<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/NCT04485377</url>
  </required_header>
  <id_info>
    <org_study_id>048228-001</org_study_id>
    <nct_id>NCT04485377</nct_id>
  </id_info>
  <brief_title>Safety Net Support Use in California</brief_title>
  <acronym>ACCESS</acronym>
  <official_title>Assessing Californians Communities' Experiences With Safety Net Supports Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Berkeley</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator's goal is to promote equity by understanding the drivers of disparities in&#xD;
      access to income support, particularly among urban and rural Latinx, African American, and&#xD;
      white populations in California (CA). This study aims to capture levels of awareness,&#xD;
      barriers to uptake, and the benefits of participation in the Earned Income Tax Credit (EITC),&#xD;
      a tax credit for low- to moderate-income working individuals and families, among households&#xD;
      with children ages 0-5 years old. To achieve this goal, the investigators will conduct a&#xD;
      mixed-methods, cross-sectional, descriptive study in three diverse counties in California:&#xD;
      Los Angeles (urban, nearly half Latinx), Alameda (urban, ethnically diverse), and Merced&#xD;
      (rural, predominantly Latinx and white).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using both focus groups and survey interviews, the investigators will recruit parents of&#xD;
      young children (ages 0-5) eligible for the EITC (confirmed with screening questions regarding&#xD;
      age, family size, marital status, and income) who either: 1) have utilized the program, or 2)&#xD;
      have not utilized the program (do not file taxes or filed taxes but have not filed for EITC&#xD;
      benefits). For the first group, the investigators will probe the value of the EITC benefits&#xD;
      for their families, what experiences they had filing their taxes and receiving the benefit,&#xD;
      how they spent the EITC benefits, and their thoughts about alternative approaches for benefit&#xD;
      delivery that would better support their families. For the second group, the investigators&#xD;
      aim to understand what they have heard of the program, why they may not have taken advantage&#xD;
      of the benefits, and their recommendations for making the program more accessible. The&#xD;
      investigators will also explore how EITC take-up varies by demographic variables, such as&#xD;
      county of residence, income, and race/ethnicity, as well as children's and parents'&#xD;
      characteristics, and enrollment in other programs designed to support low-income families&#xD;
      with young children. The investigators will also ask questions about families' experiences&#xD;
      with COVID-19 and related mitigation strategies (e.g. school closures, etc). As described in&#xD;
      greater detail below, all data collection activities will be conducted in partnership with&#xD;
      agencies such as WIC and Head Start, and through partnerships with the University of&#xD;
      California Cooperative Extension program and other similar agencies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">May 31, 2021</completion_date>
  <primary_completion_date type="Actual">May 31, 2021</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>Poverty: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Income Assets Food insecurity (USDA 6-Item Food Security Module, range=0-6 with 0=high food security and 6=very low food security) Food resources</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Employment: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Employment type and status over the past year, earned/unearned income, transfers</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety net participation and perceptions of participation: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Safety net program participation &amp; enrollment in programs, such as Special Supplemental for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), Unemployment Insurance, Medi-Cal, Children's Health Insurance Program (CHIP), Covered CA, and paid sick leave and other poverty alleviation programs, perceived barriers, amount of benefits received, stigma (Welfare Stigma Scale: 6-item Treatment Welfare Stigma Scale, a multiple choice format questionnaire, possible scores 6-30, with 30 representing high stigma towards participating in welfare programs from other individuals.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mental health: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>CES-D - Center for Epidemiologic Studies- Depression scale (Depression Scale: 10-item Center for Epidemiologic Studies Depression Scale (CESD-10), a multiple choice format questionnaire, possible scores 0-30, with 30 representing a high risk of depression diagnosis.&#xD;
Generalized Anxiety Disorder Scale: 7-item Generalized Anxiety Disorder Scale (GAD-7), a multiple choice format questionnaire, possible scores 0-21, with 21 representing a high risk of generalized anxiety diagnosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Health: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Adult and child self-rated health, comparing self-rated health to 12 months ago, occurrence of health, developmental, emotional, or behavioral problem.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health care utilization: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Health care utilization, insurance, concerns about affording healthcare, last visit with a healthcare provider, delays in receiving healthcare, forgoing healthcare.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>COVID-19-related questions</measure>
    <time_frame>Baseline</time_frame>
    <description>Effect on employment and income, essential worker, childcare/schooling, shelter-in-place, housing stability and changes, experiences with racial discrimination, risk for contracting COVID-19, ability to self-isolate, ability to partake in behaviors to prevent spread of COVID-19. Questions pulled from two different surveys: The Epidemic/Pandemic Questionnaire and COVID-19 Community Outcome Surveys.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tax Credit Question</measure>
    <time_frame>Baseline</time_frame>
