Back to resultsProject Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Primary Purpose
Substance Use, Mental Health
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Uplift
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use focused on measuring Sexual and Gender Minorities, Substance Use and Mental Health Treatment, Mental Health, Substance Use, Minority Stress, Young Adults, Intensive Case Management, Peer Support
Eligibility Criteria
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
Sites / Locations
- Mecklenburg County Community Support Services
- Duke University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Project Uplift Intervention
Arm Description
A 6-month long intervention for young adult sexual and gender minorities, ages 18-35.
Outcomes
Primary Outcome Measures
Change in substance use from baseline to 6-month follow-up
Addiction Severity Index collected via a computer assisted self-interviewing survey
Change in mental health status from baseline to 6-month follow-up
Brief Symptom Inventory collected via a computer assisted self-interviewing survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04546061
Brief Title
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Official Title
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
January 25, 2023 (Actual)
Study Completion Date
January 25, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Mental Health
Keywords
Sexual and Gender Minorities, Substance Use and Mental Health Treatment, Mental Health, Substance Use, Minority Stress, Young Adults, Intensive Case Management, Peer Support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Project Uplift Intervention
Arm Type
Experimental
Arm Description
A 6-month long intervention for young adult sexual and gender minorities, ages 18-35.
Intervention Type
Behavioral
Intervention Name(s)
Project Uplift
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in substance use from baseline to 6-month follow-up
Description
Addiction Severity Index collected via a computer assisted self-interviewing survey
Time Frame
Baseline and 6-months
Title
Change in mental health status from baseline to 6-month follow-up
Description
Brief Symptom Inventory collected via a computer assisted self-interviewing survey
Time Frame
Baseline and 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara H LeGrand, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Susan Reif, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mecklenburg County Community Support Services
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
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