[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658932":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":60,"studyPopulation":53,"armGroups":61,"interventions":72,"overallOfficials":80,"centralContacts":84,"locations":89,"responsibleParty":132,"collaborators":135,"id":143,"slug":144,"hasResults":145,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":151,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":53,"studyType":158,"phases":159,"briefSummary":161,"conditions":162,"keywords":53,"overallStatus":165,"whyStopped":53,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Naval Health Research Center","FED",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":53},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Alcohol use","Alcohol use quantity and frequency will be assessed using the Daily Drinking Questionnaire. Participants indicate the number of drinks they typically consume for each day of the week, and the number of hours over which the alcohol is consumed. Higher scores indicate higher alcohol use.","Baseline, 3-month follow-up",{"measure":14,"description":15,"timeFrame":12},"Sexual assault victimization","Sexual assault victimization and severity of victimization will be assessed using the Sexual Experiences Survey - Short Form Victimization, which will assess experience of nonconsensual sexual experiences. This will be modified to assess experiences both prior to military service and since entering military. Responses are rated on number of times each experience occurred (0, 1, 2, 3+). Higher scores indicate higher sexual assault victimization.",{"measure":17,"description":18,"timeFrame":12},"Sexual Violence Perpetration","Sexual violence perpetration will be assessed using a modified version of the Sexual Strategies Scale. Participants check all items that apply. Higher scores indicate more sexual violence perpetration.",{"measure":20,"description":21,"timeFrame":12},"Bystander Intervention Behavior","Bystander intervention behavior will be assessed using the Bystander Behavior Scale. Responses indicate if the participant engaged in each bystander behavior with a friend or not, or if they had no opportunity to engage in the behavior. Higher scores indicate higher bystander intervention behaviors.",[23,27,31,35,38,41,44,47,50],{"measure":24,"description":25,"timeFrame":26},"Program Satisfaction","Program satisfaction will be assessed using items developed by the research team. Items will assess the acceptability, satisfaction, and perceived utility of the intervention. Higher scores indicate higher program satisfaction.","Immediately after the intervention (intervention group only)",{"measure":28,"description":29,"timeFrame":30},"Motivation to Change","Motivation to change will be assessed using the Contemplation Ladder. Participants report the stage that best represents their willingness to change drinking behaviors. Higher scores indicate higher willingness to change.","Baseline, immediately after the intervention (intervention group only)",{"measure":32,"description":33,"timeFrame":34},"Bystander Intentions","Bystander intentions will be assessed using the Sexual Social Norms Inventory - Bystander Intervention subscale. Participants rate the extent to which they agree that they would engage in each bystander scenario on a scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate higher intentions to engage in bystander behaviors.","Baseline, immediately after the intervention (intervention group only), 3-month follow-up",{"measure":36,"description":37,"timeFrame":34},"Perceived Drinking Norms","Drinking norms will be assessed using a modified version of the Drinking Norms Rating Form. The modified version assesses perceived typical drinks consumed per drinking occasion and perceived typical drinking per week for Sailors of the same sex. Higher scores indicate more perceived alcohol consumption.",{"measure":39,"description":40,"timeFrame":34},"Perceived Sexual Norms","Perceived Sexual Norms will be evaluated using items developed by the research team. The items assess the extent to which the participant perceives that most Sailors would engage in various behaviors regarding sexual activity. Items are reported on a scale from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate healthier perceived sexual norms.",{"measure":42,"description":43,"timeFrame":12},"Rape Attributions","Rape attributions will be assessed using the Rape Attribution Questionnaire. Participants who experienced a sexual assault are asked to indicate how often they have attributed their assault to various reasons on a scale from 0 (never) to 4 (very often). Higher scores indicate higher rape attribution.",{"measure":45,"description":46,"timeFrame":12},"Attitudes Regarding Sexual Consent","Attitudes regarding sexual consent will be assessed using items from the Sexual Consent Scale. Participants rate the extent to which they agree with each item on a scale from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate healthier attitudes regarding sexual consent.",{"measure":48,"description":49,"timeFrame":12},"Rape Myth Acceptance","Rape myth acceptance will be assessed using a modified version of the Illinois Rape Myth Acceptance Scale. Participants rate how strongly they agree with each rape myth on a scale from 1 (strongly agree) to 5 (strongly disagree). Items are reversed scored; higher scores indicate higher rape myth acceptance.",{"measure":51,"description":52,"timeFrame":12},"Sexual Assault Risk Perceptions","Sexual assault risk perceptions will be assessed using items developed by the research team. Participants will rate how likely they are to use each response strategy in a sexual assault scenario on a scale from 1 (very unlikely) to 5 (very likely). Higher scores indicate higher likelihood of strategy use.",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE","The purpose of the project is to test the Positive Change© for Sailors program through a pilot randomized controlled trial (RCT).