xml: <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/NCT05963763</url>
    </required_header>
    <id_info>
      <org_study_id>H-43633</org_study_id>
      <nct_id>NCT05963763</nct_id>
    </id_info>
    <brief_title>Economic Mobility Pilot</brief_title>
    <official_title>Pathways to Economic Mobility Pilot</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boston Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Wagner Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Someone Elses Child</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Boston University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Boston Medical Center</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>
        Research on economic mobility barriers consistently demonstrates that lack of access to jobs&#xD;
        that pay living wages and to asset building opportunities coupled with cliff effects across&#xD;
        public assistance programs (families losing multiple benefits at the same time when their&#xD;
        incomes increase) traps families in a cycle of poverty and food insecurity, and as a result,&#xD;
        negatively impacts their financial well-being and physical and mental health.&#xD;
  &#xD;
        The investigators will explore the extent to which an Economic Mobility Pilot improves the&#xD;
        financial well-being, physical and mental health, and reduces the social risks of study&#xD;
        participants. Study participants will be eligible consented Boston Medical Center (BMC)&#xD;
        employees.&#xD;
  &#xD;
        The intervention developed for this study consists of six months of coaching session offered&#xD;
        by the Career Navigator. Participant will receive support on career and financial through&#xD;
        services, such as career pathway navigation, employee benefit maximization, financial&#xD;
        literacy, wealth building, resources, and referrals.&#xD;
  &#xD;
        A step wedge design will be implemented with participants randomized in two groups, Group 1,&#xD;
        and Group 2 - intervention on different timeframe, analysis of the difference and&#xD;
        similarities between groups pre- and post-survey. The qualitative component will include&#xD;
        focus group of participants to provide information on the employee's perception of the&#xD;
        intervention received, barriers to adherence and facilitators, and semi- structured&#xD;
        interviews of the employer leadership to help assess the barriers and facilitators of the&#xD;
        pilot.&#xD;
  &#xD;
        A primary aim of this research is to monitor changes in economic mobility and financial&#xD;
        well-being. Additional aims are to investigate changes in household hardships and employee,&#xD;
        employee depressive symptoms, and their child's health. The investigators will examine&#xD;
        whether the participants in the intervention group compared to those before receiving the&#xD;
        intervention, are more likely to:&#xD;
  &#xD;
          -  Increase employee retention and self-reported financial well-being.&#xD;
  &#xD;
          -  Improve self-reported food security.&#xD;
  &#xD;
          -  Improve housing stability, energy security, childcare access, and/or health care access.&#xD;
  &#xD;
          -  Improve employee self-reported physical health status, and/or reduce self-reported&#xD;
             anxiety and depressive symptoms.&#xD;
  &#xD;
          -  Improve employee-reported physical health status of the employee's child.&#xD;
  &#xD;
          -  Cost of delivery of the intervention&#xD;
  &#xD;
          -  Increased family income as result of this intervention&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        During the COVID-19 pandemic longstanding economic inequities have been exacerbated for&#xD;
        people with low incomes in frontline and service sector jobs. These inequities are manifested&#xD;
        downstream in the form of food insecurity (FI) and related health consequences. Research on&#xD;
        economic mobility barriers consistently demonstrates that lack of access to jobs that pay&#xD;
        living wages and to asset building opportunities coupled with cliff effects across public&#xD;
        assistance programs (families losing multiple benefits at the same time when their incomes&#xD;
        increase) traps families in a cycle of poverty and economic hardships, and as a result,&#xD;
        negatively impacts their physical and mental health. This study proposes to explore the&#xD;
        extent to which an Economic Mobility Pilot improves the financial well-being, physical and&#xD;
        mental health, and reduces the social risks of study participants.&#xD;
  &#xD;
        As part of Boston Medical Center (BMC) commitment to advancing its mission to promote equity&#xD;
        as an anchor institution in the community, the health system seeks to identify strategies&#xD;
        that increase employment and career building opportunities for members of marginalized&#xD;
        communities served by BMC. The Boston Collaborative plays a leading role in advancing these&#xD;
        goals and has deeply engaged community-led organizations and members, as well as local and&#xD;
        hospital leadership to identify economic mobility pathways and place-based solutions that are&#xD;
        responsive to the needs of specific communities.&#xD;
  &#xD;
        Social capital, the connections to people and information, increases individuals' overall&#xD;
        well-being and ability to both give and receive a range of supports that promote positive&#xD;
