RECRUITING Not applicable ClinicalTrials.gov

Trauma-Informed Care for Smoking Cessation for Pregnancy

Sponsor: University of California, San Francisco • ClinicalTrials.gov ID: NCT07129590

Registry updated: 2026-09-10

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Description

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.

Interventions

Expired carbon monoxide (CO) (Other)
Expired CO will be measured using a non-investigational device
Interviews (Other)
Participants will be interviewed via video conference or in person
Questionnaires (Other)
Participants will receive questionnaires to complete through the course of the study

Eligibility criteria

Inclusion Criteria: Clinician Eligibility Criteria (Aims 1 - 3): In Aims 1-3, will be recruiting clinicians working in our clinic sites. 1. 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. 2. Age ≥ 18 years old. Patient-participant Eligibility Criteria (Aim 1): In Aim 1, will be recruiting pregnant women (ages 18+) who: 1. Currently smoking or report having smoked during a previous pregnancy 2. Age ≥18 years old. 3. Currently Pregnant. 4. Identifies as a cisgender woman, or female at birth. 5. Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure. 6. Proficient in English or Spanish languages. Patient-Participant Eligibility Criteria (Aim 2): Patient-participants will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings. Inclusion criteria: 1. Current or former patient in the participating clinical sites. 2. Age ≥18 years old. 3. Proficient in English or Spanish languages. Patient-Participant Eligibility Criteria (Aim 3): In Aim 3, will be recruiting pregnant women who are actively smoking and have histories of trauma (ages 18+). Inclusion criteria: 1. 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) 2. ≥18 years old 3. Currently Pregnant 4. Identifies as a cisgender women, or female at birth 5. Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ) 6. English or Spanish Proficient Exclusion Criteria: Clinician- and Patient-participant Exclusion criteria (Aims 1 - 3): 1\. 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.

Conditions

Smoking Cessation Tobacco Smoking Tobacco Use Cessation Smoking Reduction Smoking, Cigarette Trauma, Psychological Trauma and Stressor Related Disorders

Locations

Zuckerberg San Francisco General Hospital — San Francisco, California, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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