<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/NCT02197052</url>
  </required_header>
  <id_info>
    <org_study_id>13-11032</org_study_id>
    <nct_id>NCT02197052</nct_id>
  </id_info>
  <brief_title>iScreen Study: Best Methods for Social Screening in Pediatric Caregivers</brief_title>
  <official_title>iScreen Study: Best Methods for Social Screening in Pediatric Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>UCSF Benioff Children's Hospital Oakland</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal is to better understand the social needs of a population seeking care in a large,&#xD;
      urban children's hospital emergency department with a large Medicaid population. Consenting&#xD;
      English and Spanish-speaking adult caregivers will be randomized to social screening via a&#xD;
      face -to-face interview with a trained bilingual researcher or via a self-completed&#xD;
      tablet-based survey. We hypothesize that there will be no difference in disclosure rates&#xD;
      between the two screening formats for items other than highly sensitive items. For highly&#xD;
      sensitive items we hypothesize disclosure rates will be higher for the self-completed&#xD;
      tablet-based survey.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Disclosure rates for social needs questions</measure>
    <time_frame>At time point 1, when the subject is first assessed</time_frame>
    <description>The difference in disclosure rates will be determined by comparing the two arms and determining significant differences for social needs variables.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">552</enrollment>
  <condition>Disclosure Rates of Social Needs</condition>
  <arm_group>
    <arm_group_label>Computer Based Survey Arm</arm_group_label>
    <description>Participants randomized to the computer based self-completed survey arm were issued a tablet computer to answer survey questions. All participants were encouraged to ask for technical assistance if needed at any point, and like in the face-to-face interviews, electronic survey could be re-initiated at the point of discontinuation after any interruption. Those in the tablet survey arm also could complete the survey in their preferred language and all were additionally given headsets so they could use audio assist with identical, pre-recorded questions in the selected language.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Face-to-face interview arm</arm_group_label>
    <description>Participants randomized to this condition were interviewed in-person by a fully bilingual (English-Spanish), bi-cultural research assistant trained in cultural humility, standard research protocols and interviewing practices. Interviews were conducted in clinical rooms in respondent's preferred language, were easily interrupted for medical care, and the survey could be re-initiated at the point of discontinuation after any interruption. Participant responses during face-to-face interviews were recorded by the research assistant on paper and later recorded electronically.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants were drawn from adult caregivers seeking treatment for a child in a fast track&#xD;
        arm of a large, urban children's hospital emergency department in Oakland, CA (CHO ED&#xD;
        Annex).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Caregiver must by age 18 years or older accompanying a child less than 18 years old&#xD;
&#xD;
          -  Primary language English or Spanish&#xD;
&#xD;
          -  Familiar with the child's household environment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura M Gottlieb, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital Oakland</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 18, 2014</last_update_submitted>
  <last_update_submitted_qc>July 18, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02197052
org study id: 13-11032
nct id: NCT02197052
lead sponsor: 
collaborator: 
has dmc: No
The goal is to better understand the social needs of a population seeking care in a large,
      urban children's hospital emergency department with a large Medicaid population. Consenting
      English and Spanish-speaking adult caregivers will be randomized to social screening via a
      face -to-face interview with a trained bilingual researcher or via a self-completed
      tablet-based survey. We hypothesize that there will be no difference in disclosure rates
      between the two screening formats for items other than highly sensitive items. For highly
      sensitive items we hypothesize disclosure rates will be higher for the self-completed
      tablet-based survey.
observational model: Cohort
time perspective: Cross-Sectional
measure: Disclosure rates for social needs questions
time frame: At time point 1, when the subject is first assessed
description: The difference in disclosure rates will be determined by comparing the two arms and determining significant differences for social needs variables.
arm group label: Computer Based Survey Arm
description: Participants randomized to the computer based self-completed survey arm were issued a tablet computer to answer survey questions. All participants were encouraged to ask for technical assistance if needed at any point, and like in the face-to-face interviews, electronic survey could be re-initiated at the point of discontinuation after any interruption. Those in the tablet survey arm also could complete the survey in their preferred language and all were additionally given headsets so they could use audio assist with identical, pre-recorded questions in the selected language.
arm group label: Face-to-face interview arm
description: Participants randomized to this condition were interviewed in-person by a fully bilingual (English-Spanish), bi-cultural research assistant trained in cultural humility, standard research protocols and interviewing practices. Interviews were conducted in clinical rooms in respondent's preferred language, were easily interrupted for medical care, and the survey could be re-initiated at the point of discontinuation after any interruption. Participant responses during face-to-face interviews were recorded by the research assistant on paper and later recorded electronically.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Laura M Gottlieb, MD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor