- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04934189
Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Hunter College, City University of New York
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Empowerment Self-Defense Training- Pre-Post Single Arm Design Pilot Trial
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Assertiveness Questionnaire
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."
These subscales have evidenced strong internal consistency (Walker, 2006).
|
Baseline
|
Sexual Assertiveness Questionnaire
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."
These subscales have evidenced strong internal consistency (Walker, 2006).
|
Change from Baseline at 3 months
|
Sexual Assertiveness Questionnaire
Time Frame: Change from Baseline and 3 months 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."
These subscales have evidenced strong internal consistency (Walker, 2006).
|
Change from Baseline and 3 months at 6 months
|
Resistance Tactics Questionnaire
Time Frame: Baseline
|
This 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.
In a prospective analysis of a self-defense training program for college women, participants assigned to the self-defense training reported greater elevations in use of these resistance tactics relative to a placebo group (Orchowski, Gidycz, & Raffle, 2008).
|
Baseline
|
Resistance Tactics Questionnaire
Time Frame: Change from Baseline at 3 months
|
This 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.
In a prospective analysis of a self-defense training program for college women, participants assigned to the self-defense training reported greater elevations in use of these resistance tactics relative to a placebo group (Orchowski, Gidycz, & Raffle, 2008).
|
Change from Baseline at 3 months
|
Resistance Tactics Questionnaire
Time Frame: Change from Baseline and 3 months at 6 months
|
This 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.
In a prospective analysis of a self-defense training program for college women, participants assigned to the self-defense training reported greater elevations in use of these resistance tactics relative to a placebo group (Orchowski, Gidycz, & Raffle, 2008).
|
Change from Baseline and 3 months at 6 months
|
Dating Self-Protection Against Rape Scale
Time Frame: Baseline
|
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.
Orchowski and her colleagues reported that the scale demonstrates good internal consistency and found that a self-defense program was effective in increasing use of self-protective strategies as measured by this scale compared to a placebo control over a 4-month interim.
|
Baseline
|
Dating Self-Protection Against Rape Scale
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.
Orchowski and her colleagues reported that the scale demonstrates good internal consistency and found that a self-defense program was effective in increasing use of self-protective strategies as measured by this scale compared to a placebo control over a 4-month interim.
|
Change from Baseline at 3 months
|
Dating Self-Protection Against Rape Scale
Time Frame: Change from Baseline and 3 months at 6 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.
Orchowski and her colleagues reported that the scale demonstrates good internal consistency and found that a self-defense program was effective in increasing use of self-protective strategies as measured by this scale compared to a placebo control over a 4-month interim.
|
Change from Baseline and 3 months at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Illinois Rape Myth Acceptance Scale
Time Frame: Baseline
|
This 45-item 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).
Exploratory and confirmatory multivariate analyses have revealed a structure consisting of both a general myth component and seven subcomponents that have been replicated in subsequent studies comprising samples of youth with a mean age of 18.8 years.
The scale has also been shown to possess sufficient internal consistency in multiple studies (Payne, 1999; Diem, 2000).
|
Baseline
|
Illinois Rape Myth Acceptance Scale
Time Frame: Change from Baseline at 3 months
|
This 45-item 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).
Exploratory and confirmatory multivariate analyses have revealed a structure consisting of both a general myth component and seven subcomponents that have been replicated in subsequent studies comprising samples of youth with a mean age of 18.8 years.
The scale has also been shown to possess sufficient internal consistency in multiple studies (Payne, 1999; Diem, 2000).
|
Change from Baseline at 3 months
|
Illinois Rape Myth Acceptance Scale
Time Frame: Change from Baseline and 3 months at 6 months
|
This 45-item 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).
Exploratory and confirmatory multivariate analyses have revealed a structure consisting of both a general myth component and seven subcomponents that have been replicated in subsequent studies comprising samples of youth with a mean age of 18.8 years.
The scale has also been shown to possess sufficient internal consistency in multiple studies (Payne, 1999; Diem, 2000).
|
Change from Baseline and 3 months at 6 months
|
Resistance Self-Efficacy Scale
Time Frame: Baseline
|
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.
The scale demonstrates good internal consistency reliability (Cronbach's alpha = .97;
Ozer & Bandura, 1990).
Orchowski and her colleagues found that a self defense program was effective in increasing selfefficacy as measured by this scale compared to a placebo control over a 4-month interim.
|
Baseline
|
Resistance Self-Efficacy Scale
Time Frame: Change from Baseline at 3 months
|
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.
The scale demonstrates good internal consistency reliability (Cronbach's alpha = .97;
Ozer & Bandura, 1990).
