Sexual OrientationUMD-PRCNCT05352659
Increasing Effective Mental Health Care for LGBT Clients
A study testing Face-to-face and online LGBTQ+ training and On-line training in people with Sexual Orientation and Gender Identity, run by University of Maryland, College Park at 1 site in United States.
Trial summary
The overall aims of the 5-year University of Maryland Prevention Research Center (UMD-PRC) Core Research Project are to identify, refine, implement, evaluate, translate, disseminate, and communicate approaches and tools that can be used to improve the competency of mental health care for LGBT persons which is a social… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Orientation, Gender Identity
- What is being tested?
- Face-to-face and online LGBTQ+ training and On-line training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 1 Jun 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Therapists must be employed by a participating study general mental health services organization in Maryland. They must be 18 years of age or older, in the process of being licensed or already licensed to provide clinical mental healthcare in Maryland, able to speak and understand English, and have at least 10 clients 16 years old and older.
Who cannot join
- Participants may not be under 18 years of age, unlicensed, or have less than 10 clients 16 years or older.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Public Health
College Park, Maryland, 20742
About this study
The overall aims of the 5-year University of Maryland Prevention Research Center (UMD-PRC) Core Research Project are to identify, refine, implement, evaluate, translate, disseminate, and communicate approaches and tools that can be used to improve the competency of mental health care for LGBT persons which is a social determinant of LGBT health disparities. The UMD-PRC research team, in collaboration with the community advisory board (CAB), have identified 5 evidence based resources (Tools) to improve health care competency with sexual and gender minority populations (lesbian/gay, bisexual, and transgender [LGBT] people). The UMD-PRC will use the Sexual and Gender Diversity Learning Community (SGDLC) program (Strategy) and these tools along with technical assistance (TA) to improve LGBT mental health care. The following hypothesis will be tested. The study intervention group will show an increase in a) organization-level LGBT-friendly policies and environment as observed by the researchers and b) LGBT competent clinician practice assessed through clinician self-reported preparedness, awareness, and knowledge as well as referral for co-occurring client health needs; client-reported satisfaction with therapy and health literacy; and research team assessment of clinician performance providing consultation to a standardized LGBT patient actor.
Read the detailed description
Mental health organizations will be randomized to two study groups. Within each organization, clinicians will be recruited. Within clinician practices, clients will be recruited. Baseline data will be collected from the two groups of mental health organization leads, clinicians, and clients. Both groups will undergo data collection with 5 tools by research teams: at the organization level the Organizational Climate Assessment and at the clinician level the Provide Self-Assessment during month 1 of each site's participation. Client level Client Satisfaction Survey data will also be collected during month 1 of each site's participation (cohort 1 clients). During months 2-4 of each site's participation, clinicians in the control group will receive standard nationally, publicly freely accessible information, specifically a letter notifying them about the on-line accessible SAMHSA LGBT services education manual and Fenway Health Webinars. In the intervention group, clinicians will also receive a letter notifying them about the nationally, publicly freely accessible on-line SAMHSA education manual and Fenway Health Webinars plus they will receive a 1-day, clinician training followed by 4 biweekly 2-hour technical assistance workshops to review and address information gleaned from the 5 tool's and to finalize the problem-solving related to needs for change based on the 5 tool's. During month 5 of each site's participation, both groups will undergo follow-up data collection and assessment by research teams at the organization and clinician levels. Client level data will also be collected during month 5 of each site's participation (cohort 2 clients). Finally, during month 6 of each site's participation, each site's 5 clinicians in both study arms will complete one first-time consultation session by screen-to-screen interaction via on-line computer interface with a LGBT standardized patient so that their objective skill-level performance can be assessed.
- Conditions
- Sexual Orientation, Gender Identity
- Being tested
- Face-to-face and online LGBTQ+ training, On-line training
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face and online LGBTQ+ trainingBehavioural
The intervention consists of Organization-level technical assistance in regard to LGBTQ climate of the organization AND Clinician-level face-to-face virtual workshop LGBTQ competency training, virtual clinical consultations, and links to publicly available LGBTQ training.
On-line trainingBehavioural
This study arm receives only links to publicly available on-line LGBTQ training.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face and online LGBTQ training+ | Experimental | The Study Intervention arm receives the organization-level LGBTQ climate assessment and technical assistance, the provider-level face-to-face LGBTQ training along with links to publicly available on-line training. Receives: Behavioral: Face-to-face and online LGBTQ+ training |
| On-line resources | Other | The Comparison Intervention arm receives only links to publicly available on-line resources. Receives: Behavioral: On-line training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virtual Simulated Client Skill Assessment
Therapists' conduct an initial consultation visit through an on-line interface with an actor trained to follow a specific client LGBTQ profile and the therapists' skills with the simulated client are assessed using a standardized performance checklist by researchers while they view an audio-video recording of the visit.
