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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date July 2029
Est. primary completion date October 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Income <$75,000 per year - One or more children under 6 years of age - Has a valid tax filing ID (SSN or ITIN) - Has access to an internet-enabled device Exclusion Criteria: - Experiencing an acute mental health crisis

Study Design


Intervention

Behavioral:
Healthcare provider referral to a tax filing app
Healthcare providers offer a referral to a tax filing app and briefly describe the potential benefits of tax credit receipt

Locations

Country Name City State
United States UCLA School of Nursing 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
Primary Rate of tax filing at 3 months: Did you file taxes this year? YES/NO Self-reported tax filing status for the current year 3 months
Primary Rate of tax filing at 9 months: Did you file taxes this year? YES/NO Self-reported tax filing status for the current year 9 months
Secondary Parent depression at baseline Patient Health Questionnaire- 2 (score range 0-6, higher scores indicate worse depression symptoms) Baseline
Secondary Parent depression at 3 months Patient Health Questionnaire- 2 (score range 0-6, higher scores indicate worse depression symptoms) 3 months
Secondary Parent depression at 9 months Patient Health Questionnaire- 2 (score range 0-6, higher scores indicate worse depression symptoms) 9 months
Secondary Child socioemotional development at 3 months PEDS:DM (Parents' Evaluation of Developmental Status - Developmental Milestones): More 'yes' responses indicate more developmental milestones met 3 months
Secondary Child socioemotional development at 9 months PEDS:DM (Parents' Evaluation of Developmental Status - Developmental Milestones): More 'yes' responses indicate more developmental milestones met 9 months
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