Orchowski and her colleagues found that a self defense program was effective in increasing selfefficacy as measured by this scale compared to a placebo control over a 4-month interim.
|
Change from Baseline at 3 months
|
Resistance Self-Efficacy Scale
Time Frame: Change from Baseline and 3 months at 6 months
|
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.
The scale demonstrates good internal consistency reliability (Cronbach's alpha = .97;
Ozer & Bandura, 1990).
Orchowski and her colleagues found that a self defense program was effective in increasing selfefficacy as measured by this scale compared to a placebo control over a 4-month interim.
|
Change from Baseline and 3 months at 6 months
|
Rape Attribution Scale
Time Frame: 3-months from Baseline, no change
|
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.
The scale demonstrates good internal consistency reliability (i.e., Frazier, 1990; Frazier, 2002).
|
3-months from Baseline, no change
|
Rape Attribution Scale
Time Frame: Change from 3 months at 6 months
|
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.
The scale demonstrates good internal consistency reliability (i.e., Frazier, 1990; Frazier, 2002).
|
Change from 3 months at 6 months
|
Gender Minority Stress and Resilience Measure: Nonaffirmation of Gender Identity, Internalized Transphobia, Concealment, Community Connectedness, & Pride Subscales
Time Frame: Baseline
|
Designed for use with transgender and gender nonconforming people, the GMSR measure is one of the few that assesses gender identity-related constructs.
It was designed to take into account unique gender minority distal stressors, such as internalized transphobia, and concealment of identity, as was a resilience factors including community connectedness and pride.
These subscales have shown strong internal consistency (Testa et al., 2015) and 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) and responses are summed.
Higher scores are indicative of greater phenomena.
|
Baseline
|
Gender Minority Stress and Resilience Measure: Nonaffirmation of Gender Identity, Internalized Transphobia, Concealment, Community Connectedness, & Pride Subscales
Time Frame: Change from Baseline at 3 months
|
Designed for use with transgender and gender nonconforming people, the GMSR measure is one of the few that assesses gender identity-related constructs.
It was designed to take into account unique gender minority distal stressors, such as internalized transphobia, and concealment of identity, as was a resilience factors including community connectedness and pride.
These subscales have shown strong internal consistency (Testa et al., 2015) and 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) and responses are summed.
Higher scores are indicative of greater phenomena.
|
Change from Baseline at 3 months
|
Gender Minority Stress and Resilience Measure: Nonaffirmation of Gender Identity, Internalized Transphobia, Concealment, Community Connectedness, & Pride Subscales
Time Frame: Change from Baseline and 3 months at 6 months
|
Designed for use with transgender and gender nonconforming people, the GMSR measure is one of the few that assesses gender identity-related constructs.
It was designed to take into account unique gender minority distal stressors, such as internalized transphobia, and concealment of identity, as was a resilience factors including community connectedness and pride.
These subscales have shown strong internal consistency (Testa et al., 2015) and 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) and responses are summed.
Higher scores are indicative of greater phenomena.
|
Change from Baseline and 3 months at 6 months
|
Sexual Experience Survey Short Form Victimization
Time Frame: Baseline
|
The SES-SFV is the most widely used measure in sexual assault research.
Beyond its high validity and reliably, a primary strength of the measure is that it does not require participants to label their experiences as "sexual assault" or "rape."
Rather, the SES-SFV utilizes a series of 10 sexually explicit questions that assess the frequency of past sexual behavior along a variety of dimensions.
Experiences can be classified as "completed rape," "attempted rape," "coercion," "attempted coercion," or "nonconsensual sexual contact."
Several trials examining the efficacy of an empowerment or feminist self-defense training program have demonstrated reductions in incidence of rape as measured by the SESSFV compared to a control group (e.g., Hollander, 2014; Orchowski, Gidycz, & Raffle, 2008; Senn et al., 2015).
|
Baseline
|
Sexual Experience Survey Short Form Victimization
Time Frame: Change from Baseline at 3 months
|
The SES-SFV is the most widely used measure in sexual assault research.
Beyond its high validity and reliably, a primary strength of the measure is that it does not require participants to label their experiences as "sexual assault" or "rape."
Rather, the SES-SFV utilizes a series of 10 sexually explicit questions that assess the frequency of past sexual behavior along a variety of dimensions.
Experiences can be classified as "completed rape," "attempted rape," "coercion," "attempted coercion," or "nonconsensual sexual contact."
