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

NCT04934189 | Completed Results DMC

• 2 other identifiers: R21MD0148075R21MD014807-02
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project aims to develop and refine a tailored Empowerment Self Defense (ESD) violence prevention training for diverse TW through a series of sequential Aims: a) develop an initial draft of an ESD violence prevention curriculum tailored to TW (Aim 1); b) evaluate the feasibility and acceptability of recruitment, assessment procedures, retention and follow-up procedures, and implementation of the new intervention (Aim 2); and c) assess the preliminary efficacy of the tailored intervention program to increase use of self-protective resistance strategies, mitigate minority stressors and attitudinal barriers to self-defense, and reduce rates of exposure to violence (Exploratory Aim). The investigators will accomplish these aims using a two-phase research design that begins with formative qualitative work engaging research partners on a community board and a small sample of research participants. Information for Phase 1 can be located in Protocol number 2020-0017. Further refinement and assessment of the feasibility and acceptability of the curriculum using Phase 1 findings will occur in Phase 2 through the delivery of the tailored ESD curriculum to 3 groups of 16 TW. To assess the preliminary efficacy of the tailored intervention, program participants will complete a battery of validated questionnaires assessing use of resistance strategies, gender-minority and general psychological factors hypothesized to mediate the behavioral effects of the intervention, and exposure to victimization experiences prior to, immediately following, and 6 months post-completion of the training. Together, the proposed research will lay the foundation for a large-scale randomized controlled trial (RCT) of the tailored ESD violence prevention curriculum.

Conditions

Violence, Sexual

Outcome Measures

Primary Outcomes (9)

• 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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  Change from Baseline at 6 months

Secondary Outcomes (17)

• Average Endorsement of Rape Myth Acceptance at Baseline Scale

  Baseline

• Change in Rape Myth Acceptance From Baseline to 3 Month Follow up

  Change from Baseline at 3 months

• Change in Rape Myth Acceptance From Baseline to 6 Month Follow up Scale

  Change from Baseline at 6 months

• Baseline Average Rating of Resistance Self-Efficacy

  Baseline

• Change in Resistance Self-Efficacy From Baseline to 3 Month Follow up

  Change from Baseline at 3 months

Study Arms (1)

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.

Behavioral: Empowerment Self Defense Training

Interventions

Empowerment Self Defense Training BEHAVIORAL

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).

Empowerment Self-Defense Training- Pre-Post Single Arm Design Pilot Trial

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Transgender women (i.e., male assigned at birth, currently identified on the transfeminine spectrum) between the ages of 18 and 65. This inclusion criteria is necessary to iteratively tailor and finalize the adapted ESD violence prevention program for transgender women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cisgender men and women
• Transgender men

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Hunter College, City University of New York

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 37011169 DERIVED

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Results Point of Contact

• Title: Danielle S. Berke, Ph.D.
• Organization: Hunter College of the City University of New York

db2800@hunter.cuny.edu

212-772-5550

Study Officials

• Danielle S Berke

  Hunter College of The City University of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 22, 2021
• Study Start: July 11, 2021
• Primary Completion: June 25, 2022
• Study Completion: February 26, 2024
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)