<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/NCT02205658</url>
  </required_header>
  <id_info>
    <org_study_id>1027</org_study_id>
    <nct_id>NCT02205658</nct_id>
  </id_info>
  <brief_title>Sensory Processing Difficulties in Adults and Adolescents</brief_title>
  <official_title>Standardization of the Adult/ Adolescent Sensory History</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Spiral Foundation at OTA Watertown</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Maxwell Hurston Charitable Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Spiral Foundation at OTA Watertown</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish normative data for the Adult/Adolescent Sensory&#xD;
      History (ASH) and to determine if the ASH is able to discriminate between individuals aged&#xD;
      13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing&#xD;
      Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically&#xD;
      functioning.&#xD;
&#xD;
      It is anticipated that individuals with ASD will have the most problems with sensory&#xD;
      processing, those with SPD will also have problems in comparison to typical individuals. It&#xD;
      is also hypothesized that the measure will be able to discriminate between the three groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">September 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensory processing difficulties</measure>
    <time_frame>15-20 minutes</time_frame>
    <description>This study proposes to measure sensory processing problems by self report</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Sensory Processing Dysfunction</condition>
  <arm_group>
    <arm_group_label>Autism</arm_group_label>
    <description>Individuals, aged 18-95 years, with a pre-existing diagnosis of Autism Spectrum Disorder with or without a co-morbid diagnosis of Sensory Processing Disorder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensory Processing</arm_group_label>
    <description>Individuals, aged 18-95 years, with a pre-existing diagnosis of Sensory Processing Disorder with no co-morbid diagnosis of Autism Spectrum Disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Typical</arm_group_label>
    <description>Typically functioning individuals aged 13-95 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals will be a nationally representative sample of US residents&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Autism and Sensory Processing groups aged 18-95 years, Typical group aged 13-95 years&#xD;
&#xD;
          -  Have no self-reported diagnosed neurological motor coordination problem (e.g. cerebral&#xD;
             palsy)&#xD;
&#xD;
          -  Have no mental health diagnoses involving psychosis (e.g. manic-depression or&#xD;
             schizophrenia)&#xD;
&#xD;
          -  Be able to read and speak sufficient English as survey is only available in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Outside of the designated age range&#xD;
&#xD;
          -  Unable to complete the survey independently&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teresa A May Benson, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Spiral Foundation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Teresa A May-Benson, ScD</last_name>
    <phone>6179234410</phone>
    <phone_ext>240</phone_ext>
    <email>tmaybenson@thespiralfoundation.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Spiral Foundation</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02458</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Teresa A May-Benson, ScD</last_name>
      <phone>617-923-4410</phone>
      <phone_ext>240</phone_ext>
      <email>tmaybenson@thespiralfoundation.org</email>
    </contact>
    <investigator>
      <last_name>Teresa A May-Benson, ScD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.thespiralfoundation.org</url>
    <description>Spiral Foundation website</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 31, 2014</study_first_posted>
  <last_update_submitted>July 29, 2014</last_update_submitted>
  <last_update_submitted_qc>July 29, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 31, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sensory Processing</keyword>
  <keyword>Autism</keyword>
  <!-- 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/NCT02205658
org study id: 1027
nct id: NCT02205658
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to establish normative data for the Adult/Adolescent Sensory
      History (ASH) and to determine if the ASH is able to discriminate between individuals aged
      13-95 years, with Autism Spectrum Disorder (ASD) with or without co-morbid Sensory processing
      Disorder (SPD), individuals with SPD with no co-morbid ASD, and individuals who are typically
      functioning.

      It is anticipated that individuals with ASD will have the most problems with sensory
      processing, those with SPD will also have problems in comparison to typical individuals. It
      is also hypothesized that the measure will be able to discriminate between the three groups.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Sensory processing difficulties
time frame: 15-20 minutes
description: This study proposes to measure sensory processing problems by self report
arm group label: Autism
description: Individuals, aged 18-95 years, with a pre-existing diagnosis of Autism Spectrum Disorder with or without a co-morbid diagnosis of Sensory Processing Disorder.
arm group label: Sensory Processing
description: Individuals, aged 18-95 years, with a pre-existing diagnosis of Sensory Processing Disorder with no co-morbid diagnosis of Autism Spectrum Disorder
arm group label: Typical
description: Typically functioning individuals aged 13-95 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 95 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Teresa A May Benson, ScD
role: Principal Investigator
affiliation: The Spiral Foundation
last name: Teresa A May-Benson, ScD
phone: 6179234410
phone ext: 240
email: tmaybenson@thespiralfoundation.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.thespiralfoundation.org
description: Spiral Foundation website
responsible party type: Sponsor