Community Investment for Child Health and Well-being

Overseen By Aditi Vasan

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Moving, Caregiver consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve health and well-being for Black children living in Philadelphia by testing a combination of community and personal financial interventions, such as neighborhood clean-ups and financial support, to see if they can reduce health disparities. Researchers will conduct the trial in specific neighborhoods with 480 children participating. Families with children aged 3 to 17 who live in these neighborhoods and have a parent who can communicate in English and is familiar with their household finances might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and potentially benefit from innovative interventions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these interventions are safe for community health?

Research has shown that place-based interventions, like those in this trial, aim to improve neighborhoods by addressing issues such as empty lots and abandoned houses. These efforts seek to enhance community well-being, but strong evidence on their impact on children's health remains limited.

Regarding safety, these interventions are generally safe as they involve environmental changes and financial support, not direct medical treatments. Since they don't involve new drugs or medical devices, no negative health effects have been reported. This makes them a safe choice for potential trial participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a holistic approach to improving child health and well-being by combining financial and environmental interventions. Unlike traditional treatments that focus solely on medical or psychological strategies, this trial targets broader social determinants of health, such as economic stability and neighborhood environment. By offering support like tax preparation, financial counseling, and neighborhood improvements, the trial aims to create lasting, positive changes in both individual and community health outcomes. This approach could pave the way for more comprehensive public health strategies that address root causes of health disparities.

What evidence suggests that this trial's interventions could be effective in addressing racial health disparities?

This trial will compare a control arm with an intervention arm. Research has shown that place-based interventions, like those in the intervention arm, can improve physical health, health habits, and social factors affecting health. Studies examining these methods found that about 26% of the results were positive and long-lasting. These interventions address neighborhood issues such as empty lots and abandoned houses, which can impact community health. By enhancing the physical environment and providing financial support, these interventions aim to build healthier, more supportive communities. Although some evidence indicates positive effects, results have varied, and further research is needed to fully understand their potential. ^{1 2 6 7 8}

Who Is on the Research Team?

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

Are You a Good Fit for This Trial?

This trial is for Black children aged 3-17 and their caregivers who are knowledgeable about household finances, can text message, and communicate in English. The child must be a permanent resident of the home within the study area. Families planning to move soon or unable to consent fully are excluded.

Inclusion Criteria

I am comfortable communicating in English.

Parent/caregiver has the ability to communicate via text messaging

Parent/caregiver has knowledge of their household finances

Exclusion Criteria

Children who plan to move out of the study microcluster within 6 months

My caregiver cannot fully consent or participate in the trial as assessed by the clinical team.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive place-based and financial well-being interventions, including tax preparation, access to public benefits, financial counseling, microgrants, abandoned house remediation, trash cleanup, vacant lot greening, and tree planting.

24 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, focusing on various health and well-being measures.

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Assigned Interventions

Trial Overview

The IGNITE for Kids Study tests interventions aimed at improving health and well-being by investing in Black neighborhoods. This includes greening lots, fixing houses, planting trees, cleaning trash, financial counseling, tax help, public benefits access, and emergency cash assistance.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Published Research Related to This Trial

In a systematic review of 17 studies involving children, the incidence of adverse drug reactions (ADRs) in hospitalized children was found to be 9.53%, with severe reactions accounting for 12.29%, highlighting the significant risk of ADRs in this population.

The study revealed that 2.09% of pediatric hospital admissions were due to ADRs, with 39.3% of these being life-threatening, indicating a critical need for improved drug safety monitoring and preventive strategies in pediatric healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Impicciatore, P., Choonara, I., Clarkson, A., et al.[2023]

From 2004 to 2016, only 166 adverse events related to baby personal care products were reported to the FDA, with most cases involving skin reactions like rashes, and nearly half of these incidents required a healthcare visit.

The study highlights the need for pediatric dermatologists to actively report adverse events and encourage consumers to do the same, as current reporting is low and may not fully capture the safety concerns associated with these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events reported to the Food and Drug Administration from 2004 to 2016 for cosmetics and personal care products marketed to newborns and infants. Cornell, E., Kwa, M., Paller, AS., et al.[2018]

In a study of 1367 children treated in a pediatric emergency department, 2.5% experienced adverse events related to their care, highlighting a significant risk of harm in this setting.

Most of these adverse events (87.9%) were deemed preventable, with management and diagnostic issues being the most common types, indicating areas where patient safety can be improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. Plint, AC., Stang, A., Newton, AS., et al.[2021]

Transcatheter PDA occlusion in infants under 6 kg has a high procedural success rate of 94.3%, but major adverse events (MAEs) occurred in 12.6% of cases, with acute arterial injury and device embolization being the most common complications.

Younger infants (under 30 days) and those weighing less than 2 kg are at a significantly higher risk for MAEs, indicating that careful patient selection is crucial for this procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Occlusion of the Patent Ductus Arteriosus in 747 Infants Backes, CH., Kennedy, KF., Locke, M., et al.[2019]

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aged children, or youth. Place-based data can also show where children live, what schools or community-based resources are available, and where there are gaps.