Violence, SexualNCT04934189
Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
A study testing Empowerment Self Defense Training in people with Violence, Sexual, run by Hunter College of City University of New York at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence, Sexual
- What is being tested?
- Empowerment Self Defense Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2021to 26 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Transgender women (i.e., male assigned at birth, currently identified on the transfeminine spectrum)
- Between the ages of 18 and 65.
Who cannot join
- Cisgender men and women
- Transgender men
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter College, City University of New York
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Violence, Sexual
- Being tested
- Empowerment Self Defense Training
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment Self Defense TrainingBehavioural
We 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).
| Study group | Role | What they receive |
|---|---|---|
| Empowerment Self-Defense Training- Pre-Post Single Arm Design Pilot Trial | Other | Refinement and assessment of the feasibility and acceptability of the Empowerment Self-Defense curriculum will occur in Phase 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. Receives: Behavioral: Empowerment Self Defense Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Rating on Sexual Assertiveness at Baseline
The Sexual Assertiveness Questionnaire uses a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores are indicative of more impaired assertiveness. The measure comprises a 14-item Relational Sexual Assertiveness subscale and consists of items such as "I worry that my partner won't like me unless I engage in sexual behavior" and "I am easily persuaded to engage in sexual activity" and a 7-item Confidence and Communication subscale. A sample item is "I lack confidence in sexual situations." A total score was created by taking the average of all 14 items (range = 1-5).
Measured: Baseline
Change in Sexual Assertiveness From Baseline to 3 Month Followup
The Sexual Assertiveness Questionnaire uses a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores are indicative of more impaired assertiveness. The measure comprises a 14-item Relational Sexual Assertiveness subscale and consists of items such as "I worry that my partner won't like me unless I engage in sexual behavior" and "I am easily persuaded to engage in sexual activity" and a 7-item Confidence and Communication subscale. A sample item is "I lack confidence in sexual situations." A total score was created by taking the average of all 14 items (range = 1-5).
Measured: Change from Baseline at 3 months
Change in Sexual Assertiveness From Baseline to 6 Month Follow up
The Sexual Assertiveness Questionnaire uses a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores are indicative of more impaired assertiveness. The measure comprises a 14-item Relational Sexual Assertiveness subscale and consists of items such as "I worry that my partner won't like me unless I engage in sexual behavior" and "I am easily persuaded to engage in sexual activity" and a 7-item Confidence and Communication subscale. A sample item is "I lack confidence in sexual situations." A total score was created by taking the average of all 14 items (range = 1-5).
Measured: Change from Baseline at 6 months
Average Number of Resistance Tactics Endorsed at Baseline
The Resistance Tactics Questionnaire will be used to measure participants use of six self-defense strategies via "yes" or "no" responses to the question prompt. The self-defense strategies assessed included (a) assertive body language (e.g., walking confidently), (b) assertive verbal responses (e.g., saying "no"), (c) avoiding telegraphing emotions (e.g., providing an assertive verbal response even when nervous), (d) attention to your intuition (e.g., trusting your gut), (e) yelling and running, and (f) physical self-defense. Higher scores indicate greater use of resistance tactics. A total score was created by calculating the sum of all 6 items (range: 0-6).
Measured: Baseline
Change in Resistance Tactics From Baseline to 3 Month Follow up
The Resistance Tactics Questionnaire will be used to measure participants use of six self-defense strategies via "yes" or "no" responses to the question prompt. The self-defense strategies assessed included (a) assertive body language (e.g., walking confidently), (b) assertive verbal responses (e.g., saying "no"), (c) avoiding telegraphing emotions (e.g., providing an assertive verbal response even when nervous), (d) attention to your intuition (e.g., trusting your gut), (e) yelling and running, and (f) physical self-defense. Higher scores indicate greater use of resistance tactics. A total score was created by calculating the sum of all 6 items (range: 0-6).
Measured: Change from Baseline at 3 months
Change in Resistance Tactics From Baseline to 6 Month Follow up
The Resistance Tactics Questionnaire will be used to measure participants use of six self-defense strategies via "yes" or "no" responses to the question prompt. The self-defense strategies assessed included (a) assertive body language (e.g., walking confidently), (b) assertive verbal responses (e.g., saying "no"), (c) avoiding telegraphing emotions (e.g., providing an assertive verbal response even when nervous), (d) attention to your intuition (e.g., trusting your gut), (e) yelling and running, and (f) physical self-defense. Higher scores indicate greater use of resistance tactics. A total score was created by calculating the sum of all 6 items (range: 0-6).
Measured: Change from Baseline and 6 months
Average Use of Dating Self-Protection Against Rape Strategies at Baseline
Participant's use of protective strategies against sexual victimization will be assessed with the Dating Self-Protection Against Rape Scale. Participants will report the frequency with which they engage in a series of 15 behaviors used to for self-protection (e.g., "How often do you pay attention to your dating partner's drug/alcohol intake?"). Responses are provided along a 6-point scale ranging from never to always. Higher scores indicate greater use of self-protective strategies. A total score was created by calculating the average of all 15 items (range: 1-6).
Measured: Baseline
Change in Dating Self-Protection Against Rape From Baseline to 3 Month Follow up
Participant's use of protective strategies against sexual victimization will be assessed with this scale. Participants will report the frequency with which they engage in a series of 15 behaviors used to for self-protection (e.g., "How often do you pay attention to your dating partner's drug alcohol intake?"). Responses are provided along a 6-point scale ranging from never to always. Higher scores indicate greater use of self-protective strategies. A total score was created by calculating the average of all 15 items (range: 1-6).
Measured: Change from Baseline at 3 months
Change in Dating Self-Protection Against Rape From Baseline to 6 Month Follow up
Participant's use of protective strategies against sexual victimization will be assessed with the Dating Self-Protection Against Rape Scale. Participants will report the frequency with which they engage in a series of 15 behaviors used to for self-protection (e.g., "How often do you pay attention to your dating partner's drug alcohol intake?"). Responses are provided along a 6-point scale ranging from never to always. Higher scores indicate greater use of self-protective strategies. A total score was created by calculating the average of all 15 items (range: 1-6).
Measured: Change from Baseline at 6 months
Secondary outcomes (17)
Average Endorsement of Rape Myth Acceptance at Baseline Scale
The 45-item scale Illinois Rape Myth Acceptance Scale assesses the endorsement of rape myth attitudes supportive of sexual coercion and aggression. Rape myths include "beliefs about rape (i.e., about its causes, context, consequences, perpetrators, victims, and their interaction) that serve to downplay, or justify sexual violence that men commit again women" (Gerger et al., 2007). The scale is formatted on a 7-point Likert-type scale ranging from "1" (strongly disagree) to "7" (strongly agree). A total score was created by calculating the average rating across all 45-items (range: 1-7).
Measured: Baseline
Change in Rape Myth Acceptance From Baseline to 3 Month Follow up
The Illinois Rape Myth Acceptance Scale is a 45-item scale assessing the endorsement of rape myth attitudes supportive of sexual coercion and aggression. Rape myths include "beliefs about rape (i.e., about its causes, context, consequences, perpetrators, victims, and their interaction) that serve to downplay, or justify sexual violence that men commit against women" (Gerger et al., 2007). The scale is formatted on a 7-point Likert-type scale ranging from "1" (strongly disagree) to "7" (strongly agree). A total score was created by calculating the average rating across all 45-items (range: 1-7). Higher scores indicate greater endorsement of rape myths.
Measured: Change from Baseline at 3 months
Change in Rape Myth Acceptance From Baseline to 6 Month Follow up Scale
This 45-item Illinois Rape Myth Acceptance Scale assesses the endorsement of rape myth attitudes supportive of sexual coercion and aggression. Rape myths include "beliefs about rape (i.e., about its causes, context, consequences, perpetrators, victims, and their interaction) that serve to downplay, or justify sexual violence that men commit against women" (Gerger et al., 2007). The scale is formatted on a 7-point Likert-type scale ranging from "1" (strongly disagree) to "7" (strongly agree). Higher scores indicate greater endorsement of rape myths. A total score was created by calculating the average rating across all 45-items (range: 1-7).
Measured: Change from Baseline at 6 months
Baseline Average Rating of Resistance Self-Efficacy
Participants' confidence in utilizing assertive responses to potentially threatening dating situations was assessed by seven items on the Resistance Self-Efficacy Scale (i.e., "If someone you were with was attempting to get you to have sex with them and you were not interested, how confident are you that you could successfully resist their advances?"; Marx, Calhoun, Wilson, \& Meyerson, 2001; Ozer \& Bandura, 1990). Responses are provided along a 7-point scale, ranging from not at all confident to very confident. Higher scores indicate great resistance self-efficacy. A total score was created by calculating the average rating across all items (range: 1-7).
Measured: Baseline
Change in Resistance Self-Efficacy From Baseline to 3 Month Follow up
Participants' confidence in utilizing assertive responses to potentially threatening dating situations was assessed by seven items on the Resistance Self-Efficacy Scale (i.e., "If someone you were with was attempting to get you to have sex with them and you were not interested, how confident are you that you could successfully resist their advances?"; Marx, Calhoun, Wilson, \& Meyerson, 2001; Ozer \& Bandura, 1990). Responses are provided along a 7-point scale, ranging from not at all confident to very confident. Higher scores indicate great resistance self-efficacy. A total score was created by calculating the average rating across all items (range: 1-7).
Measured: Change from Baseline at 3 months
Change in Resistance Self-Efficacy From Baseline to 6 Month Follow up
Participants' confidence in utilizing assertive responses to potentially threatening dating situations was assessed by seven items on the Self-Efficacy Scale (i.e., "If someone you were with was attempting to get you to have sex with them and you were not interested, how confident are you that you could successfully resist their advances?"; Marx, Calhoun, Wilson, \& Meyerson, 2001; Ozer \& Bandura, 1990). Responses are provided along a 7-point scale, ranging from not at all confident to very confident. Higher scores indicate great resistance self-efficacy. A total score was created by calculating the average rating across all items (range: 1-7).
Measured: Change from Baseline at 6 months
Average Rape Attribution at Baseline
Participants attributions of blame following experiences of sexual victimization will be assessed by 25 items on the Rape Attribution Scale (Frazier, 2002; Frazier \& Seales, 1997). Responses are provided along a 5-point scale, ranging from never to very often, whereby higher scores indicate higher levels of blame. Five subscales will be utilized to explore various attributions of blame, including (a) societal blame, (b) behavioral selfblame, (c) characterological self-blame, (d) chance, and (e) rapist blame. A total score was to be created by calculating the average rating across all items (range: 1-5).
Measured: Baseline
Change in Rape Attribution From Baseline to Follow up Assessments
Participants attributions of blame following experiences of sexual victimization will be assessed by 25 items on the Rape Attribution Scale (Frazier, 2002; Frazier \& Seales, 1997). Responses are provided along a 5-point scale, ranging from never to very often, whereby higher scores indicate higher levels of blame. Five subscales will be utilized to explore various attributions of blame, including (a) societal blame, (b) behavioral selfblame, (c) characterological self-blame, (d) chance, and (e) rapist blame. A total score was to be created by calculating the average rating across all items (range: 1-5).