    <description>Self-perceived awareness, eligibility, participation, sources of information, intended vs actual spending patterns of Federal Earned Income Tax Credit (EITC), CA EITC, Young Child Tax Credit (YCTC), and federal child tax credit (CTC), resources used to file taxes, reasons for participation or lack of participation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>2018 and 2019 Tax Return Data: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Awareness of tax filing deadline changes, tax filing status, number of dependents, EITC receipt, amount of EITC received, adjusted gross income, federal CTC receipt, amount of federal CTC received CA EITC receipt, amount of CA EITC receipt, YCTC receipt, amount of YCTC received.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Racial discrimination: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Perception of safety, major experiences of racial discrimination, minor experiences of racial discrimination. Questions pulled from Major Experiences of Discrimination Scale and Racial Microaggressions Scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Housing: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Housing status, house ownership/characteristics, current living situation, access to bathrooms, housing crowding, housing quality, cross streets, zip code, rent payment amount, frequency of rent payments, rental assistance program participation, trouble paying utilities, living in a &quot;doubled up&quot; arrangement, letting others live with them in a &quot;doubled up&quot; arrangement, history of homelessness in childhood, history of homelessness in adulthood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudinal variables: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Attitudes about public assistance, civic engagement, role of government</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Food insecurity: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Food Insecurity Survey: 6-item Food Insecurity Scale, a multiple choice format questionnaire, possible scores 0-6, with 6 representing very low food insecurity.&#xD;
Food Insecurity Survey - Kids Module: 9 additional questions to assess childrens' food insecurity.&#xD;
Self-perceived food insecurity comparison to 12 months ago Changes in food-related habits. Questions pulled from United Nations Standing Committee on Nutrition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Housing-related changes from Coronavirus pandemic (COVID-19): survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Ability to pay rent, application to emergency housing money, reasons for not applying to emergency funding, number of moves, reasons for moves (e.g. difficulty paying rent, eviction), knowledge of eviction moratoriums, legal assistance seeking behavior</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic information: survey</measure>
    <time_frame>Baseline</time_frame>
    <description>Gender, age, education level, race/ethnicity, marital status, number of children, birthplace, language spoken at home. Questions were pulled from National Health Interview Survey.</description>
  </secondary_outcome>
  <enrollment type="Actual">501</enrollment>
  <condition>Households</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Families living with low-income, in three selected counties in California&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents of children 0-6&#xD;
&#xD;
          -  Lives in Alameda, Merced of Los Angeles counties&#xD;
&#xD;
          -  Income below certain cut-offs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>
  <location>
    <facility>
      <name>UC Berkeley School of Public Health</name>
      <address>
        <city>Berkeley</city>
        <state>California</state>
        <zip>94704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>August 22, 2022</last_update_submitted>
  <last_update_submitted_qc>August 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>poverty</keyword>
  <keyword>child health</keyword>
  <keyword>safety net programs</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04485377
org study id: 048228-001
nct id: NCT04485377
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator's goal is to promote equity by understanding the drivers of disparities in
      access to income support, particularly among urban and rural Latinx, African American, and
      white populations in California (CA). This study aims to capture levels of awareness,
      barriers to uptake, and the benefits of participation in the Earned Income Tax Credit (EITC),
      a tax credit for low- to moderate-income working individuals and families, among households
      with children ages 0-5 years old. To achieve this goal, the investigators will conduct a
      mixed-methods, cross-sectional, descriptive study in three diverse counties in California:
      Los Angeles (urban, nearly half Latinx), Alameda (urban, ethnically diverse), and Merced
      (rural, predominantly Latinx and white).
Using both focus groups and survey interviews, the investigators will recruit parents of
      young children (ages 0-5) eligible for the EITC (confirmed with screening questions regarding
      age, family size, marital status, and income) who either: 1) have utilized the program, or 2)
      have not utilized the program (do not file taxes or filed taxes but have not filed for EITC
      benefits). For the first group, the investigators will probe the value of the EITC benefits
      for their families, what experiences they had filing their taxes and receiving the benefit,
      how they spent the EITC benefits, and their thoughts about alternative approaches for benefit
      delivery that would better support their families. For the second group, the investigators
      aim to understand what they have heard of the program, why they may not have taken advantage
      of the benefits, and their recommendations for making the program more accessible. The
      investigators will also explore how EITC take-up varies by demographic variables, such as
      county of residence, income, and race/ethnicity, as well as children's and parents'
      characteristics, and enrollment in other programs designed to support low-income families
      with young children. The investigators will also ask questions about families' experiences
      with COVID-19 and related mitigation strategies (e.g. school closures, etc). As described in
      greater detail below, all data collection activities will be conducted in partnership with
      agencies such as WIC and Head Start, and through partnerships with the University of
      California Cooperative Extension program and other similar agencies.
