<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/NCT03002363</url>
  </required_header>
  <id_info>
    <org_study_id>STU00203250</org_study_id>
    <nct_id>NCT03002363</nct_id>
  </id_info>
  <brief_title>The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance</brief_title>
  <official_title>The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the current study is to determine if pre-exposure through video modeling will&#xD;
      enhance testing compliance in a population of children who are receiving a diagnostic&#xD;
      evaluation for Autism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the current study is to determine if pre-exposure through video modeling will&#xD;
      enhance testing compliance in a population of children who are receiving a diagnostic&#xD;
      evaluation for Autism. Another purpose of this study is to determine if pre-exposure to the&#xD;
      test setting can increase the compliance on individual test measures. To test the central&#xD;
      hypothesis and accomplish the study objective, 2 aims guide the proposed study.&#xD;
&#xD;
        1. Determine the extent to which pre-exposure to expectations and tasks that occur during&#xD;
           the audiological evaluation will increase audiological testing compliance. Hypothesis:&#xD;
           Children receiving the intervention video, which will model what they will experience&#xD;
           during the audiological evaluation, will show greater compliance during the evaluation&#xD;
           than children who receive the placebo video.&#xD;
&#xD;
        2. Determine the extent to which enhanced testing compliance will increase the number of&#xD;
           test measures obtained during an audiological evaluation. Hypothesis: Children who are&#xD;
           more compliant during the audiological evaluation will allow the audiologist to obtain&#xD;
           more test measures in a single appointment than the children who are less compliant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">September 1, 2017</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance to audiology tests (% of audiology tests completed during an audiology session)</measure>
    <time_frame>Immediately following appointment (same day as appointment)</time_frame>
    <description>Compliance to the following audiology test battery: Otoscopy, Speech Awareness Threshold, Pure Tone Testing, Distortion, Product Otacoustic Emissions, Tympanometry. Compliance is measured as either &quot;yes&quot; or &quot;no&quot; to each of the tests in order to measure how many audiology tests are completed at the visit. The individual test units do not matter for the overall compliance of the visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent stress</measure>
    <time_frame>Immediately before and immediately after audiology appointment (same day as appointment)</time_frame>
    <description>PI developed form regarding parent perception</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>Video Modeling Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group receives a video that is a behavior modeling video that walks through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Video</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Modeling Intervention</intervention_name>
    <description>Prior to arrival of the audiological evaluation, the child and caregiver will be required to watch one of two videos created by the research personnel. One video, the intervention video, is a behavior modeling video walking through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment. The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.</description>
    <arm_group_label>Video Modeling Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Placebo Video</intervention_name>
    <description>The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.</description>
    <arm_group_label>Placebo Video</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Child must have chronological age of less than 36 months&#xD;
&#xD;
          -  Participation in the Northwestern University Center for Audiology, Speech, Language,&#xD;
             and Learning (NUCASLL) Developmental Diagnostic Program (DDP)&#xD;
&#xD;
          -  A parent or caregiver who is willing to watch the intervention video, bring the child&#xD;
             to/ participate in the audiological evaluation, and fill out a brief survey prior to&#xD;
             and following the appointment, and&#xD;
&#xD;
          -  Parent must understand English and speak English to their child.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan Y Roberts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern Clinic for Audiology, Speech, Language, and Learning</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>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</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>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>autism</keyword>
  <keyword>audiology</keyword>
  <keyword>video modeling</keyword>
  <keyword>testing compliance</keyword>
  <!-- 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/NCT03002363
org study id: STU00203250
nct id: NCT03002363
lead sponsor: 
has dmc: No
The purpose of the current study is to determine if pre-exposure through video modeling will
      enhance testing compliance in a population of children who are receiving a diagnostic
      evaluation for Autism.
The purpose of the current study is to determine if pre-exposure through video modeling will
      enhance testing compliance in a population of children who are receiving a diagnostic
      evaluation for Autism. Another purpose of this study is to determine if pre-exposure to the
      test setting can increase the compliance on individual test measures. To test the central
      hypothesis and accomplish the study objective, 2 aims guide the proposed study.

        1. Determine the extent to which pre-exposure to expectations and tasks that occur during
           the audiological evaluation will increase audiological testing compliance. Hypothesis:
           Children receiving the intervention video, which will model what they will experience
           during the audiological evaluation, will show greater compliance during the evaluation
           than children who receive the placebo video.

        2. Determine the extent to which enhanced testing compliance will increase the number of
           test measures obtained during an audiological evaluation. Hypothesis: Children who are
           more compliant during the audiological evaluation will allow the audiologist to obtain
           more test measures in a single appointment than the children who are less compliant.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Compliance to audiology tests (% of audiology tests completed during an audiology session)
time frame: Immediately following appointment (same day as appointment)
description: Compliance to the following audiology test battery: Otoscopy, Speech Awareness Threshold, Pure Tone Testing, Distortion, Product Otacoustic Emissions, Tympanometry. Compliance is measured as either "yes" or "no" to each of the tests in order to measure how many audiology tests are completed at the visit. The individual test units do not matter for the overall compliance of the visit.
measure: Parent stress
time frame: Immediately before and immediately after audiology appointment (same day as appointment)
description: PI developed form regarding parent perception
arm group label: Video Modeling Intervention
arm group type: Experimental
description: The intervention group receives a video that is a behavior modeling video that walks through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment.
arm group label: Placebo Video
arm group type: Placebo Comparator
description: The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
intervention type: Behavioral
intervention name: Video Modeling Intervention
description: Prior to arrival of the audiological evaluation, the child and caregiver will be required to watch one of two videos created by the research personnel. One video, the intervention video, is a behavior modeling video walking through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment. The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
arm group label: Video Modeling Intervention
intervention type: Behavioral
intervention name: Placebo Video
description: The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
arm group label: Placebo Video
criteria: 
gender: All
minimum age: 18 Months
maximum age: 36 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Megan Y Roberts, PhD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Megan Roberts
investigator title: Principal Investigator