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

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

Status
Enrolling by invitation
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07064915
Enrollment
1200
Registered
2025-07-15
Start date
2025-07-07
Completion date
2030-02-28
Last updated
2026-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Development, Mental Health

Keywords

Medical-Financial Partnership

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.

Interventions

BEHAVIORALMedical-Financial Partnership Support

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

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Parent Health-Related Quality of Life, including Mental Health SubscaleThrough 24 Months of Child AgeMeasured 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 ScoresThrough 24 monthsCollected 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 EnrollmentThrough 24 months of child ageRates of any public benefits enrollment.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAdam Schickedanz, MD PhD

University of California, Los Angeles

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 23, 2026