xml: <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/NCT05962047</url>
    </required_header>
    <id_info>
      <org_study_id>F723 - Project A</org_study_id>
      <nct_id>NCT05962047</nct_id>
    </id_info>
    <brief_title>Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder</brief_title>
    <official_title>Use of Augmented Reality for Restricted and Repetitive Behavior and Executive Function of Children With Autism Spectrum Disorder</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Riphah International University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Riphah International University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The aim of the study is to determine the effects of usage of augmented reality for Restricted&#xD;
        and repetitive behavior and executive function of children with autism spectrum disorder&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Augmented Reality allows children to see a representation of imaginary content and pretend&#xD;
        play overlaid on the real-world environment. Today, technology can be a safe and motivating&#xD;
        way of engaging children with autism in social interaction activities. Current research in&#xD;
        therapeutic technology for autism is aimed toward improving behavior and psychomotor&#xD;
        activities that impact social communication. The aim of this research project is to help&#xD;
        teachers, parents, practitioners, and researchers to understand the unique strengths of their&#xD;
        children with autism along with technology based educational and therapeutic activities for&#xD;
        home and classroom.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 25, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2023</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>
      <masking_description>Single (Outcome assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Developmental Behaviour Checklist (DBC)</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>The Developmental Behaviour Checklist (DBC) can be used for the assessment of behavioural and emotional problems of children and adolescents with development and intellectual disabilities. It is a questionnaire completed by parents or other primary carers, or teachers and reports problems over a six month period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Repetitive Behaviors Scale-Revised (RBS-R)</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>The RBS-R is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The flexibility Scale</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>Cognitive flexibility is the ability to switch between different thoughts and actions. It is considered part of executive functions, which are the general mental functions that help us to coordinate thought and action. The tool has a four point ordinal likert scale scoring for each item. Higher scores (after reverse scoring) mean greater endorsement of problems / characteristics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Digital span memory test</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>Digital span test will be used to determine working memory. It is a working memory test that is used in many cognitive and neuroscience research labs. Th patient is instructed to repeat the sequence of numbers shown during the test. To make it more interesting, gradually increase the Span, which starts out at 8, and change to Fast test speed. The Digit Span score is the length of the longest correctly repeated sequence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Stroop test</measure>
      <time_frame>After 8 weeks</time_frame>
      <description>The Stroop test also known as the color-word naming test, will be used for cognitive inhibition. It is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference.&#xD;
  The basic Stroop scores (time taken in seconds for each of the three cards) will be entered. Subjects (S's) basic score on each card is the total time (in seconds) to utter the 100 names.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">18</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Augmented Reality games</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Traditional therapy</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Games of WonderTree Augmented Reality</intervention_name>
      <description>Participants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree</description>
      <arm_group_label>Group 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Traditional therapy</intervention_name>
      <description>Traditional therapy based on play activities utilizing blocks, colors, Velcro-based toys.</description>
      <arm_group_label>Group 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at&#xD;
               verbal imitation and 1-step command following.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Sensory issues and patients on medication&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Suman Sheraz, PhD*</last_name>
      <role>Principal Investigator</role>
      <affiliation>Riphah International University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Suman Sheraz, PhD*</last_name>
      <phone>03335646361</phone>
      <email>suman.sheraz@riphah.edu.pk</email>
    </overall_contact>
    <location>
      <facility>
        <name>Child Development Center - Riphah International University</name>
        <address>
          <city>Islamabad</city>
          <state>AL</state>
          <zip>44000</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Suman Sheraz, PhD*</last_name>
        <phone>03335646361</phone>
        <email>suman.sheraz@riphah.edu.pk</email>
      </contact>
      <contact_backup>
        <last_name>Irum Nawaz, PhD*</last_name>
        <phone>03325382657</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Berenguer C, Baixauli I, Gomez S, Andres MEP, De Stasio S. Exploring the Impact of Augmented Reality in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 24;17(17):6143. doi: 10.3390/ijerph17176143.</citation>
      <PMID>32847074</PMID>
    </reference>
    <reference>
      <citation>Dechsling A, Orm S, Kalandadze T, Sutterlin S, Oien RA, Shic F, Nordahl-Hansen A. Virtual and Augmented Reality in Social Skills Interventions for Individuals with Autism Spectrum Disorder: A Scoping Review. J Autism Dev Disord. 2022 Nov;52(11):4692-4707. doi: 10.1007/s10803-021-05338-5. Epub 2021 Nov 16.</citation>
      <PMID>34783991</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Augmented Reality</keyword>
    <keyword>Behaviour</keyword>
    <keyword>Executive function</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>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962047
  org study id: F723 - Project A
  nct id: NCT05962047
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to determine the effects of usage of augmented reality for Restricted
        and repetitive behavior and executive function of children with autism spectrum disorder
  Augmented Reality allows children to see a representation of imaginary content and pretend
        play overlaid on the real-world environment. Today, technology can be a safe and motivating
        way of engaging children with autism in social interaction activities. Current research in
        therapeutic technology for autism is aimed toward improving behavior and psychomotor
        activities that impact social communication. The aim of this research project is to help
        teachers, parents, practitioners, and researchers to understand the unique strengths of their
        children with autism along with technology based educational and therapeutic activities for
        home and classroom.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Single (Outcome assessor)
  measure: Developmental Behaviour Checklist (DBC)
  time frame: After 8 weeks
  description: The Developmental Behaviour Checklist (DBC) can be used for the assessment of behavioural and emotional problems of children and adolescents with development and intellectual disabilities. It is a questionnaire completed by parents or other primary carers, or teachers and reports problems over a six month period
  measure: Repetitive Behaviors Scale-Revised (RBS-R)
  time frame: After 8 weeks
  description: The RBS-R is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders.
  measure: The flexibility Scale
  time frame: After 8 weeks
  description: Cognitive flexibility is the ability to switch between different thoughts and actions. It is considered part of executive functions, which are the general mental functions that help us to coordinate thought and action. The tool has a four point ordinal likert scale scoring for each item. Higher scores (after reverse scoring) mean greater endorsement of problems / characteristics.
  measure: Digital span memory test
  time frame: After 8 weeks
  description: Digital span test will be used to determine working memory. It is a working memory test that is used in many cognitive and neuroscience research labs. Th patient is instructed to repeat the sequence of numbers shown during the test. To make it more interesting, gradually increase the Span, which starts out at 8, and change to Fast test speed. The Digit Span score is the length of the longest correctly repeated sequence
  measure: The Stroop test
  time frame: After 8 weeks
  description: The Stroop test also known as the color-word naming test, will be used for cognitive inhibition. It is a neuropsychological test extensively used to assess the ability to inhibit cognitive interference.
  The basic Stroop scores (time taken in seconds for each of the three cards) will be entered. Subjects (S's) basic score on each card is the total time (in seconds) to utter the 100 names.
  arm group label: Group 1
  arm group type: Experimental
  description: Augmented Reality games
  arm group label: Group 2
  arm group type: Active Comparator
  description: Traditional therapy
  intervention type: Other
  intervention name: Games of WonderTree Augmented Reality
  description: Participants of group 1 (experimental group) will augmented reality based interventions comprising of games of Wonder Tree
  arm group label: Group 1
  intervention type: Other
  intervention name: Traditional therapy
  description: Traditional therapy based on play activities utilizing blocks, colors, Velcro-based toys.
  arm group label: Group 2
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 12 Years
  healthy volunteers: No
  last name: Suman Sheraz, PhD*
  role: Principal Investigator
  affiliation: Riphah International University
  last name: Suman Sheraz, PhD*
  phone: 03335646361
  email: suman.sheraz@riphah.edu.pk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Pakistan
  citation: Berenguer C, Baixauli I, Gomez S, Andres MEP, De Stasio S. Exploring the Impact of Augmented Reality in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 24;17(17):6143. doi: 10.3390/ijerph17176143.
  PMID: 32847074
  citation: Dechsling A, Orm S, Kalandadze T, Sutterlin S, Oien RA, Shic F, Nordahl-Hansen A. Virtual and Augmented Reality in Social Skills Interventions for Individuals with Autism Spectrum Disorder: A Scoping Review. J Autism Dev Disord. 2022 Nov;52(11):4692-4707. doi: 10.1007/s10803-021-05338-5. Epub 2021 Nov 16.
  PMID: 34783991
  responsible party type: Sponsor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: No