- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03736590
Clinic-Based Financial Coaching and Family Health and Development
The Effect of a Clinic-Based Financial Coaching on Health and Development
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With an expert group of researchers, financial coaches, and implementation scientists, we will study the impact of clinic-based financial coaching on parent health-related quality of life, child developmental risk, and social needs.We will conduct a clinical randomized controlled trial of financial coaching for low-income families. Parents of infants in a large pediatric primary care safety-net clinic will receive either 1) financial coaching from trained coaches plus social needs screening and resource navigation at all well child visits (intervention) or 2) social needs screening and navigation alone (active control) and will be followed for five years. Aims include:
1a) Examine parent outcomes of overall health-related quality of life (primary parent outcome);
1b) Examine child outcomes of developmental risk scores (primary child outcome) and well-child visit adherence;
1c) Examine family social needs outcomes, including incidence of any food insecurity, housing instability, transportation or utilities interruptions (primary family outcome any one or more) and resource use; and financial metrics.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- Adam Schickedanz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Parents/caregivers in families with children 4 months or under at enrollment receiving care at Harbor-UCLA medical center clinic.
Exclusion Criteria:
- Cognitive impairment or not speaking English or Spanish.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention - Financial Coaching Plus Social Needs Screening
Families in this intervention arm will receive financial coaching at each well child visit, in addition to clinic-based social needs screening and referral.
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The intervention will consist of clinic-based financial coaching that focuses on improving financial stability through longitudinal visits with financial services professionals to address financial goals.
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Active Comparator: Control - Social Needs Screening and Referral
Families in this active control arm will receive social needs screening and referral to community resources to address identified social needs.
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The intervention will consist of clinic-based financial coaching that focuses on improving financial stability through longitudinal visits with financial services professionals to address financial goals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
Time Frame: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
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Health-related quality of life will be measured at baseline and regular intervals using the Patient-Reported Outcomes Measurement Information System Global Health Short Form 10 (PROMIS 10).
This will be the primary outcome for parents in the study.
The PROMIS-10 measures overall health, physical health, mental health and social functioning and is scored on a T-scored range with 50 as the mean and 10 as the standard deviation.
Higher scores indicate better HRQOL.
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Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
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Developmental Risk - Ages and Stages Questionnaires
Time Frame: Interval change in developmental risk will be assessed over up to a 5 year period.
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Parent report of child developmental risk via clinic-based developmental questionnaires (Ages and Stages Questionnaires, ASQ) will be used to measure developmental risk.
The ASQ measure contains sub-scales for each developmental domain (gross motor, fine motor, problem solving, communication, problem-solving, personal-social).
Parent-reported ASQ items yield a score from 0-60 with cutoffs determining children at risk for developmental delay.
Higher scores indicate less risk of developmental delay.
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Interval change in developmental risk will be assessed over up to a 5 year period.
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Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items
Time Frame: Interval change in presence of any social need will be assessed over up to a 5 year period.
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Family social needs to be assessed at baseline and regular intervals include food insecurity, housing insecurity, transportation problems, utilities problems, and legal issues.
All of these social needs are measured using the Accountable Health Communities Social Needs Screener and the presence of any of the above social needs will be interpreted as the presence of a social need.
Social needs resource use will also be measured.
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Interval change in presence of any social need will be assessed over up to a 5 year period.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Economic Stress - Family Economic Strain Scale.
Time Frame: Interval change in FESS will be assessed over up to a 5 year period.
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Family economic stress will be measured using the Family Economic Strain Scale (FESS) score.
The FESS has 15 items and ranges from a score of 5 to 75, with higher scores indicating less financial stress.
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Interval change in FESS will be assessed over up to a 5 year period.
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Parenting Self-Efficacy - Parenting Sense of Competence Scale
Time Frame: Interval change in PSOC will be assessed over up to a 5 year period.
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Parenting self-efficacy will be measured using the Parenting Sense of Competence Scale (PSOC).
The PSOC is a 17 item scale with a range from 17 to 102, with higher scores indicating more parent competence.
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Interval change in PSOC will be assessed over up to a 5 year period.
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Pediatric Primary Care Visit Adherence
Time Frame: Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.
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Pediatric primary care visit adherence will be measured as a rate for families in the study.
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Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Financial Measures - Income
Time Frame: Interval change in financial measures will be assessed over up to a 5 year period.
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Family financial measure of dollar value of yearly income will be collected via survey.
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Interval change in financial measures will be assessed over up to a 5 year period.
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Financial Measures - Savings
Time Frame: Interval change in financial measures will be assessed over up to a 5 year period.
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Family financial measure of dollar value of savings will be collected as part of the study via survey.
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Interval change in financial measures will be assessed over up to a 5 year period.
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Financial Measures - Debt
Time Frame: Interval change in financial measures will be assessed over up to a 5 year period.
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Family financial measure of dollar value of debt will be collected as part of the study via survey.
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Interval change in financial measures will be assessed over up to a 5 year period.
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Financial Measures - Credit Score
Time Frame: Interval change in financial measures will be assessed over up to a 5 year period.
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Family financial credit score will be collected as part of the study via survey.
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Interval change in financial measures will be assessed over up to a 5 year period.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UCLAHarborSchickedanzMFP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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