<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/NCT02235467</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1157-8984</org_study_id>
    <secondary_id>2012/51584-0</secondary_id>
    <nct_id>NCT02235467</nct_id>
  </id_info>
  <brief_title>Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism</brief_title>
  <official_title>Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mackenzie Presbiterian University, São Paulo, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis&#xD;
      (ABA) parent training using video modeling to teach parents of children with Autism&#xD;
      techniques to apply to their children in order to improve eye contact and joint attention&#xD;
      behaviors.&#xD;
&#xD;
      Our hypothesis is that children with Autism whose parents will be trained by videomodeling&#xD;
      will have better eye contact and joint attention behaviors compared to children with Autism&#xD;
      whose parents will not be trained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating&#xD;
      impairments on social functioning and daily-life activities of individuals with Autism&#xD;
      Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an&#xD;
      increasing demand of families non-served in the public health system.&#xD;
&#xD;
      Our main objective is to standardize and test the efficacy of a model for parent training&#xD;
      using video modeling for teaching eye contact and joint attention behaviors in children with&#xD;
      ASD. These two behaviors are essential to develop adequate social interaction, the core&#xD;
      impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal&#xD;
      de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample&#xD;
      will be composed of 70 children divided in control and intervention groups that will be&#xD;
      randomly chosen. The intervention should be carried out in 21 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</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>Acquisition from baseline of new behaviors at 8 weeks</measure>
    <time_frame>baseline assessment to 8 weeks of therapy</time_frame>
    <description>acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acquisition from baseline of new behaviors at 16 weeks</measure>
    <time_frame>baseline assessment to 16 weeks</time_frame>
    <description>acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acquisition from baseline of new behaviors at 21 weeks</measure>
    <time_frame>baseline to 21 weeks</time_frame>
    <description>acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Eye-tracking at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>Latency, duration, and sequence of visual fixations measured with eye-tracking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Vineland Scale at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>Adaptative behavior using Vineland Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in SON-R 2½-7 at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Zaritt Burden Interview at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in OERA at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline in KAP at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>Improvement on the knowledge, attitude and practice (KAP) questionnaire</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline in Hamilton scalels and at 21 weeks</measure>
    <time_frame>baseline assessment to 21 weeks</time_frame>
    <description>Improvement on the Hamilton Depression and Anxiety scales of the caregiver</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>Autism Spectrum Disorders</condition>
  <arm_group>
    <arm_group_label>ABA parent training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Applied Behavior Analysis parent training using videomodeling in 21 sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ABA parent training control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ABA parent training</intervention_name>
    <description>A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks</description>
    <arm_group_label>ABA parent training</arm_group_label>
    <other_name>Applied Behavior Analysis parent training using videomodeling</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Diagnosis of Autism Spectrum Disorders&#xD;
&#xD;
          -  Diagnosis of Autism Spectrum Disorders by means of ADI&#xD;
&#xD;
          -  IQ equal or lower than 70 by means of SON&#xD;
&#xD;
          -  Main caregiver's level of education &gt; primary education&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ lower than 50 by means of SON&#xD;
&#xD;
          -  Child who is receiving ABA therapy at least 10 hours per week&#xD;
&#xD;
          -  Main caregiver diagnosed with Autism Spectrum Disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sheila C Caetano, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Federal University of São Paulo, São Paulo, Brazil</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of São Paulo Department of Psychiatry</name>
      <address>
        <city>São Paulo</city>
        <zip>04038-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>March 31, 2015</last_update_submitted>
  <last_update_submitted_qc>March 31, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of São Paulo</investigator_affiliation>
    <investigator_full_name>Jair Mari</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>autism</keyword>
  <keyword>videomodeling</keyword>
  <keyword>behavioral therapy</keyword>
  <keyword>parental training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <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/NCT02235467
org study id: U1111-1157-8984
secondary id: 2012/51584-0
nct id: NCT02235467
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis
      (ABA) parent training using video modeling to teach parents of children with Autism
      techniques to apply to their children in order to improve eye contact and joint attention
      behaviors.

      Our hypothesis is that children with Autism whose parents will be trained by videomodeling
      will have better eye contact and joint attention behaviors compared to children with Autism
      whose parents will not be trained.
Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating
      impairments on social functioning and daily-life activities of individuals with Autism
      Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an
      increasing demand of families non-served in the public health system.

      Our main objective is to standardize and test the efficacy of a model for parent training
      using video modeling for teaching eye contact and joint attention behaviors in children with
      ASD. These two behaviors are essential to develop adequate social interaction, the core
      impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal
      de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample
      will be composed of 70 children divided in control and intervention groups that will be
      randomly chosen. The intervention should be carried out in 21 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Acquisition from baseline of new behaviors at 8 weeks
time frame: baseline assessment to 8 weeks of therapy
description: acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
measure: Acquisition from baseline of new behaviors at 16 weeks
time frame: baseline assessment to 16 weeks
description: acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
measure: Acquisition from baseline of new behaviors at 21 weeks
time frame: baseline to 21 weeks
description: acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
measure: Change from baseline in Eye-tracking at 21 weeks
time frame: baseline assessment to 21 weeks
description: Latency, duration, and sequence of visual fixations measured with eye-tracking
measure: Change from baseline in Vineland Scale at 21 weeks
time frame: baseline assessment to 21 weeks
description: Adaptative behavior using Vineland Scale
measure: Change from baseline in SON-R 2½-7 at 21 weeks
time frame: baseline assessment to 21 weeks
description: Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
measure: Change from baseline in Zaritt Burden Interview at 21 weeks
time frame: baseline assessment to 21 weeks
description: The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
measure: Change from baseline in OERA at 21 weeks
time frame: baseline assessment to 21 weeks
description: OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.
measure: Change from baseline in KAP at 21 weeks
time frame: baseline assessment to 21 weeks
description: Improvement on the knowledge, attitude and practice (KAP) questionnaire
measure: Change from baseline in Hamilton scalels and at 21 weeks
time frame: baseline assessment to 21 weeks
description: Improvement on the Hamilton Depression and Anxiety scales of the caregiver
arm group label: ABA parent training
arm group type: Active Comparator
description: Applied Behavior Analysis parent training using videomodeling in 21 sessions
arm group label: ABA parent training control
arm group type: No Intervention
intervention type: Behavioral
intervention name: ABA parent training
description: A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
arm group label: ABA parent training
other name: Applied Behavior Analysis parent training using videomodeling
criteria: 
gender: All
minimum age: 3 Years
maximum age: 7 Years
healthy volunteers: No
last name: Sheila C Caetano, MD, PhD
role: Study Director
affiliation: Federal University of São Paulo, São Paulo, Brazil
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of São Paulo
investigator full name: Jair Mari
investigator title: MD, PhD
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder