Substance UseNCT04546061
Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
A study testing Project Uplift in people with Substance Use and Mental Health, run by Duke University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Substance Use, Mental Health
- What is being tested?
- Project Uplift
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2020to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mecklenburg County Community Support Services
Charlotte, North Carolina, 28207
Duke University
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Conditions
- Substance Use, Mental Health
- Being tested
- Project Uplift
- Keywords
- Sexual and Gender Minorities, Substance Use and Mental Health Treatment, Mental Health, Substance Use, Minority Stress, Young Adults, Intensive Case Management, Peer Support
- Medical subject headings
- Substance-Related Disorders, Psychological Well-Being, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project UpliftBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Project Uplift Intervention | Experimental | A 6-month long intervention for young adult sexual and gender minorities, ages 18-35. Receives: Behavioral: Project Uplift |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in substance use from baseline to 6-month follow-up
Addiction Severity Index collected via a computer assisted self-interviewing survey
Measured: Baseline and 6-months
Change in mental health status from baseline to 6-month follow-up
Brief Symptom Inventory collected via a computer assisted self-interviewing survey
Measured: Baseline and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start15 Sep 2020
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara H LeGrand, PhD, Principal investigator, Duke UniversitySusan Reif, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04546061
- Sponsor's protocol ID
- Pro00103883
- Other IDs
- 1H79TI081999
- Status last verified
- Mar 2023
- First submitted
- 4 Sep 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Uplift: Substance Use and Mental Health Treatment for Young Sexual and Gender Minorities
- ClinicalTrials.gov ID
- NCT04546061
- Acronym / sponsor ID
- Pro00103883
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Project Uplift Intervention | Experimental | Behavioral: Project UpliftA 6-month long intervention for young adult sexual and gender minorities, ages 18-35. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project UpliftSubstance 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. | Behavioural | Project Uplift Intervention |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara H LeGrand, PhD principal investigator
Duke University
Susan Reif, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Uplift in people with Substance Use and Mental Health, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in substance use from baseline to 6-month follow-up (time frame: Baseline and 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.