Measured: Change from 3 months at 6 months
Average Rating of Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride
Designed for use with transgender and gender nonconforming people, the Gender Minority Stress and Resilience measure is one of the few that assesses gender identity-related constructs. It was designed to take into account unique gender minority distal stressors as was a resilience factors. These subscales will be used in this current study to test hypothesized mediators of the effects of the ESD violence prevention training on behavioral outcomes. Responses are given on a a 5-point Likert response scale (Strongly Disagree to Strongly Agree). Higher scores are indicative of greater phenomena. Six subscale scores were created by calculating the average rating for measure items corresponding with each construct: nonaffirmation of transgender identity, internalized transphobia, identity nondisclosure, negative expectations, community connection, and pride. Range for all subscales: 1-5
Measured: Baseline
Change in Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 3 Month Follow up
Designed for use with transgender and gender nonconforming people, the Gender Minority Stress and Resilience measure is one of the few that assesses gender identity-related constructs. It was designed to take into account unique gender minority distal stressors as was a resilience factors. These subscales will be used in this current study to test hypothesized mediators of the effects of the ESD violence prevention training on behavioral outcomes. Responses are given on a a 5-point Likert response scale (Strongly Disagree to Strongly Agree). Higher scores are indicative of greater phenomena. Six subscale scores were created by calculating the average rating for measure items corresponding with each construct: nonaffirmation of transgender identity, internalized transphobia, identity nondisclosure, negative expectations, community connection, and pride. Range for all subscales: 1-5
Measured: Change from Baseline at 3 months
Change in Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 6 Month Follow up
Designed for use with transgender and gender nonconforming people, the Gender Minority Stress and Resilience measure is one of the few that assesses gender identity-related constructs. It was designed to take into account unique gender minority distal stressors as was a resilience factors. These subscales will be used in this current study to test hypothesized mediators of the effects of the ESD violence prevention training on behavioral outcomes. Responses are given on a a 5-point Likert response scale (Strongly Disagree to Strongly Agree). Higher scores are indicative of greater phenomena. Six subscale scores were created by calculating the average rating for measure items corresponding with each construct: nonaffirmation of transgender identity, internalized transphobia, identity nondisclosure, negative expectations, community connection, and pride. Range for all subscales: 1-5
Measured: Change from Baseline at 6 months
Percentage of Participants Endorsing Rape, Sexual Assault, and No Sexual Victimization at Baseline
The Sexual Experience Survey Short Form Victimization (SES-SFV) is the most widely used measure in sexual assault research. A primary strength of the measure is that it does not require participant to label their experiences as "sexual assault" or "rape." Rather, it utilizes a series of 10 sexually explicit questions that assess t past sexual behavior along a variety of dimensions. Experiences can be classified as "completed rape," "attempted rape," "coercion," "attempted coercion," or "nonconsensual sexual contact." Participants were assigned a score of "0" if they denied the question and a score of "1" if they endorsed the question. Participants with a score of 0 for all items were categorized as having no history of victimization. Participants with a score of 1 for any item assessing sexual coercion or nonconsensual sexual contact were categorized as having experienced sexual assault. Participants with a 1 for any rape item were catagorized as having experienced rape.
Measured: Baseline
Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 3 Month Followup
The Sexual Experience Survey Short Form Victimization (SES-SFV) is the most widely used measure in sexual assault research. A primary strength of the measure is that it does not require participant to label their experiences as "sexual assault" or "rape." Rather, it utilizes a series of 10 sexually explicit questions that assess t past sexual behavior along a variety of dimensions. Experiences can be classified as "completed rape," "attempted rape," "coercion," "attempted coercion," or "nonconsensual sexual contact." Participants were assigned a score of "0" if they denied the question and a score of "1" if they endorsed the question. Participants with a score of 0 for all items were categorized as having no history of victimization. Participants with a score of 1 for any item assessing sexual coercion or nonconsensual sexual contact were categorized as having experienced sexual assault. Participants with a 1 for any rape item were catagorized as having experienced rape.
Measured: Change from Baseline at 3 months
Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 6 Month Followup
The Sexual Experience Survey Short Form Victimization (SES-SFV) is the most widely used measure in sexual assault research. A primary strength of the measure is that it does not require participant to label their experiences as "sexual assault" or "rape." Rather, it utilizes a series of 10 sexually explicit questions that assess t past sexual behavior along a variety of dimensions. Experiences can be classified as "completed rape," "attempted rape," "coercion," "attempted coercion," or "nonconsensual sexual contact." Participants were assigned a score of "0" if they denied the question and a score of "1" if they endorsed the question. Participants with a score of 0 for all items were categorized as having no history of victimization. Participants with a score of 1 for any item assessing sexual coercion or nonconsensual sexual contact were categorized as having experienced sexual assault. Participants with a 1 for any rape item were catagorized as having experienced rape.
