<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/NCT03785327</url>
  </required_header>
  <id_info>
    <org_study_id>1806799</org_study_id>
    <nct_id>NCT03785327</nct_id>
  </id_info>
  <brief_title>Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood</brief_title>
  <official_title>Improving Social Interaction for Adolescents With Autism During the Transition to Adulthood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas at Dallas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas at Dallas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the efficacy of two intervention strategies for improving social outcomes&#xD;
      for autistic adolescents and young adults when interacting with unfamiliar non-autistic&#xD;
      peers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intellectually-capable older adolescents and young adults with autism spectrum disorder (ASD)&#xD;
      often struggle to secure and maintain employment, succeed in college, or develop satisfying&#xD;
      personal and professional relationships. Current psychosocial interventions for this&#xD;
      population have produced limited effects on real-world functioning. These programs typically&#xD;
      seek to improve social skill and understanding with the hope that these abilities will&#xD;
      translate to better functioning and are often effective at increasing knowledge of social&#xD;
      rules and norms,yet these improvements frequently do not translate to better social and life&#xD;
      outcomes in the real world. One reason for their limited efficacy may be that the mechanisms&#xD;
      involved in real-life social interaction continue to be poorly understood for this&#xD;
      population. The current study is designed to specify the factors that predict more or less&#xD;
      favorable social outcomes for autistic adolescents and young adults when interacting with an&#xD;
      unfamiliar, non-autistic peer, and test a multifaceted intervention for improving these&#xD;
      outcomes. The intervention will target both brain and behavior, not only in the individual&#xD;
      with ASD but also in their typically-developing (TD) partners. For TD participants, the&#xD;
      efficacy of a training program will be tested to determine if social experiences for older&#xD;
      adolescents with ASD can be improved by increasing knowledge, acceptance, and understanding&#xD;
      of autism among TD individuals. For the participants with ASD, this study will test the&#xD;
      efficacy of an innovative, non-invasive neurostimulation session using Transcranial Direct&#xD;
      Current Stimulation (tDCS) to target social brain regions involved in perspective-taking and&#xD;
      social reciprocity. Social outcomes for each intervention will be compared to a &quot;no&#xD;
      intervention&quot; control condition, and to each other, to provide a comprehensive examination of&#xD;
      intrinsic and extrinsic factors contributing to social interaction quality for autistic&#xD;
      adolescents and young adults.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID disrupted data collection&#xD;
  </why_stopped>
  <start_date type="Actual">January 18, 2019</start_date>
  <completion_date type="Actual">September 22, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Autistic participants were going to be recruited for an active or sham tDCS session. However, no participants were enrolled in these conditions due to COVID.&#xD;
TD participants were assigned to receive or not receive a training session.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subjective Social Interaction Quality</measure>
    <time_frame>Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes</time_frame>
    <description>Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Autism Spectrum Disorder</condition>
  <condition>Typical Development</condition>
  <arm_group>
    <arm_group_label>Active anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autism Training Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Social interaction without intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control condition: Behavioral testing without an intervention component</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS</intervention_name>
    <description>Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
    <arm_group_label>Active anodal tDCS</arm_group_label>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Autism Training</intervention_name>
    <description>Autism Information Presentation developed by Dr. Grace Iarocci's Autism &amp; Developmental Disorders Lab at Simon Fraser University</description>
    <arm_group_label>Autism Training Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18-21&#xD;
&#xD;
          -  DSM-IV-TR or DSM-5 diagnosis of an Autism Spectrum Disorder&#xD;
&#xD;
          -  IQ&gt;70&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence or history intellectual impairment (defined as IQ &lt;70)&#xD;
&#xD;
          -  Presence or history of medical, cardiac, or neurological disorders that may affect&#xD;
             brain function (e.g., cardiac disease, endocrine disorders, renal disease, pulmonary&#xD;
             disease, history of seizures or head trauma with unconsciousness for a period of 15&#xD;
             minutes or greater or CNS tumors)&#xD;
&#xD;
          -  Presence of sensory limitation including visual (e.g., blindness, glaucoma, vision&#xD;
             uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments that interfere with&#xD;
             assessment&#xD;
&#xD;
          -  Not proficient in English&#xD;
&#xD;
          -  Presence of substance abuse in the past one month&#xD;
&#xD;
          -  Presence of substance dependence not in remission for the past six months&#xD;
&#xD;
          -  Contraindications for tDCS (e.g., pregnancy or implanted devices such as pace maker)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Texas at Dallas</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080-3021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <results_first_submitted>November 9, 2022</results_first_submitted>
  <results_first_submitted_qc>December 2, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 23, 2022</results_first_posted>
  <last_update_submitted>December 2, 2022</last_update_submitted>
  <last_update_submitted_qc>December 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas at Dallas</investigator_affiliation>
