Child Care, Child Development, Child Health, Community Health Workers, Healthcare Disparities, Health Services Utilization, Hispanic or Latino, Income, Infant, Newborn, Medicaid, Mothers, Poverty, Social Services Utilization, United States
Conditions
Keywords
Guaranteed Basic Income, Community Health Workers, Medicaid, Medi-Cal, Community Partners, Coordinated Care, Coordinated Services, randomized trial, surveys, infant, newborn, newborn nursery
Brief summary
Early childhood is a critical period, laying the foundation for future growth and deveopment. This foundational period has an outsized effect, impacting health, well-being and achievement across one's lifespan. The U.S. lacks a cohesive early childhood system to support families with young children ages 0-5. The goal of this randomized controlled trial(RCT) is to test if community-based support via community health workers(CHWs) improves social and health services utilization, and child development. Furthermore, the trial will examine if income support enhances the impact of a CHW integrated system. Participants are English and Spanish speaking families with healthy newborns. This RCT was designed based on family priorities, community capacity and needs in a collective impact model. This trial is anchored at a university based children's hospital and involves many partners: families, county health, county leadership, a leading early childhood non-profit organization, the county's Medicaid managed care organization.
Interventions
BEHAVIORALCommunity Health Worker
A Community Health Worker will assist participants in navigating the medical system and connecting the participants to community services during the first three years of their child's life.
BEHAVIORALCommunity Health Worker + Guaranteed Basic Income
A Community Health Worker will assist participants in navigating the medical system and connecting the participants to community services during the first three years of their child's life. Participants will also receive a monthly unconditional cash gift for the first three years of their child's life.
Sponsors
Stanford University
Health Plan of San Mateo
The Fidelity Charitable Trust
Silicon Valley Community Foundation
San Mateo County Health
First 5 San Mateo County
The Jackie Speier Foundation
Valhalla Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to No maximum
Healthy volunteers
No
Inclusion criteria
Caregiver Eligibility Criteria * 18 and Older * Family plans to reside in San Mateo County * Does not plan to move from the County in the next year * Speaks English and/or Spanish * Cared for in Postpartum Maternity unit Child Eligibility Criteria * Baby is being cared for in well newborn nursery * Child is enrolled in Medicaid * 36 weeks or older * To be discharged home in the custody of the caregiver
Exclusion criteria
Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in attendance at well-child visits | 12, 24 and 36 months | Dates of visits for primary care in Health Plan of San Mateo (HPSM, the county-based Medicaid Managed Care organization) claims data. |
| Change in attendance at maternal postpartum follow-up visits | 12 months | Dates of visits for postpartum checks in HPSM claims data. |
| Change in pediatric Emergency Department visits | 12 months, 24 months and 36 months | Number of visits to the pediatric Emergency Department as per the HPSM claims data. |
| Change in referrals to Child Protective Services | 12 months, 24 months and 36 months | Number of referrals to Child Protective Services in San Mateo County Human Services Agency administrative data. |
| Change in utilization of the Women Infants and Children program (WIC) - survey parents | Baseline, year 1, year 2, year 3 | Research coordinators will complete a phone survey with parents regarding WIC usage |
| Change in utilization of the Women Infants and Children program (WIC) - administrative data | Baseline, 12 months, 24 months and 36 months | Administrative data from San Mateo County Family Health Services Agency regarding WIC usage |
| Change in utilization of Supplemental Nutrition Assistance Program (SNAP) services - survey parents | Baseline, year 1, year 2, year 3 | Research coordinators will complete a phone survey with parents regarding SNAP usage |
| Change in utilization of SNAP services - administrative data | Baseline, 12 months, 24 months and 36 months | Administrative data regarding SNAP obtained from San Mateo County Human Services Agency. |
| Change in food insecurity scale score as measured by U.S. Household Food Security Survey Module | Baseline, year 1, year 2, year 3 | Research coordinators will complete a phone survey with parents regarding the U.S. Household Food Security Survey Module: Six-Item Short Form |
| Change in financial well-being scale score | Baseline, year 1, year 2, year 3 | Research coordinators will complete a phone survey with parents regarding consumer Financial Protection Bureau's (CFPB) Financial Well-Being Scale (10 of 12 items) |
| Number of participants who will be able or unable to cover a $400 unexpected expense. | Baseline, year 1, year 2, year 3 | Research coordinators will complete a phone survey with parents regarding CFPB Financial Well-Being Scale |
| Change in child developmental trajectory | Approximately 18 to 22 months, and approximately 30 to 34 months. | Study team will invite participants to clinical lab where a trained assessor will complete the Bayley-III Development Assessment for each child. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in parent depression scale score as measured by Patient Health Questionnaire (PHQ-9) | Baseline, year 1, year 2, year 3 | Research coordinators will administer the PHQ-9 survey to parents to evaluate parent depression level. |
| Change in diagnoses for mental and behavioral health services for the parent - claims data | Administrative data at baseline, 12, 24 and 36 months | Assessed through claims data from HPSM Diagnosis ICD-10 of MH/BH diagnoses and BH utilization by provider type |
| Change in referrals for mental and behavioral health services for the parent - administrative data Family Health Services (FHS) | Administrative data at baseline, 12, 24 and 36 months | Assessed through FHS Administrative Data: Maternal mental health referrals, BHRS Admin Data: Enrollment in BHRS mental health services. |
| Change in referrals for mental and behavioral health services for the parent - administrative data from Behavioral health and Recovery Services (BHRS) | Administrative data at baseline, 12, 24 and 36 months | Assessed through BHRS Admin Data: Enrollment in BHRS mental health services. |
| Change in parent stress level | Year 1, year 2, year 3 | Research coordinators will administer the Parental Stress Index (PSI) to parents to evaluate the birthing parent's stress level. |
| Change in the breastfeeding duration | Baseline, Year 1, year 2 | Research coordinators will survey participants about the number of months breastfeeding. |
| Number of parents applying to childcare | Year 1, year 2, year 3 | Research coordinators will survey parents if they applied for childcare for their child. |
| Number of parents applying to preschool | Year 3 | Research coordinators will survey parents if they applied for preschool for their child. |
| Change in the purchase pattern for the child at home. | Year 1, year 2, year 3 | Research coordinators will survey parents about purchasing books, clothes, diapers, and toys for their child. |
| Change in parental involvement with child | Year 1, year 2, year 3 | Research coordinators will survey parents asking if they increased or decreased parental engagement activities with their child such as singing, sharing stories, encouraging behavior and preventing challenging behavior, building up child's interest, reading, and engaging in verbal skills. |
| Change in protective factors scale score as measured by Protective Factors Survey, 2nd Edition (PFS-2). | Baseline, year 1, year 2, year 3 | Research coordinators will administer the PFS-2 to parents. |
Countries
United States
Contacts
CONTACTElise Kuechle, MA
PRINCIPAL_INVESTIGATORRyan Padrez, MD
Stanford University
Outcome results
None listed