NCT07129590

Trauma-Informed Care for Smoking Cessation for Pregnancy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking Cessation
• Tobacco Smoking
• Tobacco Use Cessation
• Smoking Reduction
• Smoking, Cigarette
• Trauma, Psychological
• Trauma and Stressor Related Disorders

Interventions

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

Timeline

• Start date: 2025-11-19
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-08-19
• Last updated: 2025-12-15

Locations

1 site across 1 country: United States