CClinicalTrials.gg
Enrolling by invitationNCT05352659UMD-PRCUpdated May 8, 2024

Increasing Effective Mental Health Care for LGBT Clients

An interventional study of Face-to-face and online LGBTQ+ training and On-line training in Sexual Orientation and Gender Identity, sponsored by University of Maryland, College Park. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by University of Maryland, College Park · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2021, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sexual Orientation
  • Gender Identity
03

In context

Lead sponsor

University of Maryland, College Park is the lead sponsor of 60 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

Participants may not be under 18 years of age, unlicensed, or have less than 10 clients 16 years or older.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Face-to-face and online LGBTQ training+

    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.

    Behavioral: Face-to-face and online LGBTQ+ training

  • Other
    On-line resources

    The Comparison Intervention arm receives only links to publicly available on-line resources.

    Behavioral: On-line training

Interventions

  • BehavioralFace-to-face and online LGBTQ+ training

    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.

  • BehavioralOn-line training

    This study arm receives only links to publicly available on-line LGBTQ training.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 30 days after therapist completion of the intervention, an average of 6 months after enrollment.

07

Study locations

1 site
  • University of Maryland School of Public Health
    College Park, Maryland 20742, United States
08

References and documents

Study documents

  • Informed consent form · Nov 3, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Under appropriate circumstances the investigators will share de-identified client-level data with other qualified investigators.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05352659
Lead sponsor
University of Maryland, College Park
Responsible party
Brad Boekeloo (Professor, University of Maryland, College Park) — Principal investigator
First posted
Apr 29, 2022
Start date
Mar 1, 2021
Primary completion
May 1, 2022
Completion
Jun 1, 2025 (estimated)
Last update
May 8, 2024

Study contacts

Bradley Boekeloo
principal investigator · University of Maryland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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