<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/NCT04418492</url>
  </required_header>
  <id_info>
    <org_study_id>B-1904/537-302</org_study_id>
    <nct_id>NCT04418492</nct_id>
  </id_info>
  <brief_title>An Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD</brief_title>
  <official_title>An Intervention Program Targeting Daily Adaptive Skills Through Executive Function Training for Adults With Autism Spectrum Disorder: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      The current study is a single group pilot study of a novel intervention program which targets&#xD;
      improvements in executive functions and adaptive skills in transition age young adults with&#xD;
      high-functioning autism spectrum disorder. The main aim of the study is to test the&#xD;
      effectiveness of the intervention using a pretest-posttest comparison. It is hypothesised&#xD;
      that there will be an increase in executive functions and adaptive skills after the&#xD;
      intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants engaged in a 10-week group-based intervention program which aims to improve&#xD;
      daily adaptive skills based on executive functions and help the transition into adulthood in&#xD;
      young adults with ASD. Before and after the intervention, the participants and their parents&#xD;
      completed questionnaires that measure executive functions and adaptive skills, and the&#xD;
      participants additionally completed an assessment of social adaptive skills. The differences&#xD;
      between pre- and post-intervention scores of the outcome measures were analyzed using&#xD;
      Wilcoxon signed-rank tests to evaluate the effect of the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2019</start_date>
  <completion_date type="Actual">March 11, 2020</completion_date>
  <primary_completion_date type="Actual">March 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in the Korean version of Barkley Deficits in Executive Functioning Scale (K-BDEFS)</measure>
    <time_frame>1 week before the intervention, between 5th and 6th session of the intervention and 1-3 week after the intervention.</time_frame>
    <description>The Korean version of Barkley Deficits in Executive Functioning Scale measures executive functions of adults in everyday life. The score range is 89-356. Higher score indicates worse executive functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change in the Korean version of Vineland Adaptive Behavior Scale-II (K-Vineland-II)</measure>
    <time_frame>1 week before the intervention and 1-3 week after the intervention.</time_frame>
    <description>The Korean version of Vineland Adaptive Behavior Scale-II measures adaptive behavior. The scores are converted into a standard score with a mean of 100 and a standard deviation of 15. Higher score indicates better adaptive functioning.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change in the Community Integration Skills Assessment-2 (CISA-2)</measure>
    <time_frame>1 week before the intervention and 1-3 week after the intervention.</time_frame>
    <description>The Community Integration Skills Assessment-2 measures adaptive skills necessary for people with developmental disorders to integrate into the community. The scores are converted into a standard score with a mean of 100 and a standard deviation of 15. Higher score indicates better community integration skills.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The change in the Cognitive Flexibility Inventory (CFI)</measure>
    <time_frame>1 week before the intervention and 1-3 week after the intervention.</time_frame>
    <description>The Cognitive Flexibility Inventory assesses cognitive flexibility. The score range is 19-113. Higher score indicates better cognitive flexibility.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>High-functioning Autism</condition>
  <condition>Autism</condition>
  <arm_group>
    <arm_group_label>SAFE intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The single group received the SAFE intervention for 10 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Skills for Adaptive Functioning through Executive training (SAFE; tentative title)</intervention_name>
    <description>An intervention program to improve adaptive skills and executive functions in young adults with high-functioning autism spectrum disorder was administered weekly for 10 weeks to the participants. The participants also completed pre-, mid- and post-intervention assessments.</description>
    <arm_group_label>SAFE intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A clinical diagnosis of ASD as measured by the Autism Diagnostic Observation Schedule&#xD;
             and the Autism Diagnostic Interview-Revised&#xD;
&#xD;
          -  Full-scale IQ of 70 or above as measured by the Weschler Adult Intelligence Scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Full-scale IQ less than 70&#xD;
&#xD;
          -  Uncooperative and lacking motivation to participate in the programme&#xD;
&#xD;
          -  Reporting clinically significant behavioural problems, emotion regulation problems,&#xD;
             psychotic symptoms, risk of self-harm or harm to others which can affect the&#xD;
             participation to the programme, which is screened by the screening assessments and&#xD;
             interviews.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hee Jeong Yoo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autism Spectrum Disorder</keyword>
  <keyword>High-functioning Autism</keyword>
  <keyword>Autism</keyword>
  <keyword>Executive Function</keyword>
  <keyword>Intervention</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>


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/NCT04418492
org study id: B-1904/537-302
nct id: NCT04418492
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The current study is a single group pilot study of a novel intervention program which targets
      improvements in executive functions and adaptive skills in transition age young adults with
      high-functioning autism spectrum disorder. The main aim of the study is to test the
      effectiveness of the intervention using a pretest-posttest comparison. It is hypothesised
      that there will be an increase in executive functions and adaptive skills after the
      intervention.
The participants engaged in a 10-week group-based intervention program which aims to improve
      daily adaptive skills based on executive functions and help the transition into adulthood in
      young adults with ASD. Before and after the intervention, the participants and their parents
      completed questionnaires that measure executive functions and adaptive skills, and the
      participants additionally completed an assessment of social adaptive skills. The differences
      between pre- and post-intervention scores of the outcome measures were analyzed using
      Wilcoxon signed-rank tests to evaluate the effect of the program.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change in the Korean version of Barkley Deficits in Executive Functioning Scale (K-BDEFS)
time frame: 1 week before the intervention, between 5th and 6th session of the intervention and 1-3 week after the intervention.
description: The Korean version of Barkley Deficits in Executive Functioning Scale measures executive functions of adults in everyday life. The score range is 89-356. Higher score indicates worse executive functioning.
measure: The change in the Korean version of Vineland Adaptive Behavior Scale-II (K-Vineland-II)
time frame: 1 week before the intervention and 1-3 week after the intervention.
description: The Korean version of Vineland Adaptive Behavior Scale-II measures adaptive behavior. The scores are converted into a standard score with a mean of 100 and a standard deviation of 15. Higher score indicates better adaptive functioning.
measure: The change in the Community Integration Skills Assessment-2 (CISA-2)
time frame: 1 week before the intervention and 1-3 week after the intervention.
description: The Community Integration Skills Assessment-2 measures adaptive skills necessary for people with developmental disorders to integrate into the community. The scores are converted into a standard score with a mean of 100 and a standard deviation of 15. Higher score indicates better community integration skills.
measure: The change in the Cognitive Flexibility Inventory (CFI)
time frame: 1 week before the intervention and 1-3 week after the intervention.
description: The Cognitive Flexibility Inventory assesses cognitive flexibility. The score range is 19-113. Higher score indicates better cognitive flexibility.
arm group label: SAFE intervention
arm group type: Experimental
description: The single group received the SAFE intervention for 10 weeks.
intervention type: Behavioral
intervention name: Skills for Adaptive Functioning through Executive training (SAFE; tentative title)
description: An intervention program to improve adaptive skills and executive functions in young adults with high-functioning autism spectrum disorder was administered weekly for 10 weeks to the participants. The participants also completed pre-, mid- and post-intervention assessments.
arm group label: SAFE intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: No
last name: Hee Jeong Yoo
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: No