[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602905":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":70,"collaborators":72,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":44,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":44,"enrollmentInfo":85,"targetDuration":44,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":100,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Aim 1: Development, Pilot Group","EXPERIMENTAL","Both clinician- and patient-participants will participate in a 60-minute in-depth, semi-structured interview conducted either in-person or via secure University of California, San Francisco (UCSF) video-telephone software.",[13,14,15],"Other: Expired carbon monoxide (CO)","Other: Interviews","Other: Questionnaires",[17,23,29],{"type":6,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"Expired carbon monoxide (CO)","Expired CO will be measured using a non-investigational device",[9],[22],"Exhaled CO",{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Interviews","Participants will be interviewed via video conference or in person",[9],[28],"Participant Interviews",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Questionnaires","Participants will receive questionnaires to complete through the course of the study",[9],[34],"Surveys",[36],{"name":37,"affiliation":5,"role":38},"Anita Hargrave-Bouagnon, MD, MAS","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Gaby Luna-Victoria, MD, MAS","CONTACT","877-827-3222",null,"gaby.lunavictoria@ucsf.edu",{"name":47,"role":42,"phone":44,"phoneExt":44,"email":48},"Anita Hargrave-Bouagnon","anita.hargrave@ucsf.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Zuckerberg San Francisco General Hospital","RECRUITING","San Francisco","California","94115","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-122.41942,37.77493,{"lat":62,"lon":61},[65,67,69],{"name":66,"role":42,"phone":44,"phoneExt":44,"email":45},"Gaby Luna-Victoria",{"name":44,"role":42,"phone":43,"phoneExt":44,"email":68},"cancertrials@ucsf.edu",{"name":37,"role":38,"phone":44,"phoneExt":44,"email":44},{"type":71,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[73],{"name":74,"class":6},"Tobacco Related Disease Research Program","100602905","trauma-informed-care-for-smoking-cessation-for-pregnancy-100602905",false,"NCT07129590","Trauma-Informed Care for Smoking Cessation for Pregnancy","TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)","Inclusion Criteria:\n\nClinician Eligibility Criteria (Aims 1 - 3):\n\nIn Aims 1-3, will be recruiting clinicians working in our clinic sites.\n\n1. Nurse practitioner, physician assistant, nurse-midwife, medical doctor, registered nurse, clinical pharmacist, behavioral health professional, social worker, or any other healthcare professional caring for pregnant patient-participants.\n2. Age ≥ 18 years old.\n\nPatient-participant Eligibility Criteria (Aim 1):\n\nIn Aim 1, will be recruiting pregnant women (ages 18+) who:\n\n1. Currently smoking or report having smoked during a previous pregnancy\n2. Age ≥18 years old.\n3. Currently Pregnant.\n4. Identifies as a cisgender woman, or female at birth.\n5. Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.\n6. Proficient in English or Spanish languages.\n\nPatient-Participant Eligibility Criteria (Aim 2):\n\nPatient-participants will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.\n\nInclusion criteria:\n\n1. Current or former patient in the participating clinical sites.\n2. Age ≥18 years old.\n3. Proficient in English or Spanish languages.\n\nPatient-Participant Eligibility Criteria (Aim 3): In Aim 3, will be recruiting pregnant women who are actively smoking and have histories of trauma (ages 18+).\n\nInclusion criteria:\n\n1. Currently smoking (ever smoked 100 cigarettes in their lifetime, smoked in the past 7 days and at least 1 cigarette per day, verified by CO≥6ppm)\n2. ≥18 years old\n3. Currently Pregnant\n4. Identifies as a cisgender women, or female at birth\n5. Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)\n6. English or Spanish Proficient\n\nExclusion Criteria:\n\nClinician- and Patient-participant Exclusion criteria (Aims 1 - 3):\n\n1\\. Any condition, including active mental health crises or cognitive impairment, that would interfere with the ability to provide informed consent or safely complete the study.",true,"FEMALE","18 Years",{"count":86,"type":87},20,"ESTIMATED","INTERVENTIONAL",[90],"NA","Trauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) Realizing the prevalence of trauma and pathways to recovery, (2) Recognizing symptoms of trauma, (3) Responding by embedding knowledge of trauma into practices and policies and (4) Resisting re-traumatization (the 4Rs). In close partnership with Breathe California and a public safety-net clinic in San Francisco that serves primarily racial and ethnic minoritized (REM) pregnant women, the 4Rs along with the Ask, Advise, Assess, Assist and Arrange (the 5As) evidence-based intervention for tobacco cessation that is delivered by health care professionals and is a US Public Health Services clinical practice guideline for treating tobacco will be used to create and implement a smoking cessation intervention for pregnant women with experiences of trauma.",[93,94,95,96,97,98,99],"Smoking Cessation","Tobacco Smoking","Tobacco Use Cessation","Smoking Reduction","Smoking, Cigarette","Trauma, Psychological","Trauma and Stressor Related Disorders",[101],"Pregnancy","2026-04-20",{"date":104,"type":105},"2026-04-23","ACTUAL",{"date":107,"type":105},"2025-11-19",{"date":109,"type":87},"2026-07-31",{"name":5,"class":6},1]