Trauma-Informed Care for Smoking Cessation for Pregnancy

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07129590
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Study Objectives:

Aim 1: Assess barriers to successful maternal tobacco cessation for women with trauma and identify targets for intervention through interviewing pregnant women with trauma and clinicians in the safety-net using the Behavior Change Wheel (BCW), a validated implementation science behavior change framework.

Aim 2: Evaluate and adapt an evidence-based tobacco cessation intervention using the for pregnant women by incorporating trauma-informed approaches (the 4Rs) with the established 5As. Input will lead to the effective adaptation and creation of the final TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE) Pregnancy intervention to be tested in Aim 3.

Aim 3: Determine the feasibility and acceptability of the RISE Pregnancy intervention and protocol.

OUTLINE:

This study is currently enrolling for Aim 1 only.

Aim 1: Pregnant women in the safety-net who smoke and have histories of trauma, and clinicians will be interviewed using the BCW to assess barriers to smoking cessation and inform design of a smoking cessation intervention which will be used to inform the design of a smoking cessation intervention (RISE Pregnancy) for evaluation in Aim 2.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-09-01
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Clinician Eligibility Criteria (Aims 1 - 3):

In Aim 1-3, will be recruiting clinicians working in the Obstetrics, Midwifery, and Gynecology Clinic (5M) safety-net clinic.

1. Nurse practitioner, physician assistant, nurse-midwife, or medical doctor caring for pregnant patient-participants.
2. Age ≥ 18 years old.

Patient-participant Eligibility Criteria (Aims 1 & 3):

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. Age ≥18 years old.
3. Currently Pregnant.
4. Identifies as a cisgender woman, or female at birth.
5. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ).
6. Proficient in English or Spanish languages.

Patient-Participant Eligibility Criteria (Aims 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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of themes (Aim 1)	Up to 6 months	Themes related to how to improve smoking cessation for pregnant people will be identified through in-depth interviews.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States