<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/NCT01691066</url>
  </required_header>
  <id_info>
    <org_study_id>1110009256</org_study_id>
    <secondary_id>R03MH092617</secondary_id>
    <nct_id>NCT01691066</nct_id>
  </id_info>
  <brief_title>Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder</brief_title>
  <official_title>Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</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>Yale University</source>
  <brief_summary>
    <textblock>
      The purpose of this study aims to investigate the utility of Pivotal Response Treatment&#xD;
      (PRT), a behaviorally derived intervention, to improve the quality and frequency of&#xD;
      communication and social engagement of toddlers with siblings who have an autism spectrum&#xD;
      disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social&#xD;
      interaction between 12 and 15 months of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 27, 2017</completion_date>
  <primary_completion_date type="Actual">February 27, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of a novel behavioral treatment</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of Outcome:&#xD;
Attendance. Attendance to parent education sessions will be recorded by the therapist.&#xD;
Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of a novel behavioral treatment</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of Outcome:&#xD;
Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>Infant Toddler Years PRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Community Treatment</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Infant Toddler Years PRT</intervention_name>
    <arm_group_label>Infant Toddler Years PRT</arm_group_label>
    <other_name>Pivotal Response Treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  toddlers, age 12 - 15 months, who have an older sibling with ASD&#xD;
&#xD;
          -  delays of at least 1.5 standard deviations in communication (receptive/expressive&#xD;
             language) based on developmental testing&#xD;
&#xD;
          -  scores that exceed the ASD cutoff on standardized measures of social-communicative&#xD;
             behavior&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  physical or neurological disorder (e.g., seizures, cerebral palsy)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>15 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katarzyna Chawarska, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale Child Study Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 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>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</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/NCT01691066
org study id: 1110009256
secondary id: R03MH092617
nct id: NCT01691066
lead sponsor: 
collaborator: 
The purpose of this study aims to investigate the utility of Pivotal Response Treatment
      (PRT), a behaviorally derived intervention, to improve the quality and frequency of
      communication and social engagement of toddlers with siblings who have an autism spectrum
      disorder (SIBS - ASD) and who demonstrate developmental delays and impairments in social
      interaction between 12 and 15 months of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of a novel behavioral treatment
time frame: 24 months
description: Assessment of Outcome:
Attendance. Attendance to parent education sessions will be recorded by the therapist.
Parent utilization. To assess the acceptability of the PRT approach, parents will be asked to keep a weekly log of procedure use, including overall estimated duration and choice of activities.
measure: Acceptability of a novel behavioral treatment
time frame: 24 months
description: Assessment of Outcome:
Parent satisfaction. At post-treatment, parents will be asked to complete a Likert-scale and short response questionnaire rating their satisfaction with various aspects of the program
arm group label: Infant Toddler Years PRT
arm group type: Experimental
description: Infant Toddler PRT in an evidence-based, manualized treatment for children with autism spectrum disorder that involves specific motivational behavioral procedures adapted to be developmentally appropriate for 12-15 month old infants who present with developmental delays.
arm group label: Community Treatment
arm group type: No Intervention
description: Community Treatment includes the treatments offered by early intervention services (e.g., speech-language therapy, special education instruction).
intervention type: Behavioral
intervention name: Infant Toddler Years PRT
arm group label: Infant Toddler Years PRT
other name: Pivotal Response Treatment
criteria: 
gender: All
minimum age: 12 Months
maximum age: 15 Months
healthy volunteers: No
last name: Katarzyna Chawarska, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive