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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03736590
Other study ID # UCLAHarborSchickedanzMFP
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2018
Est. completion date July 1, 2024

Study information

Verified date September 2023
Source University of California, Los Angeles
Contact Chris Laybourn
Phone 310-206-1113
Email claybourn@mednet.ucla.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial 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.

Locations

Country Name City State
United States Adam Schickedanz Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

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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