Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empowerment self-defense training.
- Who it may be relevant to
- Registry conditions: Depression and Quality of Life, Sexual Violence, PTSD, Suicidal Ideation. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Evaluation of a Culturally Grounded Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence: Open Pilot Trial
Overview
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.
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).
Interventions
- 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 pote
Primary outcome measures
- Depression [Time frame: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
- PTSD [Time frame: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion)]
Secondary outcome measures (6)
- Suicidal Ideation [Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
- Alcohol Misuse [Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
- Drug Use [Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
- Suicide [Time frame: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
- Intimate Partner Violence [Time frame: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
- Sexual Victimization [Time frame: 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).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wahwala Iyohlogya/Peaceful Means — Pine Ridge
Identifiers
NCT: NCT07712796 · HUM00291298 · R34MH139782