<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/NCT04467073</url>
  </required_header>
  <id_info>
    <org_study_id>15100203</org_study_id>
    <nct_id>NCT04467073</nct_id>
  </id_info>
  <brief_title>Stepped-care Telehealth for Young Children With ASD</brief_title>
  <official_title>Examining a Stepped-care Telehealth Program for Parents of Young Children With Autism: a Proof of Concept Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proof-of-concept study addresses the gap in the access to care literature by examining a&#xD;
      stepped-care version of a telehealth naturalistic developmental behavioral intervention&#xD;
      (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation&#xD;
      Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic&#xD;
      behavioral approach to teach object and gesture imitation to young children with ASD within a&#xD;
      play-based context. The efficacy of RIT has been demonstrated through a small randomized&#xD;
      control trial, several single-subject design studies, as well as in independent replications.&#xD;
      Prior research also suggests that parents can be taught to effectively use RIT with their&#xD;
      children in person, and two single-subject design studies detail the development and&#xD;
      feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest&#xD;
      Online RIT may serve as an ideal platform for examining the potential of individualized&#xD;
      telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to&#xD;
      compare a stepped-care format of Online RIT to a waitlist control condition to determine&#xD;
      initial feasibility and effectiveness of this innovative intervention and service delivery&#xD;
      model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2016</start_date>
  <completion_date type="Actual">August 30, 2017</completion_date>
  <primary_completion_date type="Actual">August 30, 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>Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks</measure>
    <time_frame>Baseline and 15 weeks</time_frame>
    <description>Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks</measure>
    <time_frame>Baseline and 15 weeks</time_frame>
    <description>The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks</measure>
    <time_frame>Baseline and 15 weeks</time_frame>
    <description>The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks</measure>
    <time_frame>Baseline and 15 weeks</time_frame>
    <description>The SCC is a 47-item checklist completed by parents to indicate if a child uses a specific social communication skill.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks</measure>
    <time_frame>Baseline and 15 weeks</time_frame>
    <description>The FQOL Scale is a 25-item self-report measure designed to assess family interaction, parenting, emotional well-being, physical/maternal well-being, and disability-related supports.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Stepped-Care Online Reciprocal Imitation Training (Online RIT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a &quot;step up&quot; in care, in the form of remote parent coaching.&#xD;
Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated &lt;80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait List Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online RIT</intervention_name>
    <description>Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable &quot;dashboard&quot; that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log).</description>
    <arm_group_label>Stepped-Care Online Reciprocal Imitation Training (Online RIT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have a diagnosis of ASD or significant concerns of ASD&#xD;
&#xD;
          -  Parent reported imitation deficits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children of parents who are non-English speaking&#xD;
&#xD;
          -  Actively participating in other parent training programs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Months</minimum_age>
    <maximum_age>60 Months</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>60657</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</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>Research Director, AARTS Center</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/NCT04467073
org study id: 15100203
nct id: NCT04467073
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This proof-of-concept study addresses the gap in the access to care literature by examining a
      stepped-care version of a telehealth naturalistic developmental behavioral intervention
      (NDBI), Online RIT. Online RIT is an interactive website introducing Reciprocal Imitation
      Training (RIT), an NDBI focused on enhancing social imitation. RIT uses a naturalistic
      behavioral approach to teach object and gesture imitation to young children with ASD within a
      play-based context. The efficacy of RIT has been demonstrated through a small randomized
      control trial, several single-subject design studies, as well as in independent replications.
      Prior research also suggests that parents can be taught to effectively use RIT with their
      children in person, and two single-subject design studies detail the development and
      feasibility testing of Online RIT plus therapist assistance. These preliminary data suggest
      Online RIT may serve as an ideal platform for examining the potential of individualized
      telehealth delivery formats, such as stepped-care. Therefore, the goal of this study was to
      compare a stepped-care format of Online RIT to a waitlist control condition to determine
      initial feasibility and effectiveness of this innovative intervention and service delivery
      model.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline RIT Parent Fidelity Form (RIT-PFF) Score at 15 weeks
time frame: Baseline and 15 weeks
description: Trained observers scored the parent-child interactions for parent fidelity of the RIT intervention techniques.
measure: Change from Baseline Unstructured Imitation Assessment (UIA) Score at 15 weeks
time frame: Baseline and 15 weeks
description: The UIA was used to measure child social imitation. It is a standardized assessment that evaluates spontaneous imitation of actions with objects and gestures during play.
measure: Change from Baseline Early Intervention Parenting Self-Efficacy Scale (EIPSES) Score at 15 weeks
time frame: Baseline and 15 weeks
description: The EIPSES is a 20-item parent questionnaire designed to measure parenting efficacy within the context of early intervention.
measure: Change from Baseline Social Communication Checklist (SCC) Score at 15 weeks
time frame: Baseline and 15 weeks
description: The SCC is a 47-item checklist completed by parents to indicate if a child uses a specific social communication skill.
measure: Change from Baseline Beach Center Family Quality of Life Scale (FQOL) Score at 15 weeks
time frame: Baseline and 15 weeks
description: The FQOL Scale is a 25-item self-report measure designed to assess family interaction, parenting, emotional well-being, physical/maternal well-being, and disability-related supports.
arm group label: Stepped-Care Online Reciprocal Imitation Training (Online RIT)
arm group type: Experimental
description: Participants completed four telehealth modules over a period of 5 weeks (~1 per week, 1 week to practice). Two variables were selected as tailoring variables for this stepped-care model. Fidelity (RIT-PFF) and self-efficacy (EIPSES) at 5 weeks were used to determine which participants were in need of a "step up" in care, in the form of remote parent coaching.
Parents who demonstrated ≥80% on the RIT-PFF, and who reported gains on the EIPSES continued to have access to Online RIT and practiced on their own for the next 5 weeks, but did not receive any remote coaching. Parents who demonstrated <80% fidelity on the RIT-PFF and/or who didn't report increases in the EIPSES were directed into coaching. Coaching involved videoconferences once per week (wks. 6-10) with a parent coach (PI), and followed the occupational performance coaching model. Sessions included review of successes and challenges, parent practice with feedback, problem solving, and planning.
arm group label: Wait List Control
arm group type: No Intervention
description: Participants provided with information about available community resources after randomization. These participants were given the opportunity to engage in the stepped-care format of Online RIT after the post-intervention data collection time point; however their data was included exclusively in control group analyses.
intervention type: Behavioral
intervention name: Online RIT
description: Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable "dashboard" that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log).
arm group label: Stepped-Care Online Reciprocal Imitation Training (Online RIT)
criteria: 
gender: All
minimum age: 16 Months
maximum age: 60 Months
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: Research Director, AARTS Center
mesh term: Autism Spectrum Disorder