Trauma-Informed Care for Smoking Cessation for Pregnancy

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT07129590
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

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

Study Details

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.

Key Dates

Start date
Nov 19, 2025
Status verified
Apr 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Aim 1: Development, Pilot Group
    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.

Primary Outcome Measure

Number of themes (Aim 1) [ Time Frame: Up to 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94115
Gaby Luna-Victoria
[email protected]
[email protected]
877-827-3222
Anita Hargrave-Bouagnon, MD, MAS (PRINCIPAL_INVESTIGATOR)

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