        outcomes for caregivers and their children. By providing social capital, financial resources,&#xD;
        and benefit maximization, this pilot will maximize assistance benefit; improve financial&#xD;
        well-being and job retention. The participants may receive additional services, which could&#xD;
        increase quality of life.&#xD;
  &#xD;
        Social capital will be increased in participants through the intervention which is six months&#xD;
        of tailored coaching session offered by the Career Navigator. The Career Navigator will meet&#xD;
        (either in person or online) with the participant and offer support with career planning and&#xD;
        development, employee benefit maximization, financial well-being and management, flex fund&#xD;
        access, and other resources.&#xD;
  &#xD;
        The quantitative component of this pilot will help the investigators better understand&#xD;
        barriers and facilitators of economic mobility from the employee and employer perspectives.&#xD;
        The participant employees will help with lessons learned through the development and&#xD;
        implementation of the pilot, participant adherence, and challenges. The participant employer&#xD;
        leaders will help with best practices, challenges, adaptation, and innovations.&#xD;
  &#xD;
        About 60 Boston Medical Center (BMC) employees living in one of the following seven zip codes&#xD;
        (02119, 02121, 02122, 02124, 02125, 02126, 02130) will be invited to participate in this&#xD;
        study.&#xD;
  &#xD;
        Survey instruments consist of valid and reliable scales which will be used to collect&#xD;
        information on demographics, financial well-being, economic mobility, food security, housing&#xD;
        security, health care utilization, child health outcomes, child development, employee&#xD;
        physical and mental health. See attached survey instrument for detailed research questions.&#xD;
  &#xD;
        Surveys conducted after baseline will consist of questions regarding social determinants of&#xD;
        health, financial well-being, and economic mobility. Will not include variables, such as&#xD;
        demographics, that would remain unchanged from one time to the next.&#xD;
  &#xD;
        The baseline survey contains questions related to demographics, food security, housing&#xD;
        stability, and participant physical and mental health, child health, childcare, participation&#xD;
        in programs, financial well-being, and economic mobility.&#xD;
  &#xD;
        Between data collection periods, (baseline, 3, 6, 9, 12 and 18 months of enrollment),&#xD;
        subjects will be working with the Career Navigator, who will build with each participant&#xD;
        tools and resources customized to their needs. The intervention with the Career Navigator&#xD;
        will have a total duration of 6 months for each of the study arms (Group 1 and Group 2).&#xD;
  &#xD;
        Baseline, the 6-month, 12-month and the 18-month, all individuals will be approached to&#xD;
        participate in a survey. At Baseline, the Group 1 starts the intervention. At the 6-month,&#xD;
        Group 1 finalizes intervention meanwhile Group 2 starts intervention, which finalizes at&#xD;
        12-month. At the 3- and the 9-month, all participants will be approached for qualitative&#xD;
        focus groups and a quarterly check-in. At the 18-month, all the individuals will be&#xD;
        approached for the final survey.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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>
      <intervention_model_description>Step wedge design: participants randomized in two groups, Group 1, and Group 2 - intervention on different timeframe, analysis of the difference and similarities between groups pre- and post-survey.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Financial well-being</measure>
      <time_frame>18 months</time_frame>
      <description>Financial well-being will be assessed using the Consumer Financial Protection Bureau's abbreviated 5-item scale, covering aspects such as income, employment, savings, safety net, past financial experiences, and financial behaviors, skills, and attitudes. Ratings will be given on a scale from 0 to 4, indicating the level of description or frequency, with higher values representing stronger agreement or more frequent occurrences. The collected scores will be aggregated and categorized by age and administration type (self or external). The Item Response Theory (IRT) model will be employed to ensure the validity and significance of the items, while a higher score on the scale will reflect greater financial security.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Food insecurity</measure>
      <time_frame>18 months</time_frame>
      <description>Food security status over the past year will be assessed using the validated Abbreviated Child and Adult Food Security Scale (ACAFSS), which includes 6 household-specific and 2 child-specific questions. Household are classified into 3 categories: (1) household food secure (HFS) if one or none questions were endorsed as sometimes or often true, (2) household FI (HFI) if three or more, or the 4th question on household were endorsed, and (3) child FI if 2 or more child-specific questions were endorsed.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Housing instability</measure>
      <time_frame>18 months</time_frame>
