An interventional study of Active Assistance by Navigators and Passive Referral in Social Needs, Health-Related Social Needs and Social Determinants of Health (SDOH), sponsored by University of California, San Francisco. Not yet recruiting at 6 sites in United States. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
This multi-center randomized clinical trial (RCT) will compare the effectiveness of two interventions that help families connect with community-based resources to address social and economic needs (e.g., food insecurity, housing instability) on the health of hospitalized children: 1) passive referral (providing information to families about community-based organizations [CBOs] that can help address their social/economic needs and an introduction to an online resource to search for resources; vs. 2) active assistance by navigators -additionally providing the support of trained navigators to help connect families to CBOs both during and after enrollment.
The study's Specific Aims are:
AIM 1 (RCT): Conduct a multicenter, pragmatic, RCT among hospitalized children to determine the comparative effectiveness of passive referral versus active assistance by navigators on long-term, child health outcomes.
H1: Both interventions will lead to improvements, but active assistance by navigator (the higher intensity intervention) will lead to significantly more improvement in health among hospitalized children.
Aim 1B: Explore how intervention effects vary by child and family characteristics using heterogeneity of treatment (HTE) effect analyses HTE hypothesis: Children with high social needs will experience greater benefit with active assistance by navigators.
AIM 2 (Qualitative Interviews): Conduct interviews with caregivers who received resources and CBOs to identify barriers, facilitators, and mechanisms involved in connecting caregivers to CBOs and improving child health outcomes.
H1: Navigators' local knowledge of CBOs will be a key facilitator in addressing social needs.
H2: When social needs/competing demands are reduced, caregivers can focus more on their child's health.
For Aim 1, research staff will identify potentially eligible hospitalized patients through the electronic health record (EHR) and approach their caregivers about participation. Participants will first complete an eligibility screener and identify any social risks factors (e.g., food insecurity). If caregivers are deemed eligible, study staff will obtain informed consent from interested caregivers. All participating families will receive a tailored list of community resources to address their social needs informed by Findhelp, a web-based platform that helps individuals identify and connect with resources to address their social needs based on zip code. Families will also receive information on how to access and use Findhelp. Families will be randomly assigned to either: 1) the passive referral arm, for which no additional intervention activities will be provided, or 2) the active assistance by navigators arm, for which families will additionally receive hands-on support from a navigator, including follow-up contact every two weeks for three months, to help assist families in connecting with resources. The study will support both English- and Spanish-speaking families. Caregivers and their children will be followed over a 12-month period to assess health and social outcomes, with the primary outcome being assessed at 6 months after enrollment.
Aim 2 will involve interviewing a subset of caregivers who participated in Aim 1 and staff from CBOs serving recruitment site areas. Staff will conduct semi-structured interviews to explore perspectives on barriers and facilitators of connecting to CBOs to address social needs and mechanisms through which the interventions influence child health outcomes.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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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:
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:
EXCLUSION CRITERIA:
Aim 1 - Caregiver-Child Dyads Sample
Participants will be excluded from participation if they are:
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:
Passive referral intervention activities plus assistance from social needs navigators
Other: Active Assistance by Navigators
List of social resources and introduction of how to access and use Findhelp
Other: Passive Referral
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.
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.
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.
Time frame: Baseline and 6 months after recruitment
Mean Change in Caregiver-rated Child Quality of Life using the Pediatric Quality of Life Inventory (PedsQL)/PedsQL Short Form
Child quality of life will be assessed using caregiver-rated child quality of life measures from the Pediatric Quality of Life Inventory (PedsQL)/PedsQL Short For. The PedsQL includes 4 domains with 5-point Likert items that are averaged to create a single score for each domain: physical functioning, emotional functioning, social functioning, and cognitive/school functioning. It has versions that vary by age group (0-12 months, 13-23 months, 2-4 years, 5-7 years, 8-12 years, and 13-18 years). We will use the Short Form for age groups for which it is available. Mean change from baseline to 6 months will be reported for each domain.
Time frame: Baseline and 6 months after recruitment
Rate of emergency department (ED) visits or readmissions
Whether child had an emergency department visit or readmission after discharge between baseline and follow-up.
Time frame: Between baseline and 6 months after recruitment
Change in number of social risks
Change in the number of caregiver-endorsed social risk factors between baseline and follow-up.
Time frame: Between baseline and 6 months after recruitment
Plan to share: Yes — We will prepare a Full Data Package to support data integrity and reproducibility, including de-identified, analysis-ready data and accompanying documentation. We will deposit the package in the Patient-Centered Outcomes Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (ICPSR), in accordance with PCORI's Policy on Data Management and Data Sharing. Limited Data Set versions may be distributed to external collaborators with a data use agreement. Any collaborator requiring identifying data elements outside the bounds of a Limited Data Set will first be added formally as research personnel.
Supporting information: Study protocol, Sap
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University of California, San Francisco