Quality of Life Clinical Trial
Official title:
The Effect of a Clinic-Based Financial Coaching on Health and Development
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | July 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Adam Schickedanz | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Financial Measures - Income | Family financial measure of dollar value of yearly income will be collected via survey. | Interval change in financial measures will be assessed over up to a 3 year period. | |
Other | Financial Measures - Savings | Family financial measure of dollar value of savings will be collected as part of the study via survey. | Interval change in financial measures will be assessed over up to a 3 year period. | |
Other | Financial Measures - Debt | Family financial measure of dollar value of debt will be collected as part of the study via survey. | Interval change in financial measures will be assessed over up to a 3 year period. | |
Other | Financial Measures - Credit Score | Family financial credit score will be collected as part of the study via survey. | Interval change in financial measures will be assessed over up to a 3 year period. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | 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. | |
Secondary | 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. | |
Secondary | 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. |
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