      <description>Participants will be categorized as experiencing housing insecurity (HI) if they report (1) being behind on rent/mortgage in the past year, (2) moving 2 or more times in the past year, and/or (3) homelessness within the child's lifetime.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child Health Outcomes</measure>
      <time_frame>18 months</time_frame>
      <description>Child health status will be characterized by caregiver rating of child health as excellent, good, fair, or poor, using a question from the National Health and Nutrition Examination Survey (NHANES).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lifetime Child Hospitalizations</measure>
      <time_frame>18 months</time_frame>
      <description>This outcome will be assessed by a question asked to the caregiver. Any hospitalizations will be defined as ≥1 hospitalizations in the child's lifetime, excluding the birth hospitalization.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Participant Health Outcomes</measure>
      <time_frame>18 months</time_frame>
      <description>Child and subject general health status will be reported by the participating using validated questions from National Health and Nutrition Examination Survey (NHANES).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental depressive symptoms</measure>
      <time_frame>18 months</time_frame>
      <description>Parental depressive symptoms will be collected using the Patient Health Questionnaire-2 (PHQ-2) which is a 2 question instrument with potential responses from 0 to 3 where 0=Not at all, 1=Several days, 2= More than half the days, and 4=Nearly every day. PHQ-2 scores range from 0-6. If the score is 3 or greater, major depressive disorder is likely.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Public program participation</measure>
      <time_frame>18 months</time_frame>
      <description>Participants will be asked &quot;yes or no&quot; question on the following programs participation: Woman Infant and Child Program (WIC), Supplemental Nutrition Assistance Program (SNAP), and Transitional Aid to Families Needy Families (TANF). Medicaid, Earned Income Tax Credit (EITC), Subsidized housing or public housing, Energy Assistance, Water Assistance, Social Security (SSI) Disability Benefits (SSDI), Head Start or Early Start services, Free or reduced priced schools meals, Summer Meals, Childcare subsidy or voucher, Unemployment insurance, Electronic Benefit Transfer (EBT).</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Financial Hardship</condition>
    <condition>Food Insecurity</condition>
    <condition>Health Status</condition>
    <arm_group>
      <arm_group_label>Career Navigator Coaching</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants randomized into this group will be invited to participate in the quantitative and qualitative surveys. At baseline, participants in Group1 will receive the intervention- tailored coaching sessions with the Career Navigator which will continue until the end of the 6th month.&#xD;
  The intervention will be tailored for each participant according to their need. The Career Navigator will be in charge to plan and develop tools to help the participant achieve their own goals.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Delayed Career Navigator Coaching</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants randomized into this group will be invited to participate in the quantitative and qualitative surveys For the first six months, participants in Groups 2 will not receive the intervention and will function as a control group. When the study reaches the sixth-month Group 2 participants will receive the intervention - tailored coaching sessions with the Career Navigator.&#xD;
  The intervention will be tailored for each participant according to their need. The Career Navigator will be in charge to plan and develop tools to help the participant achieve their own goals.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Career Navigator Coaching</intervention_name>
      <description>The Career Navigator will support participants with a tailored approach to reach career and financial goals through one or more of the following services, in addition to referrals to other external services (community-based organizations) as needed for 6 months:&#xD;
  Career pathway navigation&#xD;
  Employee benefit maximization&#xD;
  Financial literacy and wealth building&#xD;
  Services funds for resources that mitigate specific barriers or needs.</description>
      <arm_group_label>Career Navigator Coaching</arm_group_label>
      <arm_group_label>Delayed Career Navigator Coaching</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Newly hired Boston Medical Center (hires since 2021) employees with children from the seven&#xD;
          historically marginalized zip codes in Boston (mainly in the neighborhoods of Roxbury,&#xD;
          Dorchester, and Mattapan) receiving hourly rate less than $35.00.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Recently hired Boston Medical Center employees, since June 2021&#xD;
  &#xD;
            -  Employees financially responsible for a child 18 years of age or younger&#xD;
  &#xD;
            -  Employees who live in one of the following zip codes: 02119, 02121, 02122, 02124,&#xD;
               02125, 02126, 02130&#xD;
  &#xD;
            -  Employees who have Income threshold hourly wage of $35 Dollars&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Employees who have been previously contacted by the Career Navigator&#xD;
  &#xD;
            -  Employees not financially responsible for a child of 18 years old of age or younger&#xD;
  &#xD;
