Clinical trial NCT04934189: Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
Official title: Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence, Sexual
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2021-06-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: The proposed curriculum will be systematically refined based on delivery of the intervention to 3 groups of 16 TW each in a 20-hour training program, in 5 4-hour sessions.
Primary purpose: PREVENTION

Brief summary: The proposed project aims to develop and refine a tailored Empowerment Self Defense (ESD) violence prevention training for diverse TW through a series of sequential Aims: a) develop an initial draft of an ESD violence prevention curriculum tailored to TW (Aim 1); b) evaluate the feasibility and acceptability of recruitment, assessment procedures, retention and follow-up procedures, and implementation of the new intervention (Aim 2); and c) assess the preliminary efficacy of the tailored intervention program to increase use of self-protective resistance strategies, mitigate minority stressors and attitudinal barriers to self-defense, and reduce rates of exposure to violence (Exploratory Aim).

The investigators will accomplish these aims using a two-phase research design that begins with formative qualitative work engaging research partners on a community board and a small sample of research participants. Information for Phase 1 can be located in Protocol number 2020-0017. Further refinement and assessment of the feasibility and acceptability of the curriculum using Phase 1 findings will occur in Phase 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. To assess the preliminary efficacy of the tailored intervention, program participants will complete a battery of validated questionnaires assessing use of resistance strategies, gender-minority and general psychological factors hypothesized to mediate the behavioral effects of the intervention, and exposure to victimization experiences prior to, immediately following, and 6 months post-completion of the training. Together, the proposed research will lay the foundation for a large-scale randomized controlled trial (RCT) of the tailored ESD violence prevention curriculum.

Detailed description: This study leverages the strong evidence-base for Empowerment Self-Defense (ESD) violence prevention to address disparities in violence exposure among TW. The overarching goal of this R21 is to develop and refine a tailored ESD violence prevention training for diverse TW through a series of sequential Aims: a) develop an initial draft of an ESD violence prevention curriculum tailored to TW (Aim 1); b) evaluate the feasibility and acceptability of recruitment, assessment procedures, retention and follow-up procedures, and implementation of the new intervention (Aim 2); and c) assess the preliminary efficacy of the tailored intervention program to increase use of self-protective resistance strategies, mitigate minority stressors and attitudinal barriers to self-defense, and reduce rates of exposure to violence (Exploratory Aim). Together, the proposed research will lay the foundation for a large-scale randomized controlled trial (RCT) of the tailored ESD violence prevention curriculum. The investigators will accomplish these aims using a two-phase research design that begins with formative qualitative work engaging research partners on a community board and a small sample of research participants. This data will be used to inform the development and refinement of the ESD violence prevention curriculum for TW. Further refinement and assessment of the feasibility and acceptability of the curriculum will occur in Phase 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. To assess the preliminary efficacy of the tailored intervention, program participants will complete a brief survey assessing the program directly after completion, as well as a battery of validated questionnaires assessing use of resistance strategies, gender-minority and general psychological factors hypothesized to mediate the behavioral effects of the intervention, and exposure to victimization experiences prior to, immediately following, and 6 months post-completion of the training.

The overall goal of this study is to use findings from Phase 1 to deliver and refine a tailored ESD violence prevention training for diverse trans women.

Participants for Phase 2 (n = 48) will be recruited from online forums including social media sites (e.g., Facebook, Twitter), banner ads on social networking/dating sites (e.g., Scruff, BGC Live, OK Cupid, Lex) that are trans-inclusive and through dissemination of paper and/or electronic recruitment flyers with leaders of community organizations that connect transgender individuals (e.g., AVP; Callen Lorde, Trans-lantinx network). Participants from prior studies who consented to future contact will be sent the study flyer by email.

The proposed curriculum will be systematically refined based on delivery of the intervention to 3 groups of 16 TW each in a 20-hour training program, in 5 4-hour sessions. The investigators have contracted with Prepare, Inc., the New York City chapter of IMPACT International to deliver the tailored ESD violence prevention intervention. IMPACT is an international ESD violence prevention organization with chapters across the United States. Prepare, Inc. will provide facilitators who have completed IMPACT's nationally standardized ESD violence prevention program requirements that include receipt of over 100 hours of training. IMPACT training is open to trans and cisgender women. The extensive training of IMPACT facilitators promotes intervention efficacy, while the risk of potential bias conferred by their experience with a pre-existing curriculum is mitigated by our community-engaged approach (i.e.,TW community members, service providers, and scientists \[PI and Co-I\] collectively shape the content of the final tailored ESD intervention, and TW co-facilitators will be present in every training session). Prior to the start of group, facilitators will review the tailored curriculum in detail and attend 2-3 supervision/training meetings with the PI. These meetings will consist of reviewing the curriculum, role-plays of critical intervention components, and discussion of questions or concerns.

The primary outcome of Aim 2 is to evaluate our ability to recruit our target (n = 48) and retain \>75% over the course of the intervention. Successful completion of the pilot trial, including meeting or exceeding these benchmarks for success, will determine the feasibility and acceptability of recruiting participants into a future RCT. Preliminary efficacy of the tailored ESD violence prevention intervention will be evaluated as an exploratory aim. Participants enrolled in the pilot trial will be administered a battery of validated baseline questionnaires at baseline, immediately following the course, and 6 months after course completion including:

* Demographics
* Social Class Ladder
* Community Ladder
* Service Utilization Form
* Sexual experiences Survey
* Everyday Discrimination Scale
* Conflict Tactics Scale
* Gender Minority Stress Risk and Resilience Scale
* Post Traumatic Stress Disorder Symptom Checklist for DSM-5 (PCL-5)
* Sexual Assertiveness Questionnaire
* Resistance Tactics Survey
* Dating Self-Protection
* Illinois Rape Myth Acceptance
* Resistance Self-Efficacy
* Personal Progress
* Transgender Congruence Scale
* Depression Anxiety and Stress Scale
* Quick Drinking Screen
* DAST-10

Brief acceptability checklists will be administered after each course session, which will contain a brief list of topics covered during that training session and participants will indicate which of the topics participants felt were adequately covered. Lastly, an exit interview will be scheduled on the final day of the course, and will take place over the weeks immediately following the completion of the course. Interviews will be video recorded using the Zoom videoconferencing platform. The video-recorded qualitative interviews will be recorded and transcribed verbatim using the Zoom transcription function (omitting identifying information) and verified for accuracy.