Measured: Within 30 days after therapist completion of the intervention, an average of 6 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start1 Mar 2021
- Primary completion1 May 2022
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual OrientationStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Boekeloo, University of Maryland, College Park
- Investigators
- Bradley Boekeloo, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352659
- Sponsor's protocol ID
- U48DP006382
- Acronym
- UMD-PRC
- Status last verified
- May 2024
- First submitted
- 16 Dec 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Under appropriate circumstances the investigators will share de-identified client-level data with other qualified investigators.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Effective Mental Health Care for LGBT Clients
- ClinicalTrials.gov ID
- NCT05352659
- Acronym / sponsor ID
- UMD-PRC / U48DP006382
- Conditions
- Sexual Orientation, Gender Identity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Apr 2022 (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.
The overall aims of the 5-year University of Maryland Prevention Research Center (UMD-PRC) Core Research Project are to identify, refine, implement, evaluate, translate, disseminate, and communicate approaches and tools that can be used to improve the competency of mental health care for LGBT persons which is a social determinant of LGBT health disparities. The UMD-PRC research team, in collaboration with the community advisory board (CAB), have identified 5 evidence based resources (Tools) to improve health care competency with sexual and gender minority populations (lesbian/gay, bisexual, and transgender [LGBT] people). The UMD-PRC will use the Sexual and Gender Diversity Learning Community (SGDLC) program (Strategy) and these tools along with technical assistance (TA) to improve LGBT mental health care. The following hypothesis will be tested. The study intervention group will show an increase in a) organization-level LGBT-friendly policies and environment as observed by the researchers and b) LGBT competent clinician practice assessed through clinician self-reported preparedness, awareness, and knowledge as well as referral for co-occurring client health needs; client-reported satisfaction with therapy and health literacy; and research team assessment of clinician performance providing consultation to a standardized LGBT patient actor.
Detailed description
Mental health organizations will be randomized to two study groups. Within each organization, clinicians will be recruited. Within clinician practices, clients will be recruited. Baseline data will be collected from the two groups of mental health organization leads, clinicians, and clients. Both groups will undergo data collection with 5 tools by research teams: at the organization level the Organizational Climate Assessment and at the clinician level the Provide Self-Assessment during month 1 of each site's participation. Client level Client Satisfaction Survey data will also be collected during month 1 of each site's participation (cohort 1 clients). During months 2-4 of each site's participation, clinicians in the control group will receive standard nationally, publicly freely accessible information, specifically a letter notifying them about the on-line accessible SAMHSA LGBT services education manual and Fenway Health Webinars. In the intervention group, clinicians will also receive a letter notifying them about the nationally, publicly freely accessible on-line SAMHSA education manual and Fenway Health Webinars plus they will receive a 1-day, clinician training followed by 4 biweekly 2-hour technical assistance workshops to review and address information gleaned from the 5 tool's and to finalize the problem-solving related to needs for change based on the 5 tool's. During month 5 of each site's participation, both groups will undergo follow-up data collection and assessment by research teams at the organization and clinician levels. Client level data will also be collected during month 5 of each site's participation (cohort 2 clients). Finally, during month 6 of each site's participation, each site's 5 clinicians in both study arms will complete one first-time consultation session by screen-to-screen interaction via on-line computer interface with a LGBT standardized patient so that their objective skill-level performance can be assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Face-to-face and online LGBTQ training+ | Experimental | Behavioral: Face-to-face and online LGBTQ+ trainingThe Study Intervention arm receives the organization-level LGBTQ climate assessment and technical assistance, the provider-level face-to-face LGBTQ training along with links to publicly available on-line training. |
| On-line resources | Other | Behavioral: On-line trainingThe Comparison Intervention arm receives only links to publicly available on-line resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Therapists must be employed by a participating study general mental health services organization in Maryland. They must be 18 years of age or older, in the process of being licensed or already licensed to provide clinical mental healthcare in Maryland, able to speak and understand English, and have at least 10 clients 16 years old and older.
Key exclusion criteria (1 listed)
- Participants may not be under 18 years of age, unlicensed, or have less than 10 clients 16 years or older.
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 |
|---|---|---|
| Face-to-face and online LGBTQ+ trainingThe intervention consists of Organization-level technical assistance in regard to LGBTQ climate of the organization AND Clinician-level face-to-face virtual workshop LGBTQ competency training, virtual clinical consultations, and links to publicly available LGBTQ training. | Behavioural | Face-to-face and online LGBTQ training+ |
| On-line trainingThis study arm receives only links to publicly available on-line LGBTQ training. | Behavioural | On-line resources |
Primary outcome
Virtual Simulated Client Skill Assessment
Time frame: Within 30 days after therapist completion of the intervention, an average of 6 months after enrollment.
Therapists' conduct an initial consultation visit through an on-line interface with an actor trained to follow a specific client LGBTQ profile and the therapists' skills with the simulated client are assessed using a standardized performance checklist by researchers while they view an audio-video recording of the visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No. Under appropriate circumstances the investigators will share de-identified client-level data with other qualified investigators.
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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.
Bradley Boekeloo principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face and online LGBTQ+ training and On-line training in people with Sexual Orientation and Gender Identity, run by University of Maryland, College Park at 1 site 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Virtual Simulated Client Skill Assessment (time frame: Within 30 days after therapist completion of the intervention, an average of 6 months after enrollment.). 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 8 May 2024.