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/NCT06038435</url>
    </required_header>
    <id_info>
      <org_study_id>CORAKCİ-004</org_study_id>
      <nct_id>NCT06038435</nct_id>
    </id_info>
    <brief_title>The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder</brief_title>
    <official_title>The Effect of Cognitive Orientation Approach on Daily Occupational Performance on Executive Functions and Occupational Participation in Children With Autism Spectrum Disorder: Randomized Controlled Study With 1 Month Follow-up</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bezmialem Vakif University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bezmialem Vakif University</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>
        The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily&#xD;
        Occupational Performance, which is also supported by the literature and applied by&#xD;
        occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to&#xD;
        determine how children's executive function scores and occupational participation change.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect&#xD;
             on executive functions?&#xD;
  &#xD;
          -  Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect&#xD;
             on occupational performance?&#xD;
  &#xD;
        Participants will:&#xD;
  &#xD;
          -  Evaluations will be applied to all participants&#xD;
  &#xD;
          -  Divided into intervention and control groups&#xD;
  &#xD;
          -  The intervention group will be given &quot;Cognitive Orientation Approach on Daily&#xD;
             Occupational Performance&quot; and &quot;Ayres Sensory Integration Therapy&quot; followed up for about&#xD;
             10 weeks.&#xD;
  &#xD;
          -  The control group will be given &quot;Ayres Sensory Integration Therapy&quot; followed up for&#xD;
             about 10 weeks.&#xD;
  &#xD;
          -  After 10 weeks, the results between the two groups will be compared.&#xD;
  &#xD;
          -  After the second evaluation, both groups will be followed for 1 month and the same&#xD;
             evaluations will be repeated.&#xD;
  &#xD;
        Researchers will compare intervention and control groups to see executive functions and&#xD;
        occupational participation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Autism spectrum disorder is a complex developmental disorder that can lead to dysfunctions in&#xD;
        cognitive, emotion regulation, and communication skills.&#xD;
  &#xD;
        At the beginning of the cognitive problems seen in children with autism, the pathophysiology&#xD;
        in executive functions, which is affected by individual differences, comes to the fore.&#xD;
        Difficulties related to executive functions such as cognitive flexibility and problem solving&#xD;
        cause limitations in many basic areas, especially in daily life in autism.&#xD;
  &#xD;
        The Cognitive Orientation Approach on Daily Occupational Performance, designed by Polatajko&#xD;
        and others, is an activity-oriented problem-solving approach that uses cognitive strategies&#xD;
        to develop motor skills in children who have difficulties during daily activities; It is a&#xD;
        therapy method that focuses on the goal or the task itself, rather than the acquisition of&#xD;
        functions within the activity performance. It is known that the approach is effective on&#xD;
        social, emotional and organizational skills, especially cognitive skills in children with&#xD;
        autism spectrum disorder.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 4, 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>Supportive Care</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The Behavior Rating Inventory of Executive Function</measure>
      <time_frame>10 weeks</time_frame>
      <description>It is a rating used to evaluate the behavior of children and adolescents in the home and school environment, taking into account executive functions.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Executive Function and Occupational Routines Scale</measure>
      <time_frame>10 weeks</time_frame>
      <description>It evaluates children's skills such as impulsivity, verbal and non-verbal memory, self-regulation, planning and problem solving.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The Short Child Occupational Profile</measure>
      <time_frame>10 weeks</time_frame>
      <description>The profile provides a comprehensive assessment of the child's activity participation and a holistic consideration of the factors that facilitate or limit occupational participation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Canadian Occupational Performance Measure</measure>
      <time_frame>10 weeks</time_frame>
      <description>It is a person-centered approach to establishing treatment goals and assessing perceived performance and satisfaction changes over time.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">26</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <condition>Executive Function</condition>
    <condition>Patient Participation</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cognitive Orientation Approach on Daily Occupational Performance and Ayres Sensory Integration will be applied for 10 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Ayres Sensory Integration will be applied for 10 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Orientation Approach on Daily Occupational Performance</intervention_name>
      <description>Cognitive training will be given for the selected occupation</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Ayres Sensory Integration Therapy</intervention_name>
      <description>Sensory integration therapy will be applied.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being diagnosed with Autism Spectrum Disorder according to DSM-V by the Department of&#xD;
               Child and Adolescent Mental Health&#xD;
  &#xD;
            -  Being between the ages of 7 years and 10 years and 11 months&#xD;
  &#xD;
            -  Score 30-36 points on the Childhood Autism Rating Scale&#xD;
  &#xD;
            -  Participation must be approved by the parent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a concomitant neurological, psychiatric or orthopedic diagnosis&#xD;
  &#xD;
            -  Attending a program other than individual education&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>11 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Bezmialem Vakıf University</name>
        <address>
          <city>Istanbul</city>
          <state>İ̇stanbul</state>
          <zip>34762</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zeynep Çorakcı Yazıcıoğlu</last_name>
        <phone>+905376699979</phone>
        <email>zcorakci@bezmialem.edu.tr</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Bezmialem Vakif University</investigator_affiliation>
      <investigator_full_name>Zeynep Çorakcı Yazıcıoğlu</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Autism Spectrum Disorder</keyword>
    <keyword>Cognitive Orientation</keyword>
    <keyword>Ayres Sensory Integration</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>Undecided</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/NCT06038435
  org study id: CORAKCİ-004
  nct id: NCT06038435
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is by using the Cognitive Orientation Approach on Daily
        Occupational Performance, which is also supported by the literature and applied by
        occupational therapists, in children diagnosed with Autism Spectrum Disorder, it is aimed to
        determine how children's executive function scores and occupational participation change.
  
