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Набор скоро начнётся NCT07712796

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

Без фазы С лечением Depression and Quality of Life Sexual Violence PTSD Suicidal Ideation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Empowerment self-defense training.
Кому может быть актуально
Состояния в реестре: Depression and Quality of Life, Sexual Violence, PTSD, Suicidal Ideation. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

  • Поведенческое 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

Первичные конечные точки

  • Depression [Срок оценки: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
  • PTSD [Срок оценки: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion)]
Вторичные конечные точки (6)
  • Suicidal Ideation [Срок оценки: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
  • Alcohol Misuse [Срок оценки: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
  • Drug Use [Срок оценки: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
  • Suicide [Срок оценки: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
  • Intimate Partner Violence [Срок оценки: Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).]
  • Sexual Victimization [Срок оценки: 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).]

Критерии участия

Критерии включения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Wahwala Iyohlogya/Peaceful Means — Pine Ridge

Идентификаторы

NCT: NCT07712796 · HUM00291298 · R34MH139782

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