<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/NCT04440852</url>
  </required_header>
  <id_info>
    <org_study_id>KY2016(53)</org_study_id>
    <nct_id>NCT04440852</nct_id>
  </id_info>
  <brief_title>Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH</brief_title>
  <official_title>Effect of TEACCH Program on the Rehabilitation Training for Preschool Children With Autistic Spectrum Disorder: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wuhan Mental Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wuhan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wuhan Mental Health Centre</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 study is design to evaluate the efficacy of the Treatment and Education of Autistic and&#xD;
      Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with&#xD;
      autism spectrum disorders (ASD) in China.A case-randomized controlled study was&#xD;
      conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly&#xD;
      assigned to the a TEACCH intervention group or a control group.The control group was&#xD;
      subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training&#xD;
      besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational&#xD;
      Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation&#xD;
      training.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">March 30, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)</measure>
    <time_frame>pretest</time_frame>
    <description>a validated assessment tool that comprehensively measures the development of Chinese children with ASD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)</measure>
    <time_frame>posttest: 6 months to pretest</time_frame>
    <description>a validated assessment tool that comprehensively measures the development of Chinese children with ASD</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)</measure>
    <time_frame>6 months follow-up : 1 year to pretest</time_frame>
    <description>a validated assessment tool that comprehensively measures the development of Chinese children with ASD</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>TEACCH intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TEACCH intervention for ASD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional rehabilitation group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Other conventional interventions</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>TEACCH</intervention_name>
    <description>The Treatment and Education of Autistic and Communication Handicapped Children</description>
    <arm_group_label>TEACCH intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed by two children's psychiatrists above the level of the attending physician,&#xD;
             in accordance with the diagnostic criteria of DSM-V (Diagnostic and Statistical Manual&#xD;
             of Mental Disorder, fifth revised) children's autism spectrum disorder issued by the&#xD;
             United States in 2013. Diagnostic screening scales include Autism Behavior Checklist&#xD;
             (ABC), Childhood Autism Rating Scale (CARS), and Modified Checklist for Autism in&#xD;
             Toddlers (M-CHAT) (for under 4 years old), Social Communication Questionnaire (SCQ)&#xD;
             (for over 4 years old), all children' scores above the scale suggest ASD performance;&#xD;
&#xD;
          -  able to cooperate with clinical evaluation and related examinations, and the guardian&#xD;
             signs the informed consent to agree to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  combined with other mental illnesses such as ADHD, with major physical and nervous&#xD;
             system diseases;&#xD;
&#xD;
          -  serious self-harm.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Months</minimum_age>
    <maximum_age>90 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hongling Zeng, Master</last_name>
    <role>Study Director</role>
    <affiliation>Wuhan Mental Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wuhan Mental Health Centre</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430014</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TEACCH</keyword>
  <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/NCT04440852
org study id: KY2016(53)
nct id: NCT04440852
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study is design to evaluate the efficacy of the Treatment and Education of Autistic and
      Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with
      autism spectrum disorders (ASD) in China.A case-randomized controlled study was
      conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly
      assigned to the a TEACCH intervention group or a control group.The control group was
      subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training
      besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational
      Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation
      training.
Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
time frame: pretest
description: a validated assessment tool that comprehensively measures the development of Chinese children with ASD
measure: Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
time frame: posttest: 6 months to pretest
description: a validated assessment tool that comprehensively measures the development of Chinese children with ASD
measure: Chinese Version of Psycho-educational Profile-3rd edition (CPEP-3)
time frame: 6 months follow-up : 1 year to pretest
description: a validated assessment tool that comprehensively measures the development of Chinese children with ASD
arm group label: TEACCH intervention
arm group type: Experimental
description: TEACCH intervention for ASD
arm group label: conventional rehabilitation group
arm group type: No Intervention
description: Other conventional interventions
intervention type: Behavioral
intervention name: TEACCH
description: The Treatment and Education of Autistic and Communication Handicapped Children
arm group label: TEACCH intervention
criteria: 
gender: All
minimum age: 36 Months
maximum age: 90 Months
healthy volunteers: No
last name: Hongling Zeng, Master
role: Study Director
affiliation: Wuhan Mental Health Centre
facility: 
country: China
responsible party type: Sponsor
mesh term: Autism Spectrum Disorder