame>Change from Baseline to 5 weeks assessment and 4 months assessment</time_frame>
    <description>suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in Depression</measure>
    <time_frame>Change from Baseline to 5 weeks assessment and 4 months assessment</time_frame>
    <description>Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Suicide, Attempted</condition>
  <arm_group>
    <arm_group_label>IPT A SCI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The IPT-A SCI follows the intervention protocol, which includes an intensive phase of 5 weekly 50-minute sessions and 3 follow up personal emails.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wait list</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>IPT A Suicide Crisis Intervention</intervention_name>
    <description>The intervention is comprised of five weekly sessions followed by monthly emails to the patients and their parents over a period of three months. The first session is aimed at introducing the intervention, assessing depression and suicidal risk and building a safety plan. The safety plan consists of a prioritized list of coping strategies that the patient can use when suicidal risk is increased. The second session is focused on reviewing the patient's interpersonal relationships (using the closeness circle and interpersonal inventory) and conceptualizing the interpersonal problem area. Sessions 3-4 focus on developing and practicing interpersonal, emotional and behavioral coping strategies relevant for suicidal risk. Lastly, in session 5, patient and therapist go over the process and main issues which were worked on, emphasizing relapse prevention by going back to the safety plan. First and fifth sessions always involve the parents.</description>
    <arm_group_label>IPT A SCI</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment As Usual</intervention_name>
    <description>patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks</description>
    <arm_group_label>Treatment as usual</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  depression symptoms&#xD;
&#xD;
          -  suicidal behavior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute medical condition&#xD;
&#xD;
          -  intellectual disability&#xD;
&#xD;
          -  cognitive impairment&#xD;
&#xD;
          -  linguistic limitation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan APTER, Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin MC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liat Haruvi Catalan, Dr</last_name>
    <phone>0544948037</phone>
    <email>liatcatalan@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Alan APter, Prof</last_name>
    <email>asapter@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine</name>
      <address>
        <city>Petach Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alan Apter, MD</last_name>
      <email>eapter@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Alan Apter, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>May 4, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</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, Attempted</mesh_term>
  </condition_browse>
  <!-- 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/NCT04404322
org study id: 17-0634 RMC
nct id: NCT04404322
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To address the critical need in crisis intervention for children and adolescents at suicidal
      risk the investigators developed an ultra-brief acute crisis intervention, based on
      Interpersonal Psychotherapy (IPT). The current adaptation of IPT-A is comprised of five
      weekly sessions, followed by monthly follow-up caring email contacts to the patients and
      their parents, over a period of three months.
In recent years, suicidal behaviors have shown substantial increase worldwide. This trend is
      also prominent in Israel and has led to a dramatic increase in mental health treatment demand
      resulting in long wait times and low treatment acceptance rate. To address the critical need
      in crisis intervention for children and adolescents at suicidal risk, the investigators
      developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy
      (IPT). IPT is an evidence-based intervention for various psychopathologies among different
      age groups. The current adaptation of IPT-A is comprised of five weekly sessions, followed by
      monthly follow-up caring email contacts to the patients and their parents, over a period of
      three months.
allocation: Non-Randomized
intervention model: Factorial Assignment
intervention model description: Patients are referred to SCMC depression and suicide clinic through the ER, outpatient providers or are self-referred. They undergo an initial evaluation and risk assessment. Following initial evaluation, each subject is assigned to one of three study groups, based on clinical considerations. In this stratified randomization system, the most serious acute cases are generally referred to our ultra-short crisis intervention (IPT- A SCI) and the rest are randomized to either one of the three groups: IPT- A SCI, Treatment as usual (TAU) and waiting list (WL). All participants and their parents complete the questionnaires via a secure electronic interface, with the aid of a trained research assistant. Treatment drop-out rates, thus far, seem low and stand at about 11% for the IPT-A SCI and at about 16% for patients who receive TAU.
primary purpose: Treatment
masking: None (Open Label)
measure: Suicide Ideation
time frame: Change from Baseline to 5 weeks assessment and 4 months assessment
description: suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]
measure: change in Depression
time frame: Change from Baseline to 5 weeks assessment and 4 months assessment
description: Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)
arm group label: IPT A SCI
arm group type: Experimental
description: The IPT-A SCI follows the intervention protocol, which includes an intensive phase of 5 weekly 50-minute sessions and 3 follow up personal emails.
arm group label: Treatment as usual
arm group type: Active Comparator
description: TAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks.
arm group label: wait list
arm group type: No Intervention
description: WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals.
intervention type: Other
intervention name: IPT A Suicide Crisis Intervention
description: The intervention is comprised of five weekly sessions followed by monthly emails to the patients and their parents over a period of three months. The first session is aimed at introducing the intervention, assessing depression and suicidal risk and building a safety plan. The safety plan consists of a prioritized list of coping strategies that the patient can use when suicidal risk is increased. The second session is focused on reviewing the patient's interpersonal relationships (using the closeness circle and interpersonal inventory) and conceptualizing the interpersonal problem area. Sessions 3-4 focus on developing and practicing interpersonal, emotional and behavioral coping strategies relevant for suicidal risk. Lastly, in session 5, patient and therapist go over the process and main issues which were worked on, emphasizing relapse prevention by going back to the safety plan. First and fifth sessions always involve the parents.
arm group label: IPT A SCI
intervention type: Other
intervention name: Treatment As Usual
description: patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks
arm group label: Treatment as usual
criteria: 
gender: All
minimum age: 6 Years
maximum age: 20 Years
healthy volunteers: No
last name: Alan APTER, Prof
role: Principal Investigator
affiliation: Rabin MC
last name: Liat Haruvi Catalan, Dr
phone: 0544948037
email: liatcatalan@gmail.com
last name: Alan APter, Prof
email: asapter@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Sponsor
mesh term: Suicide
mesh term: Suicide, Attempted