<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/NCT03020927</url>
  </required_header>
  <id_info>
    <org_study_id>2015B0475</org_study_id>
    <nct_id>NCT03020927</nct_id>
  </id_info>
  <brief_title>Therapist and Parent Delivered Reciprocal Imitation Training for Young Children With Autism Spectrum Disorder</brief_title>
  <acronym>ParentRIT</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine whether adding a parent education component to an&#xD;
      existing intervention (Reciprocal Imitation Training) results in improved outcomes for&#xD;
      children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral&#xD;
      intervention designed to improve spontaneous imitation skills in young children with Autism&#xD;
      Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by&#xD;
      trained therapists, teachers, siblings, and parents of children with ASD. However, it is&#xD;
      unclear to what extent training parents to use RIT strategies in the home environment may&#xD;
      enhance outcomes, compared to having therapists implement RIT individually with the child.&#xD;
      The study will compare two different versions of RIT for young children with ASD: (1) two&#xD;
      60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session&#xD;
      of therapist-implemented RIT and one weekly 60-minute session of parent education about using&#xD;
      RIT in the home environment. The investigators will examine child and family outcomes between&#xD;
      these two intervention types. Outcomes examined will include: (1) spontaneous and prompted&#xD;
      imitation skills in the child with ASD, (2) social communication skills in the child with&#xD;
      ASD, (3) parent stress, and (4) parent and child behaviors during parent-child play&#xD;
      interactions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Currently do not have resources/staff to enroll new participants.&#xD;
  </why_stopped>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Unstructured Imitation Assessment (UIA)</measure>
    <time_frame>Change from baseline to 10 weeks (immediately post-intervention)</time_frame>
    <description>The Unstructured Imitation Assessment (UIA) is a semi-structured, standardized test of imitation skills containing 10 object imitation and 10 gesture imitation tasks (Ingersoll &amp; Meyer, 2011).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of parent acts imitated during Parent-Child Play Interaction</measure>
    <time_frame>Change from baseline to 10 weeks (immediately post-intervention)</time_frame>
    <description>Percentage of parent play acts and meaningful gestures imitated by the child during a 10-minute unstructured play interaction with parent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index, 4th Edition</measure>
    <time_frame>Change from baseline to 10 weeks (immediately post-intervention)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Imitation Scales</measure>
    <time_frame>10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Early Social Communication Scales</measure>
    <time_frame>10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of time spent jointly engaged during Parent-Child Play Interaction</measure>
    <time_frame>Change from baseline to 10 weeks (immediately post-intervention)</time_frame>
    <description>Proportion of time spent in joint engagement state (joint focus on same activity) during a 10-minute unstructured play interaction with parent</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Modified Behavior Intervention Rating Scale</measure>
    <time_frame>10 weeks (immediately post-intervention)</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Therapist Delivered</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children in the therapist-delivered condition will receive two, 60-minute long sessions of Reciprocal Imitation Training each week for ten consecutive weeks. These sessions will be delivered by trained graduate, undergraduate, and post-graduate research staff. Parents will be permitted to observe sessions via live video, but will not be directly involved in intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent + Therapist Delivered</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children in the parent + therapist-delivered condition will receive one, 60-minute long session of Reciprocal Imitation Training each week for ten consecutive weeks. These sessions will be delivered by trained graduate, undergraduate, and post-graduate research staff. During the same period of time, parents/guardians of children will receive one, 60-minute long parent education session per week with graduate and post-graduate research staff, aimed at teaching parents to implement Reciprocal Imitation Training at home with the child.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reciprocal Imitation Training (Therapist-Delivered)</intervention_name>
    <description>Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.</description>
    <arm_group_label>Therapist Delivered</arm_group_label>
    <other_name>RIT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Reciprocal Imitation Training (Therapist + Parent Delivered)</intervention_name>
    <description>Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills, using a combination of therapist-delivered intervention and parent training to deliver intervention in the home setting.</description>
    <arm_group_label>Parent + Therapist Delivered</arm_group_label>
    <other_name>RIT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  have a community diagnosis of Autism Spectrum Disorder (as reported by parent)&#xD;
&#xD;
          -  meet cutoff for &quot;Autism&quot; or &quot;Autism Spectrum&quot; on the Autism Diagnostic Observation&#xD;
             Schedule, 2nd Edition&#xD;
&#xD;
          -  be between 24 and 60 months of age at the time of study enrollment&#xD;
&#xD;
          -  demonstrate difficulties with imitation skills on the Motor Imitation Scales and/or&#xD;
             the Unstructured Imitation Assessment during pre-treatment assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not be the sibling of another study participant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>60 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 3, 2016</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Katherine Walton</investigator_full_name>
    <investigator_title>Assistant Professor of Psychology and Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03020927
org study id: 2015B0475
nct id: NCT03020927
lead sponsor: 
has dmc: No
The purpose of this study is to examine whether adding a parent education component to an
      existing intervention (Reciprocal Imitation Training) results in improved outcomes for
      children with Autism Spectrum Disorder. Reciprocal Imitation Training (RIT) is a behavioral
      intervention designed to improve spontaneous imitation skills in young children with Autism
      Spectrum Disorder (ASD). Previous research suggests that it can be effective when used by
      trained therapists, teachers, siblings, and parents of children with ASD. However, it is
      unclear to what extent training parents to use RIT strategies in the home environment may
      enhance outcomes, compared to having therapists implement RIT individually with the child.
