Smoking Cessation, Tobacco Smoking, Tobacco Use Cessation, Smoking Reduction, Smoking, Cigarette, Trauma, Psychological, Trauma and Stressor Related Disorders
Conditions
Keywords
Pregnancy
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.
Interventions
Expired CO will be measured using a non-investigational device
OTHERInterviews
Participants will be interviewed via video conference or in person
OTHERQuestionnaires
Participants will receive questionnaires to complete through the course of the study
Sponsors
University of California, San Francisco
Tobacco Related Disease Research Program
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTGaby Luna-Victoria, MD, MAS
CONTACTAnita Hargrave-Bouagnon
PRINCIPAL_INVESTIGATORAnita Hargrave-Bouagnon, MD, MAS
University of California, San Francisco
Outcome results
None listed