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RECRUITING

NCT07129590

Trauma-Informed Care for Smoking Cessation for Pregnancy

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

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.

Official title: TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-11-19

Completion Date

2026-03-31

Last Updated

2025-12-15

Healthy Volunteers

Yes

Conditions

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

Interventions

OTHER

Expired carbon monoxide (CO)

Expired CO will be measured using a non-investigational device

OTHER

Interviews

Participants will be interviewed via video conference or in person

OTHER

Questionnaires

Participants will receive questionnaires to complete through the course of the study

Inclusion Criteria: Clinician Eligibility Criteria (Aims 1 - 3): In Aims 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-net clinic and the UCSF Community and Clinical Research Center (ZSFG). 1. Nurse practitioner, physician assistant, nurse-midwife, or medical doctor caring for pregnant patient-participants. 2. Age ≥ 18 years old. Patient-participant Eligibility Criteria (Aim 1): In Aim 1, will be recruiting pregnant women receiving care at the 5M safety-net clinic who are actively smoking and have histories of trauma (ages 18+) 1. Currently smoking 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 from the 5M advisory boards will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings. Inclusion criteria: 1. Participant in a 5M Clinic Patient Advisory Board. 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 receiving care at the 5M safety-net clinic 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.

Locations (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States