EITC Support Interventions for Well-being

(TAKE-UP Trial)

Overseen By Lia Fernald, PhD, MBA

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Harvard School of Public Health (HSPH)

Disqualifiers: Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Financial assistance, Earned Income Tax Credit, EITC, Financial Assistance, Information about free tax-filing support, Free Tax-Filing Support, EITC Assistance, Tax Preparation Services, Low-touch text messaging, Text Messaging Intervention, Low-Touch SMS, Personal tax filing support, Personalized Tax Assistance, Tax Filing Support Services?

Research on text messaging interventions in psychotherapy suggests that tailored text messages can improve outcomes by providing reminders and educational content, which may be applicable to the low-touch SMS component of this treatment. ^{1 2 3 4 5}

Is the EITC Support Intervention generally safe for humans?

The available research does not provide specific safety data for EITC Support Interventions, but related services like free tax preparation and text messaging interventions are generally considered safe and well-received by users. ^{6 7 8 9 10}

How does the EITC Support Interventions for Well-being treatment differ from other treatments?

The EITC Support Interventions for Well-being treatment is unique because it likely involves supportive interventions similar to text messaging programs like Text4Support, which use digital technology to provide mental health support. This approach is novel as it leverages existing technology to offer scalable, cost-effective support, unlike traditional face-to-face therapies. ^{11 12 13 14 15}

What is the purpose of this trial?

The earned income tax credit (EITC) is the largest United States poverty alleviation program, providing up to $6,600 for working families as a tax refund. Prior studies have shown the EITC's benefits for social outcomes and health. Effects are even more significant for single mothers and Black women. Despite these known benefits, 20%-33% of eligible individuals do not receive benefits, leaving $7 billion unclaimed annually. The Targeting Access and Knowledge of EITC Utilization and Policies (TAKE-UP) Study is a pilot randomized controlled trial that will develop and test the feasibility of several culturally tailored, scalable interventions to increase the take-up of the EITC among participants in the Special Supplemental Food Program for Women, Infants, and Children (WIC).

Research Team

Wendi Gosliner, DrPH

Principal Investigator

University of California Nutrition Policy Institute

Eligibility Criteria

This trial is for individuals in California who are eligible for the EITC but didn't claim it last year, enrolled in WIC with at least one child under 18, have earned income within EITC limits, and can speak English or Spanish. They must be willing to share tax info, stay in California for a year, meet immigration requirements for EITC, have text-capable phones, and agree to random assignment.

Inclusion Criteria

My (and my spouse's) income meets the EITC eligibility based on our family size.

Enrolled in WIC

Willing to be randomized.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive various interventions including low-touch text messaging, personal tax filing support, and financial assistance to increase EITC take-up.

4 months

Ongoing support via text and phone

Follow-up

Participants are monitored for outcomes such as tax filing, EITC receipt, and changes in food insecurity, anxiety, and material hardship.

12 months

Treatment Details

Interventions

• Financial assistance
• Information about free tax-filing support
• Low-touch text messaging
• Personal tax filing support

Trial Overview The TAKE-UP Study tests ways to increase EITC claims among those eligible. Interventions include personal tax support and financial advice; information on free tax services; and low-touch texting reminders. It's a pilot randomized controlled trial focusing on culturally tailored methods.

Participant Groups

Group I: Personal tax filing support Experimental Treatment 2 Interventions

Participants randomized to this intervention will be connected with a human assistor who will work with them to ensure they access resources to help them file taxes and apply for the EITC. The English- and Spanish-speaking assistors will be study team staff trained to provide personalized support to help families access resources for which they are eligible. The assistor will be available by text or phone to talk with people if they encounter barriers and will call to follow-up on a mutually agreed upon schedule.

Group II: Low-touch text messaging Experimental Treatment 2 Interventions

To address families' lack of awareness of the Earned Income Tax Credit (EITC) and the ways they may benefit from filing taxes, one study arm will receive low-touch text messages. These act in part by increasing awareness of programs and eligibility rules and in part as reminders to overcome limited attention to filing. Study participants receiving this intervention will receive behavioral science-informed text messages in English or Spanish from WIC that inform them about the EITC throughout tax season (i.e., January-April) 2024. We will personalize message contents (e.g., EITC benefit size mentioned in message based on participant income, marital status, and number of dependents) due to suggestive evidence that a tailored, individualized text message has the potential to be effective

Group III: Financial assistance Experimental Treatment 2 Interventions

Participants randomized to this intervention will receive a $100 cash incentive for tax filing, designed to offset the time, hassle, and resources spent on tax preparation and filing, as well as psychological frictions like inattention that prevent some people from filing. This will be provided to recipients as soon as they show proof of tax filing, to provide a more immediate reward relative to the delays in receiving a federal tax refund. We will test the feasibility of delivering this via gift card, check, or other modalities, in addition to evaluating the framing and incentive amount.

