<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/NCT04501588</url>
  </required_header>
  <id_info>
    <org_study_id>STU00201708</org_study_id>
    <nct_id>NCT04501588</nct_id>
  </id_info>
  <brief_title>Parent Telehealth Intervention for Children With Autism</brief_title>
  <official_title>Parent Language Intervention for Autism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern 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>
      As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent&#xD;
      importance. Given this, parents in the study will receive parent coaching through weekly&#xD;
      video calls. To help us understand the best types of telecoaching, we will offer all&#xD;
      participants responsive coaching, with half of the participants receiving an additional&#xD;
      opportunity to reflect on their own use of language strategies with a therapist using video&#xD;
      feedback and the other half receiving responsive coaching as usual, without video feedback.&#xD;
      This information is important in helping us to understand the best way to coach parents using&#xD;
      a telepractice model so that parents implement the intervention at high fidelity.&#xD;
      Furthermore, we will aim to understand how parent learning style may also influence the&#xD;
      implementation of these strategies.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2020</start_date>
  <completion_date type="Actual">November 24, 2021</completion_date>
  <primary_completion_date type="Actual">September 2, 2021</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessors who score/code the parent-child interaction are blind to condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Parent Use of Language Support Strategies (Mother-child interaction)</measure>
    <time_frame>Two months after the start of the study</time_frame>
    <description>Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys. The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct. This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MacArthur-Bates Communicative Development Inventory (MCDI) (Child)</measure>
    <time_frame>Two months after the start of the study</time_frame>
    <description>Parent report of child's expressive vocabulary and prelinguistic communication skills</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Parent Learning Style 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Parent Learning Style 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Learning Style 1 (Parent)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Learning Style 2 (Parent)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Responsive training with no video feedback</intervention_name>
    <description>Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.</description>
    <arm_group_label>Learning Style 2 (Parent)</arm_group_label>
    <arm_group_label>Parent Learning Style 1</arm_group_label>
    <other_name>No Video Feedback</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Responsive training with video feedback</intervention_name>
    <description>Parents will receive responsive training and watch themselves on video to reflect on their strategy use.</description>
    <arm_group_label>Learning Style 1 (Parent)</arm_group_label>
    <arm_group_label>Parent Learning Style 2</arm_group_label>
    <other_name>Video Feedback</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Child inclusion criteria include:&#xD;
&#xD;
          -  diagnosis of ASD or showing signs of ASD based on autism screening&#xD;
&#xD;
          -  chronological age of less than 48 months&#xD;
&#xD;
          -  a parent who is willing to learn intervention strategies&#xD;
&#xD;
          -  English as the primary language spoken in the home&#xD;
&#xD;
        Parent inclusion criteria include:&#xD;
&#xD;
        - Biological Mother&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children or parents with additional impairments (e.g., blindness, deafness, genetic&#xD;
             syndromes) will be excluded from the study.&#xD;
&#xD;
          -  Fathers or caregivers other than the child's Mother will be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>48 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.</citation>
    <PMID>25733749</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 4, 2022</last_update_submitted>
  <last_update_submitted_qc>January 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Megan Roberts</investigator_full_name>
    <investigator_title>Associate Professor of Communication Sciences and Disorders</investigator_title>
  </responsible_party>
  <keyword>autism</keyword>
  <keyword>parent intervention</keyword>
  <keyword>parent coaching</keyword>
  <keyword>early intervention</keyword>
  <keyword>parent-mediated intervention</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>
    <ipd_description>N/A at this time</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 3, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/88/NCT04501588/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04501588
org study id: STU00201708
nct id: NCT04501588
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
As a result of the COVID-19 pandemic, telecoaching/telepractice models are of urgent
      importance. Given this, parents in the study will receive parent coaching through weekly
      video calls. To help us understand the best types of telecoaching, we will offer all
      participants responsive coaching, with half of the participants receiving an additional
      opportunity to reflect on their own use of language strategies with a therapist using video
      feedback and the other half receiving responsive coaching as usual, without video feedback.
      This information is important in helping us to understand the best way to coach parents using
      a telepractice model so that parents implement the intervention at high fidelity.
      Furthermore, we will aim to understand how parent learning style may also influence the
      implementation of these strategies.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Children will enroll in the study between 18-48 months of age and will be randomly assigned to either receive responsive training with video feedback or responsive training without video feedback.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Assessors who score/code the parent-child interaction are blind to condition
measure: Parent Use of Language Support Strategies (Mother-child interaction)
time frame: Two months after the start of the study
description: Mother use of intervention strategies will be measured by transcribing and coding mother behaviors during 12-minute parent-child interactions, using a standard set of toys. The primary dependent variable will be the amount of correct strategy used expressed as a percentage correct. This is the percentage of child communication to which the adult responds correctly (i.e., contingently and within 5 seconds).
measure: MacArthur-Bates Communicative Development Inventory (MCDI) (Child)
time frame: Two months after the start of the study
description: Parent report of child's expressive vocabulary and prelinguistic communication skills
arm group label: Parent Learning Style 1
arm group type: Experimental
description: Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
arm group label: Parent Learning Style 2
arm group type: Experimental
description: Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
arm group label: Learning Style 1 (Parent)
arm group type: Active Comparator
description: Mothers with Learning Style 1 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
arm group label: Learning Style 2 (Parent)
arm group type: Active Comparator
description: Mothers with Learning Style 2 will be randomly assigned to receive the responsive intervention with video feedback or without video feedback.
intervention type: Behavioral
intervention name: Responsive training with no video feedback
description: Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
arm group label: Learning Style 2 (Parent)
arm group label: Parent Learning Style 1
other name: No Video Feedback
intervention type: Behavioral
intervention name: Responsive training with video feedback
description: Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
arm group label: Learning Style 1 (Parent)
arm group label: Parent Learning Style 2
other name: Video Feedback
criteria: 
gender: All
minimum age: 18 Months
maximum age: 48 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Roberts MY, Kaiser AP. Early intervention for toddlers with language delays: a randomized controlled trial. Pediatrics. 2015 Apr;135(4):686-93. doi: 10.1542/peds.2014-2134. Epub 2015 Mar 2.
PMID: 25733749
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Megan Roberts
investigator title: Associate Professor of Communication Sciences and Disorders
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: No
ipd description: N/A at this time
provided document: 