Advancing Health Equity Via Basic Income + Early Childhood Systems Integration: An RCT of the Baby Bonus Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 1
- 主要终点
- Change in attendance at well-child visits
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 0 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Caregiver Exclusion Criteria
- •Will not consent to share data via Epic/Study
- •Caregiver has significant cognitive impairment
- •Caregiver under contact isolation
- •Child Exclusion Criteria
- •Sibling already enrolled in the Baby Bonus Study
- •Child has significant genetic disorder issues at birth
- •Child is a multiple (not a singleton)
研究组 & 干预措施
Group A: Coordinated Care
Participants will receive coordinated Services via a Community Health Worker for 3 years in a hybrid format.
干预措施: Community Health Worker (Behavioral)
Group B: Coordinated Care + Monthly Income Support
Participants will receive the same coordinated services as in group A in addition to guaranteed basic income for 36 months.
干预措施: Community Health Worker + Guaranteed Basic Income (Behavioral)
Group C: Standard of care
Participants in this group and will receive no treatment or intervention.
结局指标
主要结局
Change in attendance at well-child visits
时间窗: 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
时间窗: 12 months
Dates of visits for postpartum checks in HPSM claims data.
Change in pediatric Emergency Department visits
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
时间窗: 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
时间窗: 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.
次要结局
- Change in parent depression scale score as measured by Patient Health Questionnaire (PHQ-9)(Baseline, year 1, year 2, year 3)
- Change in diagnoses for mental and behavioral health services for the parent - claims data(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)(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)(Administrative data at baseline, 12, 24 and 36 months)
- Change in parent stress level(Year 1, year 2, year 3)
- Change in the breastfeeding duration(Baseline, Year 1, year 2)
- Number of parents applying to childcare(Year 1, year 2, year 3)
- Number of parents applying to preschool(Year 3)
- Change in the purchase pattern for the child at home.(Year 1, year 2, year 3)
- Change in parental involvement with child(Year 1, year 2, year 3)
- Change in protective factors scale score as measured by Protective Factors Survey, 2nd Edition (PFS-2).(Baseline, year 1, year 2, year 3)
研究者
Ryan Christopher Padrez
Clinical Associate Professor, Pediatrics - General
Stanford University