Trauma-informed smoking cessation support during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers partnered with Breathe California and a San Francisco public safety-net clinic to design a smoking cessation approach tailored for pregnant women with trauma histories. In Aim 1 they are interviewing pregnant patients and clinic clinicians using the Behavior Change Wheel to identify barriers and targets for change. Input from Aim 1 will be used to adapt the evidence-based 5As tobacco cessation approach by embedding the trauma-informed 4Rs, producing the RISE Pregnancy intervention. Subsequent aims will pilot the adapted intervention and measure feasibility and acceptability before broader testing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Clinician Eligibility Criteria (Aims 1 - 3):

In Aims 1-3, will be recruiting clinicians working in our clinic sites.

1. 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.
2. Age ≥ 18 years old.

Patient-participant Eligibility Criteria (Aim 1):

In Aim 1, will be recruiting pregnant women (ages 18+) who:

1. Currently smoking or report having smoked during a previous pregnancy
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 will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.

Inclusion criteria:

1. Current or former patient in the participating clinical sites.
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 who are actively smoking and have histories of trauma (ages 18+).

Inclusion criteria:

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:

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.

Where it's running

• Zuckerberg San Francisco General Hospital
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Anita Hargrave-Bouagnon, MD, MAS — University of California, San Francisco
• Study coordinator: Gaby Luna-Victoria, MD, MAS
• Email: gaby.lunavictoria@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.