Health Behavior Clinical Trial
Official title:
A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
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 |
Verified date | June 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Children's Hospital of Philadelphia |
United States,
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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