Impact of a Medical-Financial Partnership Intervention on Parent Mental Health, Perinatal Outcomes, and Child Developmental Risk: A Community-Partnered, Multi-Site Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 1,200
- 试验地点
- 4
- 主要终点
- Child Developmental Risk (in Any Domain) - Ages & Stages Questionnaire (ASQ, version 3) Domain Scores
研究概览
简要总结
Poverty and financial stress are key social drivers of health and root causes of worse health beginning in pregnancy, continuing into childhood, and extending over the life course, but clinical tools to address the health impacts of poverty and financial stress are needed. This trial is of a multi-site medical-financial partnership intervention to examine its effect on parent, perinatal, and child outcomes, as well as health care utilization, and family financial and social risk. This pragmatic randomized clinical effectiveness trial will examine the impact of a clinic-based medical-financial partnership intervention beginning either 1) in the newborn period (Intervention Arm 1) or 2) during prenatal care (Intervention Arm 2) versus controls on parent, child, and family/household outcomes.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being an expectant parent (mother or father) who is either 1) receiving prenatal care or 2) their partner is receiving prenatal care at one of the study's prenatal care clinical sites during recruitment
- •Intending at the time of recruitment to have their child receive primary pediatric care at one of the of the study's pediatric primary care clinical sites after birth
- •Speaking English or Spanish as primary language
排除标准
- •Cognitive impairment or any other condition that would prevent participation in the intervention
- •Foster parents
- •Parent age under 18 at enrollment
研究组 & 干预措施
Standard Care Control
This arm is the comparison group, which will receive standard prenatal and pediatric care with social needs screening and intervention as provided by the health care team as usual care (no medical-financial partnership intervention).
Medical-Financial Partnership Intervention - Prenatal & Postnatal
This arm is the first experimental group and participants included in this arm will receive the Medical-Financial Partnership intervention beginning in prenatal care and continuing into the postnatal period.
干预措施: Medical-Financial Partnership Support (Behavioral)
Medical-Financial Partnership Intervention - Postnatal
This arm is the second experimental group and participants included in this arm will receive the Medical-Financial Partnership intervention beginning in the postnatal period.
干预措施: Medical-Financial Partnership Support (Behavioral)
结局指标
主要结局
Child Developmental Risk (in Any Domain) - Ages & Stages Questionnaire (ASQ, version 3) Domain Scores
时间窗: Through 24 months
Collected via participant reported standardized Ages \& Stages Questionnaire Version 3 (ASQ-3; each domain scale score ranging from 0-60 with threshold cutoffs for delays varying by child age, with lower values indicating a higher likelihood of developmental delay) forms on electronic surveys (preferred source) and at every well child visit beyond age 6 months. The presence of child developmental risk in any of five developmental domains (communication/speech/language, personal-social skills, gross motor skills, fine motor skills, or problem solving) will be measured at well child visits on parent-completed ASQ forms as well as every 6 months via online surveys from child age 6 to 24 months and rates of positive screens for developmental delay will be compared.
Parent Health-Related Quality of Life, including Mental Health Subscale
时间窗: Through 24 Months of Child Age
Measured via participant-reported electronic or paper survey via the Patient Reported Outcome Measurement Information System Short Form Global Scale 10 Item Scale (the PROMIS-10; raw scale range 10-50 then T-Scored, with lower values indicating worse outcomes), this continuous measure is calculated based on Likert scale responses to 10 participant-reported questions/prompts. A mental health subscale of four items assesses depression and anxiety symptom burden and can be T-scored in preparation for analyses.
Child Developmental Risk (in Any Domain) - Ages & Stages Questionnaire (ASQ, version 3) Domain Scores
时间窗: Through 24 months
Collected via participant reported standardized Ages \& Stages Questionnaire Version 3 (ASQ-3; each domain scale score ranging from 0-60 with threshold cutoffs for delays varying by child age, with lower values indicating a higher likelihood of developmental delay) forms on electronic surveys (preferred source) and at every well child visit beyond age 6 months. The presence of child developmental risk in any of five developmental domains (communication/speech/language, personal-social skills, gross motor skills, fine motor skills, or problem solving) will be measured at well child visits on parent-completed ASQ forms as well as every 6 months via online surveys from child age 6 to 24 months and rates of positive screens for developmental delay will be compared.
Public Benefits Program Enrollment
时间窗: Through 24 months of child age
Rates of any public benefits enrollment.
次要结局
未报告次要终点
研究者
Adam Schickedanz
Assistant Professor of Pediatrics
University of California, Los Angeles