<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/NCT03271346</url>
  </required_header>
  <id_info>
    <org_study_id>2015-GRE-1</org_study_id>
    <nct_id>NCT03271346</nct_id>
  </id_info>
  <brief_title>Intensive Trauma Treatment for Children Exposed to Parental Conflict</brief_title>
  <official_title>Intensive Trauma Treatment for Children Exposed to Parental Conflict</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Trauma Institute &amp; Child Trauma Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gratis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Trauma Institute &amp; Child Trauma Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to track outcomes of the investigator's therapy approach with&#xD;
      children of separation/divorce who have been exposed to parental conflict.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2015</start_date>
  <completion_date type="Anticipated">January 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in CROPS following treatment</measure>
    <time_frame>Pre-treatment, 2 weeks post-treatment, 2 months post-treatment</time_frame>
    <description>Child (self-) Report of Posttraumatic Symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PROPS following treatment</measure>
    <time_frame>Pre-treatment, 2 weeks post-treatment, 2 months post-treatment</time_frame>
    <description>Parent Report of Posttraumatic Symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in SUDS following treatment</measure>
    <time_frame>Pre-treatment, 2 weeks post-treatment, 2 months post-treatment</time_frame>
    <description>Subjective Units of Distress Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in PRS following treatment</measure>
    <time_frame>Pre-treatment, 2 weeks post-treatment, 2 months post-treatment</time_frame>
    <description>Problem Rating Scale</description>
  </primary_outcome>
  <enrollment type="Anticipated">4</enrollment>
  <condition>Conflict, Interparental</condition>
  <condition>Trauma, Psychological</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>intensive trauma-focused therapy</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children exposed to parental conflict and contested custody&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  child between the ages of 6 - 16&#xD;
&#xD;
          -  parent concerned re child's distress and behaviors related to custody, visitation,&#xD;
             etc.&#xD;
&#xD;
          -  parent has the legal authority to obtain treatment for the child&#xD;
&#xD;
          -  parent and child fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  as per clinical judgment of the PI during a telephone screening (interview of the&#xD;
             referring parent), determination that the child is unlikely to be responsive to the&#xD;
             intensive therapy format. This would typically be due to the child having a severe&#xD;
             intellectual impairment, major dissociative disorder, etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricky Greenwald, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Trauma Institute &amp; Child Trauma Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ricky Greenwald, PsyD</last_name>
    <phone>413-774-2340</phone>
    <email>cti@childtrauma.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karen Steward</last_name>
    <phone>413-774-2340</phone>
    <email>kjs@childtrauma.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Trauma Institute &amp; Child Trauma Institute</name>
      <address>
        <city>Northampton</city>
        <state>Massachusetts</state>
        <zip>01060</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ricky Greenwald, PsyD</last_name>
      <phone>413-774-2340</phone>
      <email>cti@childtrauma.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>February 17, 2015</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 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>Wounds and Injuries</mesh_term>
    <mesh_term>Psychological Trauma</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/NCT03271346
org study id: 2015-GRE-1
nct id: NCT03271346
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to track outcomes of the investigator's therapy approach with
      children of separation/divorce who have been exposed to parental conflict.
observational model: Case-Only
time perspective: Prospective
measure: Change in CROPS following treatment
time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
description: Child (self-) Report of Posttraumatic Symptoms
measure: Change in PROPS following treatment
time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
description: Parent Report of Posttraumatic Symptoms
measure: Change in SUDS following treatment
time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
description: Subjective Units of Distress Scale
measure: Change in PRS following treatment
time frame: Pre-treatment, 2 weeks post-treatment, 2 months post-treatment
description: Problem Rating Scale
intervention type: Behavioral
intervention name: intensive trauma-focused therapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ricky Greenwald, PsyD
role: Principal Investigator
affiliation: Trauma Institute & Child Trauma Institute
last name: Ricky Greenwald, PsyD
phone: 413-774-2340
email: cti@childtrauma.com
last name: Karen Steward
phone: 413-774-2340
email: kjs@childtrauma.com
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Psychological Trauma