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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05971160
Other study ID # Pro00113319
Secondary ID R01MD016755
Status Recruiting
Phase N/A
First received
Last updated
Start date December 12, 2023
Est. completion date March 31, 2026

Study information

Verified date July 2023
Source Duke University
Contact Jennifer Williams, PhD
Phone 919-660-1693
Email jennifer.williams@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to test the ability of small grants and/or peer support to improve mental health among transgender people experiencing material hardship. The main questions the study will answer are: 1. Do microgrants with or without peer mentoring improve mental health? 2. Do microgrants with or without peer mentoring improve mental health by reducing material hardship and/or increasing a sense of community connection? Researchers will compare mental health outcomes among three groups of participants: A. Participants who receive one small grant and monthly financial education videos B. Participants who receive a small grant every month and monthly financial education videos for a total of 6 months. C. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.


Recruitment information / eligibility

Status Recruiting
Enrollment 360
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age 18 years or older - gender identity different from sex assigned on original birth certificate - access to a mobile phone or email - score > 0 on the material hardship index Exclusion Criteria: - inability to provide informed consent in English

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Financial education videos
Brief videos providing structured information on managing one's money
Other:
Microgrant
$150 stipend
Behavioral:
Peer mentoring
One-on-one structured mentoring sessions with a trained peer

Locations

Country Name City State
United States Duke University (online recruitment) Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Duke University National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in psychological distress, as measured by Kessler 6 Kessler 6 is a 6-item scale with each item scored from 0-4 for a total score range from 0-24, with higher scores indicating greater psychological distress. Baseline, 6 months, 12 months
Secondary Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10) DAST-10 is a 10-item scale with with one one point for each "yes" response for a total score range from 0-10, with higher scores indicating more problematic substance use Baseline, 6 months, 12 months
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