The Social Needs Assistance for Hospitalized Kids Trial

NCT07687238 | Not Yet Recruiting DMC

• 2 other identifiers: 25-45380HCY-2024C3-42490
• Study Type: interventional
• Target: 1,880
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this clinical trial is to determine the best way to help families access social and economic support services in order to improve children's health for hospitalized children and their families/caregivers. The main question it aims to answer is, does providing active assistance from navigators to connect families to social/economic resources lead to greater improvements in child global health compared to providing passive referrals to resources among hospitalized children? All families will receive a tailored information sheet with referrals to community resources to address their social/economic needs and an introduction to how to search for resources using an online program. Researchers will compare families who receive these resources with families who also receive support from trained navigators, people with knowledge about local resources trained to connect families with resources. The study will examine whether the addition of navigator support improves families' access to services and children's health outcomes.

Conditions

Social Needs; Conditions Influencing Health Status; Navigation; Health-Related Social Needs; Social Needs Status; Social Determinants of Health (SDOH)

Keywords

Comparative Effectiveness Research; Randomized Control Trial; Social Determinants of Health; Child, Hospitalized; Hospital Medicine; Patient Navigation; Pediatrics

Outcome Measures

Primary Outcomes (1)

• Mean Change in Caregiver-rated Child Global Health using the National Survey of Children's Health Health Status Measure

  Child global health will be assessed using the caregiver-rated child health status item from the National Survey of Children's Health. Caregivers rate the child's overall health on a 5-point ordinal scale: Excellent, Very Good, Good, Fair, or Poor. Responses will be assigned numeric values from 1 to 5 for analysis (Excellent = 1, Very Good = 2, Good = 3, Fair = 4, Poor = 5). Scores range from 1 to 5, with lower scores indicating better child global health and higher scores indicating worse child global health. Mean change from baseline to 6 months will be reported.

  Baseline and 6 months after recruitment

Secondary Outcomes (3)

• Mean Change in Caregiver-rated Child Quality of Life using the Pediatric Quality of Life Inventory (PedsQL)/PedsQL Short Form

  Baseline and 6 months after recruitment

• Rate of emergency department (ED) visits or readmissions

  Between baseline and 6 months after recruitment

• Change in number of social risks

  Between baseline and 6 months after recruitment

Study Arms (2)

Active Assistance by Navigators

EXPERIMENTAL

Passive referral intervention activities plus assistance from social needs navigators

Other: Active Assistance by Navigators

Passive Referral

ACTIVE COMPARATOR

List of social resources and introduction of how to access and use Findhelp

Other: Passive Referral

Interventions

Active Assistance by Navigators OTHER

Participants will receive the same resources as in the passive referral group as well as support from navigators for up to 3 months after enrollment. Navigators will review resources with caregivers, assist with completion of intake applications when applicable, and provide support related to accessing social services.

Active Assistance by Navigators

Passive Referral OTHER

Participants in this group will receive a list of local resources to address social needs based on the social risks for which they screen positive and where they live. Research staff will use Findhelp, an online platform that helps identify social resources (e.g., food assistance, housing support) based on zip code, to inform creation of the lists. In addition, families will receive a brief introduction on how to access and use Findhelp.

Passive Referral

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Aim 1 - Caregiver-Child Dyads Sample
• Caregiver-child dyads will be eligible to participate in the study if they meet the following criteria assessed during the recruitment and enrollment process:
• children are hospitalized on the general pediatric/pediatric hospital medicine (PHM) team/service
• the child is between the ages of 0-17
• the child's caregiver is \>17 years-old
• the caregiver speaks English or Spanish
• the family lives in the same county as the hospital or in a neighboring county to the hospital
• the child is not in Child Protective Services custody
• the family has not previously been enrolled in the study
• the caregiver screens positive for \>=1 of the following social risks: food insecurity, housing instability, housing quality concerns, transportation needs, utilities needs, child care needs, or financial strain
• the family is not enrolled in another social needs assistance-related research study (e.g., another social needs navigation study)
• Aim 2 - Caregiver and Community-based Organization (CBO) Qualitative Interviews Sample Caregivers of children enrolled in Aim 1 will be eligible for study interviews.
• CBO staff will be eligible to participate if they are:
• \> 17 years old
• speak English or Spanish

You may not qualify if:

• Aim 1 - Caregiver-Child Dyads Sample
• Participants will be excluded from participation if they are:
• not hospitalized or hospitalized outside of general/PHM SERVICE
• children are 18 years of age or older
• caregiver/guardians are under the age of 18 years of age
• caregivers are do not speak English or Spanish
• the family does not live in the same or neighboring county of the recruitment hospital
• the child is under the care of Child Protective Services custody
• the family has already been previously enrolled in the study
• the caregiver does not screen positive for any of the following social risks: food insecurity, housing instability, housing quality concerns, transportation needs, utilities needs, child care needs, or financial strain
• the family is already enrolled in a social needs assistance-related research study (e.g., another social needs navigation study)
• Aim 2 - Caregiver and CBO qualitative interviews Caregivers of children not enrolled in Aim 1 will not be eligible to participate study interviews.
• CBO staff will not be eligible to participate if they are:
• under 18 years of age
• do not speak English or Spanish

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• Baylor University: collaborator
• Children's Hospital of Philadelphia: collaborator
• University of California, San Francisco: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (6)

UCSF Benioff Children's Hospital - Oakland

Oakland, California, 94609, United States

Location

UCSF Benioff Children's Hospital - San Francisco

San Francisco, California, 49158, United States

Location

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Texas Children's Hospital - West Campus

Houston, Texas, 77094, United States

Location

Study Officials

• Matthew S Pantell, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Wing, MA

CONTACT

510-205-7891; holly.wing@ucsf.edu

Matthew S Pantell, MD, MS

CONTACT

matt.pantell@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 7, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (6)