Group IV: Information about free tax-filing support Active Control 1 Intervention

Basic information about where to find free tax filing support in their community will be provided to all participants by email once upon enrollment.

Who Is Running the Clinical Trial?

Harvard School of Public Health (HSPH)

Lead Sponsor

Trials

283

Recruited

17,030,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Blue Shield of California Foundation

Collaborator

Trials

1

Recruited

200+

University of California Nutrition Policy Institute

Collaborator

Trials

2

Recruited

1,400+

University of California, Merced

Collaborator

Trials

18

Recruited

6,100+

Findings from Research

The Pro-Active Call Center Treatment Support (PACCTS) program significantly improved glycemic control in individuals with type 2 diabetes, showing an overall reduction in HbA1c levels by 0.31% compared to usual care in a study of 591 participants over one year.

For patients with higher baseline HbA1c levels (>7%), the improvement was even greater at 0.49%, and PACCTS also increased the likelihood of achieving a reduction of at least 1% in HbA1c by 10% overall, indicating its effectiveness in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Young, RJ., Taylor, J., Friede, T., et al.[2022]

The study involved 68 participants who received individually tailored text messages alongside telephone-based psychotherapy, but there were no significant differences in clinical outcomes compared to a historical control group of 157 participants who only received psychotherapy.

While both groups showed improvement over time, the SMS intervention did not enhance clinical outcomes, and the study suggests that further research with a larger sample size is needed to better assess the potential benefits of text messaging in psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. Furber, G., Jones, GM., Healey, D., et al.[2021]

The eHealth intervention was delivered with high fidelity, with 93% of participants receiving initial training and 98.45% of expected follow-ups conducted, indicating strong program adherence.

Despite high engagement from 40.4% of users over 12 months, increased usage did not lead to significant improvements in clinical outcomes or lifestyle changes, suggesting that simply using the intervention more frequently does not guarantee better health results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. Coorey, G., Peiris, D., Scaria, A., et al.[2021]

The study involved 179 pregnant women who had used cocaine, and while access to computer services did not significantly improve health status or reduce drug use, it did increase participation in formal drug treatment for those who used the service frequently.

Women who accessed the computer services more than three times a week were 1.5 times more likely to engage in formal drug treatment, indicating that higher usage of the service may enhance motivation to seek help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a telecommunications network for pregnant women who use cocaine. Alemi, F., Stephens, RC., Javalghi, RG., et al.[2019]

Telephone, correspondence-based, and computerized interventions for alcohol problems are emerging as effective alternatives to traditional face-to-face treatments, with studies showing they can significantly reduce hazardous drinking among university students and delay heavy drinking initiation in youth.

These interventions are well-accepted by patients and the public, suggesting they could enhance access to alcohol treatment and provide cost-effective solutions within the healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative approaches to intervention for problem drinking. Kypri, K., Sitharthan, T., Cunningham, JA., et al.[2007]

A study involving 1139 participants from a larger trial found that 96% of respondents supported the use of SMS for monitoring vaccine safety after immunization, indicating a strong public acceptance of this method.

While most participants favored SMS surveillance, 62% believed that consent should be obtained beforehand, highlighting a need for addressing privacy concerns and understanding demographic factors that may affect compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Bednarz, J., et al.[2021]

Embedding a Volunteer Income Tax Assistance (VITA) site within a pediatric medical home (PMH) proved to be a convenient and trusted resource for caregivers, potentially changing their tax-filing behaviors.

Many caregivers were unaware of the free tax filing services available through the PMH-VITA site, indicating a need for better marketing to increase awareness and utilization among the target population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Medical Financial Partnership in a Pediatric Medical Home. Markowitz, MA., Harper, A., Rosenthal, MS., et al.[2022]

A study involving 27 breast cancer survivors showed that tailored text messages were effective in helping maintain weight loss and promote healthy behaviors after an initial 6-month telephone-delivered weight loss intervention.

Participants found the text messages useful for accountability and motivation, although some preferred the more personal support of telephone calls, suggesting a combination of both methods could enhance the intervention's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's Perceptions of Participation in an Extended Contact Text Message-Based Weight Loss Intervention: An Explorative Study. Job, JR., Spark, LC., Fjeldsoe, BS., et al.[2019]

The STARSS trial, involving 6,338 participants, showed that using SMS prompts for reporting adverse events following immunization (AEFI) significantly improved detection rates, with a 13-fold increase in AEFI detection compared to traditional methods.

Out of the SMS group, 184 verified AEFIs were reported, while only 6 were reported in the control group, highlighting the efficacy of mobile health technology in enhancing vaccine safety surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. Gold, MS., Lincoln, G., Cashman, P., et al.[2021]

The Zm-STARSS trial, involving 4560 participants, demonstrated that using SMS and telephone interviews significantly improved the detection of adverse events following immunization (AEFIs) compared to traditional passive surveillance methods, with a detection rate of 2%.

