Trauma-Informed Care for Smoking Cessation for Pregnancy

University of California, San Francisco20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Trauma-Informed Care for Smoking Cessation for Pregnancy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts