[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467217":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":33,"locations":41,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":18,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Rhode Island","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Native HEALTH Condition","EXPERIMENTAL","Participants randomized to the Native HEALTH condition will complete the Native HEALTH intervention. This is a newly developed cultural program designed to reduce harm from alcohol use and improve quality of life among people in Kingsclear First Nation.",[13],"Behavioral: Native HEALTH",{"label":15,"type":16,"description":17,"interventionNames":18},"Wait-List Control","NO_INTERVENTION","Participants randomized to the wait-list control group will complete the Native HEALTH intervention after two months.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Native HEALTH","This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.",[9],[26],"To be named based on community feedback",[28,31],{"name":29,"affiliation":5,"role":30},"Nichea S Spillane, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":32,"affiliation":5,"role":30},"Nicole H Weiss, Ph.D.",[34,38],{"name":29,"role":35,"phone":36,"phoneExt":18,"email":37},"CONTACT","4018744252","nspillane@uri.edu",{"name":32,"role":35,"phone":39,"phoneExt":18,"email":40},"4012775492","nicole_weiss@uri.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Kingsclear First Nation","RECRUITING","Fredericton","New Brunswick","E3E 1K3","Canada","CA",{"type":51,"coordinates":52},"Point",[53,54],-66.66558,45.94541,{"lat":54,"lon":53},[57],{"name":58,"role":35,"phone":59,"phoneExt":18,"email":60},"Nichea Spillane, PhD","8593219918","nspillane@asu.edu",{"type":62,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[64],{"name":65,"class":66},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100467217","development-of-a-culturally-grounded-trauma-informed-alcohol-intervention-with-a-reserve-dwelling-first-nation-group-100467217",false,"NCT05363878","Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group","NativeHEALTH","Inclusion Criteria:\n\n* At least 18 years of age\n* Used alcohol in the past week\n* Self-identify as a First Nation member\n* Reside within the partner community\n* Want to cut down or stop alcohol use\n\nExclusion Criteria:\n\n* Experiencing current psychotic symptoms\n* High scores (\\>10) on the Clinical Institute Withdrawal Assessment for Alcohol, Revised","ALL","18 Years","90 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"NA","The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention. The specific aims are to (1) use Community-Based Participatory Research methods to deepen partnerships with First Nation through capacity-building and knowledge sharing; (2) collect and apply qualitative data to develop a culturally grounded, trauma-informed alcohol intervention that is focused on historical trauma for use with a First Nation sample; and (3) conduct a pilot RCT study to examine acceptability, sustainability, and initial efficacy data of the intervention compared to waitlist control. This work is important, timely, and innovative. Addressing alcohol use has important implications for the health of Indigenous populations.",[85,86,87],"Alcohol Drinking","Trauma, Psychological","Historical Trauma","2025-04-21",{"date":90,"type":91},"2025-04-24","ACTUAL",{"date":93,"type":91},"2025-01-13",{"date":95,"type":79},"2025-09-29",{"name":5,"class":6},1]