Child DevelopmentPhase 2NCT07064915
Impact of a Medical-Financial Partnership Intervention on Parent Mental Health, Perinatal Outcomes, and Child Developmental Risk
A Phase 2 study testing Medical-Financial Partnership Support in people with Child Development and Mental Health, run by University of California, Los Angeles at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Development, Mental Health
- What is being tested?
- Medical-Financial Partnership Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 4 sitesUnited States
- Study dates
- 7 Jul 2025to 28 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment or any other condition that would prevent participation in the intervention
- Foster parents
- Parent age under 18 at enrollment
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Lomita Family Health Center
Harbor City, California, 90710
Martin Luther King, Jr. Outpatient Center
Los Angeles, California, 90059
Olive View-UCLA/ERI
Sylmar, California, 91342
Harbor-UCLA/Lundquist Institute
Torrance, California, 90502
About this study
Official 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
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
- Being tested
- Medical-Financial Partnership Support
- Keywords
- Medical-Financial Partnership
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical-Financial Partnership SupportBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Medical-Financial Partnership Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through 24 months
Public Benefits Program Enrollment
Rates of any public benefits enrollment.
Measured: Through 24 months of child age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start7 Jul 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Adam Schickedanz, University of California, Los Angeles
- Investigators
- Adam Schickedanz, MD PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064915
- Sponsor's protocol ID
- UCLA_DHS_MFP_Evolution_2025
- Other IDs
- 1R01HD115000-01A1
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to share data as required by sponsor policy.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07064915
- Acronym / sponsor ID
- UCLA_DHS_MFP_Evolution_2025
- Conditions
- Child Development, Mental Health
- Keywords
- Medical-Financial Partnership
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Medical-Financial Partnership SupportThis 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. |
| Medical-Financial Partnership Intervention - Postnatal | Experimental | Behavioral: Medical-Financial Partnership SupportThis arm is the second experimental group and participants included in this arm will receive the Medical-Financial Partnership intervention beginning in the postnatal period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment or any other condition that would prevent participation in the intervention
- Foster parents
- Parent age under 18 at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical-Financial Partnership SupportThe 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 | Behavioural | Medical-Financial Partnership Intervention - Postnatal, Medical-Financial Partnership Intervention - Prenatal & Postnatal |
Primary outcome
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.
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.
Public Benefits Program Enrollment
Time frame: Through 24 months of child age
Rates of any public benefits enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Yes. The plan is to share data as required by sponsor policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Schickedanz, MD PhD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medical-Financial Partnership Support in people with Child Development and Mental Health, run by University of California, Los Angeles at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Health-Related Quality of Life, including Mental Health Subscale (time frame: Through 24 Months of Child Age). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.