<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/NCT02184390</url>
  </required_header>
  <id_info>
    <org_study_id>5R44MH086936</org_study_id>
    <secondary_id>5R44MH086936</secondary_id>
    <nct_id>NCT02184390</nct_id>
  </id_info>
  <brief_title>Parenting Your Young Child With Autism: A Web-Based Tutorial</brief_title>
  <official_title>Parenting Your Young Child With Autism: A Web-Based Tutorial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Center for Psychological Consultation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Center for Psychological Consultation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the efficacy and user satisfaction with a web-based interactive&#xD;
      tutorial for caregivers of young children with autism designed to a) teach parents how to&#xD;
      promote their child's development in the core deficit areas, b) help parents understand and&#xD;
      improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress&#xD;
      through more effective interactions. It emphasizes everyday situations as opportunities for&#xD;
      learning, including common home routines and contains videotaped illustrations of parents&#xD;
      using the techniques taught in the home environment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Autism is a neurodevelopmental disorder characterized by core deficits in social reciprocity,&#xD;
      verbal and nonverbal communication, and behavior. Early detection and intervention has been&#xD;
      shown to improve these core deficits, resulting in better long-term outcomes in language&#xD;
      functioning, cognitive/developmental skills, and social and adaptive behavior. Despite the&#xD;
      demonstrated benefits of effective intervention, few children receive these specialized&#xD;
      services, due in part to critical resource barriers, such as the shortage of specialists&#xD;
      trained to deliver them. The broad, long-term objective of this project is to improve&#xD;
      outcomes for children with autism and their families by empowering caregivers with the&#xD;
      knowledge and skills needed to effectively intervene directly with their children as part of&#xD;
      their daily interactions and routines. By targeting those with the most invested in the&#xD;
      child's success and the longest lasting influence on a child's long-term growth and&#xD;
      development, we can help parents in several ways: a) teach parents how to promote their&#xD;
      child's development in the core deficit areas seen in young children with autism spectrum&#xD;
      disorders: social interaction, communication, play, and imitation; b) help parents understand&#xD;
      and improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress&#xD;
      through more effective interactions.&#xD;
&#xD;
      To make this training widely accessible to parents of children with autism, we will deliver&#xD;
      this training through a web-based, multi-media, interactive tutorial. The tutorial will use&#xD;
      principles of instructional design to more effectively deliver the material and utilize high&#xD;
      levels of interactivity afforded by the web-based platform to maximize learning. The tutorial&#xD;
      teaches skills to improve their child's behavior and communication within the framework of&#xD;
      everyday routines and activities, utilizing interactive exercises and a comprehensive set of&#xD;
      videos of real parents implementing these strategies with their children within the context&#xD;
      of everyday situations.&#xD;
&#xD;
      The specific aims of the proposed Phase II study are:&#xD;
&#xD;
      Aim 1. To evaluate parents' satisfaction and acceptance of the tutorial program Aim 2. To&#xD;
      demonstrate the tutorial increases parental knowledge of the principles and techniques for&#xD;
      improving effective parenting of children with Autism Spectrum Disorder.&#xD;
&#xD;
      Aim 3. To demonstrate behavioral improvements in actual parenting skills during the daily&#xD;
      interactions with their child based on the knowledge gained.&#xD;
&#xD;
      Aim 4. To demonstrate that the improved parenting skills result in social, communication, and&#xD;
      behavioral improvements in the children of parents who complete the tutorial.&#xD;
&#xD;
      Aim 5. To demonstrate that improving parenting skills through the use of this web-based&#xD;
      tutorial program reduces caregiver stress and depression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>System Usability Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>User satisfaction with the technical aspects of the Enhancing Interactions tutorial will be assessed using the ratings on the System Usability Scale (SUS). The SUS is a reliable, well-validated 10-item scale 1,49 designed to evaluate the usability and user satisfaction with web-based applications and other technologies. It yields quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction of users while interacting with engineered systems.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Autism Knowledge Test</measure>
    <time_frame>8 weeks</time_frame>
    <description>Gains in parents' knowledge regarding of the principles and techniques for more effective parenting of children will be demonstrated using a pre and post test of 24-items developed by the content experts (Drs. Stone and Warren, and Lisa Wallace) that covers the core concepts of the tutorials. The test items were piloted in parents who (a) had received face-to-face training during Enhancing Interactions seminars and (b) other parents prior to being trained. Items were selected based on their psychometric properties and sensitivity to discriminate between parents who had and had not been exposed to the Enhancing Interactions training.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The Parent Interview for Autism-Clinical Version</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Parenting Efficacy Scale</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Parenting Stress Index</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Child and Parent Behavior Form</measure>
    <time_frame>8 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Autistic Disorder</condition>
  <arm_group>
    <arm_group_label>tutorial</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents who receive access to the tutorial immediately</description>
  </arm_group>
  <arm_group>
    <arm_group_label>wait list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Parents who are assessed at the same time points as the intervention arm, but do no receive access to the tutorial</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>On LIne Parent Training Tutorial</intervention_name>
    <description>Interactive on line tutorial for parenting skills for autism</description>
    <arm_group_label>tutorial</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  parents or caregivers of children with ASD between the ages of 18 months and 6 years&#xD;
             with an autism spectrum disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center for Psychological Consulation</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53717</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kobak KA, Stone WL, Wallace E, Warren Z, Swanson A, Robson K. A web-based tutorial for parents of young children with autism: results from a pilot study. Telemed J E Health. 2011 Dec;17(10):804-8. doi: 10.1089/tmj.2011.0060. Epub 2011 Oct 19.</citation>
    <PMID>22011005</PMID>
  </reference>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>February 1, 2016</last_update_submitted>
  <last_update_submitted_qc>February 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Center for Psychological Consultation</investigator_affiliation>
    <investigator_full_name>Kenneth A. Kobak, Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Internet</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic 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/NCT02184390
org study id: 5R44MH086936
secondary id: 5R44MH086936
nct id: NCT02184390
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the efficacy and user satisfaction with a web-based interactive
      tutorial for caregivers of young children with autism designed to a) teach parents how to
      promote their child's development in the core deficit areas, b) help parents understand and
      improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress
      through more effective interactions. It emphasizes everyday situations as opportunities for
      learning, including common home routines and contains videotaped illustrations of parents
      using the techniques taught in the home environment.
Autism is a neurodevelopmental disorder characterized by core deficits in social reciprocity,
      verbal and nonverbal communication, and behavior. Early detection and intervention has been
      shown to improve these core deficits, resulting in better long-term outcomes in language
      functioning, cognitive/developmental skills, and social and adaptive behavior. Despite the
      demonstrated benefits of effective intervention, few children receive these specialized
      services, due in part to critical resource barriers, such as the shortage of specialists
      trained to deliver them. The broad, long-term objective of this project is to improve
      outcomes for children with autism and their families by empowering caregivers with the
      knowledge and skills needed to effectively intervene directly with their children as part of
      their daily interactions and routines. By targeting those with the most invested in the
      child's success and the longest lasting influence on a child's long-term growth and
      development, we can help parents in several ways: a) teach parents how to promote their
      child's development in the core deficit areas seen in young children with autism spectrum
      disorders: social interaction, communication, play, and imitation; b) help parents understand
      and improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress
      through more effective interactions.

