Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence (ESD)

Development and Evaluation of a Culturally Grounded Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence: Open Pilot Trial

The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI/AN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and/or PTSD symptoms (primary outcomes). Previous research with non-AI/AN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI/AN survivors despite calls from our tribal partners to implement ESD with AI/AN adult women survivors. We have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.

Study Overview

• Status: Not yet recruiting
• Conditions: PTSD; Suicidal Ideation; Sexual Violence; Problem Drinking; Depression and Quality of Life
• Intervention / Treatment: Behavioral: Empowerment self-defense training

Detailed Description

American Indian/Alaska Native (AI/AN) women experience disproportionately high rates of sexual violence (SV) and subsequent symptoms of depression and posttraumatic stress disorder (PTSD) as well as related issues such as suicidality, problem drinking, sexual revictimization, and intimate partner violence (IPV). We know little about how to address mental health problems related to SV in AI/AN women, particularly those living in rural/remote tribal communities where access to quality care is limited or non-existent. Current best practices for AI/AN populations suggest that existing empirically supported treatments for mental health concerns have limited applicability and stress the need to develop and test culturally adapted interventions. The current proposal supports a culturally grounded mental health initiative that centers AI/AN voices, leverages the power of connection to others, and moves away from individualistic interventions.

Aim 1 (Adaptation) includes using an Indigenized ADAPT-ITT Model to refine IMpower into an Indigenized ESD for survivors (IMpower-Survivors) via ongoing feedback from the Topical Experts/TKKs and the SAB (Aim 1a), theatre testing IMpower-Survivors (Aim 1b), and an open pilot trial of the IMpower-Survivors with 14 AI/AN women survivors to further refine and evaluate the feasibility of the program and research procedures (Aim 1c).

Aim 2 (Evaluation) will include a pilot RCT of 100 AI/AN women who have experienced SV and have elevated PTSD and/or depressive symptoms randomly assigned to the treatment or wait list control condition. We will assess the acceptability and feasibility of the IMpower-Survivors (Aim 2a) via program observations, post-session surveys, and exit interviews with AI/AN women who have survived SV. We will test the hypotheses that IMpower-Survivors will lead to changes in intervention targets (reduced fear of future SV, reduced self-blame, increased empowerment, increased social support, and increased cultural identity) compared to the wait-list control condition (Aim 2b). We will also examine the hypotheses that there will be reductions in symptoms of depression and PTSD (primary outcomes; Aim 2c) and suicidality, problem drinking, exposure to IPV, and sexual revictimization (secondary outcomes; Aim 2d) among AI/AN women survivors in the treatment condition compared to control.

*NOTE: This registration is for the open pilot trial (Aim 1c).

• Study Type: Interventional
• Enrollment (Estimated): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Edwards (Principal Investigator),, PHD; Phone Number: 734-647-8812; Email: edkatie@umich.edu

Study Locations

• United States
  • South Dakota
    • Pine Ridge, South Dakota, United States, 57770
      • Wahwala Iyohlogya/Peaceful Means
      • Contact: Thalia Wilson, Project Research Coordinator, BS; Phone Number: 605-430-9575; Email: peacefulmeans@umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Identify as Indigenous (including American Indian or Alaska Native), including individuals who identify as multiracial and Indigenous.
• Identify as a woman, trans woman, and/or Two Spirit..
• Be 18 years of age or older.
• Have experienced sexual violence or unwanted sexual experiences.
• Report moderate to high levels of Meet criteria for depression and/or PTSD.
• NOT report high risk for suicidality
• NOT report active psychosis
• Live on or near the Pine Ridge Indian Reservation.
• Be able to read and speak English.
• Report an ability and willingness to participate in the program sessions and related research activities, including surveys and potential exit interviews.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Open Pilot Trial; Empowerment self-defense curriculum and practical skills training for Indigenous women survivors.

