Creating Access to Resources and Economic Support

Psychological Distress Clinical Trial

— CARES  

Official title:

Creating Access to Resources and Economic Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05971160
• Other study ID #: Pro00113319
• Secondary ID: R01MD016755
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Psychological Distress

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