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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD115000-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Control | No Intervention | 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 | Experimental | 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. |
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| Medical-Financial Partnership Intervention - Postnatal | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical-Financial Partnership Support | Behavioral | The Medical-Financial Partnership (MFP) intervention will include (at minimum):
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| Measure | Description | Time Frame |
|---|---|---|
| Parent Health-Related Quality of Life, including Mental Health Subscale | 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. | Through 24 Months of Child Age |
| Child Developmental Risk (in Any Domain) - Ages & Stages Questionnaire (ASQ, version 3) Domain Scores | 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. | Through 24 months |
| Public Benefits Program Enrollment | Rates of any public benefits enrollment. | Through 24 months of child age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Schickedanz, MD PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lomita Family Health Center | Harbor City | California | 90710 | United States | ||
| Martin Luther King, Jr. Outpatient Center |
We plan to share data as required by sponsor policy.
After the end of the study or publications, as required by sponsor.
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| Los Angeles |
| California |
| 90059 |
| United States |
| Olive View-UCLA/ERI | Sylmar | California | 91342 | United States |
| Harbor-UCLA/Lundquist Institute | Torrance | California | 90502 | United States |
| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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