Impact of a Medical-Financial Partnership Intervention on Parent Mental Health, Perinatal Outcomes, and Child Developmental Risk

Phase 2Enrolling By InvitationNCT07064915

University of California, Los Angeles1,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

1,200

Conditions

Child Development Mental Health

Interventions

The Medical-Financial Partnership (MFP) intervention will include (at minimum): 1. A relationship with a trained MFP intervention team member 2. Establishment of financial and social goals in the initial meeting, with connection to public anti-poverty programs, employment opportunities, and other income supports, among others, as tailored to participant goals 3. Establishment of an action plan to reach short, medium and long-term goals in core MFP domains 4. Co-designing with the participant to identify and refine goals and action steps longitudinally 5. A standard toolkit for access to financial services and public benefits

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * Cognitive impairment or any other condition that would prevent participation in the intervention * Foster parents * Parent age under 18 at enrollment

Locations (4)

Lomita Family Health Center

Harbor City, California, United States

Martin Luther King, Jr. Outpatient Center

Los Angeles, California, United States

Olive View-UCLA/ERI

Sylmar, California, United States

Harbor-UCLA/Lundquist Institute

Torrance, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Through 24 months

Public Benefits Program Enrollment

Rates of any public benefits enrollment.

Time frame: Through 24 months of child age