Measured: Change from Baseline at 6 months
Baseline Average Likelihood of Endorsing Gender-Based Victimization
This subscale of the Gender Minority Stress and Resilience Measure will be used to assess the exploratory hypothesis that the ESD violence prevention training will produce reductions in rates of exposure to gender-related violence. At baseline, participants will indicate whether they have been exposed to a list of gender-related victimization experiences since the age of 18. At the 3- and 6- month post-intervention followup, participants will indicate whether they have been exposed to these experiences "since your last assessment." Sample items include "I have been threatened with physical harm because of my gender identity or expression." "I have been pushed, shoved, hit, or had somethin thrown at me because of my gender identity or expression." Higher scores indicate greater exposure to gender-related violence. A likelihood of victimization score was calculated based on the average response to all measures on this subscale ("yes" vs "no"). Range: 0-1
Measured: Baseline
Change in Endorsement of Gender-Based Victimization From Baseline to 3 Month Follow up
This subscale of the Gender Minority Stress and Resilience Measure will be used to assess the exploratory hypothesis that the ESD violence prevention training will produce reductions in rates of exposure to gender-related violence. At baseline, participants will indicate whether they have been exposed to a list of gender-related victimization experiences since the age of 18. At the 3- and 6- month post-intervention followup, participants will indicate whether they have been exposed to these experiences "since your last assessment." Sample items include "I have been threatened with physical harm because of my gender identity or expression." "I have been pushed, shoved, hit, or had somethin thrown at me because of my gender identity or expression." Higher scores indicate greater exposure to gender-related violence. A likelihood of victimization score was calculated based on the average response to all measures on this subscale ("yes" vs "no"). Range: 0-1
Measured: Change from Baseline at 3 months
Change in Endorsement of Gender-Based Victimization From Baseline to 6 Month Follow up
This subscale of the Gender Minority Stress and Resilience Measure will be used to assess the exploratory hypothesis that the ESD violence prevention training will produce reductions in rates of exposure to gender-related violence. At baseline, participants will indicate whether they have been exposed to a list of gender-related victimization experiences since the age of 18. At the 3- and 6- month post-intervention followup, participants will indicate whether they have been exposed to these experiences "since your last assessment." Sample items include "I have been threatened with physical harm because of my gender identity or expression." "I have been pushed, shoved, hit, or had somethin thrown at me because of my gender identity or expression." Higher scores indicate greater exposure to gender-related violence. A likelihood of victimization score was calculated based on the average response to all measures on this subscale ("yes" vs "no"). Range: 0-1
Measured: Change from Baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start11 Jul 2021
- Primary completion25 Jun 2022
- Study completion26 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Violence, SexualStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Danielle Berke, Hunter College of City University of New York
- Investigators
- Danielle S Berke, Principal investigator, Hunter College of The City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934189
- Sponsor's protocol ID
- R21MD014807
- Other IDs
- 5R21MD014807-02
- Status last verified
- Apr 2024
- First submitted
- 4 Jun 2021
- Last updated
- 30 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith AM, Hotchkiss M, Gilbert C, Williams DN, Madhav K, Bloomfield K, Pautz CR, Berke DS. Process adaptations to community-engaged research for preventing victimization against trans women: Failure as a blueprint toward nonexploitative implementation science. Am Psychol. 2023 Feb-Mar;78(2):186-198. doi: 10.1037/amp0001063.
PubMed 37011169
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
- ClinicalTrials.gov ID
- NCT04934189
- Acronym / sponsor ID
- R21MD014807
- Conditions
- Violence, Sexual
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Jul 2021 (actual)
- Primary completion
- 25 Jun 2022 (actual)
- Study completion
- 26 Feb 2024 (actual)
- First posted
- 22 Jun 2021 (actual)
- Results
- Posted 30 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Empowerment Self-Defense Training- Pre-Post Single Arm Design Pilot Trial | Other | Behavioral: Empowerment Self Defense TrainingRefinement and assessment of the feasibility and acceptability of the Empowerment Self-Defense curriculum will occur in Phase 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Transgender women (i.e., male assigned at birth, currently identified on the transfeminine spectrum)
- Between the ages of 18 and 65.
