Low-income PopulationsNCT05251311
A Mixed-Method Evaluation of the Impact of Social Risk Screening on Uptake of Social Assistance
A study testing Social Risk Screening Tool, Electronic Resource Map and Resource Menu in people with Low-income Populations and Social Determinants of Health, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-income Populations, Social Determinants of Health
- What is being tested?
- Social Risk Screening Tool, Electronic Resource Map and Resource Menu
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,949 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2022to 22 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers presenting with a child to the pediatric clinical setting
- Child age 0-25
Who cannot join
- Engaged in complex care management services
- Child in critical condition
- Presenting to clinical setting specifically for social work intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
About this study
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.
- Being tested
- Social Risk Screening Tool, Electronic Resource Map, Resource Menu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Risk Screening ToolBehavioural
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.
Electronic Resource MapOther
All participants will receive access to an electronic, geographically searchable resource map hosted on Aunt Bertha
Resource MenuBehavioural
Participants randomized to this experimental arm will receive a social resource menu tool, which assess desire for social resources.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Social Risk Screening Tool; Other: Electronic Resource Map |
| Resource Map | Active comparator | Participants randomized to the active comparator group will receive only an electronic resource map Receives: 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. Receives: Behavioral: Resource Menu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resource Uptake By Search
total number of searches
Measured: 30 days
Resource Uptake By Domain
number of searches by domain
Measured: 30 days
Resource Engagement By Time
time spent on site
Measured: 30 days
Resource Engagement By Saves
number of resources saved
Measured: 30 days
Resource Engagement By Domain
number of resources saved by domain
Measured: 30 days
Resource Utilization
rates of resource utilization
Measured: 30 days
Resource Impact
perceived impact of resource use on social need measured by using a modified version of the WE CARE screening tool
Measured: 30 days
Secondary outcomes (2)
Perceived impact of screening on resource acceptance
Qualitative semi-structured interviews
Measured: up to 45 days
Perceived impact of screening on resource perception
Qualitative semi-structured interviews
Measured: up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start19 Apr 2022
- Primary completion22 Sep 2023
- Study completion22 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low-income PopulationsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 3,949 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danielle Cullen, MD MPH MSHP, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251311
- Sponsor's protocol ID
- 21-018785
- Status last verified
- Nov 2024
- First submitted
- 30 Sep 2021
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40033458
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-Method Evaluation of the Impact of Social Risk Screening on Uptake of Social Assistance
- ClinicalTrials.gov ID
- NCT05251311
- Acronym / sponsor ID
- 21-018785
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,949 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 22 Sep 2023 (actual)
- Study completion
- 22 Sep 2023 (actual)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Social Risk Screening + Resource Map | Experimental | Behavioral: Social Risk Screening Tool, Other: Electronic Resource MapParticipants randomized to the experimental arm will receive a social risk assessment tool followed by an electronic resource map |
| Resource Map | Active comparator | Other: Electronic Resource MapParticipants randomized to the active comparator group will receive only an electronic resource map |
| Resource Menu + Resource Map | Experimental | Behavioral: Resource MenuParticipants randomized to this experimental arm will receive a social resource menu tool followed by an electronic resource map. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Caregivers presenting with a child to the pediatric clinical setting
- Child age 0-25
Key exclusion criteria (3 listed)
- Engaged in complex care management services
- Child in critical condition
- Presenting to clinical setting specifically for social work intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Risk Screening ToolInvestigators 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. | Behavioural | Social Risk Screening + Resource Map |
| Electronic Resource MapAll participants will receive access to an electronic, geographically searchable resource map hosted on Aunt Bertha | Other | Resource Map, Social Risk Screening + Resource Map |
| Resource MenuParticipants randomized to this experimental arm will receive a social resource menu tool, which assess desire for social resources. | Behavioural | Resource Menu + Resource Map |
Primary outcome
Resource Uptake By Search
Time frame: 30 days
total number of searches
Resource Uptake By Domain
Time frame: 30 days
number of searches by domain
Resource Engagement By Time
Time frame: 30 days
time spent on site
Resource Engagement By Saves
Time frame: 30 days
number of resources saved
Resource Engagement By Domain
Time frame: 30 days
number of resources saved by domain
Resource Utilization
Time frame: 30 days
rates of resource utilization
Resource Impact
Time frame: 30 days
perceived impact of resource use on social need measured by using a modified version of the WE CARE screening tool
2 secondary outcomes
Perceived impact of screening on resource acceptance
Time frame: up to 45 days
Perceived impact of screening on resource perception
Time frame: up to 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 40033458Brown 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Cullen, MD MPH MSHP principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Risk Screening Tool, Electronic Resource Map and Resource Menu in people with Low-income Populations and Social Determinants of Health, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resource Uptake By Search (time frame: 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.