<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/NCT01717365</url>
  </required_header>
  <id_info>
    <org_study_id>15007</org_study_id>
    <nct_id>NCT01717365</nct_id>
  </id_info>
  <brief_title>Psychometric / Validation Study</brief_title>
  <official_title>SCOPE: A Psychometric Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Woman's University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Woman's University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Data for the study will be collected from therapist across the world. The therapists will&#xD;
      share data they have already compiled from their caseload. Data will be stripped of all&#xD;
      personal identifiers and personal health information. The TWU SCOPE research team has no&#xD;
      contact with clients whose assessment data is being shared for secondary analysis or clinical&#xD;
      data repository. For educational and training purposes clients can be videotaped by the&#xD;
      therapist who will obtain consent and/or assent from the client. Not every client will be&#xD;
      videotaped. The subjects from the data shared by the therapists are from the ages of 0-21,&#xD;
      both male and female, and of any ethnicity. The total amount of data collected from all&#xD;
      participating therapists will be 500 pieces.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who&#xD;
      wish to participate will send a data sharing letter to the PI of the study. Once the TWU&#xD;
      SCOPE research team has received the data sharing letter, a clinical data packet will then be&#xD;
      distributed to the therapist through the U.S. mail or an email will be sent containing a web&#xD;
      address link to http://www.myweb.twu.edu/~ttioseco for access to the clinical data packet via&#xD;
      the internet. Those therapists who collect ten pieces or more of de-identified data and send&#xD;
      them to the TWU SCOPE research team will receive an incentive in the form of a gift card.&#xD;
&#xD;
      Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank&#xD;
      (new de-identified data input) → data analysis (analysis of new and old de-identified data) →&#xD;
      publication/presentation&#xD;
&#xD;
      No risks are involved because data collected is without any personal identifiers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE</measure>
    <time_frame>36 months</time_frame>
    <description>To determine the psychometric properties of the Short Child Occupational Profile (SCOPE) and validate the SCOPE.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">499</enrollment>
  <condition>To Determine the Psychometric Properties of the Short Child Occupational Profile</condition>
  <arm_group>
    <arm_group_label>OTs</arm_group_label>
    <description>Occupational therapists</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects from the data shared by the therapists are from the ages of 0-21, both male&#xD;
        and female, and of any ethnicity.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects receiving therapy from participating therapists.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age over 21.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Texas Woman's University</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Texas Woman's University</investigator_affiliation>
    <investigator_full_name>Patricia Bowyer</investigator_full_name>
    <investigator_title>Patricia Bowyer, EdD, , MS, OTR, FAOTA</investigator_title>
  </responsible_party>
  <keyword>SCOPE</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/NCT01717365
org study id: 15007
nct id: NCT01717365
lead sponsor: 
has dmc: No
Data for the study will be collected from therapist across the world. The therapists will
      share data they have already compiled from their caseload. Data will be stripped of all
      personal identifiers and personal health information. The TWU SCOPE research team has no
      contact with clients whose assessment data is being shared for secondary analysis or clinical
      data repository. For educational and training purposes clients can be videotaped by the
      therapist who will obtain consent and/or assent from the client. Not every client will be
      videotaped. The subjects from the data shared by the therapists are from the ages of 0-21,
      both male and female, and of any ethnicity. The total amount of data collected from all
      participating therapists will be 500 pieces.
Therapists will be recruited by a TWU SCOPE research team member via email. Therapists who
      wish to participate will send a data sharing letter to the PI of the study. Once the TWU
      SCOPE research team has received the data sharing letter, a clinical data packet will then be
      distributed to the therapist through the U.S. mail or an email will be sent containing a web
      address link to http://www.myweb.twu.edu/~ttioseco for access to the clinical data packet via
      the internet. Those therapists who collect ten pieces or more of de-identified data and send
      them to the TWU SCOPE research team will receive an incentive in the form of a gift card.

      Flow Chart of Research Study Process Collaborators (share new de-identified data) → databank
      (new de-identified data input) → data analysis (analysis of new and old de-identified data) →
      publication/presentation

      No risks are involved because data collected is without any personal identifiers.
observational model: Cohort
time perspective: Retrospective
measure: To determine the psychometric properties of the Short Child Occupational Profile Validate SCOPE
time frame: 36 months
description: To determine the psychometric properties of the Short Child Occupational Profile (SCOPE) and validate the SCOPE.
arm group label: OTs
description: Occupational therapists
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 21 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Texas Woman's University
investigator full name: Patricia Bowyer
investigator title: Patricia Bowyer, EdD, , MS, OTR, FAOTA