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

NCT07064915 | Enrolling By Invitation Phase 2 DMC

• 2 other identifiers: UCLA_DHS_MFP_Evolution_20251R01HD115000-01A1
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Child Development; Mental Health

Keywords

Medical-Financial Partnership

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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.

Behavioral: Medical-Financial Partnership Support

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.

Behavioral: Medical-Financial Partnership Support

Interventions

Medical-Financial Partnership Support BEHAVIORAL

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

Medical-Financial Partnership Intervention - Postnatal; Medical-Financial Partnership Intervention - Prenatal & Postnatal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment or any other condition that would prevent participation in the intervention
• Foster parents
• Parent age under 18 at enrollment

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Lomita Family Health Center

Harbor City, California, 90710, United States

Location

Martin Luther King, Jr. Outpatient Center

Los Angeles, California, 90059, United States

Location

Olive View-UCLA/ERI

Sylmar, California, 91342, United States

Location

Harbor-UCLA/Lundquist Institute

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Adam Schickedanz, MD PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 15, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): February 28, 2030
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of the study or publications, as required by sponsor.

Locations

US (4)