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

2026年8月19日 更新者:Katie M Edwards、University of Michigan

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. The investigators have assembled an interdisciplinary expert team and Elders/Traditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.

調査の概要

詳細な説明

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). Science knows 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. The investigators 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. The investigators 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). The investigators 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).

研究の種類

介入

入学 (推定)

14

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Katie Edwards (Principal Investigator),, PHD
  • 電話番号:734-647-8812
  • メール:edkatie@umich.edu

研究場所

    • South Dakota
      • Pine Ridge、South Dakota、アメリカ、57770
        • Wahwala Iyohlogya/Peaceful Means
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Open Pilot Trial
Empowerment self-defense curriculum and practical skills training for Indigenous women survivors.

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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Depression
時間枠:Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
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
時間枠:Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion)
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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Suicidal Ideation
時間枠:Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
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
時間枠:Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

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

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
時間枠:Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
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
時間枠:Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

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
時間枠: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).

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).

その他の成果指標

結果測定
メジャーの説明
時間枠
(Intermediary Outcome) Difficulty in Emotional Regulation
時間枠:Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

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

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月30日

一次修了 (推定)

2028年6月14日

研究の完了 (推定)

2028年6月14日

試験登録日

最初に提出

2026年7月11日

QC基準を満たした最初の提出物

2026年7月11日

最初の投稿 (実際)

2026年7月20日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月21日

QC基準を満たした最後の更新が送信されました

2026年8月19日

最終確認日

2026年8月1日

詳しくは

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個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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いいえ

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