      The study will compare two different versions of RIT for young children with ASD: (1) two
      60-minute weekly sessions of therapist-implemented RIT and (2) one weekly 60-minute session
      of therapist-implemented RIT and one weekly 60-minute session of parent education about using
      RIT in the home environment. The investigators will examine child and family outcomes between
      these two intervention types. Outcomes examined will include: (1) spontaneous and prompted
      imitation skills in the child with ASD, (2) social communication skills in the child with
      ASD, (3) parent stress, and (4) parent and child behaviors during parent-child play
      interactions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Unstructured Imitation Assessment (UIA)
time frame: Change from baseline to 10 weeks (immediately post-intervention)
description: The Unstructured Imitation Assessment (UIA) is a semi-structured, standardized test of imitation skills containing 10 object imitation and 10 gesture imitation tasks (Ingersoll & Meyer, 2011).
measure: Percentage of parent acts imitated during Parent-Child Play Interaction
time frame: Change from baseline to 10 weeks (immediately post-intervention)
description: Percentage of parent play acts and meaningful gestures imitated by the child during a 10-minute unstructured play interaction with parent
measure: Parenting Stress Index, 4th Edition
time frame: Change from baseline to 10 weeks (immediately post-intervention)
measure: Motor Imitation Scales
time frame: 10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
measure: Early Social Communication Scales
time frame: 10 weeks (immediately post-intervention), 3 months post-treatment, 6 months post-treatment
measure: Proportion of time spent jointly engaged during Parent-Child Play Interaction
time frame: Change from baseline to 10 weeks (immediately post-intervention)
description: Proportion of time spent in joint engagement state (joint focus on same activity) during a 10-minute unstructured play interaction with parent
measure: Modified Behavior Intervention Rating Scale
time frame: 10 weeks (immediately post-intervention)
arm group label: Therapist Delivered
arm group type: Active Comparator
description: Children in the therapist-delivered condition will receive two, 60-minute long sessions of Reciprocal Imitation Training each week for ten consecutive weeks. These sessions will be delivered by trained graduate, undergraduate, and post-graduate research staff. Parents will be permitted to observe sessions via live video, but will not be directly involved in intervention.
arm group label: Parent + Therapist Delivered
arm group type: Experimental
description: Children in the parent + therapist-delivered condition will receive one, 60-minute long session of Reciprocal Imitation Training each week for ten consecutive weeks. These sessions will be delivered by trained graduate, undergraduate, and post-graduate research staff. During the same period of time, parents/guardians of children will receive one, 60-minute long parent education session per week with graduate and post-graduate research staff, aimed at teaching parents to implement Reciprocal Imitation Training at home with the child.
intervention type: Behavioral
intervention name: Reciprocal Imitation Training (Therapist-Delivered)
description: Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.
arm group label: Therapist Delivered
other name: RIT
intervention type: Behavioral
intervention name: Reciprocal Imitation Training (Therapist + Parent Delivered)
description: Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills, using a combination of therapist-delivered intervention and parent training to deliver intervention in the home setting.
arm group label: Parent + Therapist Delivered
other name: RIT
criteria: 
gender: All
minimum age: 24 Months
maximum age: 60 Months
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Katherine Walton
investigator title: Assistant Professor of Psychology and Psychiatry
mesh term: Autism Spectrum Disorder
sharing ipd: No