[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07712796":3,"trial-entities:NCT07712796":118,"trial-summary:NCT07712796":122},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":49,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":88,"locations":91,"central_contacts":107,"overall_officials":112,"references":113,"see_also_links":114},"NCT07712796","HUM00291298","Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence","Development and Evaluation of a Culturally Grounded Empowerment Self Defense Program for Adult Native Women Survivors of Sexual Violence: Open Pilot Trial","NOT_YET_RECRUITING","2028-06-14","2026-07","2026-07-20","2026-07-15","University of Michigan","OTHER",true,"The purpose of this study is to culturally adapt and evaluate an empowerment self-defense (ESD) program (i.e., IMpower) for AI\u002FAN women who have experienced SV in their lifetime and currently experiencing moderate to severe levels of depression and\u002For PTSD symptoms (primary outcomes). Previous research with non-AI\u002FAN women finds that ESD reduces depression and PTSD symptoms, but no research has examined ESD among AI\u002FAN survivors despite calls from our tribal partners to implement ESD with AI\u002FAN adult women survivors. We have assembled an interdisciplinary expert team and Elders\u002FTraditional Knowledge Keepers (TKKs) as well as Survivor Advisory Board (SAB) in the proposed work.","American Indian\u002FAlaska Native (AI\u002FAN) 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\u002FAN women, particularly those living in rural\u002Fremote tribal communities where access to quality care is limited or non-existent. Current best practices for AI\u002FAN 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\u002FAN voices, leverages the power of connection to others, and moves away from individualistic interventions.\n\nAim 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\u002FTKKs and the SAB (Aim 1a), theatre testing IMpower-Survivors (Aim 1b), and an open pilot trial of the IMpower-Survivors with 14 AI\u002FAN women survivors to further refine and evaluate the feasibility of the program and research procedures (Aim 1c).\n\nAim 2 (Evaluation) will include a pilot RCT of 100 AI\u002FAN women who have experienced SV and have elevated PTSD and\u002For 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\u002FAN 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\u002FAN women survivors in the treatment condition compared to control.\n\n\\*NOTE: This registration is for the open pilot trial (Aim 1c).",[19,20,21,22,23],"Depression and Quality of Life","Sexual Violence","PTSD","Suicidal Ideation","Problem Drinking",[25,26,27],"Native American","Sexual violence","Depression","INTERVENTIONAL","PREVENTION",[31],"NA",{"count":33,"type":34},14,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"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.\n\nSessions will follow a structured curriculum designed to provide participants with practical skills for recognizing risk, setting boundaries, and responding to potentially harmful situations.\n\nFacilitators delivering the program receive training in trauma-informed practice and are already certified to teach the ESD curriculum.",[41],"Open Pilot Trial",[43,46],{"measure":27,"description":44,"timeFrame":45},"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).",{"measure":21,"description":47,"timeFrame":48},"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)",[50,53,56,59,63,66],{"measure":22,"description":51,"timeFrame":52},"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).",{"measure":54,"description":55,"timeFrame":52},"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\u002Fdaily\u002Falmost 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.\n\nThe 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.",{"measure":57,"description":58,"timeFrame":52},"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.\n\nA higher score on the DUDIT (Drug Use Disorders Identification Test) indicates a higher likelihood of harmful drug use, substance abuse, or drug dependence.",{"measure":60,"description":61,"timeFrame":62},"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).",{"measure":64,"description":65,"timeFrame":52},"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.\n\nA 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.",{"measure":67,"description":68,"timeFrame":69},"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.\n\nA 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).","FEMALE","18 Years",null,false,{"inclusion":75,"exclusion":86,"raw_text":87},[76,77,78,79,80,81,82,83,84,85],"Identify as Indigenous (including American Indian or Alaska Native), including individuals who identify as multiracial and Indigenous.","Identify as a woman, trans woman, and\u002For 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\u002For 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.",[],"Inclusion Criteria:\n\n* Identify as Indigenous (including American Indian or Alaska Native), including individuals who identify as multiracial and Indigenous.\n* Identify as a woman, trans woman, and\u002For Two Spirit..\n* Be 18 years of age or older.\n* Have experienced sexual violence or unwanted sexual experiences.\n* Report moderate to high levels of Meet criteria for depression and\u002For PTSD.\n* NOT report high risk for suicidality\n* NOT report active psychosis\n* Live on or near the Pine Ridge Indian Reservation.\n* Be able to read and speak English.\n* Report an ability and willingness to participate in the program sessions and related research activities, including surveys and potential exit interviews.",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"contacts":98,"geoPoint":104},"Wahwala Iyohlogya\u002FPeaceful Means","Pine Ridge","South Dakota","57770","United States",[99],{"name":100,"role":101,"phone":102,"email":103},"Thalia Wilson, Project Research Coordinator, BS","CONTACT","605-430-9575","peacefulmeans@umich.edu",{"lat":105,"lon":106},43.02554,-102.55627,[108],{"name":109,"role":101,"phone":110,"email":111},"Katie Edwards (Principal Investigator),, PHD","734-647-8812","edkatie@umich.edu",[],[],[115],{"label":116,"url":117},"Survivor Empowerment Self-Defense","https:\u002F\u002Fstatic1.squarespace.com\u002Fstatic\u002F675af1d3b8dc1b05598c725b\u002Ft\u002F694597bcf0eae0291fc8f2f3\u002F1766168508911\u002FCM-Survivors+ESD.pdf",{"nct_id":4,"conditions":119,"biomarkers":121},[27,120,20],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":15,"summary":123,"prompt_version":133},{"design":124,"status":125,"heading":126,"summary":127,"follow_up":128,"word_count":129,"commitments":130,"compensation":131,"drugs_mentioned":132},"This is an interventional study with a planned enrollment of 14 participants. It is an open pilot trial to refine and evaluate the program's feasibility.","completed","Empowerment Self-Defense Program for Native Women Survivors of Sexual Violence","This study is testing an Empowerment Self-Defense (ESD) program called IMpower-Survivors for adult Native women who have experienced sexual violence. The program aims to help reduce symptoms of depression and PTSD (post-traumatic stress disorder) by teaching personal safety skills, boundary setting, and communication strategies. You might be able to join if you are an Indigenous woman (including American Indian or Alaska Native, trans women, or Two Spirit individuals) aged 18 or older, have experienced sexual violence, and currently have moderate to high levels of depression and\u002For PTSD. The study will measure changes in depression and PTSD symptoms after you complete the program to see if it helps.","Your depression and PTSD symptoms will be measured within one week of the intervention's conclusion.",107,"You will participate in the empowerment self-defense (ESD) program delivered in a small-group format. Depression and PTSD will be measured at the start of the study and again within one week of finishing the intervention.","Not stated in the trial record.",[],"v2"]