- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05760001
The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being
A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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:
At the neighborhood level:
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Health Questionnaire Parent Form 28 (CHQ-PF28) Composite Score
Time Frame: 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)
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parent-reported child health
Time Frame: 24 months
|
(5-pt Likert ranging from poor to excellent) (Child Health Questionnaire)
|
24 months
|
|
Caregiver-reported child health care utilization, well child visits
Time Frame: 24 months
|
Well child visits in previous 12 months (National Survey of Children's Health)
|
24 months
|
|
Caregiver-reported child health care utilization, sick clinic visits
Time Frame: 24 months
|
Sick clinic visits in previous 12 months (National Survey of Children's Health)
|
24 months
|
|
Caregiver-reported child health care utilization, emergency room visits
Time Frame: 24 months
|
Emergency room visits in previous 12 months (National Survey of Children's Health)
|
24 months
|
|
Caregiver-reported child health care utilization, hospitalization
Time Frame: 24 months
|
Hospitalizations in previous 12 months (National Survey of Children's Health)
|
24 months
|
|
Forgone health care
Time Frame: 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)
|
24 months
|
|
Uninsurance or gaps in insurance
Time Frame: 24 months
|
Uninsurance or gaps in insurance in the previous 12 months (National Survey of Children's Health)
|
24 months
|
|
School attendance
Time Frame: 24 months
|
School attendance, based on Philadelphia school district data (Proportion of school days attended, internally developed)
|
24 months
|
|
School performance
Time Frame: 24 months
|
School performance, based on Philadelphia school district data (Grade point average over previous 12 months, internally developed)
|
24 months
|
|
Rate of preterm birth
Time Frame: 24 months
|
Rate of preterm birth (birth < 37 weeks of gestation age), based on Pennsylvania birth certificate data
|
24 months
|
|
Rate of low birthweight
Time Frame: 24 months
|
Rate of low birthweight (birthweight <2000 grams), based on Pennsylvania birth certificate data
|
24 months
|
|
Health care utilization: hospitalizations
Time Frame: 24 months
|
Health care utilization: hospitalizations in the previous 12 months, based on Children's Hospital of Philadelphia EHR data
|
24 months
|
|
Health care utilization: emergency room visits in the previous 12mon
Time Frame: 24 months
|
Monthly or quarterly data from 2 years prior to enrollment through approximately 1 year after from HealthShare Exchange
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Eugenia South, MD, MSHP, University of Pennsylvania
- Principal Investigator: Aditi Vasan, MD, MSHP, Children's Hospital of Philadelphia
- Principal Investigator: Atheendar Venkataramani, MD, PhD, University of Pennsylvania
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 850178b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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