RecruitingNot ApplicableNCT07129590

Trauma-Informed Care for Smoking Cessation for Pregnancy

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

Sponsor

University of California, San Francisco

Enrollment

20 participants

Start Date

Nov 19, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria24

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).
Nurse practitioner, physician assistant, nurse-midwife, or medical doctor caring for pregnant patient-participants.
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+)
Currently smoking
Age ≥18 years old.
Currently Pregnant.
Identifies as a cisgender woman, or female at birth.
Reports having experienced trauma aligned with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) definition for traumatic exposure.
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.
Participant in a 5M Clinic Patient Advisory Board.
Age ≥18 years old.
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+).
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)
≥18 years old
Currently Pregnant
Identifies as a cisgender women, or female at birth
Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)
English or Spanish Proficient

Exclusion Criteria1

\. 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.

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