The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT05760001
Collaborator
Children's Hospital of Philadelphia (Other)
480
1
2
26
18.4

Study Details

Study Description

Brief Summary

Black children and adults in the United States fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities result in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place- based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood micro-clusters, with a total of 480 children. The investigators hypothesize that this "big push" intervention will have significant impact on children's health and wellbeing.

Condition or Disease Intervention/Treatment Phase
  • Other: Assigned Interventions
N/A

Detailed Description

Black individuals in the United States fare worse than White individuals across almost every social, economic, and health indicator. The Black health disadvantage starts at birth, reflecting the cumulative toll of racialized social stressors and healthcare discrimination on maternal health and resulting in higher rates of pre-term birth and low birth weight. Black youth are disproportionately exposed to environmental toxins such as lead and adverse childhood events such as financial hardship and neighborhood violence. Black children also have higher rates of chronic disease, including asthma and diabetes. These and other forces result in inequities in child health and well-being and can also impact children's educational and earning potential. Furthermore, these inequities culminate in a stark racial longevity gap: in Philadelphia, the location of this study, life expectancy for people living in a poor, predominantly Black neighborhood is 20 years lower than for people living in a nearby affluent, predominantly White neighborhood.

The fundamental cause of these striking and pervasive disparities is structural racism - the confluence of deep historical, institutional, cultural, and ideological forces that unequally distribute resources and risks across racialized groups. Structural racism patterns health by affecting a range of interconnected, mutually reinforcing social determinants of health at the national, neighborhood, household, and individual levels. Most notably, longstanding, systematic disinvestment has resulted in highly segregated Black neighborhoods with dilapidated environmental conditions and severe economic insecurity within Black households, leading to a "feedback loop of concentrated racial disadvantage," all of which have been strongly tied to poor health.

Most interventions seeking to address racial health disparities focus on individual-level behaviors and outcomes, or individual channels by which structural racism harms health. However, by failing to address upstream social determinants, these interventions have had limited population level impact. A multi-level, multi-component intervention package focused on a range of social determinants of health is necessary to meaningfully address structural racism as a fundamental cause of racial health disparities. In this trial, we aim to implement such a multi-level, multi-component intervention and then evaluate its impact on child health and well-being.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
The investigators are not masked. Our recruitment team will be masked until cluster recruitment is complete. The outcomes assessor will be masked.
Primary Purpose:
Other
Official Title:
A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
May 1, 2025
Anticipated Study Completion Date :
May 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Arm

At the individual level, participants in the intervention arm will receive place-based and financial well-being interventions. These will include, at the individual level: Tax preparation Access to public benefits Financial counseling and microgrants At the neighborhood level: Abandoned house remediation Trash cleanup Vacant lot greening Tree planting

Other: Assigned Interventions
Financial well-being interventions: • Tax preparation; access to public benefits; financial counseling and microgrants Place-based interventions: • Vacant lot greening; abandoned house remediation; trash cleanup; tree planting

No Intervention: Control Arm

Participants in the control arm will not receive any of the listed interventions

Outcome Measures

Primary Outcome Measures

  1. Child Health Questionnaire Parent Form 28 (CHQ-PF28) Composite Score [24 months]

    Composite index using CHQ-28 scoring method, based on a series of 28 questions focused on overall child health, activity limitation, emotional/behavioral difficulties, mood, relationships, and family cohesion. (Child Health Questionnaire)

Secondary Outcome Measures

  1. Parent-reported child health [24 months]

    (5-pt Likert ranging from poor to excellent) (Child Health Questionnaire)

  2. Caregiver-reported child health care utilization, well child visits [24 months]

    Well child visits in previous 12 months (National Survey of Children's Health)

  3. Caregiver-reported child health care utilization, sick clinic visits [24 months]

    Sick clinic visits in previous 12 months (National Survey of Children's Health)

  4. Caregiver-reported child health care utilization, emergency room visits [24 months]

    Emergency room visits in previous 12 months (National Survey of Children's Health)

  5. Caregiver-reported child health care utilization, hospitalization [24 months]

    Hospitalizations in previous 12 months (National Survey of Children's Health)

  6. Usual source of care [24 months]

    Whether a child has a usual source of care when they are ill or when a parent/caregiver needs advice about their health (National Survey of Children's Health)

  7. Forgone health care [24 months]

    Caregiver report of whether the child needed but did not receive medical, mental health, dental, or vision care in the previous 12 months (National Survey of Children's Health)

  8. Difficulty paying medical bills [24 months]

    Difficulty paying medical bills in the previous 12 months (National Survey of Children's Health)

  9. Uninsurance or gaps in insurance [24 months]

    Uninsurance or gaps in insurance in the previous 12 months (National Survey of Children's Health)

  10. Average sleep duration [24 months]

    Average sleep duration in the previous week (National Survey of Children's Health)

  11. Time spent playing outdoors, weekdays [24 months]

    Time spent playing outdoors on weekdays (National Survey of Children's Health)

  12. Time spent playing outdoors, weekends [24 months]

    Time spent playing outdoors on weekends (National Survey of Children's Health)

  13. Screen time [24 months]

    Screen time (National Survey of Children's Health)

  14. Perceived neighborhood cohesion [24 months]

    Perceived neighborhood cohesion (National Survey of Children's Health)

  15. Perceived safety of child in neighborhood [24 months]

    Perceived safety of child in neighborhood (National Survey of Children's Health)

  16. Parenting: Difficulty caring for child [24 months]

    Parenting: Difficulty caring for child (National Survey of Children's Health)

  17. Parenting: Child bothers parent [24 months]

    Parenting: Child bothers parent (National Survey of Children's Health)

  18. Parenting: Anger with child [24 months]

    Parenting: Anger with child (National Survey of Children's Health)

  19. Parenting: Handling the day-to-day demands of raising children [24 months]

    Parenting: Handling the day-to-day demands of raising children (National Survey of Children's Health)

  20. School attendance [24 months]

    School attendance, based on Philadelphia school district data (Proportion of school days attended, internally developed)

  21. School performance [24 months]

    School performance, based on Philadelphia school district data (Grade point average over previous 12 months, internally developed)

  22. Rate of preterm birth [24 months]

    Rate of preterm birth (birth < 37 weeks of gestation age), based on Pennsylvania birth certificate data

  23. Rate of low birthweight [24 months]

    Rate of low birthweight (birthweight <2000 grams), based on Pennsylvania birth certificate data

  24. Health care utilization: emergency room visits [24 months]

    Health care utilization: emergency room visits in the previous we months, based on Children's Hospital of Philadelphia EHR data

  25. Health care utilization: hospitalizations [24 months]

    Health care utilization: hospitalizations in the previous 12 months, based on Children's Hospital of Philadelphia EHR data

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Child is between the ages of 5 and 18 years

  • Parent/caregiver is at least 18 years of age

  • Parent/caregiver has the ability to communicate via text messaging

  • Parent/caregiver is comfortable communicating in English

  • Child is a permanent resident of the home where they are to be enrolled

  • Parent/caregiver has knowledge of their household finances

Exclusion Criteria:
  • Children who plan to move out of the study microcluster within 6 months

  • Children whose caregivers are unable to fully consent and participate based on recruitment team assessment

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Atheendar Venkataramani, MD, PhD, University of Pennsylvania
  • Principal Investigator: Eugenia South, MD, MSHP, University of Pennsylvania
  • Principal Investigator: Aditi Vasan, MD, MSHP, Children's Hospital of Philadelphia

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT05760001
Other Study ID Numbers:
  • 850178b
First Posted:
Mar 8, 2023
Last Update Posted:
Mar 8, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 8, 2023