Trauma-Informed Care for Smoking Cessation for Pregnancy

NCT ID: NCT07129590

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-19
• Study Completion Date: 2026-03-31

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

This study is currently enrolling for Aim 1 only.

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Questionnaires

Intervention Type: OTHER

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

Expired carbon monoxide (CO)

Intervention Type: OTHER

Expired CO will be measured using a non-investigational device

Interviews

Intervention Type: OTHER

Participants will be interviewed via video conference or in person

Interventions

Questionnaires

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

Intervention Type: OTHER

Expired carbon monoxide (CO)

Expired CO will be measured using a non-investigational device

Intervention Type: OTHER

Interviews

Participants will be interviewed via video conference or in person

Intervention Type: OTHER

Other Intervention Names

Exhaled CO; Participant Interviews; Surveys

Eligibility Criteria

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.

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+).

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tobacco Related Disease Research Program

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anita Hargrave-Bouagnon, MD, MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gaby Luna-Victoria, MD, MAS

Role: CONTACT

gaby.lunavictoria@ucsf.edu

877-827-3222

Anita Hargrave-Bouagnon

Role: CONTACT

anita.hargrave@ucsf.edu

Facility Contacts

Gaby Luna-Victoria

Role: primary

gaby.lunavictoria@ucsf.edu

Role: backup

cancertrials@ucsf.edu

877-827-3222

Other Identifiers

NCI-2025-05151

Identifier Type: REGISTRY

Identifier Source: secondary_id

25634

Identifier Type: -

Identifier Source: org_study_id