Smoking Cessation for American Indian Women
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Black Hills Center for American Indian Health
Disqualifiers: Cognitive impairment, Pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this project is to refine and test a culturally-tailored smoking cessation intervention for American Indian women who have experienced intimate partner violence (IPV). The primary aims of this study are to: (a) use a community-based participatory approach to refine intervention materials and finalize pilot intervention methodology for a culturally tailored, trauma-informed smoking cessation intervention for AI women who have experienced IPV; (b) examine feasibility, acceptability, satisfaction, and preliminary efficacy of the intervention; and (c) explore changes in alcohol and drug use over the course of the intervention.
Participants will be asked to participate in the 8-week Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence, and complete interviews at baseline, end-of-treatment, and three months from the end of treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Healing Within for smoking cessation among American Indian women?
The All Nations Breath of Life program, which uses community-based support and motivational interviewing, shows promise with a 65% quit rate at program completion and 25% at six months, suggesting that culturally tailored, trauma-informed approaches can be effective for American Indian populations.
12345Is the smoking cessation treatment for American Indian women safe?
The research does not provide specific safety data for the smoking cessation treatment for American Indian women, but it emphasizes the importance of culturally tailored, trauma-informed approaches, which are generally considered safe and supportive for participants.
24678How is the Healing Within treatment for smoking cessation unique for American Indian women experiencing intimate partner violence?
The Healing Within treatment is unique because it is a trauma-informed smoking cessation intervention specifically designed for American Indian women experiencing intimate partner violence, addressing both cultural and trauma-related factors that are often overlooked in standard smoking cessation programs.
125910Eligibility Criteria
This trial is for American Indian women from the Northern Plains who smoke at least five cigarettes daily, have faced intimate partner violence recently, live around Rapid City, SD, are willing to quit smoking during the study and are 18 or older.Inclusion Criteria
I live in or near Rapid City, SD.
I am an American Indian woman from the Northern Plains.
I smoke at least five cigarettes daily.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage in an 8-week culturally-tailored, trauma-informed smoking cessation intervention
8 weeks
Weekly sessions
Follow-up
Participants are monitored for smoking cessation success and changes in alcohol and drug use
3 months
Interviews at end-of-treatment and 3 months post-treatment
Participant Groups
The study tests 'Healing Within,' a program tailored for these women to help them stop smoking. It involves an 8-week course with interviews before starting, after finishing, and three months later to check its effectiveness and impact on alcohol/drug use.
1Treatment groups
Experimental Treatment
Group I: Healing WithinExperimental Treatment1 Intervention
A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.
Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence is already approved in United States for the following indications:
🇺🇸 Approved in United States as Healing Within for:
- Smoking cessation for American Indian women experiencing intimate partner violence
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Black Hills Center for American Indian HealthRapid City, SD
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Who Is Running the Clinical Trial?
Black Hills Center for American Indian HealthLead Sponsor
Yale UniversityCollaborator
References
Characteristics of American Indian women cigarette smokers: prevalence and cessation status. [2017]A high rate of cigarette smoking is documented among the American Indian population in California, but data on Indian women smokers have not been widely studied. This paper reports on a survey conducted in a smoking cessation project implemented and evaluated as part of a National Cancer Institute (NCI) cooperative agreement. Characteristics of Indian women smokers are presented and cessation status is examined. The overall goal of the project was to increase long-term smoking cessation among American Indian populations through a reproducible clinic-based smoking cessation program. To ascertain smoking prevalence and tobacco use patterns, a self-administered survey was completed by 1,369 adult male and female American Indian health clinic users in Northern California. Study results reported several important characteristics of Indian women smokers. Single and divorced participants had a higher smoking rate (40.4% and 42%) than married participants (34.4%); 54.5% of unemployed women smoked; and level of education was strongly associated with smoking status (p = .011). Almost 80% (79.9%) of women former smokers quit using the "cold turkey" method. Fewer than 50% of Indian women smokers reported willingness to quit at the following smoking cessation stages: "immediately" or "ready" (12.4%), "in one month" (10.5%), and "in six months" (25.2%). This points to a need for effective tobacco cessation interventions for American Indians, which will take into consideration Indian women smokers' demographic characteristics, lenient attitudes toward smoking, and smoking behaviors.