    <investigator_full_name>Noah Sasson</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 1, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03785327/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Anodal tDCS</title>
          <description>Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
        </group>
        <group group_id="P2">
          <title>Sham tDCS</title>
          <description>Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
        </group>
        <group group_id="P3">
          <title>Autism Training Program</title>
          <description>Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program&#xD;
Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism &amp; Developmental Disorders Lab at Simon Fraser University</description>
        </group>
        <group group_id="P4">
          <title>Social Interaction Without Intervention</title>
          <description>Control condition: Behavioral testing without an intervention component</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="38"/>
                <participants group_id="P4" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Active and Sham tDCS were terminated before beginning due to COVID</population>
      <group_list>
        <group group_id="B1">
          <title>Active Anodal tDCS</title>
          <description>Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
        </group>
        <group group_id="B2">
          <title>Sham tDCS</title>
          <description>Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
        </group>
        <group group_id="B3">
          <title>Autism Training Program</title>
          <description>Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program&#xD;
Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism &amp; Developmental Disorders Lab at Simon Fraser University</description>
        </group>
        <group group_id="B4">
          <title>Social Interaction Without Intervention</title>
          <description>Control condition: Behavioral testing without an intervention component</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="38"/>
            <count group_id="B4" value="40"/>
            <count group_id="B5" value="78"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="20.26" spread="1.79"/>
                    <measurement group_id="B4" value="20.63" spread="1.75"/>
                    <measurement group_id="B5" value="20.45" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="32"/>
                    <measurement group_id="B5" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="40"/>
                    <measurement group_id="B5" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Subjective Social Interaction Quality</title>
        <description>Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner.</description>
        <time_frame>Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes</time_frame>
        <population>Zero participants are listed for the Active and Sham tDCS arms because these arms were terminated before data collection began.</population>
        <group_list>
          <group group_id="O1">
            <title>Active Anodal tDCS</title>
            <description>Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
          </group>
          <group group_id="O2">
            <title>Sham tDCS</title>
            <description>Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
          </group>
          <group group_id="O3">
            <title>Autism Training Program</title>
            <description>Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program&#xD;
Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism &amp; Developmental Disorders Lab at Simon Fraser University</description>
          </group>
          <group group_id="O4">
            <title>Social Interaction Without Intervention</title>
            <description>Control condition: Behavioral testing without an intervention component</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Social Interaction Quality</title>
          <description>Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner.</description>
          <population>Zero participants are listed for the Active and Sham tDCS arms because these arms were terminated before data collection began.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="38"/>
                <count group_id="O4" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O3" value="2.74" spread="0.45"/>
                    <measurement group_id="O4" value="2.45" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1-2 hours, which is the average duration of participation for each individual participant in the &quot;Autism Training Program&quot; arm and &quot;Social Interaction without Intervention &quot; arm; participants were not enrolled in the &quot;active and sham tCDS&quot; arms.</time_frame>
      <desc>Zero participants are listed as at risk in the active and sham tCDS arms because these arms were terminated before beginning. No participants were tested in them.</desc>
      <group_list>
        <group group_id="E1">
          <title>Active Anodal tDCS</title>
          <description>Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
        </group>
        <group group_id="E2">
          <title>Sham tDCS</title>
          <description>Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS&#xD;
tDCS: Participants either complete active and sham tDCS sessions one week apart or an autism training program.</description>
        </group>
        <group group_id="E3">
          <title>Autism Training Program</title>
          <description>Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program&#xD;
Autism Training: Autism Information Presentation developed by Dr. Grace Iarocci's Autism &amp; Developmental Disorders Lab at Simon Fraser University</description>
        </group>
        <group group_id="E4">
          <title>Social Interaction Without Intervention</title>
          <description>Control condition: Behavioral testing without an intervention component</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Noah Sasson</name_or_title>
      <organization>The University of Texas at Dallas</organization>
      <phone>972-883-2541</phone>
      <email>nsasson@utdallas.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03785327
org study id: 1806799
nct id: NCT03785327
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study compares the efficacy of two intervention strategies for improving social outcomes
      for autistic adolescents and young adults when interacting with unfamiliar non-autistic
      peers.
