Gender Affirming Communication Skills Clinical Trial
Official title:
Simulated Conversation Training for Mental Healthcare Providers to Improve Care for Transgender and Gender Nonconforming Individuals
Verified date | March 2021 |
Source | SIMmersion, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | October 2, 2021 |
Est. primary completion date | October 2, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Phase I: Feasibility Evaluation: Participants (n=20) will be masters and doctoral candidates from M.A. and Ph.D. psychology programs. Participants will meet the following inclusion criteria: (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): In Phase II participants (n=100) in the Randomized Controlled Trial (RCT) are students enrolled in graduate clinical and counselling psychology programs in the Baltimore/Washington D.C. area. The study will include male and female subjects, all 18 years of age or older. One-Hundred (100) participants will be enrolled, from those that apply by a specified deadline, that meet the following inclusion criteria: (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. |
Country | Name | City | State |
---|---|---|---|
United States | SIMmersion | Columbia | Maryland |
United States | Towson University | Towson | Maryland |
Lead Sponsor | Collaborator |
---|---|
SIMmersion, LLC | Towson University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 |