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The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being

Primary Purpose

Financial Stress, Economic Problems, Environmental Exposure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assigned Interventions
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Financial Stress

Eligibility Criteria

3 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Parent-reported child health
(5-pt Likert ranging from poor to excellent) (Child Health Questionnaire)
Caregiver-reported child health care utilization, well child visits
Well child visits in previous 12 months (National Survey of Children's Health)
Caregiver-reported child health care utilization, sick clinic visits
Sick clinic visits in previous 12 months (National Survey of Children's Health)
Caregiver-reported child health care utilization, emergency room visits
Emergency room visits in previous 12 months (National Survey of Children's Health)
Caregiver-reported child health care utilization, hospitalization
Hospitalizations in previous 12 months (National Survey of Children's Health)
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)
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)
Difficulty paying medical bills
Difficulty paying medical bills in the previous 12 months (National Survey of Children's Health)
Uninsurance or gaps in insurance
Uninsurance or gaps in insurance in the previous 12 months (National Survey of Children's Health)
Average sleep duration
Average sleep duration in the previous week (National Survey of Children's Health)
Time spent playing outdoors, weekdays
Time spent playing outdoors on weekdays (National Survey of Children's Health)
Time spent playing outdoors, weekends
Time spent playing outdoors on weekends (National Survey of Children's Health)
Screen time
Screen time (National Survey of Children's Health)
Perceived neighborhood cohesion
Perceived neighborhood cohesion (National Survey of Children's Health)
Perceived safety of child in neighborhood
Perceived safety of child in neighborhood (National Survey of Children's Health)
Parenting: Difficulty caring for child
Parenting: Difficulty caring for child (National Survey of Children's Health)
Parenting: Child bothers parent
Parenting: Child bothers parent (National Survey of Children's Health)
Parenting: Anger with child
Parenting: Anger with child (National Survey of Children's Health)
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)
School attendance
School attendance, based on Philadelphia school district data (Proportion of school days attended, internally developed)
School performance
School performance, based on Philadelphia school district data (Grade point average over previous 12 months, internally developed)
Rate of preterm birth
Rate of preterm birth (birth < 37 weeks of gestation age), based on Pennsylvania birth certificate data
Rate of low birthweight
Rate of low birthweight (birthweight <2000 grams), based on Pennsylvania birth certificate data
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
Health care utilization: hospitalizations
Health care utilization: hospitalizations in the previous 12 months, based on Children's Hospital of Philadelphia EHR data

Full Information

First Posted
February 23, 2023
Last Updated
June 16, 2023
Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT05760001
Brief Title
The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being
Official Title
A Randomized Controlled Trial of Concentrated Investment in Black Neighborhoods to Address Structural Racism as a Fundamental Cause of Poor Child Health
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Financial Stress, Economic Problems, Environmental Exposure, Health Behavior, Health, Subjective, Mental Health Wellness

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The investigators are not masked. Our recruitment team will be masked until cluster recruitment is complete. The outcomes assessor will be masked.
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
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
Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
Participants in the control arm will not receive any of the listed interventions
Intervention Type
Other
Intervention Name(s)
Assigned Interventions
Intervention Description
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
Primary Outcome Measure Information:
Title
Child Health Questionnaire Parent Form 28 (CHQ-PF28) Composite Score
Description
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)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Parent-reported child health
Description
(5-pt Likert ranging from poor to excellent) (Child Health Questionnaire)
Time Frame
24 months
Title
Caregiver-reported child health care utilization, well child visits
Description
Well child visits in previous 12 months (National Survey of Children's Health)
Time Frame
24 months
Title
Caregiver-reported child health care utilization, sick clinic visits
Description
Sick clinic visits in previous 12 months (National Survey of Children's Health)
Time Frame
24 months
Title
Caregiver-reported child health care utilization, emergency room visits
Description
Emergency room visits in previous 12 months (National Survey of Children's Health)
Time Frame
24 months
Title
Caregiver-reported child health care utilization, hospitalization
Description
Hospitalizations in previous 12 months (National Survey of Children's Health)
Time Frame
24 months
Title
Usual source of care
Description
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)
Time Frame
24 months
Title
Forgone health care
Description
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)
Time Frame
24 months
Title
Difficulty paying medical bills
Description
Difficulty paying medical bills in the previous 12 months (National Survey of Children's Health)
Time Frame
24 months
Title
Uninsurance or gaps in insurance
Description
Uninsurance or gaps in insurance in the previous 12 months (National Survey of Children's Health)
Time Frame
24 months
Title
Average sleep duration
Description
Average sleep duration in the previous week (National Survey of Children's Health)
Time Frame
24 months
Title
Time spent playing outdoors, weekdays
Description
Time spent playing outdoors on weekdays (National Survey of Children's Health)
Time Frame
24 months
Title
Time spent playing outdoors, weekends
Description
Time spent playing outdoors on weekends (National Survey of Children's Health)
Time Frame
24 months
Title
Screen time
Description
Screen time (National Survey of Children's Health)
Time Frame
24 months
Title
Perceived neighborhood cohesion
Description
Perceived neighborhood cohesion (National Survey of Children's Health)
Time Frame
24 months
Title
Perceived safety of child in neighborhood
Description
Perceived safety of child in neighborhood (National Survey of Children's Health)
Time Frame
24 months
Title
Parenting: Difficulty caring for child
Description
Parenting: Difficulty caring for child (National Survey of Children's Health)
Time Frame
24 months
Title
Parenting: Child bothers parent
Description
Parenting: Child bothers parent (National Survey of Children's Health)
Time Frame
24 months
Title
Parenting: Anger with child
Description
Parenting: Anger with child (National Survey of Children's Health)
Time Frame
24 months
Title
Parenting: Handling the day-to-day demands of raising children
Description
Parenting: Handling the day-to-day demands of raising children (National Survey of Children's Health)
Time Frame
24 months
Title
School attendance
Description
School attendance, based on Philadelphia school district data (Proportion of school days attended, internally developed)
Time Frame
24 months
Title
School performance
Description
School performance, based on Philadelphia school district data (Grade point average over previous 12 months, internally developed)
Time Frame
24 months
Title
Rate of preterm birth
Description
Rate of preterm birth (birth < 37 weeks of gestation age), based on Pennsylvania birth certificate data
Time Frame
24 months
Title
Rate of low birthweight
Description
Rate of low birthweight (birthweight <2000 grams), based on Pennsylvania birth certificate data
Time Frame
24 months
Title
Health care utilization: emergency room visits
Description
Health care utilization: emergency room visits in the previous we months, based on Children's Hospital of Philadelphia EHR data
Time Frame
24 months
Title
Health care utilization: hospitalizations
Description
Health care utilization: hospitalizations in the previous 12 months, based on Children's Hospital of Philadelphia EHR data
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hilena Addis
Phone
215-898-7036
Email
hilena.addis@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Aditi Vasan
Email
vasana@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atheendar Venkataramani, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eugenia South, MD, MSHP
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Aditi Vasan, MD, MSHP
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilena Addis
Phone
215-898-7036
Email
hilena.addis@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Aditi Vasan
Email
vasana@chop.edu
First Name & Middle Initial & Last Name & Degree
Atheendar Venkataramani, MD, PhD
First Name & Middle Initial & Last Name & Degree
Eugenia South, MD, MSHP
First Name & Middle Initial & Last Name & Degree
Aditi Vasan, MD, MSHP

12. IPD Sharing Statement

Plan to Share IPD
No

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The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being

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