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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05760001
Other study ID # 850178b
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2023
Est. completion date November 17, 2023

Study information

Verified date June 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 221
Est. completion date November 17, 2023
Est. primary completion date November 17, 2023
Accepts healthy volunteers No
Gender All
Age group 3 Years to 19 Years
Eligibility 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 Design


Intervention

Other:
Assigned Interventions
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

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 24 months
Secondary Parent-reported child health (5-pt Likert ranging from poor to excellent) (Child Health Questionnaire) 24 months
Secondary Caregiver-reported child health care utilization, well child visits Well child visits in previous 12 months (National Survey of Children's Health) 24 months
Secondary Caregiver-reported child health care utilization, sick clinic visits Sick clinic visits in previous 12 months (National Survey of Children's Health) 24 months
Secondary Caregiver-reported child health care utilization, emergency room visits Emergency room visits in previous 12 months (National Survey of Children's Health) 24 months
Secondary Caregiver-reported child health care utilization, hospitalization Hospitalizations in previous 12 months (National Survey of Children's Health) 24 months
Secondary Usual source of care Whether a child has a usual source of care when they are ill or when a parent/caregiver needs advice about their health (National Survey of Children's Health) 24 months
Secondary 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) 24 months
Secondary Difficulty paying medical bills Difficulty paying medical bills in the previous 12 months (National Survey of Children's Health) 24 months
Secondary Uninsurance or gaps in insurance Uninsurance or gaps in insurance in the previous 12 months (National Survey of Children's Health) 24 months
Secondary Average sleep duration Average sleep duration in the previous week (National Survey of Children's Health) 24 months
Secondary Time spent playing outdoors, weekdays Time spent playing outdoors on weekdays (National Survey of Children's Health) 24 months
Secondary Time spent playing outdoors, weekends Time spent playing outdoors on weekends (National Survey of Children's Health) 24 months
Secondary Screen time Screen time (National Survey of Children's Health) 24 months
Secondary Perceived neighborhood cohesion Perceived neighborhood cohesion (National Survey of Children's Health) 24 months
Secondary Perceived safety of child in neighborhood Perceived safety of child in neighborhood (National Survey of Children's Health) 24 months
Secondary Parenting: Difficulty caring for child Parenting: Difficulty caring for child (National Survey of Children's Health) 24 months
Secondary Parenting: Child bothers parent Parenting: Child bothers parent (National Survey of Children's Health) 24 months
Secondary Parenting: Anger with child Parenting: Anger with child (National Survey of Children's Health) 24 months
Secondary Parenting: Handling the day-to-day demands of raising children Parenting: Handling the day-to-day demands of raising children (National Survey of Children's Health) 24 months
Secondary School attendance School attendance, based on Philadelphia school district data (Proportion of school days attended, internally developed) 24 months
Secondary School performance School performance, based on Philadelphia school district data (Grade point average over previous 12 months, internally developed) 24 months
Secondary Rate of preterm birth Rate of preterm birth (birth < 37 weeks of gestation age), based on Pennsylvania birth certificate data 24 months
Secondary Rate of low birthweight Rate of low birthweight (birthweight <2000 grams), based on Pennsylvania birth certificate data 24 months
Secondary Health care utilization: emergency room visits Health care utilization: emergency room visits in the previous we months, based on Children's Hospital of Philadelphia EHR data 24 months
Secondary Health care utilization: hospitalizations Health care utilization: hospitalizations in the previous 12 months, based on Children's Hospital of Philadelphia EHR data 24 months
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