            -  Employees not interested in receiving support from Career Navigator&#xD;
  &#xD;
            -  Employees who do not accept consent&#xD;
  &#xD;
            -  Employees who Do not reside in one of the seven zip codes&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Megan Sandel, MD MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Boston Medical Center and Boston University Chobanian</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carolina Giudice, MSc</last_name>
      <phone>617-414-3528</phone>
      <email>carolina.giudice@bmc.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ana Poblacion, PhD</last_name>
      <phone>617-414-3528</phone>
      <email>ana.poblacion@bmc.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Boston Medical Center</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02119</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Carolina Giudice, MSc</last_name>
        <phone>617-414-3528</phone>
        <email>carolina.giudice@bmc.org</email>
      </contact>
      <contact_backup>
        <last_name>Ana Poblacion, PhD</last_name>
        <phone>617-414-3528</phone>
        <email>ana.poblacion@bmc.org</email>
      </contact_backup>
      <investigator>
        <last_name>Megan Sandel, MD MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stephanie Ettinger de Cuba, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ana Poblacion, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Richard Sheward, MPP</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Bethell CD, Read D, Stein RE, Blumberg SJ, Wells N, Newacheck PW. Identifying children with special health care needs: development and evaluation of a short screening instrument. Ambul Pediatr. 2002 Jan-Feb;2(1):38-48. doi: 10.1367/1539-4409(2002)0022.0.co;2.</citation>
      <PMID>11888437</PMID>
    </reference>
    <reference>
      <citation>Woolfenden S, Eapen V, Williams K, Hayen A, Spencer N, Kemp L. A systematic review of the prevalence of parental concerns measured by the Parents' Evaluation of Developmental Status (PEDS) indicating developmental risk. BMC Pediatr. 2014 Sep 13;14:231. doi: 10.1186/1471-2431-14-231.</citation>
      <PMID>25218133</PMID>
    </reference>
    <reference>
      <citation>Sandel M, Sheward R, Ettinger de Cuba S, Coleman SM, Frank DA, Chilton M, Black M, Heeren T, Pasquariello J, Casey P, Ochoa E, Cutts D. Unstable Housing and Caregiver and Child Health in Renter Families. Pediatrics. 2018 Feb;141(2):e20172199. doi: 10.1542/peds.2017-2199. Epub 2018 Jan 22.</citation>
      <PMID>29358482</PMID>
    </reference>
    <reference>
      <citation>Kemper KJ, Babonis TR. Screening for maternal depression in pediatric clinics. Am J Dis Child. 1992 Jul;146(7):876-8. doi: 10.1001/archpedi.1992.02160190108031.</citation>
      <PMID>1496962</PMID>
    </reference>
    <reference>
      <citation>Glascoe FP. Evidence-based approach to developmental and behavioural surveillance using parents' concerns. Child Care Health Dev. 2000 Mar;26(2):137-49. doi: 10.1046/j.1365-2214.2000.00173.x.</citation>
      <PMID>10759753</PMID>
    </reference>
    <reference>
      <citation>Ettinger de Cuba S, Chilton M, Bovell-Ammon A, Knowles M, Coleman SM, Black MM, Cook JT, Cutts DB, Casey PH, Heeren TC, Frank DA. Loss Of SNAP Is Associated With Food Insecurity And Poor Health In Working Families With Young Children. Health Aff (Millwood). 2019 May;38(5):765-773. doi: 10.1377/hlthaff.2018.05265.</citation>
      <PMID>31059367</PMID>
    </reference>
    <reference>
      <citation>Cook JT, Frank DA, Casey PH, Rose-Jacobs R, Black MM, Chilton M, Ettinger de Cuba S, Appugliese D, Coleman S, Heeren T, Berkowitz C, Cutts DB. A brief indicator of household energy security: associations with food security, child health, and child development in US infants and toddlers. Pediatrics. 2008 Oct;122(4):e867-75. doi: 10.1542/peds.2008-0286.</citation>
      <PMID>18829785</PMID>
    </reference>
    <reference>
      <citation>O'Hara B, Caswell K. Health Status, Health Insurance, and Medical Services Utilization: 2010. Household Economic Studies. Washington, DC: US Census Bureau. 2013.</citation>
    </reference>
    <reference>
      <citation>Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.</citation>
      <PMID>26154451</PMID>
    </reference>
    <reference>
      <citation>Bailey MJ, DiNardo J, Stuart BA. THE ECONOMIC IMPACT OF A HIGH NATIONAL MINIMUM WAGE: EVIDENCE FROM THE 1966 FAIR LABOR STANDARDS ACT. J Labor Econ. 2021 Apr;39(Suppl 2):S329-S367. doi: 10.1086/712554.</citation>
      <PMID>35414741</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Financial insecurity</keyword>
    <keyword>Food insecurity</keyword>
    <keyword>Health Status</keyword>
    <keyword>Mental Health Assessment</keyword>
    <keyword>Mental Health</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Financial Stress</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is not a plan to make IPD available.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963763
  org study id: H-43633
  nct id: NCT05963763
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Research on economic mobility barriers consistently demonstrates that lack of access to jobs
        that pay living wages and to asset building opportunities coupled with cliff effects across
        public assistance programs (families losing multiple benefits at the same time when their
        incomes increase) traps families in a cycle of poverty and food insecurity, and as a result,
        negatively impacts their financial well-being and physical and mental health.
  
        The investigators will explore the extent to which an Economic Mobility Pilot improves the
        financial well-being, physical and mental health, and reduces the social risks of study
        participants. Study participants will be eligible consented Boston Medical Center (BMC)
        employees.
  
        The intervention developed for this study consists of six months of coaching session offered
        by the Career Navigator. Participant will receive support on career and financial through
        services, such as career pathway navigation, employee benefit maximization, financial
        literacy, wealth building, resources, and referrals.
  
        A step wedge design will be implemented with participants randomized in two groups, Group 1,
        and Group 2 - intervention on different timeframe, analysis of the difference and
        similarities between groups pre- and post-survey. The qualitative component will include
        focus group of participants to provide information on the employee's perception of the
        intervention received, barriers to adherence and facilitators, and semi- structured
        interviews of the employer leadership to help assess the barriers and facilitators of the
        pilot.
  
        A primary aim of this research is to monitor changes in economic mobility and financial
        well-being. Additional aims are to investigate changes in household hardships and employee,
        employee depressive symptoms, and their child's health. The investigators will examine
        whether the participants in the intervention group compared to those before receiving the
        intervention, are more likely to:
  
          -  Increase employee retention and self-reported financial well-being.
  
          -  Improve self-reported food security.
  
          -  Improve housing stability, energy security, childcare access, and/or health care access.
  
          -  Improve employee self-reported physical health status, and/or reduce self-reported
             anxiety and depressive symptoms.
  
          -  Improve employee-reported physical health status of the employee's child.
  
          -  Cost of delivery of the intervention
  
          -  Increased family income as result of this intervention
  During the COVID-19 pandemic longstanding economic inequities have been exacerbated for
        people with low incomes in frontline and service sector jobs. These inequities are manifested
        downstream in the form of food insecurity (FI) and related health consequences. Research on
        economic mobility barriers consistently demonstrates that lack of access to jobs that pay
        living wages and to asset building opportunities coupled with cliff effects across public
        assistance programs (families losing multiple benefits at the same time when their incomes
        increase) traps families in a cycle of poverty and economic hardships, and as a result,
        negatively impacts their physical and mental health. This study proposes to explore the
        extent to which an Economic Mobility Pilot improves the financial well-being, physical and
        mental health, and reduces the social risks of study participants.
  
        As part of Boston Medical Center (BMC) commitment to advancing its mission to promote equity
        as an anchor institution in the community, the health system seeks to identify strategies
        that increase employment and career building opportunities for members of marginalized
        communities served by BMC. The Boston Collaborative plays a leading role in advancing these
        goals and has deeply engaged community-led organizations and members, as well as local and
        hospital leadership to identify economic mobility pathways and place-based solutions that are
        responsive to the needs of specific communities.
  
        Social capital, the connections to people and information, increases individuals' overall
        well-being and ability to both give and receive a range of supports that promote positive
        outcomes for caregivers and their children. By providing social capital, financial resources,
        and benefit maximization, this pilot will maximize assistance benefit; improve financial
        well-being and job retention. The participants may receive additional services, which could
        increase quality of life.
  
        Social capital will be increased in participants through the intervention which is six months
        of tailored coaching session offered by the Career Navigator. The Career Navigator will meet
        (either in person or online) with the participant and offer support with career planning and
        development, employee benefit maximization, financial well-being and management, flex fund
        access, and other resources.
  
        The quantitative component of this pilot will help the investigators better understand
        barriers and facilitators of economic mobility from the employee and employer perspectives.
        The participant employees will help with lessons learned through the development and
        implementation of the pilot, participant adherence, and challenges. The participant employer
        leaders will help with best practices, challenges, adaptation, and innovations.
  
        About 60 Boston Medical Center (BMC) employees living in one of the following seven zip codes
        (02119, 02121, 02122, 02124, 02125, 02126, 02130) will be invited to participate in this
        study.
  
        Survey instruments consist of valid and reliable scales which will be used to collect
        information on demographics, financial well-being, economic mobility, food security, housing
        security, health care utilization, child health outcomes, child development, employee
        physical and mental health. See attached survey instrument for detailed research questions.
  
        Surveys conducted after baseline will consist of questions regarding social determinants of
        health, financial well-being, and economic mobility. Will not include variables, such as
        demographics, that would remain unchanged from one time to the next.
  
        The baseline survey contains questions related to demographics, food security, housing
        stability, and participant physical and mental health, child health, childcare, participation
        in programs, financial well-being, and economic mobility.
  
        Between data collection periods, (baseline, 3, 6, 9, 12 and 18 months of enrollment),
        subjects will be working with the Career Navigator, who will build with each participant
        tools and resources customized to their needs. The intervention with the Career Navigator
        will have a total duration of 6 months for each of the study arms (Group 1 and Group 2).
  
