- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04546061
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
March 2, 2023 updated by: Duke University
This study provides substance use and mental health treatment for young sexual and gender minority adults in Durham and Charlotte, NC and seeks to provide intensive wraparound services that address factors that influence substance use and mental health among this population such as minority stressors and lack of social support, housing instability, lack of access to affirmative health care, and limited job opportunities.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Project Uplift provides evidenced-based substance use and mental health treatment, intensive case management, and peer support services for sexual and gender minorities, ages 18-35.
The program is based in two metropolitan areas in North Carolina, Durham and Charlotte, and will offer services for approximately 80 sexual and gender minority young adults.
Survey data collected from participants at baseline and at the end of the 6-month program will be used to evaluate the effectiveness the comprehensive care program.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sara H LeGrand, PhD
- Phone Number: 919-438-0448
- Email: sara.legrand@duke.edu
Study Contact Backup
- Name: Susan Reif, PhD
- Phone Number: 704-258-7111
- Email: susan.reif@duke.edu
Study Locations
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28207
- Mecklenburg County Community Support Services
-
Durham, North Carolina, United States, 27710
- Duke University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: 1) age 18-35; 2) substance use in the last 90 days; 3) self-identify as a sexual and/or gender minority; 4) reside in the Durham or Charlotte geographic areas including neighboring counties
Exclusion Criteria: 1) inability to speak and read English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Project Uplift Intervention
A 6-month long intervention for young adult sexual and gender minorities, ages 18-35.
|
Substance use and mental health treatment for young sexual and gender minorities in Durham and Charlotte, NC in conjunction with intensive wraparound services that address factors that influence substance use and mental health among this population.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in substance use from baseline to 6-month follow-up
Time Frame: Baseline and 6-months
|
Addiction Severity Index collected via a computer assisted self-interviewing survey
|
Baseline and 6-months
|
Change in mental health status from baseline to 6-month follow-up
Time Frame: Baseline and 6-months
|
Brief Symptom Inventory collected via a computer assisted self-interviewing survey
|
Baseline and 6-months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara H LeGrand, PhD, Duke University
- Principal Investigator: Susan Reif, PhD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2020
Primary Completion (Actual)
January 25, 2023
Study Completion (Actual)
January 25, 2023
Study Registration Dates
First Submitted
September 4, 2020
First Submitted That Met QC Criteria
September 4, 2020
First Posted (Actual)
September 11, 2020
Study Record Updates
Last Update Posted (Estimate)
March 6, 2023
Last Update Submitted That Met QC Criteria
March 2, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00103883
- 1H79TI081999 (Other Grant/Funding Number: SAMHSA)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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