Creating Access to Resources and Economic Support (CARES)

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.

Study Overview

• Status: Recruiting
• Conditions: Psychological Distress
• Intervention / Treatment: Behavioral: Financial education videos; Other: Microgrant; Behavioral: Peer mentoring

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Williams, PhD; Phone Number: 919-660-1693; Email: jennifer.williams@duke.edu
• Study Contact Backup: Name: Tonia C Poteat, PhD; Phone Number: 919-684-9303; Email: tonia.poteat@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University (online recruitment)
      • Contact: Study Coordinator; Phone Number: 919-660-9303

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Tonia C. Poteat, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2023
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Pro00113319; R01MD016755 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to share data via one of the NIH repositories listed by the Trans-NIH BioMedical Informatics Coordinating Committee (BMIC). The final available dataset from this proposed research will include self-reported demographic, psychosocial, and behavioral data from quantitative surveys. No personal identifiers will be included with the final available dataset.
• IPD Sharing Time Frame: Data will become available 12 months after publication of primary study findings.
• IPD Sharing Access Criteria: In accordance with the NIH Data Sharing Policy and Implementation Guidance, the investigators will make the data and supporting information available to users under a data-sharing agreement that provides for: (1) complete protection of human subjects training and a commitment to research ethics; (2) a commitment to using the data only for research purposes and not to identify an individual participant; (3) a commitment to securing the data using appropriate technology, and (4) a commitment to destroying or returning the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No