Intellectually-capable older adolescents and young adults with autism spectrum disorder (ASD)
      often struggle to secure and maintain employment, succeed in college, or develop satisfying
      personal and professional relationships. Current psychosocial interventions for this
      population have produced limited effects on real-world functioning. These programs typically
      seek to improve social skill and understanding with the hope that these abilities will
      translate to better functioning and are often effective at increasing knowledge of social
      rules and norms,yet these improvements frequently do not translate to better social and life
      outcomes in the real world. One reason for their limited efficacy may be that the mechanisms
      involved in real-life social interaction continue to be poorly understood for this
      population. The current study is designed to specify the factors that predict more or less
      favorable social outcomes for autistic adolescents and young adults when interacting with an
      unfamiliar, non-autistic peer, and test a multifaceted intervention for improving these
      outcomes. The intervention will target both brain and behavior, not only in the individual
      with ASD but also in their typically-developing (TD) partners. For TD participants, the
      efficacy of a training program will be tested to determine if social experiences for older
      adolescents with ASD can be improved by increasing knowledge, acceptance, and understanding
      of autism among TD individuals. For the participants with ASD, this study will test the
      efficacy of an innovative, non-invasive neurostimulation session using Transcranial Direct
      Current Stimulation (tDCS) to target social brain regions involved in perspective-taking and
      social reciprocity. Social outcomes for each intervention will be compared to a "no
      intervention" control condition, and to each other, to provide a comprehensive examination of
      intrinsic and extrinsic factors contributing to social interaction quality for autistic
      adolescents and young adults.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Autistic participants were going to be recruited for an active or sham tDCS session. However, no participants were enrolled in these conditions due to COVID.
TD participants were assigned to receive or not receive a training session.
primary purpose: Basic Science
masking: Single (Participant)
measure: Subjective Social Interaction Quality
time frame: Interaction with unfamiliar partner occurs immediately following the autism training; self-report measure given immediately after the interaction, duration of completion averages around 2 minutes
description: Non-autistic participants social interest in autistic partners as measured by the First Impression Scale (Sasson et al., 2017). Four items, each scored on a Likert Scale from 1 to 4 in which higher values indicate greater social interest, are averaged to produce a social interest composite that serves as the primary outcome measure of the non-autistic participant's social interest in their autistic conversation partner.
arm group label: Active anodal tDCS
arm group type: Experimental
description: Active anodal tDCS followed by behavioral testing Intervention: Device: active anodal tDCS
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Sham tDCS followed by behavioral testing Intervention: Device: sham tDCS
arm group label: Autism Training Program
arm group type: Experimental
description: Training program designed to increase autism understanding followed by behavioral testing Intervention:Training program
arm group label: Social interaction without intervention
arm group type: No Intervention
description: Control condition: Behavioral testing without an intervention component
intervention type: Device
intervention name: tDCS
description: Participants either complete active and sham tDCS sessions one week apart or an autism training program.
arm group label: Active anodal tDCS
arm group label: Sham tDCS
intervention type: Behavioral
intervention name: Autism Training
description: Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University
arm group label: Autism Training Program
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas at Dallas
investigator full name: Noah Sasson
investigator title: Associate Professor
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 