Development, Child, Economic Problems, Quality of Life
Conditions
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 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.
Interventions
BEHAVIORALFinancial coaching and services
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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Pediatricians and outcomes assessors will not be aware of study arm.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related Quality of Life (HRQOL) - Patient Reported Outcome Measurement Information System Global Health Short Form 10-Item Scale (PROMIS-10) | Interval change in PROMIS-10 HRQOL will be assessed over up to a 5 year period. | 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. |
| Developmental Risk - Ages and Stages Questionnaires | Interval change in developmental risk will be assessed over up to a 5 year period. | 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. |
| Presence of Any Social Need - Accountable Health Communities Social Needs Screening Items | Interval change in presence of any social need will be assessed over up to a 5 year period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Economic Stress - Family Economic Strain Scale. | Interval change in FESS will be assessed over up to a 5 year period. | 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. |
| Parenting Self-Efficacy - Parenting Sense of Competence Scale | Interval change in PSOC will be assessed over up to a 5 year period. | 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. |
| Pediatric Primary Care Visit Adherence | Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period. | Pediatric primary care visit adherence will be measured as a rate for families in the study. |
Countries
United States
Outcome results
None listed