Social NeedsSNAKNCT07687238
The Social Needs Assistance for Hospitalized Kids Trial
A study testing Active Assistance by Navigators and Passive Referral in people with Social Needs and Health-Related Social Needs, run by University of California, San Francisco at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Social Needs, Health-Related Social Needs, Social Determinants of Health (SDOH)
- What is being tested?
- Active Assistance by Navigators and Passive Referral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,880 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2026to Sep 2030
- Phase
- Interventional
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
- work at a CBO serving the area in which patients at the study sites live
Who cannot join
- 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
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- 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
- do not work at a CBO serving the recruitment site areas
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew S Pantell, MD, MS contact
6 sites in 1 country
United States6 sites
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Sheela Gavvala, DO, sheela.gavvala@uth.tmc.edu
Texas Children's Hospital - West Campus
Houston, Texas, 77094
Marina Masciale, MD, MPH, marina.masciale@bcm.edu
Michelle Lopez, MD, MPH, MEd, malopez@texaschildrens.org
UCSF Benioff Children's Hospital - Oakland
Oakland, California, 94609
Bella Doshi, MD, Bella.Doshi@ucsf.edu
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Aditi Vasan, MD, MSHP, vasana@chop.edu
UCSF Benioff Children's Hospital - San Francisco
San Francisco, California, 49158
Nora Pfaff, MD, Nora.Pfaff@ucsf.edu
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
Mabel Chan, MD, Mabel.Chan@ucsf.edu
About this study
Official title: Comparing Two Social Needs Assistance Interventions to Improve Health Among Hospitalized Children
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.
Read the detailed description
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.
- Conditions
- Social Needs, Health-Related Social Needs, Social Determinants of Health (SDOH), Social Needs Status, Conditions Influencing Health Status, Navigation
- Being tested
- Active Assistance by Navigators, Passive Referral
- Keywords
- Comparative Effectiveness Research, Randomized Control Trial, Social Determinants of Health, Child, Hospitalized, Hospital Medicine, Patient Navigation, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Assistance by NavigatorsOther
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.
Passive ReferralOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Assistance by Navigators | Experimental | Passive referral intervention activities plus assistance from social needs navigators Receives: Other: Active Assistance by Navigators |
| Passive Referral | Active comparator | List of social resources and introduction of how to access and use Findhelp Receives: Other: Passive Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Between baseline and 6 months after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social NeedsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, The University of Texas Health Science Center, Houston, Baylor University, Children's Hospital of Philadelphia
- Responsible party
- Sponsor
- Investigators
- Matthew S Pantell, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687238
- Sponsor's protocol ID
- 25-45380
- Other IDs
- HCY-2024C3-42490
- Acronym
- SNAK
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.