TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of themes (Aim 1)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Clinician Eligibility Criteria (Aims 1 - 3):
- •In Aims 1-3, will be recruiting clinicians working in our clinic sites.
- •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.
- •Age ≥ 18 years old.
- •Patient-participant Eligibility Criteria (Aim 1):
- •In Aim 1, will be recruiting pregnant women (ages 18+) who:
- •Currently smoking or report having smoked during a previous pregnancy
- •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 will be recruited to give feedback on our intervention using Evidence-Based Quality Improvement (EBQI) meetings.
- •Inclusion criteria:
- •Current or former patient in the participating clinical sites.
- •Age ≥18 years old.
- •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:
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Expired carbon monoxide (CO) (Other)
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.
干预措施: Interviews (Other)
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.
干预措施: Questionnaires (Other)
结局指标
主要结局
Number of themes (Aim 1)
时间窗: Up to 6 months
Themes related to how to improve smoking cessation for pregnant people will be identified through in-depth interviews.
次要结局
未报告次要终点