<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/NCT03840642</url>
  </required_header>
  <id_info>
    <org_study_id>ORA 16122005</org_study_id>
    <secondary_id>KL2TR002387</secondary_id>
    <nct_id>NCT03840642</nct_id>
  </id_info>
  <brief_title>Examining an Adaptive Telehealth Intervention</brief_title>
  <official_title>Examining an Adaptive Telehealth Intervention for Young Children With Autism Spectrum Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Eotvos Lorand University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</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 explore the acceptability and effects of internet-based&#xD;
      approaches for helping parents learn early intervention strategies (e.g., methods or tips for&#xD;
      improving a child's behavior and development). As part of this study, families will be&#xD;
      randomly(selected by chance like the flip of a coin) assigned to one of two different formats&#xD;
      of an interactive telehealth program called Mirror Me. One format families complete on their&#xD;
      own, the other involves the option to meet with a parent coach over the internet for&#xD;
      feedback. The goal of the study is to understand how parents/caregivers and children benefit&#xD;
      from using online programs, and to identify barriers (blocks) and facilitators (helpers) to&#xD;
      this kind of service delivery model.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mirror Me is a telehealth parent training intervention that teaches parents to promote their&#xD;
      child's social imitation during play and daily routines. It uses content from Reciprocal&#xD;
      Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within&#xD;
      affect-laden playful interactions. RIT techniques include imitating the child (contingent&#xD;
      imitation), modeling language, behavioral prompting, and natural reinforcement during&#xD;
      child-direct activities. There is strong empirical support for the effect of individual&#xD;
      techniques on imitation, joint attention, and language and RIT has been cited as one of only&#xD;
      seven early intervention packages with &quot;strong&quot; evidence of efficacy with children &lt; 3 with&#xD;
      ASD or at risk for ASD. Because RIT focuses on a skill that emerges early in development and&#xD;
      does not require language competency, it can be used with children at very young&#xD;
      chronological, language, and developmental levels, making it an ideal early intervention.&#xD;
      Given that RIT is meant to be used in a child's natural environment and only involves a&#xD;
      handful of intervention techniques, it is well suited for delivery in a parent training&#xD;
      format, with initial data supporting the effectiveness of parent training in RIT. Mirror Me&#xD;
      presents intervention content in four interactive modules. Program development was guided by&#xD;
      the technology acceptance model, media richness theory, and principles of instructional&#xD;
      design. To ensure usability and acceptability, the investigators used an iterative&#xD;
      development process with input from pilot participants. The investigators have subsequently&#xD;
      upgraded the website to ensure mobile compatibility, user-friendly material, and enhanced&#xD;
      assessment and monitoring capabilities. Mirror Me can be used as a standalone website or in&#xD;
      combination with remote parent &quot;coaching.&quot; Initial data indicate roughly one third to one&#xD;
      half of parents learn RIT techniques from the website alone, while the rest require coaching.&#xD;
      These data support the investigation of a stepped-care telehealth intervention, where parents&#xD;
      use the Mirror Me website and then receive remote parent coaching, if the anticipated&#xD;
      response to the program is not observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2023</completion_date>
  <primary_completion_date type="Actual">November 1, 2022</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Unstructured Imitation Assessment (UIA)</measure>
    <time_frame>Baseline, Week 10, and Week 15</time_frame>
    <description>An assessment that is used to measure a child's ability to imitate in a spontaneous, social-interactive context. A higher summed score on this assessment indicates better imitation abilities.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Early Intervention Parenting Self Efficacy Scale</measure>
    <time_frame>Baseline, Week 5, Week 10, Week 15</time_frame>
    <description>Asks about the extent to which parents feel as though they have the skills and knowledge to help their child's development. A higher summed score on this scale indicates greater parental self-efficacy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Parent Fidelity</measure>
    <time_frame>Baseline, Week 5, Week 10, Week 15</time_frame>
    <description>Ten minute parent-child play interactions videos that will be saved and later coded by trained research assistants who will be blinded to study condition.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)</measure>
    <time_frame>Baseline, Week 10, Week 15</time_frame>
    <description>A survey administered to a parent or caregiver that is organized around four Behavior Domains:Communication, Daily Living Skills, Socialization, and Motor Skills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Social Communication Checklist Revised</measure>
