CARES: Creating Access to Resources and Economic Support

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05971160
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD) (NIH)
360
3
30

Study Details

Study Description

Brief 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:
  1. 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.

  2. Participants who receive a small grant every month, peer mentoring support, and monthly financial education videos for a total of 6 months.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Financial education videos
  • Other: Microgrant
  • Behavioral: Peer mentoring
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Creating Access to Resources and Economic Support
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Usual Care

Monthly financial education videos and one-time microgrant

Behavioral: Financial education videos
Brief videos providing structured information on managing one's money

Other: Microgrant
$150 stipend

Active Comparator: Monthly microgrants

Monthly financial education videos and monthly microgrants

Behavioral: Financial education videos
Brief videos providing structured information on managing one's money

Other: Microgrant
$150 stipend

Active Comparator: Monthly microgrants plus peer mentoring

Monthly financial education videos, monthly microgrants, and peer mentoring support

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

Outcome Measures

Primary Outcome Measures

  1. Change in psychological distress, as measured by Kessler 6 [Baseline, 6 months, 12 months]

    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.

Secondary Outcome Measures

  1. Change in substance use, as measured by the Drug Abuse Screening Test (DAST-10) [Baseline, 6 months, 12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke University
  • National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Tonia C. Poteat, PhD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05971160
Other Study ID Numbers:
  • Pro00113319
  • R01MD016755
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 2, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 2, 2023