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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05609188
Other study ID # 1U01OD033266-01
Secondary ID 1U01OD033266-01
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date July 30, 2025

Study information

Verified date July 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary goal is to understand the potential impacts of Guaranteed Income (GI) on Black youth and young adults' financial, emotional, and physical well-being. The main question it aims to answer is: What are the impacts of GI on Black young adults' investments in their future, mental health and unmet mental and sexual/reproductive health service needs? Participants will receive guaranteed income for 12 months and will be offered enrollment in financial capability programs.


Description:

The BEEM project is a randomized controlled crossover trial in which 300 low-income Black Emerging Adults (BEA) (aged 18-24) are allocated to receive a $500/month Guaranteed Income (GI) either during the first twelve months of follow-up (phase I) or to receive GI in the second 12 months of a total of 24 months follow-up (phase II). All participants will be offered enrollment in financial capability programs (including peer learning circles and individual financial coaching) to bolster GI effectiveness and will also receive a periodic cell phone-based text messages to ensure that BEA with unmet health service needs receive referrals. The investigators hypothesize that this intervention will increase BEA's investment in their future (education, employment training), improve mental health (depression, anxiety), and reduce unmet mental health and sexual/reproductive health service needs.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date July 30, 2025
Est. primary completion date July 30, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 24 Years
Eligibility Inclusion Criteria: - Between 18-24 years of age at enrollment - Self-Identify as African American or Black - Live in a low-income housing tax credit (LIHTC) qualified census tract (QCT) in San Francisco or Oakland. Youth who are homeless or marginally housed in San Francisco and Oakland are also eligible; those who are marginally housed will need a letter from a youth agency that can affirm their marginal housing status. - Must not be currently enrolled in another GI project - Must have lived in the US for at least 3 years. - Must provide informed consent Exclusion Criteria: - Participation in another GI program at the time of enrollment - Lived in the United States for less than 3 years - Have plans to permanently leave the Bay Area - Being under the influence of alcohol or other substances at the time of enrollment.

Study Design


Intervention

Other:
Guaranteed Income
Monthly cash transfer of $500 per month for 12 months.
Behavioral:
Peer learning circles
Participants can opt-in to attend peer learning circles (also called My Money Hour), which are discussion groups of 10-12 participants about financial topics co-led by a peer (Black youth) with experience in financial programming and an adult financial coach. My Money Hour sessions will be offered on-line multiple times throughout every month of the project, with rotating themes, to ensure that the 50-minute sessions are available different days of the week and times of the day.
Financial coaching
Participants can opt-in to receive financial coaching sessions with a trained financial mentor. Meetings will occur monthly and typically include six one hour sessions. The mentor will be responsive to individual needs, but will touch on the following priority areas: building credit (credit repair, improving credit scores, credit products); savings (emergency savings plans, savings habits and strategies, understanding savings accounts); money management (creating budgets, understanding income vs expense, assessing spending, making better financial decisions); financial products (credit building products, auto loans, credit cards); and long-term goals (home ownership, investments).

Locations

Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (4)

Lead Sponsor Collaborator
University of California, San Francisco MyPath, National Institutes of Health (NIH), Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Participants with a Major or Probable Major Depressive Episode Using the Center for Epidemiologic Studies Depression Scale Revised (CESDR-10), a 'major depressive episode' is defined as 1) the presence of anhedonia (inability to feel pleasure), dysphoria (generalized dissatisfaction with life), or irritability 'all the time' or 5-7 days for the past week and 2) at least 4 additional symptoms endorsed as occurring 'all the time' or 5-7 days in the past week. A 'probable major depressive episode' is defined as 1) the presence of anhedonia, dysphoria or irritability nearly every day for the past week, and 2) an additional 3 symptoms endorsed as occurring 'all the time' or 5-7 days in the past week. The analysis plan includes use of repeated measures to estimate the difference in depressive symptoms at 12 months between study arms relative to baseline proportion. 12 months of follow-up
Primary Proportion of Participants Reporting Investments in the future Indication of enrollment in education, certification, or employment training programs. The analysis plan includes use of repeated measures to estimate the difference in investments in the future at 12 months between study arms relative to baseline proportion. 12 months of follow-up
Primary Proportion of Participants with Unmet Mental Health Service Needs Defined as the absence of receiving mental health care when needed. Unmet mental health need will be assessed by scoring 15 or above on the CESDR-10 or = 10 on the brief Generalized Anxiety Disorder scale (GAD-7), and not reporting that care was utilized. Service utilization is based on self-report as stating "no" to having accessed any MH service from any kind of health professional. The analysis plan includes the use of repeated measures to estimate the difference in unmet mental health service needs between study arms. 12 months of follow-up
Primary Unmet Sexual and Reproductive Health Service Needs Defined as the absence of receiving sexual and reproductive health services when needed, including STI testing and family planning. This will be measured as self-reported need for SRH (having symptoms of an STI, unprotected sex, or being at risk of unwanted pregnancy) and not reporting that SRH services were utilized. Service utilization is based on self-report as stating "no" to having accessed any SRH service from any kind of health professional. The analysis plan includes the use of repeated measures to estimate the difference in unmet sexual and reproductive health service needs between study arms. 12 months of follow-up
Secondary Savings: Proportion of participants with saving to cover a $400 expense Participants will self-report having enough savings to cover an unexpected expense of $400. Baseline and 12 months
Secondary Proportion of Participants with Debt Self- reported holding of debt, including: fraudulent debt, owed child support, banking/overdraft fees, bail debts, school debts, utility debts, and credit card or payday loan debt. Baseline and 12 months
Secondary Credit score Having a good credit score, defined as a FICO score of 680 points or higher vs. no credit (being credit invisible) or having low a credit score, defined as a FICO score of less than 680. Baseline and 12 months
Secondary Proportion of participants with Generalized Anxiety Score of 10 or above on the brief Generalized Anxiety Disorder scale (GAD-7) represents moderate to severe anxiety. The GAD-7 scale ranges from 0-21 with higher scores indicating more generalized anxiety. The analysis plan includes the use of repeated measures to estimate the difference in generalized anxiety at 12 months between study arms relative to baseline proportion. 12 months of follow-up
Secondary Hope for the future Hope will be measured using the Hope Matters scale, including 12 items that elicit future expectancy characterized by an individual's perception that a desirable future outcome can be achieved. Participants' level of hope will be classified by using a mean score, with a range of 1-4, with increasing values signifying higher levels of hope. Baseline and 12 months
Secondary Financial Capability Score A composite measure of financial knowledge, skills, practices, and mindset Baseline and 12 months
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