NCT04820088

Brief Summary

Phase I: Eligible participants (n=20) will be recruited to participate in a feasibility evaluation of the client intake module to be developed. Participants will complete pre- and post-intervention knowledge assessment outcome measures. The gain score, defined as the difference between the pre-training and post-training score, will be calculated for each participant. Each participant will spend up to 2 hours interacting with the intervention. Additionally, an implementation focus group (n=6) of administrators, educators, and key decision-makers will be conducted to assess the feasibility of implementing the proposed training suite in their programs. Phase II: During Phase II, participants (n=100) will complete in two standardized patient encounters pre- and post-intervention to evaluate the efficacy of the proposed training suite. Participants assigned to the intervention group will receive 10 hours of training with the product and will be asked to complete a Training Experience Questionnaire after their post-intervention standardized patient encounter. Control group participants will receive the APA guidelines for Psychological Practice with Transgender and Gender Non-Conforming People for review. Control group participants will submit their notes taken while reviewing the guidelines. It is expected that the intervention group will show increased knowledge, skill, awareness, and cultural competency when working with the target population as measured by the Standardized Patient encounters as rated on a Standardized Patient Checklist. Additionally, the team anticipates the experimental group participants will rate the training suite as easy to use, relevant, and realistic.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

April 1, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2021

Completed
Last Updated

March 29, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 4, 2021

Last Update Submit

March 25, 2021

Conditions

Keywords

Communication SkillsGender

Outcome Measures

Primary Outcomes (3)

  • Knowledge Assessment

    The research team will create a bank of 45 multiple-choice questions related to Intake and general cultural competencies including, gender , and communication skills. These will align and correlated with the skills in the training program. The program will randomly select 20 questions for each participant's pre-test. For the post-test, the program will randomly select 20 of the remaining 45 questions to ensure that individual participants are not assesed with repeat questions. AS no evidence-based based knowledge assessment measure exists related to the targeted skills, the team will rely on the expertise of investigative team and expert consultants to create the question bank. These questions will be informed by minority stress theory, intersectionality theory and multicultural competency frameworks. To ensure that participants are not learning from the test, answers and total scores will not be revealed to participants.

    Phase I, Month 6

  • Standardized Patient Checklist

    The team, with assistance from the expert panel, will create behavior checklists for each SP scenarios. These SP Checklists will be based on 15 items, using a yes/no/partial scoring format (i.e., the subject demonstrated the required skill); each item will be given 5 points (yes), 0 points (no), or 2 points (partial), respectively. There will be an additional 25 points awarded based on overall performance focused on empathy, rapport building, and general communication skills. The primary teaching objectives to be included on the checklists will be informed by APA Guidelines (2015) and identified by the team and converted into yes/no/partial question format. This methodology has proven successful in past SBIRs in which the SPs evaluated the participant after the encounter (i.e., R42-AA016486, R44-AA022265, R44-DP003845, R44-DA026229, and R44-MH080496).

    Phase II, Months 17-22

  • Training Experience Questionnaire

    Upon completion of the Phase II intervention period and the Standardized Patient performance improvement assessment, each participant in the intervention arm will be asked to complete a Training Experience Questionnaire (TEQ) which will allow them to evaluate TTACS using a series of 5-point Likert scale questions and open-ended prompts.

    Phase II, Months 17-22

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The educational intervention will be TTACS, the training program with simulated roleplays. Each participant will be asked to schedule 10 hours of time to utilize the simulation. In order to ensure all participants adhere to the minimum intervention requirements, each will be asked to schedule training time with a member of the research team. Participants will attend an initial training session where each participant will receive a short orientation about the product and its capabilities. Participants will attend an initial training session at one of two sites Psychology Department at Towson University or SIMmersion's office in Columbia, MD based on participant preference. Subsequent training sessions may be completed at Towson, SIMmersion or can be completed individually. Participants will receive confirmation emails the day before a scheduled session and a phone call to reschedule any missed sessions.

Other: Computer based role play trianing

Contro Arm

NO INTERVENTION

Students randomized to the control group will be given an electronic copy of the Guidelines for Psychological Practice with Transgender and Gender Non-Conforming People (APA, 2015) and asked to take notes in the pdf document. The amount of time students spend on the document and note-taking will be recorded and notes will be analyzed for content. As an incentive, the participants in the control group will be given access to TTACS after they complete the post-intervention assessment.

Interventions

Participants will train with a computer-based role-play simulation. They will interact with a lifelike video character on screen. They will interact with the character in one of four scenarios (i.e., patient intake, traditional needs, high-risk needs,and social and physical transition). They will receive real-time and after-action feedback in a safe, non-stressful environment. Their usage of the system will be monitored and transcripts will be collected.

Also known as: American Psychological Association Guidelines for Psychological Practice with Transgender and Gender Non-Conforming People (APA, 2015)
Intervention Arm

Eligibility Criteria

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

You may qualify if:

  • (1) Currently enrolled full-time in one of the following programs: The University of Massachusetts-Boston Clinical Ph.D. Program, the University of Kentucky M.A. and Ph.D. programs in Counseling Psychology, the University of Tennessee Ph.D. program in Counseling Psychology, and the Palo Alto University Ph.D. Program in Clinical Psychology (see letters of support).
  • Participants will be excluded for the following:
  • No participants will be excluded on the basis of race, gender, background, or ethnicity.
  • Implementation Focus Group (n=6):
  • Participants will be included if they are the director of a psychology program or provider training organization. Participants will be excluded if they have (1) uncorrected vision or hearing problems that prevent using the software. No participants will be excluded on the basis of race, gender, background, or ethnicity.
  • Phase II:
  • Randomized Controlled Trial (RCT):
  • (1) Currently enrolled full-time in one of the following programs: Towson University Counseling M.A. Program, Towson University Clinical M.A. Program, Howard University Counseling Ph.D. program, and The George Washington University graduate program in LGBT Health (see letters of support).
  • Participants will be excluded if:
  • No participants will be excluded on the basis of race, gender, background, or ethnicity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SIMmersion

Columbia, Maryland, 21046, United States

NOT YET RECRUITING

Towson University

Towson, Maryland, 21252, United States

RECRUITING

MeSH Terms

Conditions

Coitus

Interventions

Glutamyl Aminopeptidase

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

AminopeptidasesExopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloexopeptidasesMetalloproteases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 29, 2021

Study Start

April 1, 2019

Primary Completion

October 2, 2021

Study Completion

October 2, 2021

Last Updated

March 29, 2021

Record last verified: 2021-03

Locations