Clinic-Based Financial Coaching and Family Health and Development

• ClinicalTrials.gov Identifier: NCT03736590
• Recruitment Status: Recruiting
• First Posted: November 9, 2018
• Last Update Posted: January 12, 2021
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Adam Schickedanz, University of California, Los Angeles

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Economic Problems; Development, Child; Quality of Life	Behavioral: Financial coaching and services	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial
• Masking: None (Open Label)
• Masking Description: Pediatricians and outcomes assessors will not be aware of study arm.
• Primary Purpose: Health Services Research
• Official Title: The Effect of a Clinic-Based Financial Coaching on Health and Development
• Actual Study Start Date: November 7, 2018
• Estimated Primary Completion Date: July 1, 2023
• Estimated Study Completion Date: July 1, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention - Financial Coaching Plus Social Needs Screening; 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; 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.
Active Comparator: Control - Social Needs Screening and Referral; 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; 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Financial Measures - Income [ Time Frame: Interval change in financial measures will be assessed over up to a 3 year period. ]
   Family financial measure of dollar value of yearly income will be collected via survey.
2. Financial Measures - Savings [ Time Frame: Interval change in financial measures will be assessed over up to a 3 year period. ]
   Family financial measure of dollar value of savings will be collected as part of the study via survey.
3. Financial Measures - Debt [ Time Frame: Interval change in financial measures will be assessed over up to a 3 year period. ]
   Family financial measure of dollar value of debt will be collected as part of the study via survey.
4. Financial Measures - Credit Score [ Time Frame: Interval change in financial measures will be assessed over up to a 3 year period. ]
   Family financial credit score will be collected as part of the study via survey.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, California

Adam Schickedanz; Recruiting

Los Angeles, California, United States, 90024

Contact: Adam Schickedanz, MD PhD 310-794-2583 Aschickedanz@mednet.ucla.edu

Sponsors and Collaborators

University of California, Los Angeles

More Information

• Responsible Party: Adam Schickedanz, Assistant Professor of Pediatrics, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03736590
• Other Study ID Numbers: UCLAHarborSchickedanzMFP
• First Posted: November 9, 2018
• Last Update Posted: January 12, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No