NCT05963763

Brief 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 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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

1.5 years

First QC Date

July 19, 2023

Last Update Submit

March 28, 2024

Conditions

Keywords

Financial insecurityFood insecurityHealth StatusMental Health AssessmentMental Health

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    18 months

Secondary Outcomes (6)

  • Housing instability

    18 months

  • Child Health Outcomes

    18 months

  • Lifetime Child Hospitalizations

    18 months

  • Participant Health Outcomes

    18 months

  • Parental depressive symptoms

    18 months

  • +1 more secondary outcomes

Study Arms (2)

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.

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.

Behavioral: Career Navigator Coaching

Interventions

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: 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.

Career Navigator CoachingDelayed Career Navigator Coaching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02119, United States

Location

Related Publications (10)

  • 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: 11888437BACKGROUND
  • 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: 25218133BACKGROUND
  • 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: 29358482BACKGROUND
  • 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: 1496962BACKGROUND
  • 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: 10759753BACKGROUND
  • 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: 31059367BACKGROUND
  • 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: 18829785BACKGROUND
  • O'Hara B, Caswell K. Health Status, Health Insurance, and Medical Services Utilization: 2010. Household Economic Studies. Washington, DC: US Census Bureau. 2013.

    BACKGROUND
  • 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: 26154451BACKGROUND
  • 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: 35414741BACKGROUND

MeSH Terms

Conditions

Financial StressPsychological Well-Being

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorPersonal Satisfaction

Study Officials

  • Megan Sandel, MD MPH

    Boston Medical Center and Boston University Chobanian

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2023

First Posted

July 27, 2023

Study Start

March 1, 2024

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

There is not a plan to make IPD available.

Locations