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

NCT07712796 | Not Yet Recruiting DMC

• 2 other identifiers: HUM00291298R34MH139782
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression and Quality of Life; Sexual Violence; PTSD; Suicidal Ideation; Problem Drinking

Keywords

Native American; Sexual violence; Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Suicidal Ideation

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Alcohol Misuse

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Drug Use

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Suicide

  Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Intimate Partner Violence

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

Other Outcomes (6)

• (Intermediary Outcome) Difficulty in Emotional Regulation

  Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• (Intermediary Outcome) Fear of future sexual assault

  Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• (Intermediary Outcome) Self Blame

  Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

Study Arms (1)

Open Pilot Trial

EXPERIMENTAL

Empowerment self-defense curriculum and practical skills training for Indigenous women survivors.

Behavioral: Empowerment self-defense training

Interventions

Empowerment self-defense training BEHAVIORAL

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.

Open Pilot Trial

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Wahwala Iyohlogya/Peaceful Means

Pine Ridge, South Dakota, 57770, United States

Location

Related Links

• Survivor Empowerment Self-Defense

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic; Suicidal Ideation; Alcoholism

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Central Study Contacts

Katie Edwards (Principal Investigator),, PHD

CONTACT

734-647-8812; edkatie@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Social Work

Model Details: Intervention

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 20, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 14, 2028
• Study Completion (Estimated): June 14, 2028
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)