        Baseline, the 6-month, 12-month and the 18-month, all individuals will be approached to
        participate in a survey. At Baseline, the Group 1 starts the intervention. At the 6-month,
        Group 1 finalizes intervention meanwhile Group 2 starts intervention, which finalizes at
        12-month. At the 3- and the 9-month, all participants will be approached for qualitative
        focus groups and a quarterly check-in. At the 18-month, all the individuals will be
        approached for the final survey.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Step wedge design: participants randomized in two groups, Group 1, and Group 2 - intervention on different timeframe, analysis of the difference and similarities between groups pre- and post-survey.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Financial well-being
  time frame: 18 months
  description: Financial well-being will be assessed using the Consumer Financial Protection Bureau's abbreviated 5-item scale, covering aspects such as income, employment, savings, safety net, past financial experiences, and financial behaviors, skills, and attitudes. Ratings will be given on a scale from 0 to 4, indicating the level of description or frequency, with higher values representing stronger agreement or more frequent occurrences. The collected scores will be aggregated and categorized by age and administration type (self or external). The Item Response Theory (IRT) model will be employed to ensure the validity and significance of the items, while a higher score on the scale will reflect greater financial security.
  measure: Food insecurity
  time frame: 18 months
  description: Food security status over the past year will be assessed using the validated Abbreviated Child and Adult Food Security Scale (ACAFSS), which includes 6 household-specific and 2 child-specific questions. Household are classified into 3 categories: (1) household food secure (HFS) if one or none questions were endorsed as sometimes or often true, (2) household FI (HFI) if three or more, or the 4th question on household were endorsed, and (3) child FI if 2 or more child-specific questions were endorsed.
  measure: Housing instability
  time frame: 18 months
  description: Participants will be categorized as experiencing housing insecurity (HI) if they report (1) being behind on rent/mortgage in the past year, (2) moving 2 or more times in the past year, and/or (3) homelessness within the child's lifetime.
  measure: Child Health Outcomes
  time frame: 18 months
  description: Child health status will be characterized by caregiver rating of child health as excellent, good, fair, or poor, using a question from the National Health and Nutrition Examination Survey (NHANES).
  measure: Lifetime Child Hospitalizations
  time frame: 18 months
  description: This outcome will be assessed by a question asked to the caregiver. Any hospitalizations will be defined as ≥1 hospitalizations in the child's lifetime, excluding the birth hospitalization.
  measure: Participant Health Outcomes
  time frame: 18 months
  description: Child and subject general health status will be reported by the participating using validated questions from National Health and Nutrition Examination Survey (NHANES).
  measure: Parental depressive symptoms
  time frame: 18 months
  description: Parental depressive symptoms will be collected using the Patient Health Questionnaire-2 (PHQ-2) which is a 2 question instrument with potential responses from 0 to 3 where 0=Not at all, 1=Several days, 2= More than half the days, and 4=Nearly every day. PHQ-2 scores range from 0-6. If the score is 3 or greater, major depressive disorder is likely.
  measure: Public program participation
  time frame: 18 months
  description: Participants will be asked "yes or no" question on the following programs participation: Woman Infant and Child Program (WIC), Supplemental Nutrition Assistance Program (SNAP), and Transitional Aid to Families Needy Families (TANF). Medicaid, Earned Income Tax Credit (EITC), Subsidized housing or public housing, Energy Assistance, Water Assistance, Social Security (SSI) Disability Benefits (SSDI), Head Start or Early Start services, Free or reduced priced schools meals, Summer Meals, Childcare subsidy or voucher, Unemployment insurance, Electronic Benefit Transfer (EBT).
  arm group label: Career Navigator Coaching
  arm group type: Other
  description: Participants randomized into this group will be invited to participate in the quantitative and qualitative surveys. At baseline, participants in Group1 will receive the intervention- tailored coaching sessions with the Career Navigator which will continue until the end of the 6th month.