observational model: Cohort
time perspective: Cross-Sectional
measure: Poverty: survey
time frame: Baseline
description: Income Assets Food insecurity (USDA 6-Item Food Security Module, range=0-6 with 0=high food security and 6=very low food security) Food resources
measure: Employment: survey
time frame: Baseline
description: Employment type and status over the past year, earned/unearned income, transfers
measure: Safety net participation and perceptions of participation: survey
time frame: Baseline
description: Safety net program participation & enrollment in programs, such as Special Supplemental for Women, Infants, and Children (WIC), Supplemental Nutrition Assistance Program (SNAP), Unemployment Insurance, Medi-Cal, Children's Health Insurance Program (CHIP), Covered CA, and paid sick leave and other poverty alleviation programs, perceived barriers, amount of benefits received, stigma (Welfare Stigma Scale: 6-item Treatment Welfare Stigma Scale, a multiple choice format questionnaire, possible scores 6-30, with 30 representing high stigma towards participating in welfare programs from other individuals.)
measure: Mental health: survey
time frame: Baseline
description: CES-D - Center for Epidemiologic Studies- Depression scale (Depression Scale: 10-item Center for Epidemiologic Studies Depression Scale (CESD-10), a multiple choice format questionnaire, possible scores 0-30, with 30 representing a high risk of depression diagnosis.
Generalized Anxiety Disorder Scale: 7-item Generalized Anxiety Disorder Scale (GAD-7), a multiple choice format questionnaire, possible scores 0-21, with 21 representing a high risk of generalized anxiety diagnosis.
measure: Physical Health: survey
time frame: Baseline
description: Adult and child self-rated health, comparing self-rated health to 12 months ago, occurrence of health, developmental, emotional, or behavioral problem.
measure: Health care utilization: survey
time frame: Baseline
description: Health care utilization, insurance, concerns about affording healthcare, last visit with a healthcare provider, delays in receiving healthcare, forgoing healthcare.
measure: COVID-19-related questions
time frame: Baseline
description: Effect on employment and income, essential worker, childcare/schooling, shelter-in-place, housing stability and changes, experiences with racial discrimination, risk for contracting COVID-19, ability to self-isolate, ability to partake in behaviors to prevent spread of COVID-19. Questions pulled from two different surveys: The Epidemic/Pandemic Questionnaire and COVID-19 Community Outcome Surveys.
measure: Tax Credit Question
time frame: Baseline
description: Self-perceived awareness, eligibility, participation, sources of information, intended vs actual spending patterns of Federal Earned Income Tax Credit (EITC), CA EITC, Young Child Tax Credit (YCTC), and federal child tax credit (CTC), resources used to file taxes, reasons for participation or lack of participation
measure: 2018 and 2019 Tax Return Data: survey
time frame: Baseline
description: Awareness of tax filing deadline changes, tax filing status, number of dependents, EITC receipt, amount of EITC received, adjusted gross income, federal CTC receipt, amount of federal CTC received CA EITC receipt, amount of CA EITC receipt, YCTC receipt, amount of YCTC received.
measure: Racial discrimination: survey
time frame: Baseline
description: Perception of safety, major experiences of racial discrimination, minor experiences of racial discrimination. Questions pulled from Major Experiences of Discrimination Scale and Racial Microaggressions Scale.
measure: Housing: survey
time frame: Baseline
description: Housing status, house ownership/characteristics, current living situation, access to bathrooms, housing crowding, housing quality, cross streets, zip code, rent payment amount, frequency of rent payments, rental assistance program participation, trouble paying utilities, living in a "doubled up" arrangement, letting others live with them in a "doubled up" arrangement, history of homelessness in childhood, history of homelessness in adulthood
measure: Attitudinal variables: survey
time frame: Baseline
description: Attitudes about public assistance, civic engagement, role of government
measure: Food insecurity: survey
time frame: Baseline
description: Food Insecurity Survey: 6-item Food Insecurity Scale, a multiple choice format questionnaire, possible scores 0-6, with 6 representing very low food insecurity.
Food Insecurity Survey - Kids Module: 9 additional questions to assess childrens' food insecurity.
Self-perceived food insecurity comparison to 12 months ago Changes in food-related habits. Questions pulled from United Nations Standing Committee on Nutrition.
measure: Housing-related changes from Coronavirus pandemic (COVID-19): survey
time frame: Baseline
description: Ability to pay rent, application to emergency housing money, reasons for not applying to emergency funding, number of moves, reasons for moves (e.g. difficulty paying rent, eviction), knowledge of eviction moratoriums, legal assistance seeking behavior
measure: Demographic information: survey
time frame: Baseline
description: Gender, age, education level, race/ethnicity, marital status, number of children, birthplace, language spoken at home. Questions were pulled from National Health Interview Survey.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No