        The main questions it aims to answer are:
  
          -  Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect
             on executive functions?
  
          -  Does the Cognitive Orientation Approach on Daily Occupational Performance have an effect
             on occupational performance?
  
        Participants will:
  
          -  Evaluations will be applied to all participants
  
          -  Divided into intervention and control groups
  
          -  The intervention group will be given "Cognitive Orientation Approach on Daily
             Occupational Performance" and "Ayres Sensory Integration Therapy" followed up for about
             10 weeks.
  
          -  The control group will be given "Ayres Sensory Integration Therapy" followed up for
             about 10 weeks.
  
          -  After 10 weeks, the results between the two groups will be compared.
  
          -  After the second evaluation, both groups will be followed for 1 month and the same
             evaluations will be repeated.
  
        Researchers will compare intervention and control groups to see executive functions and
        occupational participation.
  Autism spectrum disorder is a complex developmental disorder that can lead to dysfunctions in
        cognitive, emotion regulation, and communication skills.
  
        At the beginning of the cognitive problems seen in children with autism, the pathophysiology
        in executive functions, which is affected by individual differences, comes to the fore.
        Difficulties related to executive functions such as cognitive flexibility and problem solving
        cause limitations in many basic areas, especially in daily life in autism.
  
        The Cognitive Orientation Approach on Daily Occupational Performance, designed by Polatajko
        and others, is an activity-oriented problem-solving approach that uses cognitive strategies
        to develop motor skills in children who have difficulties during daily activities; It is a
        therapy method that focuses on the goal or the task itself, rather than the acquisition of
        functions within the activity performance. It is known that the approach is effective on
        social, emotional and organizational skills, especially cognitive skills in children with
        autism spectrum disorder.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Participant)
  measure: The Behavior Rating Inventory of Executive Function
  time frame: 10 weeks
  description: It is a rating used to evaluate the behavior of children and adolescents in the home and school environment, taking into account executive functions.
  measure: The Executive Function and Occupational Routines Scale
  time frame: 10 weeks
  description: It evaluates children's skills such as impulsivity, verbal and non-verbal memory, self-regulation, planning and problem solving.
  measure: The Short Child Occupational Profile
  time frame: 10 weeks
  description: The profile provides a comprehensive assessment of the child's activity participation and a holistic consideration of the factors that facilitate or limit occupational participation.
  measure: Canadian Occupational Performance Measure
  time frame: 10 weeks
  description: It is a person-centered approach to establishing treatment goals and assessing perceived performance and satisfaction changes over time.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Cognitive Orientation Approach on Daily Occupational Performance and Ayres Sensory Integration will be applied for 10 weeks.
  arm group label: Control Group
  arm group type: Active Comparator
  description: Ayres Sensory Integration will be applied for 10 weeks.
  intervention type: Behavioral
  intervention name: Cognitive Orientation Approach on Daily Occupational Performance
  description: Cognitive training will be given for the selected occupation
  arm group label: Intervention Group
  intervention type: Behavioral
  intervention name: Ayres Sensory Integration Therapy
  description: Sensory integration therapy will be applied.
  arm group label: Control Group
  arm group label: Intervention Group
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 11 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Bezmialem Vakif University
  investigator full name: Zeynep Çorakcı Yazıcıoğlu
  investigator title: Lecturer
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: Undecided