Key exclusion criteria (2 listed)
- Cisgender men and women
- Transgender men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment Self Defense TrainingWe 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). | Behavioural | Empowerment Self-Defense Training- Pre-Post Single Arm Design Pilot Trial |
Primary outcome
Average Rating on Sexual Assertiveness at Baseline
Time frame: Baseline
The Sexual Assertiveness Questionnaire uses a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores are indicative of more impaired assertiveness. The measure comprises a 14-item Relational Sexual Assertiveness subscale and consists of items such as "I worry that my partner won't like me unless I engage in sexual behavior" and "I am easily persuaded to engage in sexual activity" and a 7-item Confidence and Communication subscale. A sample item is "I lack confidence in sexual situations." A total score was created by taking the average of all 14 items (range = 1-5).
Change in Sexual Assertiveness From Baseline to 3 Month Followup
Time frame: Change from Baseline at 3 months
The Sexual Assertiveness Questionnaire uses a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores are indicative of more impaired assertiveness. The measure comprises a 14-item Relational Sexual Assertiveness subscale and consists of items such as "I worry that my partner won't like me unless I engage in sexual behavior" and "I am easily persuaded to engage in sexual activity" and a 7-item Confidence and Communication subscale. A sample item is "I lack confidence in sexual situations." A total score was created by taking the average of all 14 items (range = 1-5).
Change in Sexual Assertiveness From Baseline to 6 Month Follow up
Time frame: Change from Baseline at 6 months
The Sexual Assertiveness Questionnaire uses a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). Higher scores are indicative of more impaired assertiveness. The measure comprises a 14-item Relational Sexual Assertiveness subscale and consists of items such as "I worry that my partner won't like me unless I engage in sexual behavior" and "I am easily persuaded to engage in sexual activity" and a 7-item Confidence and Communication subscale. A sample item is "I lack confidence in sexual situations." A total score was created by taking the average of all 14 items (range = 1-5).
Average Number of Resistance Tactics Endorsed at Baseline
Time frame: Baseline
The Resistance Tactics Questionnaire will be used to measure participants use of six self-defense strategies via "yes" or "no" responses to the question prompt. The self-defense strategies assessed included (a) assertive body language (e.g., walking confidently), (b) assertive verbal responses (e.g., saying "no"), (c) avoiding telegraphing emotions (e.g., providing an assertive verbal response even when nervous), (d) attention to your intuition (e.g., trusting your gut), (e) yelling and running, and (f) physical self-defense. Higher scores indicate greater use of resistance tactics. A total score was created by calculating the sum of all 6 items (range: 0-6).
Change in Resistance Tactics From Baseline to 3 Month Follow up
Time frame: Change from Baseline at 3 months
The Resistance Tactics Questionnaire will be used to measure participants use of six self-defense strategies via "yes" or "no" responses to the question prompt. The self-defense strategies assessed included (a) assertive body language (e.g., walking confidently), (b) assertive verbal responses (e.g., saying "no"), (c) avoiding telegraphing emotions (e.g., providing an assertive verbal response even when nervous), (d) attention to your intuition (e.g., trusting your gut), (e) yelling and running, and (f) physical self-defense. Higher scores indicate greater use of resistance tactics. A total score was created by calculating the sum of all 6 items (range: 0-6).
Change in Resistance Tactics From Baseline to 6 Month Follow up
Time frame: Change from Baseline and 6 months
The Resistance Tactics Questionnaire will be used to measure participants use of six self-defense strategies via "yes" or "no" responses to the question prompt. The self-defense strategies assessed included (a) assertive body language (e.g., walking confidently), (b) assertive verbal responses (e.g., saying "no"), (c) avoiding telegraphing emotions (e.g., providing an assertive verbal response even when nervous), (d) attention to your intuition (e.g., trusting your gut), (e) yelling and running, and (f) physical self-defense. Higher scores indicate greater use of resistance tactics. A total score was created by calculating the sum of all 6 items (range: 0-6).
Average Use of Dating Self-Protection Against Rape Strategies at Baseline
Time frame: Baseline
Participant's use of protective strategies against sexual victimization will be assessed with the Dating Self-Protection Against Rape Scale. Participants will report the frequency with which they engage in a series of 15 behaviors used to for self-protection (e.g., "How often do you pay attention to your dating partner's drug/alcohol intake?"). Responses are provided along a 6-point scale ranging from never to always. Higher scores indicate greater use of self-protective strategies. A total score was created by calculating the average of all 15 items (range: 1-6).
Change in Dating Self-Protection Against Rape From Baseline to 3 Month Follow up
Time frame: Change from Baseline at 3 months
Participant's use of protective strategies against sexual victimization will be assessed with this scale. Participants will report the frequency with which they engage in a series of 15 behaviors used to for self-protection (e.g., "How often do you pay attention to your dating partner's drug alcohol intake?"). Responses are provided along a 6-point scale ranging from never to always. Higher scores indicate greater use of self-protective strategies. A total score was created by calculating the average of all 15 items (range: 1-6).
Change in Dating Self-Protection Against Rape From Baseline to 6 Month Follow up
Time frame: Change from Baseline at 6 months
Participant's use of protective strategies against sexual victimization will be assessed with the Dating Self-Protection Against Rape Scale. Participants will report the frequency with which they engage in a series of 15 behaviors used to for self-protection (e.g., "How often do you pay attention to your dating partner's drug alcohol intake?"). Responses are provided along a 6-point scale ranging from never to always. Higher scores indicate greater use of self-protective strategies. A total score was created by calculating the average of all 15 items (range: 1-6).
17 secondary outcomes
Average Endorsement of Rape Myth Acceptance at Baseline Scale
Time frame: Baseline
Change in Rape Myth Acceptance From Baseline to 3 Month Follow up
Time frame: Change from Baseline at 3 months
Change in Rape Myth Acceptance From Baseline to 6 Month Follow up Scale
Time frame: Change from Baseline at 6 months
Baseline Average Rating of Resistance Self-Efficacy
Time frame: Baseline
Change in Resistance Self-Efficacy From Baseline to 3 Month Follow up
Time frame: Change from Baseline at 3 months
Change in Resistance Self-Efficacy From Baseline to 6 Month Follow up
Time frame: Change from Baseline at 6 months
Average Rape Attribution at Baseline
Time frame: Baseline
Change in Rape Attribution From Baseline to Follow up Assessments
Time frame: Change from 3 months at 6 months
Average Rating of Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride
Time frame: Baseline
Change in Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 3 Month Follow up
Time frame: Change from Baseline at 3 months
Change in Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 6 Month Follow up
Time frame: Change from Baseline at 6 months
Percentage of Participants Endorsing Rape, Sexual Assault, and No Sexual Victimization at Baseline
Time frame: Baseline
Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 3 Month Followup
Time frame: Change from Baseline at 3 months
Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 6 Month Followup
Time frame: Change from Baseline at 6 months
Baseline Average Likelihood of Endorsing Gender-Based Victimization
Time frame: Baseline
Change in Endorsement of Gender-Based Victimization From Baseline to 3 Month Follow up
Time frame: Change from Baseline at 3 months
Change in Endorsement of Gender-Based Victimization From Baseline to 6 Month Follow up
Time frame: Change from Baseline at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37011169Smith AM, Hotchkiss M, Gilbert C, Williams DN, Madhav K, Bloomfield K, Pautz CR, Berke DS. Process adaptations to community-engaged research for preventing victimization against trans women: Failure as a blueprint toward nonexploitative implementation science. Am Psychol. 2023 Feb-Mar;78(2):186-198. doi: 10.1037/amp0001063.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle S Berke principal investigator
Hunter College of The City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment Self Defense Training in people with Violence, Sexual, run by Hunter College of City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Rating on Sexual Assertiveness at Baseline (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04934189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.