    <time_frame>Baseline, Week 10, Week 15</time_frame>
    <description>Questionnaire that helps determine the child's level of child social communication skills.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Parenting Stress Index-Short Form</measure>
    <time_frame>Baseline, Week 10, Week 15</time_frame>
    <description>A caregiver self-report questionnaire that assesses dysfunctional parent-child dyads in three domains of parental-distress, difficult child characteristics, and dysfunctional parent-child interaction.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Family Quality of Life Scale</measure>
    <time_frame>Baseline, Week 10, Week 15</time_frame>
    <description>Questionnaire used to determine family quality of life. Higher summed scores indicate greater family quality of life.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Mirror Me</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Parents randomized to the Mirror Me condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then they will be told their condition and to continue to use the website and practice what they have learned with their children.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirror Me Plus Remote Coaching</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents randomized to the Mirror Me plus remote coaching condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then all parents in this condition will be told about the opportunity to participate in remote video teleconferences once per week for 5 weeks. Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week. Sessions will be recorded for data collection and therapist coaching fidelity. Participants will have access to Mirror Me for the duration of the research study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mirror Me</intervention_name>
    <description>Mirror Me is a telehealth parent training intervention that teaches parents to promote their child's social imitation during play and daily routines. It uses content from Reciprocal Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within affect-laden playful interactions. Mirror Me presents intervention content in four interactive modules. Program development was guided by the technology acceptance model, media richness theory, and principles of instructional design.</description>
    <arm_group_label>Mirror Me</arm_group_label>
    <arm_group_label>Mirror Me Plus Remote Coaching</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Remote Coaching</intervention_name>
    <description>Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week</description>
    <arm_group_label>Mirror Me Plus Remote Coaching</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a pre-existing diagnosis of ASD&#xD;
&#xD;
          -  behaviorally-based caregiver concerns about ASD&#xD;
&#xD;
          -  behaviorally-based physician concerns about ASD&#xD;
&#xD;
          -  a positive screen on a validated ASD screening tool.&#xD;
&#xD;
          -  a score of 40% or less on the Unstructured Imitation Assessment (UIA) at&#xD;
             screening/baseline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Months</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Allison Wainer, Ph.D.</investigator_full_name>
    <investigator_title>Assistant Professor</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>
  <!-- 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/NCT03840642
org study id: ORA 16122005
secondary id: KL2TR002387
nct id: NCT03840642
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to explore the acceptability and effects of internet-based
      approaches for helping parents learn early intervention strategies (e.g., methods or tips for
      improving a child's behavior and development). As part of this study, families will be
      randomly(selected by chance like the flip of a coin) assigned to one of two different formats
      of an interactive telehealth program called Mirror Me. One format families complete on their
      own, the other involves the option to meet with a parent coach over the internet for
      feedback. The goal of the study is to understand how parents/caregivers and children benefit
      from using online programs, and to identify barriers (blocks) and facilitators (helpers) to
      this kind of service delivery model.
Mirror Me is a telehealth parent training intervention that teaches parents to promote their
      child's social imitation during play and daily routines. It uses content from Reciprocal
      Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within
      affect-laden playful interactions. RIT techniques include imitating the child (contingent
      imitation), modeling language, behavioral prompting, and natural reinforcement during
      child-direct activities. There is strong empirical support for the effect of individual
      techniques on imitation, joint attention, and language and RIT has been cited as one of only
      seven early intervention packages with "strong" evidence of efficacy with children < 3 with
      ASD or at risk for ASD. Because RIT focuses on a skill that emerges early in development and
      does not require language competency, it can be used with children at very young
      chronological, language, and developmental levels, making it an ideal early intervention.
      Given that RIT is meant to be used in a child's natural environment and only involves a
      handful of intervention techniques, it is well suited for delivery in a parent training
      format, with initial data supporting the effectiveness of parent training in RIT. Mirror Me
      presents intervention content in four interactive modules. Program development was guided by
      the technology acceptance model, media richness theory, and principles of instructional
      design. To ensure usability and acceptability, the investigators used an iterative
      development process with input from pilot participants. The investigators have subsequently
      upgraded the website to ensure mobile compatibility, user-friendly material, and enhanced
      assessment and monitoring capabilities. Mirror Me can be used as a standalone website or in
      combination with remote parent "coaching." Initial data indicate roughly one third to one
      half of parents learn RIT techniques from the website alone, while the rest require coaching.
      These data support the investigation of a stepped-care telehealth intervention, where parents
      use the Mirror Me website and then receive remote parent coaching, if the anticipated
      response to the program is not observed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Unstructured Imitation Assessment (UIA)
time frame: Baseline, Week 10, and Week 15
description: An assessment that is used to measure a child's ability to imitate in a spontaneous, social-interactive context. A higher summed score on this assessment indicates better imitation abilities.
measure: Change in Early Intervention Parenting Self Efficacy Scale
time frame: Baseline, Week 5, Week 10, Week 15
description: Asks about the extent to which parents feel as though they have the skills and knowledge to help their child's development. A higher summed score on this scale indicates greater parental self-efficacy
measure: Change in Parent Fidelity
time frame: Baseline, Week 5, Week 10, Week 15
description: Ten minute parent-child play interactions videos that will be saved and later coded by trained research assistants who will be blinded to study condition.
measure: Change in Vineland Scales of Adaptive Functioning (3rd edition, survey form)
time frame: Baseline, Week 10, Week 15
description: A survey administered to a parent or caregiver that is organized around four Behavior Domains:Communication, Daily Living Skills, Socialization, and Motor Skills.
measure: Change in Social Communication Checklist Revised
time frame: Baseline, Week 10, Week 15
description: Questionnaire that helps determine the child's level of child social communication skills.
measure: Change in Parenting Stress Index-Short Form
time frame: Baseline, Week 10, Week 15
description: A caregiver self-report questionnaire that assesses dysfunctional parent-child dyads in three domains of parental-distress, difficult child characteristics, and dysfunctional parent-child interaction.
measure: Change in Family Quality of Life Scale
time frame: Baseline, Week 10, Week 15
description: Questionnaire used to determine family quality of life. Higher summed scores indicate greater family quality of life.
arm group label: Mirror Me
arm group type: Active Comparator
description: Parents randomized to the Mirror Me condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then they will be told their condition and to continue to use the website and practice what they have learned with their children.
arm group label: Mirror Me Plus Remote Coaching
arm group type: Experimental
description: Parents randomized to the Mirror Me plus remote coaching condition will complete the 4 Mirror Me modules over a period of 5 weeks (~1 per week plus a week to practice). They will be provided with a visual guide for how to access the website. At 5 weeks, they will complete a remote parent-child interaction. Then all parents in this condition will be told about the opportunity to participate in remote video teleconferences once per week for 5 weeks. Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week. Sessions will be recorded for data collection and therapist coaching fidelity. Participants will have access to Mirror Me for the duration of the research study.
intervention type: Behavioral
intervention name: Mirror Me
description: Mirror Me is a telehealth parent training intervention that teaches parents to promote their child's social imitation during play and daily routines. It uses content from Reciprocal Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within affect-laden playful interactions. Mirror Me presents intervention content in four interactive modules. Program development was guided by the technology acceptance model, media richness theory, and principles of instructional design.
arm group label: Mirror Me
arm group label: Mirror Me Plus Remote Coaching
intervention type: Behavioral
intervention name: Remote Coaching
description: Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week
arm group label: Mirror Me Plus Remote Coaching
criteria: 
gender: All
minimum age: 16 Months
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Allison Wainer, Ph.D.
investigator title: Assistant Professor
mesh term: Autism Spectrum Disorder