<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/NCT03778827</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-49033</org_study_id>
    <nct_id>NCT03778827</nct_id>
  </id_info>
  <brief_title>A Center Based Study of Pivotal Response Treatment for Preschoolers With Autism</brief_title>
  <acronym>PRT-C</acronym>
  <official_title>A Center Based Randomized Controlled Trial of Pivotal Response Treatment for Preschoolers With Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>John &amp; Marcia Goldman Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</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>
      The purpose of this study is to examine the effectiveness of pivotal response training (PRT)&#xD;
      in an intensive center-based environment to treat social communication deficits in children&#xD;
      with autism spectrum disorder (ASD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to examine the effectiveness of pivotal response training (PRT)&#xD;
      in an intensive center-based preschool environment to treat social communication deficits in&#xD;
      children with autism spectrum disorder (ASD). The study will compare Pivotal Response&#xD;
      Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral&#xD;
      intervention based on the principles of applied behavior analysis which has shown to be&#xD;
      effective in treating the core deficits in children with ASD. The study will compare the&#xD;
      combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will&#xD;
      include 44 children ages 2 to 3.11 years with ASD and social communication deficits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 8, 2019</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2025</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks</measure>
    <time_frame>Baseline and Week 12</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Intensive Center-Based Pivotal Response Treatment (PRT-C)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Treatment Group (DTG)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intensive Center-Based Pivotal Response Treatment (PRT-C)</intervention_name>
    <description>Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours.</description>
    <arm_group_label>Intensive Center-Based Pivotal Response Treatment (PRT-C)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Autism Spectrum Disorder (ASD) based on clinical interview and Diagnostic&#xD;
             and Statistical Manual, 5th edition (DSM-5) and confirmed using the Autism Diagnostic&#xD;
             Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule, 2nd edition&#xD;
             (ADOS-2) or Childhood Autism Rating Scale (CARS-2); Diagnostic and Statistical Manual,&#xD;
             5th edition (DSM-5), and expert clinical opinion&#xD;
&#xD;
          -  Boys and girls between 2 years and 3 years and 11 months&#xD;
&#xD;
          -  Ability to participate in the testing procedures to the extent that valid standard&#xD;
             scores can be obtained&#xD;
&#xD;
          -  Stable treatment (e.g., applied behavior analysis (ABA), speech therapy, psychotropic&#xD;
             medication(s) or biomedical intervention(s) for at least 1 month prior to baseline&#xD;
             measurements with no anticipated changes during study participation&#xD;
&#xD;
          -  Developmentally delayed with Mullen Scales of Early Learning (MSEL) or Developmental&#xD;
             Profile (DP-4) composite score below 85 (1 Standard Deviation below the mean)&#xD;
&#xD;
          -  Availability of at least one English-speaking parent who can consistently participate&#xD;
             in parent training and research measures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or lifetime diagnosis of severe psychiatric disorder (e.g., bipolar disorder,&#xD;
             etc.)&#xD;
&#xD;
          -  Presence of active medical problem (e.g., unstable seizure disorder or heart disease)&#xD;
&#xD;
          -  Child primary language other than English&#xD;
&#xD;
          -  Previous adequate trial of Pivotal Response Treatment&#xD;
&#xD;
          -  More than 15 hours per week of in-home applied behavior analysis (ABA).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonio Y. Hardan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Madeleine Clark, BS</last_name>
    <phone>(650)736-1235</phone>
    <email>mclark11@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Estefania Millan, MA</last_name>
    <phone>(650)736-1235</phone>
    <email>mmillan2@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Madeleine Clark, BS</last_name>
      <phone>650-736-1235</phone>
      <email>mclark11@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Estefania Millan, MA</last_name>
      <phone>(650)736-1235</phone>
      <email>mmillan2@stanford.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Antonio Hardan</investigator_full_name>
    <investigator_title>Professor of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>Pivotal Response Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</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/NCT03778827
org study id: IRB-49033
nct id: NCT03778827
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine the effectiveness of pivotal response training (PRT)
      in an intensive center-based environment to treat social communication deficits in children
      with autism spectrum disorder (ASD).
The purpose of this study is to examine the effectiveness of pivotal response training (PRT)
      in an intensive center-based preschool environment to treat social communication deficits in
      children with autism spectrum disorder (ASD). The study will compare Pivotal Response
      Treatment (PRT) to a delayed treatment group (DTG). PRT is a naturalistic behavioral
      intervention based on the principles of applied behavior analysis which has shown to be
      effective in treating the core deficits in children with ASD. The study will compare the
      combination of parent training with intensive center-based PRT (PRT-C) to a DTG and will
      include 44 children ages 2 to 3.11 years with ASD and social communication deficits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Mean Change from baseline on the Social Responsiveness Scale-2 Total Score at 12 Weeks
time frame: Baseline and Week 12
measure: Mean change from baseline on the Brief Observation of Communication Change (BOSCC) total score at 12 Weeks
time frame: Baseline and Week 12
measure: Mean change from baseline on the frequency if the child's functional utterances on the structured lab observation at 12 Weeks
time frame: Baseline and Week 12
measure: Mean change from baseline on the Vineland Adaptive Behavior Scales 3rd Edition Socialization subscale at 12 Weeks
time frame: Baseline and Week 12
measure: Mean change from baseline on the MacArthur-Bates Communication Development Inventory at 12 Weeks
time frame: Baseline and Week 12
arm group label: Intensive Center-Based Pivotal Response Treatment (PRT-C)
arm group type: Experimental
description: Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours.
arm group label: Delayed Treatment Group (DTG)
arm group type: No Intervention
description: Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase.
intervention type: Behavioral
intervention name: Intensive Center-Based Pivotal Response Treatment (PRT-C)
description: Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours.
arm group label: Intensive Center-Based Pivotal Response Treatment (PRT-C)
criteria: 
gender: All
minimum age: 2 Years
maximum age: 3 Years
healthy volunteers: No
last name: Antonio Y. Hardan, MD
role: Principal Investigator
affiliation: Stanford University
last name: Madeleine Clark, BS
phone: (650)736-1235
email: mclark11@stanford.edu
last name: Estefania Millan, MA
phone: (650)736-1235
email: mmillan2@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Antonio Hardan
investigator title: Professor of Psychiatry and Behavioral Sciences
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No