NCT05352659

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

December 16, 2021

Last Update Submit

May 6, 2024

Conditions

Outcome Measures

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.

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

Study Arms (2)

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.

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.

Behavioral: On-line training

Interventions

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.

Face-to-face and online LGBTQ training+

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

On-line resources

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland School of Public Health

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Bradley Boekeloo

    University of Maryland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Provider skills assessors will be masked to condition.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2021

First Posted

April 29, 2022

Study Start

March 1, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2025

Last Updated

May 8, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Under appropriate circumstances the investigators will share de-identified client-level data with other qualified investigators.

Locations