NCT05760001

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

February 23, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 8, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 10, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

February 23, 2023

Last Update Submit

March 9, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (25)

  • Parent-reported child health

    24 months

  • Caregiver-reported child health care utilization, well child visits

    24 months

  • Caregiver-reported child health care utilization, sick clinic visits

    24 months

  • Caregiver-reported child health care utilization, emergency room visits

    24 months

  • Caregiver-reported child health care utilization, hospitalization

    24 months

  • +20 more secondary outcomes

Study Arms (2)

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

Other: Assigned Interventions

Control Arm

NO INTERVENTION

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

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

Intervention Arm

Eligibility Criteria

Age3 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Financial StressHealth Behavior

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Atheendar Venkataramani, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Eugenia South, MD, MSHP

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR
  • Aditi Vasan, MD, MSHP

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The investigators are not masked. Our recruitment team will be masked until cluster recruitment is complete. The outcomes assessor will be masked.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 8, 2023

Study Start

June 10, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations