Financial StressNCT05760001
The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being
A study testing Assigned Interventions in people with Financial Stress and Economic Problems, run by University of Pennsylvania at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 19 years
- Conditions the study is for
- Financial Stress, Economic Problems, Environmental Exposure
- What is being tested?
- Assigned Interventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2023to 13 Feb 2026
- 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 3 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
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.
Read the 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.
- Conditions
- Financial Stress, Economic Problems, Environmental Exposure, Health Behavior, Health, Subjective, Mental Health Wellness
- Being tested
- Assigned Interventions
- Medical subject headings
- Financial Stress, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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 Receives: Other: Assigned Interventions |
| Control Arm | No intervention | Participants in the control arm will not receive any of the listed interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Health Questionnaire Parent Form 28 (CHQ-PF28) Composite Score
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)
Measured: 24 months
Secondary outcomes (13)
Parent-reported child health
(5-pt Likert ranging from poor to excellent) (Child Health Questionnaire)
Measured: 24 months
Caregiver-reported child health care utilization, well child visits
Well child visits in previous 12 months (National Survey of Children's Health)
Measured: 24 months
Caregiver-reported child health care utilization, sick clinic visits
Sick clinic visits in previous 12 months (National Survey of Children's Health)
Measured: 24 months
Caregiver-reported child health care utilization, emergency room visits
Emergency room visits in previous 12 months (National Survey of Children's Health)
Measured: 24 months
Caregiver-reported child health care utilization, hospitalization
Hospitalizations in previous 12 months (National Survey of Children's Health)
Measured: 24 months
Forgone health care
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)
Measured: 24 months
Uninsurance or gaps in insurance
Uninsurance or gaps in insurance in the previous 12 months (National Survey of Children's Health)
Measured: 24 months
School attendance
School attendance, based on Philadelphia school district data (Proportion of school days attended, internally developed)
Measured: 24 months
School performance
School performance, based on Philadelphia school district data (Grade point average over previous 12 months, internally developed)
Measured: 24 months
Rate of preterm birth
Rate of preterm birth (birth < 37 weeks of gestation age), based on Pennsylvania birth certificate data
Measured: 24 months
Rate of low birthweight
Rate of low birthweight (birthweight <2000 grams), based on Pennsylvania birth certificate data
Measured: 24 months
Health care utilization: emergency room visits in the previous 12mon
Monthly or quarterly data from 2 years prior to enrollment through approximately 1 year after from HealthShare Exchange
Measured: 24 months
Health care utilization: hospitalizations
Health care utilization: hospitalizations in the previous 12 months, based on Children's Hospital of Philadelphia EHR data
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start10 Jun 2023
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial StressStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Atheendar Venkataramani, MD, PhD, Principal investigator, University of PennsylvaniaEugenia South, MD, MSHP, Principal investigator, University of PennsylvaniaAditi Vasan, MD, MSHP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05760001
- Sponsor's protocol ID
- 850178b
- Status last verified
- Jul 2026
- First submitted
- 23 Feb 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
- ClinicalTrials.gov ID
- NCT05760001
- Acronym / sponsor ID
- 850178b
- Conditions
- Financial Stress, Economic Problems, Environmental Exposure, Health Behavior, Health, Subjective, Mental Health Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 8 Mar 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Assigned InterventionsAt 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 |
| Control Arm | No intervention | –Participants in the control arm will not receive any of the listed interventions |
Who may qualify
- Ages
- 3 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Assigned InterventionsFinancial 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 | Other | Intervention Arm |
Primary outcome
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)
13 secondary outcomes
Parent-reported child health
Time frame: 24 months
Caregiver-reported child health care utilization, well child visits
Time frame: 24 months
Caregiver-reported child health care utilization, sick clinic visits
Time frame: 24 months
Caregiver-reported child health care utilization, emergency room visits
Time frame: 24 months
Caregiver-reported child health care utilization, hospitalization
Time frame: 24 months
Forgone health care
Time frame: 24 months
Uninsurance or gaps in insurance
Time frame: 24 months
School attendance
Time frame: 24 months
School performance
Time frame: 24 months
Rate of preterm birth
Time frame: 24 months
Rate of low birthweight
Time frame: 24 months
Health care utilization: emergency room visits in the previous 12mon
Time frame: 24 months
Health care utilization: hospitalizations
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Atheendar Venkataramani, MD, PhD principal investigator
University of Pennsylvania
Eugenia South, MD, MSHP principal investigator
University of Pennsylvania
Aditi Vasan, MD, MSHP principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions in people with Financial Stress and Economic Problems, run by University of Pennsylvania 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 30 Jul 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Child Health Questionnaire Parent Form 28 (CHQ-PF28) Composite Score (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.