20 Participants Needed

Trauma-Informed Care for Quitting Smoking During Pregnancy

GL
AH
AH
Overseen ByAnita Hargrave-Bouagnon, MD, MAS
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women quit smoking using a trauma-informed care approach. The researchers seek to determine if understanding and addressing past trauma can facilitate smoking cessation. The trial collaborates with healthcare professionals to develop and test a program that combines trauma-informed care (a supportive therapy approach) with an existing smoking cessation method. Women who are currently pregnant, have experienced trauma, and still smoke might be suitable candidates for this trial. Participants should be comfortable speaking English or Spanish.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance support for pregnant women trying to quit smoking.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this trauma-informed care approach is safe for pregnant women?

Previous studies have shown that trauma-informed care aids recovery from substance use disorders. This approach emphasizes understanding trauma and supporting recovery compassionately. Although specific safety data for trauma-informed care is lacking, it focuses on emotional and psychological support rather than medications or medical procedures, thus avoiding the risks associated with drug treatments.

The studies report no major negative effects linked to trauma-informed care itself, suggesting it is well-tolerated. It builds on existing practices like the 5As for quitting smoking, which are standard and safe methods used by healthcare providers. Given its nature, this type of care is likely safe for pregnant women seeking to quit smoking.12345

Why are researchers excited about this trial?

Researchers are excited about trauma-informed care for quitting smoking during pregnancy because it offers a personalized approach that considers the emotional and psychological aspects of trauma. Unlike traditional smoking cessation methods, which often focus solely on behavioral changes or nicotine replacement therapies, trauma-informed care addresses the underlying trauma that may contribute to smoking habits. This approach fosters a supportive environment where pregnant individuals can better understand and manage their triggers, potentially leading to more effective and lasting results. By integrating trauma awareness into the care process, this method aims to empower individuals with greater self-awareness and coping strategies, which could significantly improve smoking cessation success rates during pregnancy.

What evidence suggests that trauma-informed care is effective for quitting smoking during pregnancy?

Studies have shown that trauma-informed care can aid recovery from substance use problems, such as smoking. This approach involves understanding how trauma affects individuals, recognizing its signs, and applying this knowledge in treatment. Research has also demonstrated that the 5As method—asking, advising, assessing, assisting, and arranging support—significantly helps pregnant women quit smoking. This trial will explore combining trauma-informed care with the 5As, which could be particularly beneficial for pregnant women with past trauma who wish to stop smoking. This combination has shown promise in helping them quit during pregnancy.24678

Who Is on the Research Team?

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Anita Hargrave-Bouagnon, MD, MAS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for pregnant women who smoke and have experienced trauma. It aims to help them quit smoking using a trauma-informed approach. Participants should be from racial and ethnic minoritized groups, primarily served by a public safety-net clinic in San Francisco.

Inclusion Criteria

I am a healthcare provider (NP, PA, nurse-midwife, MD) for pregnant patients.
I am 18 years old or older.
I am 18 years old or older.
See 9 more

Exclusion Criteria

I am mentally capable of understanding and consenting to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Development and Pilot

Clinician- and patient-participants will participate in a 60-minute in-depth, semi-structured interview to assess barriers to smoking cessation and inform the design of the RISE Pregnancy intervention.

Up to 6 months
1 visit (in-person or virtual)

Follow-up

Participants are monitored for feedback and effectiveness of the intervention design.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Trauma-Informed Care
Trial Overview The study tests a smoking cessation intervention combining the '4Rs' (realizing, recognizing, responding, resisting re-traumatization) with the '5As' (ask, advise, assess, assist, arrange) guideline for tobacco treatment. It includes measuring expired carbon monoxide levels and gathering data through questionnaires and interviews.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Aim 1: Development, Pilot GroupExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials
27
Recruited
26,300+

Citations

Trauma-Informed Care for Smoking Cessation for PregnancyTrauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) ...
Effectiveness of smoking cessation interventions in ...Five studies indicated that the intervention significantly reduced tobacco use in pregnancy. These interventions included the 5As intervention, psycho- ...
Trauma-Informed Care for Smoking Cessation for PregnancyTrauma-informed approaches have been shown to support recovery from other substance use disorders and involve four key elements: (1) ...
A Systematic Review and Meta-Analysis of Pregnancy ...Pregnant women respond well to cognitive-behavioral counseling and financial incentives for quitting smoking, which improve pregnancy outcomes like birth ...
Maternal Smoking During Pregnancy and Adverse ...Less than half of the mothers in vulnerable groups, such as women in low socioeconomic conditions, manage to successfully quit during pregnancy ...
Smoking cessation in pregnancy: An update for maternity ...This paper provides an up-to-date summary of the effects of smoking in pregnancy as well as challenges and best practices for supporting smoking cessation ...
Tailored Intervention for Smoking Reduction and Cessation ...Publicly available data suggest that the rate of smoking during pregnancy among women ages 25 to 44 years decreased from 17.7% in 2001 to 4.8% in 2012 (Health ...
Trauma-Informed Care for Quitting Smoking During ...This trial is for pregnant women who smoke and have experienced trauma. It aims to help them quit smoking using a trauma-informed approach. Participants should ...
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