<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/NCT02217748</url>
  </required_header>
  <id_info>
    <org_study_id>MH096620-S2</org_study_id>
    <nct_id>NCT02217748</nct_id>
  </id_info>
  <brief_title>Name Generator Order Effects in Social Networks</brief_title>
  <official_title>Understanding Name Generator Order Effects When Eliciting Social Networks in Rural Uganda: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Mbarara University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of our study was to determine the extent to which the order of specific items&#xD;
      in a multiple name generator survey affects how social networks are measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interpersonal relationships are one feature of the social environment that have been shown to&#xD;
      have important influences on health and health behaviors (Berkman et al., 2000; Berkman &amp;&#xD;
      Syme, 1979) and mental health (Tsai et al., 2014). While the majority of these studies have&#xD;
      been conducted in resource-rich settings, studies conducted in resource-limited settings have&#xD;
      similarly demonstrated associations between social networks and health (Perkins, Subramanian,&#xD;
      &amp; Christakis, 2014). In this literature, the tie between two persons is the important unit of&#xD;
      measurement. Classically, the social tie is typically elicited using a &quot;name generator&quot;&#xD;
      survey that inquires about ties based on the affective content of the relationship (Laumann,&#xD;
      1966; Wellman, 1979) or normative bonds such as kinship ties (Kleiner &amp; Parker, 1976).&#xD;
&#xD;
      Another popular approach to eliciting social ties has employed multiple name generators&#xD;
      inquiring about specific types of interactions, such as discussions about important matters&#xD;
      or exchanges of money (Burt, 1984; Marsden, 1987; McCallister &amp; Fischer, 1978). These types&#xD;
      of name generators have strong face validity, are less likely to be subjectively interpreted&#xD;
      in different ways by different respondents, and are therefore likely to be more reliable.&#xD;
      These are accompanied by a heavy respondent burden, however, and single-item name generators&#xD;
      may perform comparably to multiple name generators only under limited circumstances (Marin &amp;&#xD;
      Hampton, 2007). It remains unclear, however, whether the order of name generators may affect&#xD;
      study participant responses. While no studies have examined this empirically, there is a&#xD;
      broad literature on public opinion polling suggesting that alternative specifications of&#xD;
      question ordering can have important effects on respondents' answers (McFarland, 1981).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Parallel Assignment</intervention_model>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of social ties elicited by a specific name generator</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of social ties elicited by the composite name generator</measure>
    <time_frame>Baseline</time_frame>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">1557</enrollment>
  <condition>Social Interaction</condition>
  <arm_group>
    <arm_group_label>Survey questionnaire version 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name generator order: leisure, money, support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name generator order: leisure, support, money</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name generator order: money, leisure, support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name generator order: money, support, leisure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name generator order: support, leisure, money</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Survey questionnaire version 6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Name generator order: support, money, leisure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey questionnaire</intervention_name>
    <arm_group_label>Survey questionnaire version 1</arm_group_label>
    <arm_group_label>Survey questionnaire version 2</arm_group_label>
    <arm_group_label>Survey questionnaire version 3</arm_group_label>
    <arm_group_label>Survey questionnaire version 4</arm_group_label>
    <arm_group_label>Survey questionnaire version 5</arm_group_label>
    <arm_group_label>Survey questionnaire version 6</arm_group_label>
    <other_name>Each of the survey questionnaires administers the name generators in a different order</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years and older&#xD;
&#xD;
          -  Emancipated minors aged 16-18 years&#xD;
&#xD;
          -  Considers Nyakabare Parish their primary place of residence&#xD;
&#xD;
          -  Capable of providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minors younger than 18 years, with the exception of emancipated minors&#xD;
&#xD;
          -  Does not consider Nyakabare Parish their primary place of residence&#xD;
&#xD;
          -  Unable to communicate with research staff, e.g., due to deafness, mutism, or aphasia&#xD;
&#xD;
          -  Persons with psychosis, neurological damage, acute intoxication, or an intelligence&#xD;
             quotient less than 70, as determined in the field by non-clinical research staff in&#xD;
             consultation with a supervisor&#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>Alexander C Tsai, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bernard Kakuhikire, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mbarara University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mbarara University of Science and Technology</name>
      <address>
        <city>Mbarara</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Uganda</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>November 29, 2015</last_update_submitted>
  <last_update_submitted_qc>November 29, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Alexander Tsai</investigator_full_name>
    <investigator_title>Assistant Professor of Psychiatry</investigator_title>
  </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/NCT02217748
org study id: MH096620-S2
nct id: NCT02217748
lead sponsor: 
collaborator: 
has dmc: No
The objective of our study was to determine the extent to which the order of specific items
      in a multiple name generator survey affects how social networks are measured.
Interpersonal relationships are one feature of the social environment that have been shown to
      have important influences on health and health behaviors (Berkman et al., 2000; Berkman &
      Syme, 1979) and mental health (Tsai et al., 2014). While the majority of these studies have
      been conducted in resource-rich settings, studies conducted in resource-limited settings have
      similarly demonstrated associations between social networks and health (Perkins, Subramanian,
      & Christakis, 2014). In this literature, the tie between two persons is the important unit of
      measurement. Classically, the social tie is typically elicited using a "name generator"
      survey that inquires about ties based on the affective content of the relationship (Laumann,
      1966; Wellman, 1979) or normative bonds such as kinship ties (Kleiner & Parker, 1976).

      Another popular approach to eliciting social ties has employed multiple name generators
      inquiring about specific types of interactions, such as discussions about important matters
      or exchanges of money (Burt, 1984; Marsden, 1987; McCallister & Fischer, 1978). These types
      of name generators have strong face validity, are less likely to be subjectively interpreted
      in different ways by different respondents, and are therefore likely to be more reliable.
      These are accompanied by a heavy respondent burden, however, and single-item name generators
      may perform comparably to multiple name generators only under limited circumstances (Marin &
      Hampton, 2007). It remains unclear, however, whether the order of name generators may affect
      study participant responses. While no studies have examined this empirically, there is a
      broad literature on public opinion polling suggesting that alternative specifications of
      question ordering can have important effects on respondents' answers (McFarland, 1981).
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Number of social ties elicited by a specific name generator
time frame: Baseline
measure: Number of social ties elicited by the composite name generator
time frame: Baseline
arm group label: Survey questionnaire version 1
arm group type: Experimental
description: Name generator order: leisure, money, support
arm group label: Survey questionnaire version 2
arm group type: Experimental
description: Name generator order: leisure, support, money
arm group label: Survey questionnaire version 3
arm group type: Experimental
description: Name generator order: money, leisure, support
arm group label: Survey questionnaire version 4
arm group type: Experimental
description: Name generator order: money, support, leisure
arm group label: Survey questionnaire version 5
arm group type: Experimental
description: Name generator order: support, leisure, money
arm group label: Survey questionnaire version 6
arm group type: Experimental
description: Name generator order: support, money, leisure
intervention type: Other
intervention name: Survey questionnaire
arm group label: Survey questionnaire version 1
arm group label: Survey questionnaire version 2
arm group label: Survey questionnaire version 3
arm group label: Survey questionnaire version 4
arm group label: Survey questionnaire version 5
arm group label: Survey questionnaire version 6
other name: Each of the survey questionnaires administers the name generators in a different order
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander C Tsai, MD, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Bernard Kakuhikire, MBA
role: Principal Investigator
affiliation: Mbarara University of Science and Technology
facility: 
country: Uganda
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Alexander Tsai
investigator title: Assistant Professor of Psychiatry