\n\nThe objective is to assess feasibility and examine preliminary differences in behavioral, perceived norms, and attitudes\u002Fself-efficacy outcomes using baseline, post-program, and 3-month follow-up assessments in a pilot RCT. Feasibility of Positive Change© for Sailors will be assessed through successful recruitment and retention of 75% of the sample. Feasibility will also be measured through time spent on each component. Preliminary efficacy will be assessed via changes in primary outcome measures.\n\nPrimary outcome measures include changes in behavior (frequency of alcohol use, sexual assault victimization, sexual assault perpetration, and bystander intervention), perceived norms (alcohol use and sexual assault), and related attitudes\u002Fself-efficacy outcomes.\n\nIt is hypothesized that Positive Change© for Sailors will be deemed feasible and show preliminary efficacy in a pilot RCT of 120 Sailors randomly assigned to either the Positive Change© for Sailors program or an assessment-only control condition. While the primary expected outcomes of the pilot RCT pertain to feasibility and the study is not powered to conduct formal hypothesis testing, preliminary analyses will be performed to assess trends and relative group changes.\n\nExploratory analyses will evaluate trends of changes in perceived norms for alcohol use and sexual assault as a potential mechanism of change (mediator) of behavioral and attitudinal changes. Exploratory analyses will also examine the role of prior history of sexual victimization\u002Faggression as a moderator of behavioral and attitudinal changes.",[62,66],{"label":63,"type":64,"description":65,"interventionNames":53},"Control","NO_INTERVENTION","This is an assessment only control condition",{"label":67,"type":68,"description":69,"interventionNames":70},"Positive Change© for Sailors","EXPERIMENTAL","This is an integrated social norms-based personalized feedback intervention for Sailors. This intervention targets alcohol misuse, sexual assault victimization risk, sexual assault perpetration, and bystander intervention among Sailors.",[71],"Behavioral: Positive Change© for Sailors",[73],{"type":74,"name":67,"description":75,"armGroupLabels":76,"otherNames":77},"BEHAVIORAL","Positive Change© for Sailors is a multipronged, integrated program addressing alcohol misuse, sexual assault victimization risk, sexual assault perpetration, and bystander intervention among Sailors. It uses social norms-based personalized feedback and is tailored based on sex.",[67],[78,79],"+Change","Positive Change",[81],{"name":82,"affiliation":5,"role":83},"Kristen H Walter, PhD","PRINCIPAL_INVESTIGATOR",[85],{"name":82,"role":86,"phone":87,"phoneExt":53,"email":88},"CONTACT","619-540-4108","Kristen.h.Walter.civ@health.mil",[90,103,112,122],{"facility":91,"status":53,"city":92,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":53},"Arizona State University","Tempe","Arizona","85281","United States","US",{"type":98,"coordinates":99},"Point",[100,101],-111.90931,33.41477,{"lat":101,"lon":100},{"facility":5,"status":53,"city":104,"state":105,"zip":106,"country":95,"countryCode":96,"cosmosGeoPoint":107,"geoPoint":111,"contacts":53},"San Diego","California","92106",{"type":98,"coordinates":108},[109,110],-117.16472,32.71571,{"lat":110,"lon":109},{"facility":113,"status":53,"city":114,"state":115,"zip":116,"country":95,"countryCode":96,"cosmosGeoPoint":117,"geoPoint":121,"contacts":53},"Georgia State University","Atlanta","Georgia","30303",{"type":98,"coordinates":118},[119,120],-84.38798,33.749,{"lat":120,"lon":119},{"facility":123,"status":53,"city":124,"state":125,"zip":126,"country":95,"countryCode":96,"cosmosGeoPoint":127,"geoPoint":131,"contacts":53},"Rhode Island Hospital","Providence","Rhode Island","02903",{"type":98,"coordinates":128},[129,130],-71.41283,41.82399,{"lat":130,"lon":129},{"type":83,"investigatorFullName":133,"investigatorTitle":134,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Kristen Walter","Clinical Research Psychologist",[136,138,139,140],{"name":113,"class":137},"OTHER",{"name":91,"class":137},{"name":123,"class":137},{"name":141,"class":142},"Leidos","UNKNOWN","100658932","phase-1-positive-change-for-sailors-100658932",false,"NCT07858305","Positive Change for Sailors","Evaluating Positive Change for Sailors: A Web-based Sexual Assault Prevention Program","+Change Sailor","Inclusion Criteria:\n\n* Active duty\n* Navy service branch\n* Enlisted rank\n* Ages 18-24\n\nExclusion Criteria:\n\n* Not active duty\n* Serving in a military branch other than the Navy\n* Not of enlisted rank (e.g., Commissioned officer, Warrant officer)\n* Under 18 years of age\n* Over 24 years of age",true,"ALL","18 Years","24 Years",{"count":156,"type":157},120,"ESTIMATED","INTERVENTIONAL",[160],"PHASE1","Alcohol use and sexual violence are significant public health issues affecting military personnel. This study includes a pilot randomized control trial of Positive Change© for Sailors, an integrated alcohol and sexual assault prevention program tailored to U.S. Navy personnel. Active duty Sailors aged 18-24 will be randomized to receive Positive Change© for Sailors or an assessment-only control condition. Analyses will be conducted to assess feasibility and examine preliminary differences in behavior, perceived norms, and related attitudes immediately following the program and at a three month follow-up assessment.",[163,164],"Alcohol Misuse","Sexual Assault","NOT_YET_RECRUITING","2026-09-29",{"date":168,"type":169},"2026-10-05","ACTUAL",{"date":171,"type":157},"2026-10",{"date":173,"type":157},"2027-06",{"name":5,"class":6},4]