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Enrolling by Invitation

NCT Number: NCT07064915

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

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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Key information

Conditions

Child Development Behavior Mental Health Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lomita Family Health Center, Harbor City, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical-Financial Partnership Support

Behavioral

The Medical-Financial Partnership (MFP) intervention will include (at minimum):

  • A relationship with a trained MFP intervention team member
  • 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
  • Establishment of an action plan to reach short, medium and long-term goals in core MFP domains
  • Co-designing with the participant to identify and refine goals and action steps longitudinally
  • A standard toolkit for access to financial services and public benefits

Primary outcomes

  1. Parent Health-Related Quality of Life, including Mental Health Subscale

    Time frame: 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.

  2. Child Developmental Risk (in Any Domain) - Ages & Stages Questionnaire (ASQ, version 3) Domain Scores

    Time frame: 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.

  3. Public Benefits Program Enrollment

    Time frame: Through 24 months of child age

    Rates of any public benefits enrollment.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Jul 15, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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