Clinic-Based Financial Coaching and Family Health and Development

Study Overview
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Brief Summary
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This study will examine the impact of clinic-based financial coaching on parent health-related quality of life and child development measures, as well as family social needs for families with young children receiving pediatric care at a primary care practice in the Los Angeles County safety net.

Detailed Description
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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 two 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 financial metrics.

Official Title
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The Effect of a Clinic-Based Financial Coaching on Health and Development

Conditions
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Economic Problems, Development, Child, Quality of Life

Intervention / Treatment
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* Behavioral: Financial coaching and services


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention - Financial Coaching Plus Social Needs Screening<br>Families in this intervention arm will receive financial coaching at each well child visit, in addition to clinic-based social needs screening and referral. | Behavioral: Financial coaching and services<br>* 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.<br>|
| Active Comparator: Control - Social Needs Screening and Referral<br>Families in this active control arm will receive social needs screening and referral to community resources to address identified social needs. | Behavioral: Financial coaching and services<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10) | 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. | Interval change in PROMIS-10 HRQOL will be assessed over up to a 3 year period. | 
| Developmental Risk - Ages and Stages Questionnaires | 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. | Interval change in developmental risk will be assessed over up to a 3 year period. | 
| Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items | 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. | Interval change in presence of any social need will be assessed over up to a 3 year period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic Stress - Family Economic Strain Scale. | 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. | Interval change in FESS will be assessed over up to a 3 year period. | 
| Parenting Self-Efficacy - Parenting Sense of Competence Scale | 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. | Interval change in PSOC will be assessed over up to a 3 year period. | 
| Pediatric Primary Care Visit Adherence | Pediatric primary care visit adherence will be measured as a rate for families in the study. | Interval change in pediatric primary care visit adherence will be assessed over up to a 3 year period. |