  The intervention will be tailored for each participant according to their need. The Career Navigator will be in charge to plan and develop tools to help the participant achieve their own goals.
  arm group label: Delayed Career Navigator Coaching
  arm group type: Other
  description: Participants randomized into this group will be invited to participate in the quantitative and qualitative surveys For the first six months, participants in Groups 2 will not receive the intervention and will function as a control group. When the study reaches the sixth-month Group 2 participants will receive the intervention - tailored coaching sessions with the Career Navigator.
  The intervention will be tailored for each participant according to their need. The Career Navigator will be in charge to plan and develop tools to help the participant achieve their own goals.
  intervention type: Behavioral
  intervention name: Career Navigator Coaching
  description: The Career Navigator will support participants with a tailored approach to reach career and financial goals through one or more of the following services, in addition to referrals to other external services (community-based organizations) as needed for 6 months:
  Career pathway navigation
  Employee benefit maximization
  Financial literacy and wealth building
  Services funds for resources that mitigate specific barriers or needs.
  arm group label: Career Navigator Coaching
  arm group label: Delayed Career Navigator Coaching
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Megan Sandel, MD MPH
  role: Principal Investigator
  affiliation: Boston Medical Center and Boston University Chobanian
  last name: Carolina Giudice, MSc
  phone: 617-414-3528
  email: carolina.giudice@bmc.org
  last name: Ana Poblacion, PhD
  phone: 617-414-3528
  email: ana.poblacion@bmc.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United States
  citation: Bethell CD, Read D, Stein RE, Blumberg SJ, Wells N, Newacheck PW. Identifying children with special health care needs: development and evaluation of a short screening instrument. Ambul Pediatr. 2002 Jan-Feb;2(1):38-48. doi: 10.1367/1539-4409(2002)0022.0.co;2.
  PMID: 11888437
  citation: Woolfenden S, Eapen V, Williams K, Hayen A, Spencer N, Kemp L. A systematic review of the prevalence of parental concerns measured by the Parents' Evaluation of Developmental Status (PEDS) indicating developmental risk. BMC Pediatr. 2014 Sep 13;14:231. doi: 10.1186/1471-2431-14-231.
  PMID: 25218133
  citation: Sandel M, Sheward R, Ettinger de Cuba S, Coleman SM, Frank DA, Chilton M, Black M, Heeren T, Pasquariello J, Casey P, Ochoa E, Cutts D. Unstable Housing and Caregiver and Child Health in Renter Families. Pediatrics. 2018 Feb;141(2):e20172199. doi: 10.1542/peds.2017-2199. Epub 2018 Jan 22.
  PMID: 29358482
  citation: Kemper KJ, Babonis TR. Screening for maternal depression in pediatric clinics. Am J Dis Child. 1992 Jul;146(7):876-8. doi: 10.1001/archpedi.1992.02160190108031.
  PMID: 1496962
  citation: Glascoe FP. Evidence-based approach to developmental and behavioural surveillance using parents' concerns. Child Care Health Dev. 2000 Mar;26(2):137-49. doi: 10.1046/j.1365-2214.2000.00173.x.
  PMID: 10759753
  citation: Ettinger de Cuba S, Chilton M, Bovell-Ammon A, Knowles M, Coleman SM, Black MM, Cook JT, Cutts DB, Casey PH, Heeren TC, Frank DA. Loss Of SNAP Is Associated With Food Insecurity And Poor Health In Working Families With Young Children. Health Aff (Millwood). 2019 May;38(5):765-773. doi: 10.1377/hlthaff.2018.05265.
  PMID: 31059367
  citation: Cook JT, Frank DA, Casey PH, Rose-Jacobs R, Black MM, Chilton M, Ettinger de Cuba S, Appugliese D, Coleman S, Heeren T, Berkowitz C, Cutts DB. A brief indicator of household energy security: associations with food security, child health, and child development in US infants and toddlers. Pediatrics. 2008 Oct;122(4):e867-75. doi: 10.1542/peds.2008-0286.
  PMID: 18829785
  citation: O'Hara B, Caswell K. Health Status, Health Insurance, and Medical Services Utilization: 2010. Household Economic Studies. Washington, DC: US Census Bureau. 2013.
  citation: Falci SG, Marques LS. CONSORT: when and how to use it. Dental Press J Orthod. 2015 May-Jun;20(3):13-5. doi: 10.1590/2176-9451.20.3.013-015.ebo. No abstract available.
  PMID: 26154451
  citation: Bailey MJ, DiNardo J, Stuart BA. THE ECONOMIC IMPACT OF A HIGH NATIONAL MINIMUM WAGE: EVIDENCE FROM THE 1966 FAIR LABOR STANDARDS ACT. J Labor Econ. 2021 Apr;39(Suppl 2):S329-S367. doi: 10.1086/712554.
  PMID: 35414741
  responsible party type: Sponsor
  mesh term: Financial Stress
  sharing ipd: No
  ipd description: There is not a plan to make IPD available.