A Novel Approach to Transforming Smoking Cessation Practice for Pregnant Aboriginal Women and Girls Living in the Pilbara. [2020]Tobacco smoking during pregnancy contributes to a range of adverse perinatal outcomes; but is a potentially modifiable behavior. In Australia Aboriginal and Torres Strait Islander women face a range of barriers that hinder; rather than support smoking cessation. Few smoking cessation programs consider the broader social determinants of women's lives; the gendered nature of these or the complexities which impinge on behavior change in the presence of social and economic disadvantage and substantial individual and intergenerational trauma. Drawing on the salient gender and trauma-informed literature this paper describes the rationale underpinning formative research which will inform the design of a localized, culturally meaningful smoking cessation program for Aboriginal women living in the Hedland and Western Desert communities of the remote Pilbara region of Western Australia. We contend that a women-centered, trauma-informed approach to smoking cessation has much to offer those seeking to address this critical public health issue.
All Nations Breath of Life: using community-based participatory research to address health disparities in cigarette smoking among American Indians. [2022]Using a community-based participatory research (CBPR) approach, we developed the All Nations Breath of Life smoking cessation program and pilot-tested it in urban and reservation communities. The program combines weekly in-person group support sessions with individual telephone calls using motivational interviewing. All sessions include discussion of sacred tobacco and information about quitting and health. We have assessed the scientific validity, cultural-appropriateness, and readability of our program materials and found them to be adequate; participant satisfaction is high. The program shows promise for improving quit rates among American Indians, who have the highest smoking rates and lowest quit rates of any ethnic group. Our preliminary self-report data show quit rates of 65% at program completion and 25% at six months post-baseline.
"Tobacco has a purpose, not just a past": Feasibility of developing a culturally appropriate smoking cessation program for a pan-tribal native population. [2019]Tobacco has long held spiritual significance to Native people of North America but, because of recreational use, it has become a health risk relatively recently. More Native people smoke than any other ethnic group (41 percent vs. 24 percent in whites and blacks), and death rates caused by tobacco-related diseases are disproportionately high. However, no tested, culturally tailored smoking cessation programs exist for this group. We used a critical-interpretive framework to understand the meaning of tobacco and the feasibility of smoking cessation interventions in a pan-tribal population. In June 2004, the University of Kansas Medical Center (KUMC) and the Oklahoma Area Indian Health Service (IHS) collaborated on six focus groups with (IHS) patients. The patients served represent over 200 different nations. Our participants provided us with modifications to a currently untested program designed by the Muscogee Nation of Oklahoma's Tobacco Prevention Program to enhance cultural appropriateness, including (1) an emphasis on visual presentation and a "Native" look to program educational materials; (2) comprehensive information about tobacco, quitting, and coping among Native people; (3) an acknowledgment and incorporation of traditional tobacco use and its diversity; and (4) the use of talking circles and counseling with Native facilitators.
Culturally-Tailored Smoking Cessation for Adult American Indian Smokers: A Clinical Trial. [2022]This collaborative, community-engaged project developed and tested a Culturally-Tailored Treatment (CTT) for American Indian/Alaska Native (AI/AN) smokers in the Menominee tribal community. One hundred three adult AI/AN smokers were randomized to receive either Standard Treatment (n= 53) or CTT (n = 50) for smoking cessation. Both treatment conditions included 12 weeks of varenicline and four individual counseling sessions but differed in terms of cultural tailoring of the counseling. The primary outcome was 7-day biochemically-confirmed point-prevalence abstinence (PPA) at the 6-month end-of-study visit. Both intention-to-treat (ITT) and responder-only analyses were conducted. There were no statistically significant group differences in 7-day PPA. The overall ITT abstinence rate at 6 months was 20%; the responder-only rate was 42%. The current study represents the first randomized smoking cessation clinical trial testing a culturally-tailored smoking cessation intervention designed for a specific AI/AN tribal community that combined FDA-approved cessation medication (varenicline) and innovative cultural intervention components.
