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临床试验/NCT04934189
NCT04934189已完成不适用

Empowerment Self-Defense Training for the Prevention of Victimization of Transgender Women

Hunter College of City University of New York1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Average Rating on Sexual Assertiveness at Baseline

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Cisgender men and women
  • Transgender men

结局指标

主要结局

Average Rating on Sexual Assertiveness at Baseline

时间窗: 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 Resistance Tactics From Baseline to 3 Month Follow up

时间窗: 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).

Average Use of Dating Self-Protection Against Rape Strategies at Baseline

时间窗: 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 6 Month Follow up

时间窗: 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).

Change in Dating Self-Protection Against Rape From Baseline to 3 Month Follow up

时间窗: 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 Sexual Assertiveness From Baseline to 3 Month Followup

时间窗: 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 Resistance Tactics From Baseline to 6 Month Follow up

时间窗: 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).

Change in Sexual Assertiveness From Baseline to 6 Month Follow up

时间窗: 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

时间窗: 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).

次要结局

  • Change in Rape Myth Acceptance From Baseline to 3 Month Follow up(Change from Baseline at 3 months)
  • Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 3 Month Followup(Change from Baseline at 3 months)
  • Baseline Average Rating of Resistance Self-Efficacy(Baseline)
  • Average Endorsement of Rape Myth Acceptance at Baseline Scale(Baseline)
  • Change in Rape Myth Acceptance From Baseline to 6 Month Follow up Scale(Change from Baseline at 6 months)
  • Change in Rape Attribution From Baseline to Follow up Assessments(Change from 3 months at 6 months)
  • Percentage of Participants Endorsing Rape, Sexual Assault, and No Sexual Victimization at Baseline(Baseline)
  • Change in Resistance Self-Efficacy From Baseline to 3 Month Follow up(Change from Baseline at 3 months)
  • Change in Resistance Self-Efficacy From Baseline to 6 Month Follow up(Change from Baseline at 6 months)
  • Average Rape Attribution at Baseline(Baseline)
  • Average Rating of Gender Identity Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride(Baseline)
  • Change in Percentage of Participants Endorsing Rape, Sexual Assault, and No Victimization From Baseline to 6 Month Followup(Change from Baseline at 6 months)
  • Change in Non-Affirmation, Internalized Transphobia, Concealment, Community Connectedness, and Pride From Baseline to 3 Month Follow up(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(Change from Baseline at 6 months)
  • Baseline Average Likelihood of Endorsing Gender-Based Victimization(Baseline)
  • Change in Endorsement of Gender-Based Victimization From Baseline to 6 Month Follow up(Change from Baseline at 6 months)
  • Change in Endorsement of Gender-Based Victimization From Baseline to 3 Month Follow up(Change from Baseline at 3 months)

研究者

发起方
Hunter College of City University of New York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Danielle Berke

Assistant Professor

Hunter College of City University of New York

研究点 (1)

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