      To make this training widely accessible to parents of children with autism, we will deliver
      this training through a web-based, multi-media, interactive tutorial. The tutorial will use
      principles of instructional design to more effectively deliver the material and utilize high
      levels of interactivity afforded by the web-based platform to maximize learning. The tutorial
      teaches skills to improve their child's behavior and communication within the framework of
      everyday routines and activities, utilizing interactive exercises and a comprehensive set of
      videos of real parents implementing these strategies with their children within the context
      of everyday situations.

      The specific aims of the proposed Phase II study are:

      Aim 1. To evaluate parents' satisfaction and acceptance of the tutorial program Aim 2. To
      demonstrate the tutorial increases parental knowledge of the principles and techniques for
      improving effective parenting of children with Autism Spectrum Disorder.

      Aim 3. To demonstrate behavioral improvements in actual parenting skills during the daily
      interactions with their child based on the knowledge gained.

      Aim 4. To demonstrate that the improved parenting skills result in social, communication, and
      behavioral improvements in the children of parents who complete the tutorial.

      Aim 5. To demonstrate that improving parenting skills through the use of this web-based
      tutorial program reduces caregiver stress and depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: System Usability Scale
time frame: 8 weeks
description: User satisfaction with the technical aspects of the Enhancing Interactions tutorial will be assessed using the ratings on the System Usability Scale (SUS). The SUS is a reliable, well-validated 10-item scale 1,49 designed to evaluate the usability and user satisfaction with web-based applications and other technologies. It yields quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction of users while interacting with engineered systems.
measure: Autism Knowledge Test
time frame: 8 weeks
description: Gains in parents' knowledge regarding of the principles and techniques for more effective parenting of children will be demonstrated using a pre and post test of 24-items developed by the content experts (Drs. Stone and Warren, and Lisa Wallace) that covers the core concepts of the tutorials. The test items were piloted in parents who (a) had received face-to-face training during Enhancing Interactions seminars and (b) other parents prior to being trained. Items were selected based on their psychometric properties and sensitivity to discriminate between parents who had and had not been exposed to the Enhancing Interactions training.
measure: The Parent Interview for Autism-Clinical Version
time frame: 8 weeks
measure: Parenting Efficacy Scale
time frame: 8 weeks
measure: Parenting Stress Index
time frame: 8 weeks
measure: Child and Parent Behavior Form
time frame: 8 weeks
arm group label: tutorial
arm group type: Experimental
description: Parents who receive access to the tutorial immediately
arm group label: wait list control
arm group type: No Intervention
description: Parents who are assessed at the same time points as the intervention arm, but do no receive access to the tutorial
intervention type: Other
intervention name: On LIne Parent Training Tutorial
description: Interactive on line tutorial for parenting skills for autism
arm group label: tutorial
criteria: 
gender: All
minimum age: 18 Months
maximum age: 6 Years
healthy volunteers: No
facility: 
country: United States
citation: Kobak KA, Stone WL, Wallace E, Warren Z, Swanson A, Robson K. A web-based tutorial for parents of young children with autism: results from a pilot study. Telemed J E Health. 2011 Dec;17(10):804-8. doi: 10.1089/tmj.2011.0060. Epub 2011 Oct 19.
PMID: 22011005
responsible party type: Principal Investigator
investigator affiliation: Center for Psychological Consultation
investigator full name: Kenneth A. Kobak, Ph.D.
investigator title: Principal Investigator
mesh term: Autistic Disorder