The investigators will use three strategies to improve retention, based on an intensive evidence-based follow-up protocol with which the PI has considerable experience. First, participants will be compensated for completion of the assessment appointments at increasing increments over time. Second, at baseline, participants will be asked to provide extensive locating information and to provide names of two local persons to be contacted in the event that the participant cannot be reached. This information will be updated at the time of follow-up survey administration. Third, participants will receive cash for each of the five session acceptability checklists the participants complete.

Analyses will be of two primary types: (a) examinations of whether feasibility targets were met across a variety of measures; and (b) examinations of the efficacy of the tailored ESD violence prevention intervention. The investigators will use repeated measures one-way ANOVA to test if the tailored ESD curriculum has statistically significant effect on measures of behavioral and psychological/attitudinal change. If a significant effect is detected, the investigators will use Tukey's pairwise-comparison procedure to compare all treatment means, with a 95% family confidence coefficient. To assess changes in exposure to victimization, the investigators will collapse into three levels: (a) no history of victimization; (b) moderate victimization; (c) severe victimization. For this categorical data, a chi-square test of independence will be performed to compare posttreatment vs. pre-treatment, and 6-month FU vs. pre-treatment respectively to assess the preliminary efficacy of the program, with a family-wise type I error controlled at 0.05 using Bonferroni procedure. Our efficacy outcomes are exploratory and powered to detect large effect sizes. In the largest scale RCT of an ESD violence prevention program to date, rates of completed assault among women receiving resistance training were reduced by half at 1-year follow-up. However, as there are no existing studies that report on ESD efficacy among TW, the investigators will use results of our exploratory efficacy analysis to shape power analyses for a subsequent, fully powered, RCT.

Eligibility criteria: Inclusion Criteria:

* Transgender women (i.e., male assigned at birth, currently identified on the transfeminine spectrum)
* Between the ages of 18 and 65.

Exclusion Criteria:

* Cisgender men and women
* Transgender men

Primary outcomes:
measure: Average Rating on Sexual Assertiveness at Baseline
timeFrame: Baseline
measure: Change in Sexual Assertiveness From Baseline to 3 Month Followup
timeFrame: Change from Baseline at 3 months
measure: Change in Sexual Assertiveness From Baseline to 6 Month Follow up
timeFrame: Change from Baseline at 6 months
measure: Average Number of Resistance Tactics Endorsed at Baseline
timeFrame: Baseline
measure: Change in Resistance Tactics From Baseline to 3 Month Follow up
timeFrame: Change from Baseline at 3 months
measure: Change in Resistance Tactics From Baseline to 6 Month Follow up
timeFrame: Change from Baseline and 6 months
measure: Average Use of Dating Self-Protection Against Rape Strategies at Baseline
timeFrame: Baseline
measure: Change in Dating Self-Protection Against Rape From Baseline to 3 Month Follow up
timeFrame: Change from Baseline at 3 months
measure: Change in Dating Self-Protection Against Rape From Baseline to 6 Month Follow up
timeFrame: Change from Baseline at 6 months
Secondary outcomes:
measure: Average Endorsement of Rape Myth Acceptance at Baseline Scale
timeFrame: Baseline
measure: Change in Rape Myth Acceptance From Baseline to 3 Month Follow up
timeFrame: Change from Baseline at 3 months
measure: Change in Rape Myth Acceptance From Baseline to 6 Month Follow up Scale
timeFrame: Change from Baseline at 6 months
measure: Baseline Average Rating of Resistance Self-Efficacy
timeFrame: Baseline
measure: Change in Resistance Self-Efficacy From Baseline to 3 Month Follow up
timeFrame: Change from Baseline at 3 months
measure: Change in Resistance Self-Efficacy From Baseline to 6 Month Follow up
timeFrame: Change from Baseline at 6 months
measure: Average Rape Attribution at Baseline
timeFrame: Baseline
measure: Change in Rape Attribution From Baseline to Follow up Assessments
timeFrame: Change from 3 months at 6 months
measure: Average Rating of Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride
timeFrame: Baseline
measure: Change in Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 3 Month Follow up
timeFrame: Change from Baseline at 3 months
measure: Change in Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 6 Month Follow up
timeFrame: Change from Baseline at 6 months
measure: Percentage of Participants Endorsing Rape, Sexual Assault, and No Sexual Victimization at Baseline
timeFrame: Baseline
measure: Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 3 Month Followup
timeFrame: Change from Baseline at 3 months
measure: Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 6 Month Followup
timeFrame: Change from Baseline at 6 months
measure: Baseline Average Likelihood of Endorsing Gender-Based Victimization
timeFrame: Baseline
measure: Change in Endorsement of Gender-Based Victimization From Baseline to 3 Month Follow up
timeFrame: Change from Baseline at 3 months
measure: Change in Endorsement of Gender-Based Victimization From Baseline to 6 Month Follow up
timeFrame: Change from Baseline at 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Hunter College, City University of New York
state: New York
Study officials:
affiliation: Hunter College of The City University of New York
name: Danielle S Berke
role: PRINCIPAL_INVESTIGATOR
References: