Clinical trial NCT03736590: Clinic-Based Financial Coaching and Family Health and Development
Official title: The Effect of a Clinic-Based Financial Coaching on Health and Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Economic Problems
Development, Child
Quality of Life
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10)
timeFrame: Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period.
measure: Developmental Risk - Ages and Stages Questionnaires
timeFrame: Interval change in developmental risk will be assessed over up to a 5 year period.
measure: Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items
timeFrame: Interval change in presence of any social need will be assessed over up to a 5 year period.
Secondary outcomes:
measure: Economic Stress - Family Economic Strain Scale.
timeFrame: Interval change in FESS will be assessed over up to a 5 year period.
measure: Parenting Self-Efficacy - Parenting Sense of Competence Scale
timeFrame: Interval change in PSOC will be assessed over up to a 5 year period.
measure: Pediatric Primary Care Visit Adherence
timeFrame: Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.
Other outcomes:
measure: Financial Measures - Income
timeFrame: Interval change in financial measures will be assessed over up to a 5 year period.
measure: Financial Measures - Savings
timeFrame: Interval change in financial measures will be assessed over up to a 5 year period.
measure: Financial Measures - Debt
timeFrame: Interval change in financial measures will be assessed over up to a 5 year period.
measure: Financial Measures - Credit Score
timeFrame: Interval change in financial measures will be assessed over up to a 5 year period.
Locations:
city: Los Angeles
country: United States
facility: Adam Schickedanz
state: California
Study officials:
References: