Trauma-Informed Care for Smoking Cessation for Pregnancy

NCT07129590 | Recruiting

• 2 other identifiers: 25634NCI-2025-05151
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Number of themes (Aim 1)

  Themes related to how to improve smoking cessation for pregnant people will be identified through in-depth interviews.

  Up to 6 months

Study Arms (1)

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.

Other: Expired carbon monoxide (CO); Other: Interviews; Other: Questionnaires

Interventions

Expired carbon monoxide (CO) OTHER

Expired CO will be measured using a non-investigational device

Also known as: Exhaled CO

Aim 1: Development, Pilot Group

Interviews OTHER

Participants will be interviewed via video conference or in person

Also known as: Participant Interviews

Aim 1: Development, Pilot Group

Questionnaires OTHER

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

Also known as: Surveys

Aim 1: Development, Pilot Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinician Eligibility Criteria (Aims 1 - 3):
• In Aims 1-3, will be recruiting clinicians working in our clinic sites.
• 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.
• Age ≥ 18 years old.
• Patient-participant Eligibility Criteria (Aim 1):
• In Aim 1, will be recruiting pregnant women (ages 18+) who:
• Currently smoking or report having smoked during a previous pregnancy
• 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 will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.
• Current or former patient in the participating clinical sites.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Conditions

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

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use; Stress Disorders, Traumatic; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anita Hargrave-Bouagnon, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaby Luna-Victoria, MD, MAS

CONTACT

877-827-3222; gaby.lunavictoria@ucsf.edu

Anita Hargrave-Bouagnon

CONTACT

anita.hargrave@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 19, 2025
• Study Start: November 19, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)