Several trials examining the efficacy of an empowerment or feminist self-defense training program have demonstrated reductions in incidence of rape as measured by the SESSFV compared to a control group (e.g., Hollander, 2014; Orchowski, Gidycz, & Raffle, 2008; Senn et al., 2015).
|
Change from Baseline at 3 months
|
Sexual Experience Survey Short Form Victimization
Time Frame: Change from Baseline and 3 months at 6 months
|
The SES-SFV is the most widely used measure in sexual assault research.
Beyond its high validity and reliably, a primary strength of the measure is that it does not require participants to label their experiences as "sexual assault" or "rape."
Rather, the SES-SFV utilizes a series of 10 sexually explicit questions that assess the frequency of past sexual behavior along a variety of dimensions.
Experiences can be classified as "completed rape," "attempted rape," "coercion," "attempted coercion," or "nonconsensual sexual contact."
Several trials examining the efficacy of an empowerment or feminist self-defense training program have demonstrated reductions in incidence of rape as measured by the SESSFV compared to a control group (e.g., Hollander, 2014; Orchowski, Gidycz, & Raffle, 2008; Senn et al., 2015).
|
Change from Baseline and 3 months at 6 months
|
Gender Minority Stress and Resilience Measure Gender Related Victimization Subscale
Time Frame: Baseline
|
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 something thrown at me because of my gender identity or expression."
"I have had sexual contact with someone against my will because of my gender identity or expression."
|
Baseline
|
Gender Minority Stress and Resilience Measure Gender Related Victimization Subscale
Time Frame: Change from Baseline at 3 months
|
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 something thrown at me because of my gender identity or expression."
"I have had sexual contact with someone against my will because of my gender identity or expression."
|
Change from Baseline at 3 months
|
Gender Minority Stress and Resilience Measure Gender Related Victimization Subscale
Time Frame: Change from Baseline and 3 months at 6 months
|
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 something thrown at me because of my gender identity or expression."
"I have had sexual contact with someone against my will because of my gender identity or expression."
|
Change from Baseline and 3 months at 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Danielle S Berke, Hunter College of the City University of New York
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R21MD014807 (U.S. NIH Grant/Contract)
- 5R21MD014807-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Violence, Sexual
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Medical Research Council, South AfricaUniversity of GhanaUnknownSexual Violence | Domestic Violence | Physical ViolenceGhana
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Johns Hopkins UniversityNational Institute on Minority Health and Health Disparities (NIMHD)RecruitingViolence, Domestic | Violence | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Violence-Related SymptomUnited States
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Johns Hopkins Bloomberg School of Public HealthUjamaa AfricaRecruitingViolence, Domestic | Violence, Sexual | Violence, Gender-BasedKenya
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University of PittsburghCenters for Disease Control and PreventionNot yet recruitingViolence, Domestic | Violence in Adolescence | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Social Cohesion | Violence, Structural | Community ViolenceUnited States
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Johns Hopkins UniversityUniversity of Pittsburgh; Office of Research on Women's Health (ORWH); Futures...CompletedViolence, Domestic | Violence, SexualUnited States
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RTI InternationalNo Means No WorldwideCompleted
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University of PittsburghCenters for Disease Control and Prevention; Population CouncilRecruitingCoping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Gender-Based | Communication, Social | Racism | Violence, Non-accidental | Communication, PersonalUnited States
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University of PittsburghCenters for Disease Control and PreventionCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
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University of PittsburghThe Grable Foundation; Department Human Services, Pennsylvania; Fisa FoundationCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
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The University of Hong KongCompleted
Clinical Trials on Empowerment Self Defense Training
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Stanford UniversityCompletedDepression | Stress Disorders, Post-Traumatic | AnxietyUnited States
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Stanford UniversityMedical Research Council, South Africa; African Institute for Health and Development...CompletedViolence, Non-accidental | Sexual Assault and RapeKenya
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Azienda Per I Servizi Sanitari N. 2 IsontinaAzienda per i servizi Sanitari 4 Medio Friuli, Dipartimento di Salute Mentale... and other collaboratorsCompletedObesity | Overweight | Power, PersonalItaly
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Center for Hunger-Free CommunitiesCompletedChild Development | Hunger | Social IsolationUnited States
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Universidade Federal do vale do São FranciscoRegional Hospital of Juazeiro, BA, Brazil; Research support foundation of the...CompletedAged | Lipid Metabolism | Physical Conditioning, HumanBrazil
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Radboud University Medical CenterCompleted
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University of Texas at AustinCompletedDepression | PTSD | Anxiety | Intimate Partner ViolenceUnited States
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University of New MexicoPatient-Centered Outcomes Research InstituteCompleted
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Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
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University of British ColumbiaCanadian Diabetes AssociationUnknown