<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/NCT02202915</url>
  </required_header>
  <id_info>
    <org_study_id>4R33MH096828-03</org_study_id>
    <nct_id>NCT02202915</nct_id>
  </id_info>
  <brief_title>CBT for Pediatric OCD: Community Training Pilot</brief_title>
  <official_title>CBT for Pediatric OCD: Community Training Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rhode Island Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rhode Island Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines a training program for clinicians who work in mental health clinics that&#xD;
      serve children with OCD. We will provide clinician training in conducting exposure-based&#xD;
      treatments for children with OCD. The purpose of the project is to test the use of a new tool&#xD;
      to enhance training in exposure-based treatments for clinicians. Therapists will receive&#xD;
      training and oversight from the researchers regarding the treatment procedures and use of the&#xD;
      new tool. All children enrolled in the study will receive treatment by clinicians who are&#xD;
      participating in this study. Therapists and youth will be recruited separately for the study&#xD;
      and will be assigned to work together.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Observed therapist behaviors</measure>
    <time_frame>9 months</time_frame>
    <description>We will us the Exposure Process Coding System to identify behaviors that therapists used during the exposures</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Obsessive Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Fidelity Checklist Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Therapists are receiving training using the fidelity Checklist</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral Checklist</intervention_name>
    <arm_group_label>Fidelity Checklist Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Obsessive Compulsive Disorder is primary diagnosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Psychosis, Pervasive Developmental Disorder, or Mental Retardation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Bradley Hospital</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rhode Island Hospital</investigator_affiliation>
    <investigator_full_name>Kristen Benito, Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor/Staff Psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT02202915
org study id: 4R33MH096828-03
nct id: NCT02202915
lead sponsor: 
has dmc: Yes
This study examines a training program for clinicians who work in mental health clinics that
      serve children with OCD. We will provide clinician training in conducting exposure-based
      treatments for children with OCD. The purpose of the project is to test the use of a new tool
      to enhance training in exposure-based treatments for clinicians. Therapists will receive
      training and oversight from the researchers regarding the treatment procedures and use of the
      new tool. All children enrolled in the study will receive treatment by clinicians who are
      participating in this study. Therapists and youth will be recruited separately for the study
      and will be assigned to work together.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Observed therapist behaviors
time frame: 9 months
description: We will us the Exposure Process Coding System to identify behaviors that therapists used during the exposures
arm group label: Fidelity Checklist Arm
arm group type: Experimental
description: Therapists are receiving training using the fidelity Checklist
intervention type: Behavioral
intervention name: Behavioral Checklist
arm group label: Fidelity Checklist Arm
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rhode Island Hospital
investigator full name: Kristen Benito, Ph.D.
investigator title: Assistant Professor/Staff Psychologist
mesh term: Obsessive-Compulsive Disorder