Behavioral: Empowerment self-defense training; Participants will take part in the empowerment self-defense (ESD) program delivered in a small-group format. Sessions will be facilitated by trained facilitators and will focus on empowerment, personal safety skills, boundary setting, communication strategies, and trauma-informed discussions relevant to survivors of sexual violence. Sessions will follow a structured curriculum designed to provide participants with practical skills for recognizing risk, setting boundaries, and responding to potentially harmful situations. Facilitators delivering the program receive training in trauma-informed practice and are already certified to teach the ESD curriculum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms.	Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
PTSD	Participant responses to items from the PTSD checklist for DSM-5 to measure post traumatic stress disorder behaviors in the past month. The 20-item scale includes likert response options ranging from 0 = Not at all to 4 = Extremely with higher scores indicating more trauma related stress.	Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Suicidal Ideation	Participants will respond to items on the Suicidal Ideation Attributes Scale. This is a five measure with a slider scale from 0=never to 10=always. A score greater or equal to 21 is an elevated suicide risk. A score of 0 - 20: Indicates the presence of suicidal thoughts but generally reflects a lower behavioral risk. A score of 21 or higher: Indicates a higher risk of suicidal thoughts and behavior.	Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Alcohol Misuse	Participants will respond to items on the Alcohol Use Disorders Identification Test. This measures the participants alcohol use. This is a 10 item multiple choice option scale. For items 1-8, 0=never, 1=monthly or less, 2=2-4 times a month, 3=2-3 times a week, 4=4 or more times a week/daily/almost daily. For item 2 (special response) 0=1 or 2 drinks, 1=3 or 4 drinks, 2=5 or 6 drinks, 3=7 to 9 drinks, 4=10 or more drinks. For items 9-10, choices are 0=No, 2=Yes, but not in the last month, 4=Yes, during the last month. The AUDIT (a 10-question survey) is scored from 0 to 40 with higher scores indicating hazardous or harmful alcohol consumption and a higher probability of alcohol dependence.	Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Drug Use	Participants will respond to items on the Drug Use Disorders Identification Test. This measures the participants use of drugs other than alcohol. This is a 11 items measure with multiple choice options. For items 1-2 the options are 0=Never, 1=Once a month or less often, 2=2-4 times month, 3=2-3 times a week, 4=4 times a week or more often. For item 3, the choices are 0=0, 1=1-2, 2=3-4, 3=5-6, 4=7 or more. For items 4-9, the choices are 0=never, 1=Less often than once a month, 2=Every month, 3=Every week, 4=Daily or almost every day. For items 10-11, the choices are 0=no, 1=Yes, but not over the past month, 2=Yes, over the past month. A higher score on the DUDIT (Drug Use Disorders Identification Test) indicates a higher likelihood of harmful drug use, substance abuse, or drug dependence.	Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Suicide	Participant responses to items from the Columbia Suicide Severity Rating Scale (C-SSRS) Self Report to measure suicide and life-threatening behavior in the past month. The 6-item scale includes two response options ranging from 0 = No to 1 = Yes with higher scores indicating severity of suicidal ideation. Low risk : score of 1-2; Moderate risk: score of 3 or certain history; High risk: score of 4-6 A higher score indicates increased levels of suicide risk and future suicidal behavior.	Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Intimate Partner Violence	Participants will respond to items on the Conflict Tactics Scale Revised including subscales: psychological aggression, physical assault, sexual coercion or injury. This scale measures the participant's relationship with their partner in the past month. The scale is an 78 item multiple choice scale with the ranges of 0=Once in the past month, 1=Once in the past month, 2=Twice in the past month, 3=3-5 times in the past month, 4=6-10 times in the past month, 5=11-20 times in the past month, and 6=More than 20 times int he past month. A higher score indicates a higher frequency and severity of intimate partner violence. A higher score on the negotiation subscale indicates better outcomes to resolve relationship conflicts.	Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
Sexual Victimization	Participants will respond to selected items on the Sexual Experiences Survey Victimization Version-Acts Collapsed. This is a scale divided into 4 sections: Non-contact, Cybersex, Contact and Sexual Pressure. Non-contact is 3 items with a scale from 0-10+ times since participant's 14th birthday, Cybersex is 2 items with a scale from 0-10+ times since participant's 14th birthday, Contact is 9 items with 4 subitems each with a scale from 0-10+ times since participant's 14th birthday, and Sexual Pressure is 3 items with 4 subitems each with a scale from 0-10+ times since participant's 14th birthday. A higher score indicates a higher lifetime prevalence, frequency, or severity of unwanted sexual experiences or sexual exploitation.	Collected during the pre-test (enrollment) for lifetime and past 30 days AND post-test for past 30 days (within 1 week of intervention conclusion).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
(Intermediary Outcome) Difficulty in Emotional Regulation	The Difficulty in Emotion Regulation Scale 18 is an 18 item measure with a 5 point scale ranging from 1=Almost never to 5=Almost always. It will include subscales of Awareness: Items 1, 4, 6 (reverse scored); Clarity: Items 2, 3, 5; Goals: Items 8, 12, 15; Impulse: Items 9, 16, 18; Nonacceptance: Items 7, 13, 14; Strategies: Items 10, 11, 17. Sum items within each subscale to obtain subscale scores. Score of 8 - 35: Low difficulties. Score of 36 - 62: Moderate difficulties. Score of 63 - 90: High difficulties. A higher score indicates a greater difficulty managing emotions, meaning you likely struggle more to recognize, accept, and manage your feelings.	Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
(Intermediary Outcome) Fear of future sexual assault	Participants will respond to items on the Fear of Sexual Assault Scale. This is a 31 measure with a Likert scale ranging from 1=always to 5=never for items 1-26 and a Likert scale ranging from 1=very safe to 5 very unsafe for items 27-31. A higher score indicates an elevated level of anxiety, apprehension, or perceived vulnerability to becoming a victim of sexual violence.	Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
(Intermediary Outcome) Self Blame	Participants will respond to items on the Rape Attribution Questionnaire. The Questionnaire uses multiple subscales: Behavioral self-blame, characterological self-blame, perpetrator blame, and external/societal blame. This is a 20 item measure with a Likert scale ranging from 1=strongly disagree to 6=strongly agree. A higher score indicates greater endorsement of blame or cause of sexual assault to a specific factor.	Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
(Intermediary Outcome) Empowerment	Participants will respond to items on the Personal Progress scale. Participants will respond to statements that identify feelings or experiences and how each statement applies to them. The scale consists of a 28 items with a slider scale ranging from 1=almost never, 4=sometimes true, 7=almost always. This scale measures perceptions of power and competence, self-nurturance and resource access, interpersonal assertiveness, awareness of cultural discrimination, expression of anger and confrontation, autonomy, and personal strength and social activism. A higher score indicates positive increased personal Empowerment and Coping.	Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
(Intermediary Outcome) Cultural Identity	Participants will respond to items on the Cultural Connectedness Scale which consists of three parts. The first part is a 15 item likart scale with range from 1=Strongly disagree to 5=Strongly agree. The second items are the frequency items, with 3 items with multiple choices of never, once in the past month, 2-3 times in the past month, about once a week, several times a week, and every day or almost every day. The last items are the Yes/No items. These are 11 statements with either Yes or No answers. A higher scores indicates a stronger, more positive engagement with one's heritage culture, encompassing cultural identity, traditions, and spirituality. Higher scores are strongly associated with protective, strength-based health outcomes, including: Improved Mental Health, Substance Abuse Protection, Better Physical Health, and Social and Academic Success.	Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
(Intermediary) Social Support	Participants will respond to items on the Medical Outcome Study Social Support Survey Instrument to measure types of support available to the participant. This is a 19 item likert scale with 0=none of the time to 4=all of the time. Subscales measure Emotional/Informational support (2, 3, 7, 8, 12, 15, 16, 18), Tangible Support (1, 4, 11, 14), Affectionate support (5, 9, 19), and Positive social interaction (6, 10, 17). A higher scores indicates a greater availability of functional social support. Scores are typically transformed onto a 0-100 scale: Higher scores denote more positive perceived, available support. Lower scores denote a lack of or lower support or social isolation.	Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

Helpful Links

• Survivor Empowerment Self-Defense

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): June 14, 2028

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Depression; Native American; Sexual violence
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Self-Injurious Behavior; Alcohol-Related Disorders; Suicide; Stress Disorders, Traumatic; Behavior; Suicidal Ideation; Alcoholism; Depression; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: HUM00291298; R34MH139782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No