<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/NCT03812068</url>
  </required_header>
  <id_info>
    <org_study_id>201809001RINC</org_study_id>
    <nct_id>NCT03812068</nct_id>
  </id_info>
  <brief_title>Parent-mediated Developmental Behavioral Intervention</brief_title>
  <acronym>PDBI</acronym>
  <official_title>The Effectiveness of a Parent-mediated Developmental Behavioral Intervention for Children With Autism Spectrum Disorder and Developmental Delay: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      This study explores the effectiveness of two intervention programs: &quot;Long-distance&#xD;
      developmental behavioral intervention&quot; and &quot;developmental behavioral interventions&quot; for&#xD;
      children with autism spectrum disorder or multiple developmental delays.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 30, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2021</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>The Autism Diagnostic Observation Schedule</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of autism status and severity level</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child Behavior Checklist Ages 1.5-5</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of child's behavioral syndrome and problems</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pediatric Evaluation of Disability Inventory</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of child's daily living function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mullen Scale of Early Learning</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of child's cognitive and motor development</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Movement Assessment Battery for Children</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of child's motor coordination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3D Gait Assessment Foot-worn Inertial Sensor</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of gait performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peabody Developmental Motor Scales, Second Edition</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of multiple fine and gross motor functions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of parenting stress for parents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Sense of Competence Scale</measure>
    <time_frame>3 months</time_frame>
    <description>measurement of the parent's self-efficacy and satisfaction as being parents</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Long-distance developmental behavioral intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Long-distance learning program combined parent-mediated developmental behavioral intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Developmental behavioral intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>only parent-mediated developmental behavioral intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Long-distance developmental behavioral intervention</intervention_name>
    <description>Long-distance learning program combined parent-mediated developmental behavioral intervention</description>
    <arm_group_label>Long-distance developmental behavioral intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Developmental behavioral intervention</intervention_name>
    <description>Parent-mediated developmental behavioral intervention</description>
    <arm_group_label>Developmental behavioral intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Child's age between 30-84 months old.&#xD;
&#xD;
          -  Children have a diagnosis of autism spectrum disorder or multiple developmental&#xD;
             delays.&#xD;
&#xD;
          -  Children without physical disabilities or major health problems, such as congenital&#xD;
             limb defects.&#xD;
&#xD;
          -  One of the fathers or mothers involved in the study shall be the primary caregiver of&#xD;
             the child.&#xD;
&#xD;
          -  The father or mother participating in the study has at least 9 education years and can&#xD;
             read and understand Chinese.&#xD;
&#xD;
          -  The father or mother participating in the study is willing to allow the child to&#xD;
             undergo a comprehensive development assessment and is willing to video during the&#xD;
             training process.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of chromosome abnormalities, congenital anomalies, and major neurological or&#xD;
             sensory impairments or disorders (e.g., cerebral palsy, microcephalus, macrocephalus,&#xD;
             severe brain damage, uncorrected vision, or hearing loss).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Months</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yen-Tzu Wu, PhD</last_name>
    <phone>886-2-33668136</phone>
    <email>yenwu@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>School and Graduate Institute of Physical Therapy, National Taiwan University</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yen-Tzu Wu, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ASD</keyword>
  <keyword>Early intervention</keyword>
  <keyword>Development</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autism Spectrum Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03812068
org study id: 201809001RINC
nct id: NCT03812068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study explores the effectiveness of two intervention programs: "Long-distance
      developmental behavioral intervention" and "developmental behavioral interventions" for
      children with autism spectrum disorder or multiple developmental delays.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: The Autism Diagnostic Observation Schedule
time frame: 3 months
description: measurement of autism status and severity level
measure: Child Behavior Checklist Ages 1.5-5
time frame: 3 months
description: measurement of child's behavioral syndrome and problems
measure: Pediatric Evaluation of Disability Inventory
time frame: 3 months
description: measurement of child's daily living function
measure: Mullen Scale of Early Learning
time frame: 3 months
description: measurement of child's cognitive and motor development
measure: Movement Assessment Battery for Children
time frame: 3 months
description: measurement of child's motor coordination
measure: 3D Gait Assessment Foot-worn Inertial Sensor
time frame: 3 months
description: measurement of gait performance
measure: Peabody Developmental Motor Scales, Second Edition
time frame: 3 months
description: measurement of multiple fine and gross motor functions
measure: Parenting Stress Index
time frame: 3 months
description: measurement of parenting stress for parents
measure: Parenting Sense of Competence Scale
time frame: 3 months
description: measurement of the parent's self-efficacy and satisfaction as being parents
arm group label: Long-distance developmental behavioral intervention
arm group type: Experimental
description: Long-distance learning program combined parent-mediated developmental behavioral intervention
arm group label: Developmental behavioral intervention
arm group type: Active Comparator
description: only parent-mediated developmental behavioral intervention
intervention type: Behavioral
intervention name: Long-distance developmental behavioral intervention
description: Long-distance learning program combined parent-mediated developmental behavioral intervention
arm group label: Long-distance developmental behavioral intervention
intervention type: Behavioral
intervention name: Developmental behavioral intervention
description: Parent-mediated developmental behavioral intervention
arm group label: Developmental behavioral intervention
criteria: 
gender: All
minimum age: 30 Months
maximum age: N/A
healthy volunteers: No
last name: Yen-Tzu Wu, PhD
phone: 886-2-33668136
email: yenwu@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder
sharing ipd: Undecided