NCT03736590

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Nov 2018Jul 2030

First Submitted

Initial submission to the registry

November 7, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

November 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2030

Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

11.2 years

First QC Date

November 7, 2018

Last Update Submit

July 4, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 5 year period.

  • 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 5 year period.

  • 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. Social needs resource use will also be measured.

    Interval change in presence of any social need will be assessed over up to a 5 year period.

Secondary Outcomes (3)

  • Economic Stress - Family Economic Strain Scale.

    Interval change in FESS will be assessed over up to a 5 year period.

  • Parenting Self-Efficacy - Parenting Sense of Competence Scale

    Interval change in PSOC will be assessed over up to a 5 year period.

  • Pediatric Primary Care Visit Adherence

    Interval change in pediatric primary care visit adherence will be assessed over up to a 5 year period.

Other Outcomes (4)

  • Financial Measures - Income

    Interval change in financial measures will be assessed over up to a 5 year period.

  • Financial Measures - Savings

    Interval change in financial measures will be assessed over up to a 5 year period.

  • Financial Measures - Debt

    Interval change in financial measures will be assessed over up to a 5 year period.

  • +1 more other outcomes

Study Arms (2)

Intervention - Financial Coaching Plus Social Needs Screening

EXPERIMENTAL

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

Control - Social Needs Screening and Referral

ACTIVE COMPARATOR

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

Interventions

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.

Control - Social Needs Screening and ReferralIntervention - Financial Coaching Plus Social Needs Screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents/caregivers in families with children 4 months or under at enrollment receiving care at Harbor-UCLA medical center clinic.

You may not qualify if:

  • Cognitive impairment or not speaking English or Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adam Schickedanz

Los Angeles, California, 90024, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Pediatricians and outcomes assessors will not be aware of study arm.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 9, 2018

Study Start

November 7, 2018

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

July 31, 2030

Last Updated

July 10, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations