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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
2,400
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.
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.
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
RECRUITINGChange in attendance at well-child visits
Dates of visits for primary care in Health Plan of San Mateo (HPSM, the county-based Medicaid Managed Care organization) claims data.
Time frame: 12, 24 and 36 months
Change in attendance at maternal postpartum follow-up visits
Dates of visits for postpartum checks in HPSM claims data.
Time frame: 12 months
Change in pediatric Emergency Department visits
Number of visits to the pediatric Emergency Department as per the HPSM claims data.
Time frame: 12 months, 24 months and 36 months
Change in referrals to Child Protective Services
Number of referrals to Child Protective Services in San Mateo County Human Services Agency administrative data.
Time frame: 12 months, 24 months and 36 months
Change in utilization of the Women Infants and Children program (WIC) - survey parents
Research coordinators will complete a phone survey with parents regarding WIC usage
Time frame: Baseline, year 1, year 2, year 3
Change in utilization of the Women Infants and Children program (WIC) - administrative data
Administrative data from San Mateo County Family Health Services Agency regarding WIC usage
Time frame: Baseline, 12 months, 24 months and 36 months
Change in utilization of Supplemental Nutrition Assistance Program (SNAP) services - survey parents
Research coordinators will complete a phone survey with parents regarding SNAP usage
Time frame: Baseline, year 1, year 2, year 3
Change in utilization of SNAP services - administrative data
Administrative data regarding SNAP obtained from San Mateo County Human Services Agency.
Time frame: Baseline, 12 months, 24 months and 36 months
Change in food insecurity scale score as measured by U.S. Household Food Security Survey Module
Research coordinators will complete a phone survey with parents regarding the U.S. Household Food Security Survey Module: Six-Item Short Form
Time frame: Baseline, year 1, year 2, year 3
Change in financial well-being scale score
Research coordinators will complete a phone survey with parents regarding consumer Financial Protection Bureau's (CFPB) Financial Well-Being Scale (10 of 12 items)
Time frame: Baseline, year 1, year 2, year 3
Number of participants who will be able or unable to cover a $400 unexpected expense.
Research coordinators will complete a phone survey with parents regarding CFPB Financial Well-Being Scale
Time frame: Baseline, year 1, year 2, year 3
Change in child developmental trajectory
Study team will invite participants to clinical lab where a trained assessor will complete the Bayley-III Development Assessment for each child.
Time frame: Approximately 18 to 22 months, and approximately 30 to 34 months.
Change in parent depression scale score as measured by Patient Health Questionnaire (PHQ-9)
Research coordinators will administer the PHQ-9 survey to parents to evaluate parent depression level.
Time frame: Baseline, year 1, year 2, year 3
Change in diagnoses for mental and behavioral health services for the parent - claims data
Assessed through claims data from HPSM Diagnosis ICD-10 of MH/BH diagnoses and BH utilization by provider type
Time frame: Administrative data at baseline, 12, 24 and 36 months
Change in referrals for mental and behavioral health services for the parent - administrative data Family Health Services (FHS)
Assessed through FHS Administrative Data: Maternal mental health referrals, BHRS Admin Data: Enrollment in BHRS mental health services.
Time frame: Administrative data at baseline, 12, 24 and 36 months
Change in referrals for mental and behavioral health services for the parent - administrative data from Behavioral health and Recovery Services (BHRS)
Assessed through BHRS Admin Data: Enrollment in BHRS mental health services.
Time frame: Administrative data at baseline, 12, 24 and 36 months
Change in parent stress level
Research coordinators will administer the Parental Stress Index (PSI) to parents to evaluate the birthing parent's stress level.
Time frame: Year 1, year 2, year 3
Change in the breastfeeding duration
Research coordinators will survey participants about the number of months breastfeeding.
Time frame: Baseline, Year 1, year 2
Number of parents applying to childcare
Research coordinators will survey parents if they applied for childcare for their child.
Time frame: Year 1, year 2, year 3
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Number of parents applying to preschool
Research coordinators will survey parents if they applied for preschool for their child.
Time frame: Year 3
Change in the purchase pattern for the child at home.
Research coordinators will survey parents about purchasing books, clothes, diapers, and toys for their child.
Time frame: Year 1, year 2, year 3
Change in parental involvement with child
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.
Time frame: Year 1, year 2, year 3
Change in protective factors scale score as measured by Protective Factors Survey, 2nd Edition (PFS-2).
Research coordinators will administer the PFS-2 to parents.
Time frame: Baseline, year 1, year 2, year 3