Although the response rate to SMS prompts was low (31%), the study suggests that active surveillance methods like SMS-CATI can enhance AEFI monitoring in low- and middle-income countries, highlighting the potential for digital approaches in vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and feasibility of SMS m-Health for the detection of adverse events following immunisation (AEFIs) in resource-limited setting-The Zimbabwe stimulated telephone assisted rapid safety surveillance (Zm-STARSS) randomised control trial. Nyambayo, PPM., Gold, MS., Mehta, UC., et al.[2023]

The Text4Support service, which provides supportive text messages to patients after discharge from psychiatric care, was well received by 40% of participants who reported high satisfaction with the service's impact on their mental well-being.

Participants suggested that future iterations of the service could benefit from more personalized messages and opportunities for interaction with healthcare personnel, indicating a desire for enhanced engagement in their mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Expectations and Experiences With a Mental Health-Focused Supportive Text Messaging Program: Mixed Methods Evaluation. Shalaby, R., Vuong, W., Eboreime, E., et al.[2022]

Extended contact interventions delivered via text messages can effectively support weight management, resulting in an average weight loss of -0.82 kg compared to control groups and -2.16 kg within the intervention groups.

Effective interventions were typically longer than 12 weeks, suggesting that duration may play a crucial role in the success of text message-based weight management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of extended contact interventions for weight management delivered via text messaging: a systematic review and meta-analysis. Job, JR., Fjeldsoe, BS., Eakin, EG., et al.[2019]

A study involving 225 participants showed that five fully automated self-help e-therapy programs for various anxiety disorders led to significant improvements in clinical severity ratings, with effect sizes indicating strong efficacy (Cohen d range 0.72-1.22).

Participants reported increased confidence in managing their mental health and significant improvements in quality of life, particularly for generalized anxiety disorder, obsessive-compulsive disorder, posttraumatic stress disorder, and social anxiety disorder, suggesting these e-therapy programs are effective and well-received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety online: a virtual clinic: preliminary outcomes following completion of five fully automated treatment programs for anxiety disorders and symptoms. Klein, B., Meyer, D., Austin, DW., et al.[2022]

A 1-year SMS intervention significantly reduced heavy drinking among 462 patients with alcohol dependence after detoxification, with 22.2% in the intervention group compared to 32.3% in the treatment as usual group.

The SMS intervention showed an odds ratio of 1.68 for reducing heavy drinking, indicating it was effective in promoting better drinking outcomes compared to standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a 1-year short message service in detoxified alcohol-dependent patients: a multi-center, open-label randomized controlled trial. Lucht, M., Quellmalz, A., Mende, M., et al.[2021]

The Text4Support program, a text-messaging intervention based on cognitive behavioral therapy, aims to improve mental well-being for individuals dealing with addiction or mental health issues, and was evaluated over a 6-month period with surveys at baseline, 12 weeks, and 6 months.

Although the study did not have a large enough sample size to achieve statistical significance, it highlights the potential of digital technologies like text messaging to support mental health interventions and suggests areas for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text4Support Mobile-Based Programming for Individuals Accessing Addictions and Mental Health Services-Retroactive Program Analysis at Baseline, 12 Weeks, and 6 Months. Noble, JM., Vuong, W., Surood, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

A comparison between phone-based psychotherapy with and without text messaging support in between sessions for crisis patients. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

An Internet-Based Intervention for Cardiovascular Disease Management Integrated With Primary Care Electronic Health Records: Mixed Methods Evaluation of Implementation Fidelity and User Engagement. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of a telecommunications network for pregnant women who use cocaine. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Innovative approaches to intervention for problem drinking. [2007]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Consumer acceptability and validity of m-Health for the detection of adverse events following immunization - The Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) randomised control trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A Medical Financial Partnership in a Pediatric Medical Home. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

Women's Perceptions of Participation in an Extended Contact Text Message-Based Weight Loss Intervention: An Explorative Study. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of m-Health for the detection of adverse events following immunization - The stimulated telephone assisted rapid safety surveillance (STARSS) randomised control trial. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and feasibility of SMS m-Health for the detection of adverse events following immunisation (AEFIs) in resource-limited setting-The Zimbabwe stimulated telephone assisted rapid safety surveillance (Zm-STARSS) randomised control trial. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

Patients' Expectations and Experiences With a Mental Health-Focused Supportive Text Messaging Program: Mixed Methods Evaluation. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Effectiveness of extended contact interventions for weight management delivered via text messaging: a systematic review and meta-analysis. [2019]

13. Canada pubmed.ncbi.nlm.nih.gov

Anxiety online: a virtual clinic: preliminary outcomes following completion of five fully automated treatment programs for anxiety disorders and symptoms. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Effect of a 1-year short message service in detoxified alcohol-dependent patients: a multi-center, open-label randomized controlled trial. [2021]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Text4Support Mobile-Based Programming for Individuals Accessing Addictions and Mental Health Services-Retroactive Program Analysis at Baseline, 12 Weeks, and 6 Months. [2021]