Overview
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.
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.
Eligibility
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).
- Nurse practitioner, physician assistant, nurse-midwife, or medical doctor caring for pregnant patient-participants.
- 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+)
- Currently smoking
- 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 from the 5M advisory boards will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.
Inclusion criteria:
- Participant in a 5M Clinic Patient Advisory Board.
- Age ≥18 years old.
- 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+).
Inclusion criteria:
- 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)
- ≥18 years old
- Currently Pregnant
- Identifies as a cisgender women, or female at birth
- Meets DSM-5 Criterion A for trauma exposure on the Brief Trauma Questionnaire (BTQ)
- 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.