Financial HardshipNCT05963763
Economic Mobility Pilot
A study testing Career Navigator Coaching in people with Financial Hardship and Food Insecurity, run by Boston Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Financial Hardship, Food Insecurity, Health Status
- What is being tested?
- Career Navigator Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2024to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recently hired Boston Medical Center employees, since June 2021
- Employees financially responsible for a child 18 years of age or younger
- Employees who live in one of the following zip codes: 02119, 02121, 02122, 02124, 02125, 02126, 02130
- Employees who have Income threshold hourly wage of $35 Dollars
Who cannot join
- Employees who have been previously contacted by the Career Navigator
- Employees not financially responsible for a child of 18 years old of age or younger
- Employees not interested in receiving support from Career Navigator
- Employees who do not accept consent
- Employees who Do not reside in one of the seven zip codes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathways to Economic Mobility Pilot
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.
Read more
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
Read the detailed description
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.
- Conditions
- Financial Hardship, Food Insecurity, Health Status
- Being tested
- Career Navigator Coaching
- Keywords
- Financial insecurity, Food insecurity, Health Status, Mental Health Assessment, Mental Health
- Medical subject headings
- Financial Stress, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Career Navigator CoachingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Career Navigator Coaching | Other | 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. Receives: Behavioral: Career Navigator Coaching |
| Delayed Career Navigator Coaching | Other | 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. Receives: Behavioral: Career Navigator Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial well-being
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.
Measured: 18 months
Food insecurity
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.
Measured: 18 months
Secondary outcomes (6)
Housing instability
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.
Measured: 18 months
Child Health Outcomes
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).
Measured: 18 months
Lifetime Child Hospitalizations
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.
Measured: 18 months
Participant Health Outcomes
Child and subject general health status will be reported by the participating using validated questions from National Health and Nutrition Examination Survey (NHANES).
Measured: 18 months
Parental depressive symptoms
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.
Measured: 18 months
Public program participation
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study startMar 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Why it stopped: Due to a shift in organizational factors this study will not be conducted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Financial HardshipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Wagner Foundation, Someone Elses Child, Boston University
- Responsible party
- Sponsor
- Investigators
- Megan Sandel, MD MPH, Principal investigator, Boston Medical Center and Boston University Chobanian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963763
- Sponsor's protocol ID
- H-43633
- Status last verified
- Mar 2024
- First submitted
- 19 Jul 2023
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
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.
PubMed 11888437Woolfenden 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.
PubMed 25218133Sandel 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.
PubMed 29358482Kemper 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.
PubMed 1496962Glascoe 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.
PubMed 10759753Ettinger 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.
PubMed 31059367Cook 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.
PubMed 18829785O'Hara B, Caswell K. Health Status, Health Insurance, and Medical Services Utilization: 2010. Household Economic Studies. Washington, DC: US Census Bureau. 2013.
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.
PubMed 26154451Bailey 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.
PubMed 35414741
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways to Economic Mobility Pilot
- ClinicalTrials.gov ID
- NCT05963763
- Acronym / sponsor ID
- H-43633
- Conditions
- Financial Hardship, Food Insecurity, Health Status
- Keywords
- Financial insecurity, Food insecurity, Health Status, Mental Health Assessment, Mental Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a shift in organizational factors this study will not be conducted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Wagner Foundation, Someone Elses Child, Boston University
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Career Navigator Coaching | Other | Behavioral: Career Navigator CoachingParticipants 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. |
| Delayed Career Navigator Coaching | Other | Behavioral: Career Navigator CoachingParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recently hired Boston Medical Center employees, since June 2021
- Employees financially responsible for a child 18 years of age or younger
- Employees who live in one of the following zip codes: 02119, 02121, 02122, 02124, 02125, 02126, 02130
- Employees who have Income threshold hourly wage of $35 Dollars
Key exclusion criteria (5 listed)
- Employees who have been previously contacted by the Career Navigator
- Employees not financially responsible for a child of 18 years old of age or younger
- Employees not interested in receiving support from Career Navigator
- Employees who do not accept consent
- Employees who Do not reside in one of the seven zip codes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Career Navigator CoachingThe 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: 1. Career pathway navigation 2. Employee benefit maximization 3. Financial literacy and wealth building 4. Services funds for resources that mitigate specific barriers or needs. | Behavioural | Career Navigator Coaching, Delayed Career Navigator Coaching |
Primary outcome
Financial well-being
Time frame: 18 months
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.
Food insecurity
Time frame: 18 months
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.
6 secondary outcomes
Housing instability
Time frame: 18 months
Child Health Outcomes
Time frame: 18 months
Lifetime Child Hospitalizations
Time frame: 18 months
Participant Health Outcomes
Time frame: 18 months
Parental depressive symptoms
Time frame: 18 months
Public program participation
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Background: PubMed 11888437Bethell 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.
- Background: PubMed 25218133Woolfenden 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.
- Background: PubMed 29358482Sandel 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.
- Background: PubMed 1496962Kemper 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.
- Background: PubMed 10759753Glascoe 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.
- Background: PubMed 31059367Ettinger 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.
- Background: PubMed 18829785Cook 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.
- BackgroundO'Hara B, Caswell K. Health Status, Health Insurance, and Medical Services Utilization: 2010. Household Economic Studies. Washington, DC: US Census Bureau. 2013.
- Background: PubMed 26154451Falci 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.
- Background: PubMed 35414741Bailey 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.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Recruiting
PediRISE Feasibility
Pediatric Cancer, Financial Stress
RecruitingObservational study
Development of Measures to Screen for Financial Hardship in Alzheimer's Disease and Dementia
Financial Hardship, Alzheimer's Disease (AD)
Active, not recruiting
Recovery Finance: Financial Health and Mental Health After Incarceration
Financial Hardship, Mental Health Issue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Sandel, MD MPH principal investigator
Boston Medical Center and Boston University Chobanian
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Career Navigator Coaching in people with Financial Hardship and Food Insecurity, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial well-being (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05963763, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.