NCT05251311

Brief Summary

Children are disproportionately affected by the rise in poverty rates in the United States. Economic hardships can compromise child development, overall health, and the ability to succeed in school and in life. The current economic recession and racial disparities underscored by COVID19 have magnified this impact on children and hastened the already rapid growth of screening protocols for social risk factors- such as food and housing insecurity, financial strain, and unsafe environments-within pediatric health care. However, it remains unclear what effect standardized screening has on family perception of and engagement with resources. Current implementation momentum for screening protocols is outpacing research, and is raising concern among patient advocates for unintended harm-alienating families for fear of stigma or worse, and overpromising services that may not exist. Through a rigorous mixed-method approach, the proposed study will explore the impact of screening on acceptance, perception, and engagement with social resources among families with children. Furthermore, by leveraging the new technology of resource mapping as the method of resource referral, this study will provide insight regarding its effectiveness as a social needs assistance strategy. The knowledge gained will provide guidance for policymakers and other healthcare systems on how to integrate social risk interventions into healthcare delivery in order to maximize the benefit to children and families.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,949

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 30, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2023

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

September 30, 2021

Last Update Submit

November 25, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Resource Uptake By Search

    total number of searches

    30 days

  • Resource Uptake By Domain

    number of searches by domain

    30 days

  • Resource Engagement By Time

    time spent on site

    30 days

  • Resource Engagement By Saves

    number of resources saved

    30 days

  • Resource Engagement By Domain

    number of resources saved by domain

    30 days

  • Resource Utilization

    rates of resource utilization

    30 days

  • Resource Impact

    perceived impact of resource use on social need measured by using a modified version of the WE CARE screening tool

    30 days

Secondary Outcomes (2)

  • Perceived impact of screening on resource acceptance

    up to 45 days

  • Perceived impact of screening on resource perception

    up to 45 days

Study Arms (3)

Social Risk Screening + Resource Map

EXPERIMENTAL

Participants randomized to the experimental arm will receive a social risk assessment tool followed by an electronic resource map

Behavioral: Social Risk Screening ToolOther: Electronic Resource Map

Resource Map

ACTIVE COMPARATOR

Participants randomized to the active comparator group will receive only an electronic resource map

Other: Electronic Resource Map

Resource Menu + Resource Map

EXPERIMENTAL

Participants randomized to this experimental arm will receive a social resource menu tool followed by an electronic resource map.

Behavioral: Resource Menu

Interventions

Investigators will use an adapted version of the evidence-based WE CARE screening tool, which assesses need in the 5 domains most frequently requested by our patient population: housing, transportation, child care, food security, and household heat and electricity. This tool was selected as it is evidence-based, takes fewer than 5 minutes to complete, is written at a 3rd grade reading level, and allows for differentiation between social risk and caregiver desire for assistance, as well as areas of "emergency" need.

Social Risk Screening + Resource Map

All participants will receive access to an electronic, geographically searchable resource map hosted on Aunt Bertha

Resource MapSocial Risk Screening + Resource Map
Resource MenuBEHAVIORAL

Participants randomized to this experimental arm will receive a social resource menu tool, which assess desire for social resources.

Resource Menu + Resource Map

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers presenting with a child to the pediatric clinical setting
  • Child age 0-25

You may not qualify if:

  • Engaged in complex care management services
  • Child in critical condition
  • Presenting to clinical setting specifically for social work intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (1)

  • Brown R, Cigarroa Kennedy S, Carranco Chavez E, Dumeng-Rodriguez J, Cullen D. Evaluation of a notes-based rapid qualitative analysis method to facilitate implementation. Implement Sci Commun. 2025 Mar 3;6(1):23. doi: 10.1186/s43058-025-00709-w.

Study Officials

  • Danielle Cullen, MD MPH MSHP

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Social worker that follows up with each participant will be blinded to randomization arm
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

February 22, 2022

Study Start

April 19, 2022

Primary Completion

September 22, 2023

Study Completion

September 22, 2023

Last Updated

November 27, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations