Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05612685 |
Other study ID # |
22-001575 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 1, 2023 |
Est. completion date |
July 2029 |
Study information
Verified date |
May 2023 |
Source |
University of California, Los Angeles |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary
efficacy of healthcare provider referrals to a tax filing app within parent-child health
programs to test whether such referrals can increase receipt of tax credits among low-income
parents. The study will use a single-group, pre/post test design with a sample of
approximately 100 women who have a child under 6 years of age. Participants will be recruited
from parental-child health programs and clinics in Los Angeles and will complete surveys at
baseline, immediately after tax filing season, and six months after tax filing season to
assess 1) frequency of tax filing after referral (Feasibility), 2) the acceptability of the
tax filing app from the perspective of users (Acceptability), and 3) pre/posttest changes to
parent and child health, child development, and healthcare utilization measures for users
(preliminary efficacy).
Description:
Aims: The purpose of this study is to pilot test the feasibility, acceptability, and
preliminary efficacy of healthcare provider referrals to a tax filing app within
parental-child health programs whether such referrals can increase receipt of tax credits
among low-income parents. The study will use a single-group, pre/posttest design. The primary
outcome is feasibility, defined as whether or not participants filed taxes after referral.
Secondary outcomes are acceptability of the app and preliminary efficacy of the app on
improved parent and child health. Specific aims are to:
1. assess frequency of tax filing among parents referred to a tax filing app (Primary
outcome/Feasibility)
2. examine the acceptability of a tax filing app from the perspective of users (Secondary
outcome/Acceptability), and
3. explore pre/posttest changes to parent and child health, child development, and
healthcare utilization measures for users the app after referral (Secondary
outcome/Preliminary efficacy).
Design: This pilot study will use a single-group, pre/post-test design to assess the
feasibility, acceptability, and preliminary efficacy of healthcare provider referrals to a
tax filing app.
Intervention: Referrals to a tax filing app
Setting: The setting for this study is maternal/child health programs and clinics in Los
Angeles.
Sample: The target population is parents making less than $75,000 per year in income .
Parents will be eligible to participate in the study if they are within the income threshold,
have one or more children under six years of age, speak English or Spanish, have access to an
internet-enabled device (smart phone or tablet), and have a valid tax filing ID (SSN or
ITIN). Parents will be ineligible if they have already filed taxes during the study period or
are experiencing an acute mental health crisis (e.g., suicidality). We focus on children
under six years of age because this is a critical and sensitive developmental window when
interventions have potential for outsized impact on child health.
Procedures: Parents will be recruited during program visits/encounters early in tax season in
2023. Those that provide informed consent to participate in the study will complete a
baseline survey and receive the assigned intervention (referral to a tax filing app) the same
day or within the same week of their program visit. Parents will complete a follow-up survey
to assess outcome measures after they receive tax refunds. A second follow-up survey will be
sent 3-6 months later (depending on time of filing, and average time of receipt of tax credit
this season) to assess medium-term outcomes.
Outcomes. We will assess the following outcomes. The primary study outcome is feasibility;
acceptability and preliminary health efficacy are secondary outcomes.
Feasibility: Self-reported tax filing (items developed for this study) Acceptability: Health
app acceptability measure (Chen et al., 2022) Preliminary efficacy: We will assess
pre/posttest changes in the following health-related measures as indicators of preliminary
efficacy: 1a) parent health (PROMIS® Scale v1.2 - Global Health [Hays et al., 2009]; Patient
Health Questionnaire- 2 [Kroenke et al., 2003); Perceived Stress Scale [Cohen et al., 1994];
PROMIS®-29 Profile v2.1 [Hays et al., 2018]) and 1b) child health (PROMIS® Early Childhood
Parent Report Global Health [Forrest et al., 2014]); 2) child development (PEDS-DM [Pritchard
et al., 2012]); and 3) and 4) healthcare utilization (adapted from survey items by Patrick et
al,. 2020 for this study).
Demographic and family health background information (see survey: age, gender,
race/ethnicity, income, social determinants of health, health background, other tax filing
characteristics) will be collected to identify characteristics of the sample. In future
studies, we intend to study in greater depth the physical health outcomes that might be
sensitive to this intervention with longer-term follow up.