Clinical trial NCT05760001: The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being
Official title: A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Financial Stress
Economic Problems
Environmental Exposure
Health Behavior
Health, Subjective
Mental Health Wellness
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2023-03-08
Enrollment: 221
Sex: ALL
Minimum age (years): 3
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: Inclusion Criteria:

* Child is between the ages of 3 and 17 years at the start of the trial (between the ages of 5 and 19 years at the end of the trial)
* 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 CC team assessment

Primary outcomes:
measure: Child Health Questionnaire Parent Form 28 (CHQ-PF28) Composite Score
timeFrame: 24 months
Secondary outcomes:
measure: Parent-reported child health
timeFrame: 24 months
measure: Caregiver-reported child health care utilization, well child visits
timeFrame: 24 months
measure: Caregiver-reported child health care utilization, sick clinic visits
timeFrame: 24 months
measure: Caregiver-reported child health care utilization, emergency room visits
timeFrame: 24 months
measure: Caregiver-reported child health care utilization, hospitalization
timeFrame: 24 months
measure: Usual source of care
timeFrame: 24 months
measure: Forgone health care
timeFrame: 24 months
measure: Difficulty paying medical bills
timeFrame: 24 months
measure: Uninsurance or gaps in insurance
timeFrame: 24 months
measure: Average sleep duration
timeFrame: 24 months
measure: Time spent playing outdoors, weekdays
timeFrame: 24 months
measure: Time spent playing outdoors, weekends
timeFrame: 24 months
measure: Screen time
timeFrame: 24 months
measure: Perceived neighborhood cohesion
timeFrame: 24 months
measure: Perceived safety of child in neighborhood
timeFrame: 24 months
measure: Parenting: Difficulty caring for child
timeFrame: 24 months
measure: Parenting: Child bothers parent
timeFrame: 24 months
measure: Parenting: Anger with child
timeFrame: 24 months
measure: Parenting: Handling the day-to-day demands of raising children
timeFrame: 24 months
measure: School attendance
timeFrame: 24 months
measure: School performance
timeFrame: 24 months
measure: Rate of preterm birth
timeFrame: 24 months
measure: Rate of low birthweight
timeFrame: 24 months
measure: Health care utilization: emergency room visits
timeFrame: 24 months
measure: Health care utilization: hospitalizations
timeFrame: 24 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Atheendar Venkataramani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Eugenia South, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Aditi Vasan, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References: