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

221 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Assigned Interventions in the Community Investment for Child Health and Well-being trial?

The research highlights the importance of structured child- and parent-reported outcome measures in identifying children at risk and improving health outcomes. Additionally, cross-sector partnerships and community-connected opportunities are emphasized as effective strategies for advancing child health equity, which may support the effectiveness of the treatment in the trial. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The research articles provided do not contain specific safety data for the treatment in question, as they focus on adverse events related to cosmetics, emergency department treatments, and injury prevention strategies, rather than the treatment itself. ^{6 7 8 9 10}

How does the 'Community Investment for Child Health and Well-being' treatment differ from other treatments for child health?

This treatment is unique because it combines community gardens, nutrition workshops, and parenting workshops to improve child health and development, focusing on reducing food insecurity and language delays. Unlike traditional medical treatments, it involves community health promoters and a 'step-by-step' learning system to empower caregivers with skills in gardening, nutrition, and parenting. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Research Team

Aditi Vasan, MD, MSHP

Principal Investigator

Children's Hospital of Philadelphia

Atheendar Venkataramani, MD, PhD

Principal Investigator

University of Pennsylvania

Eugenia South, MD, MSHP

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementation of the norwegian 'Starting right' child health service innovation: implementation adjustments, adoption, and acceptability. [2021]

2. England pubmed.ncbi.nlm.nih.gov

How paediatricians can improve developmental outcomes for children. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Outcomes research on children, adolescents, and their families: directions for future inquiry. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Implementation of child-centred outcome measures in routine paediatric healthcare practice: a systematic review. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pursuing a Cross-Sector Approach to Advance Child Health Equity. [2023]

6. United States 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. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Individual-level injury prevention strategies in the clinical setting. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Adverse events in the paediatric emergency department: a prospective cohort study. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Occlusion of the Patent Ductus Arteriosus in 747 Infants [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Whole of Systems Trial of Prevention Strategies for Childhood Obesity: WHO STOPS Childhood Obesity. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Diet and behavior in at-risk children: evaluation of an early intervention program. [2019]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Research and Evaluation in a Child-Focused Place-Based Initiative: West Philly Promise Neighborhood. [2023]

14. Switzerland pubmed.ncbi.nlm.nih.gov

A Multi-Sectoral Approach Improves Early Child Development in a Disadvantaged Community in Peru: Role of Community Gardens, Nutrition Workshops and Enhanced Caregiver-Child Interaction: Project "Wawa Illari". [2021]

15. England pubmed.ncbi.nlm.nih.gov

Community-based intervention packages facilitated by NGOs demonstrate plausible evidence for child mortality impact. [2022]