Trauma-Informed Care for Smoking Cessation for Pregnancy

Официальное название

TRauma-Informed Care in Smoking cEssation for Pregnancy (RISE Pregnancy)

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Expired carbon monoxide (CO)
  Expired CO will be measured using a non-investigational device
• Другое Interviews
  Participants will be interviewed via video conference or in person
• Другое Questionnaires
  Participants will receive questionnaires to complete through the course of the study

Первичные конечные точки

• Number of themes (Aim 1) [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

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.

Критерии включения

• 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+).

Критерии включения

• 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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Zuckerberg San Francisco General Hospital — San Francisco

Идентификаторы

NCT: NCT07129590 · 25634 · NCI-2025-05151

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