Indigenous Cultural Safety in Recognizing and Responding to Family Violence: A Systematic Scoping Review. [2023]This systematic scoping review synthesizes the recommended approaches for providing culturally safe family violence interventions to Indigenous peoples in health care and social service settings. A total of 3783 sources were identified through our electronic database searches, hand-searching of Indigenous-focused journals, and backward and forward citation chaining. After screening those sources in duplicate, 28 papers were included for synthesis in June 2020. Forward citation chaining of these 28 included articles in June 2022 identified an additional 304 possible articles for inclusion; following the screening of those 304 articles, an additional 6 were retained in the review. Thus, a total of 34 articles were included for data extraction and narrative synthesis. Initial results were presented to members of the Six Nations of the Grand River Youth Mental Wellness Committee, and their feedback was incorporated into our inductive organization of findings. Our findings represent three thematic areas that reflect key recommendations for health care and social service provision to Indigenous families for whom family violence is a concern: (1) creating the conditions for cultural safety; (2) healing at the individual and community level; and (3) system-level change. These findings demonstrate the need to center Indigenous peoples and perspectives in the development and implementation of cultural safety approaches, to acknowledge and address historically contingent causes of past and present family violence including colonization and related state policies, and to transform knowledge and power relationships at the provider, organization, and government level.
Formative Research and Cultural Tailoring of a Substance Abuse Prevention Program for American Indian Youth: Findings From the Intertribal Talking Circle Intervention. [2022]Background. Substance use among American Indians (AIs) is a critical health issue and accounts for many health problems such as chronic liver disease, cirrhosis, behavioral health conditions, homicide, suicide, and motor vehicle accidents. In 2013, the highest rates of substance use and dependence were seen among AIs when compared to all other population groups, although these rates vary across different tribes. Among AI adolescents, high rates of substance use have been associated with environmental and historical factors, including poverty, historical trauma, bicultural stress, and changing tribal/familial roles. Our project, the Intertribal Talking Circle intervention, involved adapting, tailoring, implementing, and evaluating an existing intervention for AI youth of three tribal communities in the United States. Formative Results. Community partnership committees (CPCs) identified alcohol, marijuana, and prescription medications as high priority substances. CPC concerns focused on the increasing substance use in their communities and the corresponding negative impacts on families, stating a lack of coping skills, positive role models, and hope for the future as concerns for youth. Cultural Tailoring Process Results. Each site formed a CPC that culturally tailored the intervention for their tribal community. This included translating Keetoowah-Cherokee language, cultural practices, and symbolism into the local tribal customs for relevance. The CPCs were essential for incorporating local context and perceived concerns around AI adolescent substance use. These results may be helpful to other tribal communities developing/implementing substance use prevention interventions for AI youth. It is critical that Indigenous cultures and local context be factored into such programs.
Improving Aboriginal Maternal Health by Strengthening Connection to Culture, Family and Community. [2021](1) Background: To explore the function of smoking in Aboriginal women's lives from a trauma-informed, women-centred approach in order to inform the design of a culturally meaningful smoking cessation program for women living in the Pilbara, Western Australia; (2) Methods: Qualitative and Community Based Participatory Action Research (CBPAR) was used to discover what Aboriginal women know about smoking, the specific contextual issues that influence their smoking, and what community supports are available to help them quit smoking. Inductive analysis was used to determine key themes; (3) Results: 25 Aboriginal women (smokers, non-smokers, and ex-smokers) participated in focus groups or individual interviews. Women smoked to deal with stress, trauma and for maintaining social connections. Women who stopped smoking did so on their own when the reason was important enough or when they saw alternative ways of living. Creating safe places to bring women together to yarn about women's business and link with health services was identified as critical to support women to stop smoking. Conclusions: Strategies to address smoking need to bring community, culture and health together in a meaningful way for women and their families; build on existing community strengths; and educate communities about the effects of smoking, and health professionals about how to support women to stop smoking.
Smoking Behaviors Among Indigenous Pregnant People Compared to a Matched Regional Cohort. [2023]Smoking commercial tobacco products is highly prevalent in American Indian and Alaska Native (Indigenous) pregnancies. This disparity directly contributes to maternal and fetal mortality. Our objective was to describe cigarette smoking prevalence, cessation intervention uptake, and cessation behaviors of pregnant Indigenous people compared to sex and age-matched regional cohort.
Application of the PEN-3 Model to Tobacco Initiation, Use, and Cessation Among American Indian and Alaska Native Adults. [2020]American Indian (AI) and Alaska Native (AN) communities confront some of the highest rates of tobacco use and its sequelae. As part of a formative research project investigating stakeholder understandings, preferences, and needs surrounding the use of pharmacogenetics toward tobacco cessation treatment, we sought to characterize sociocultural issues related to tobacco use and cessation. We used the PEN-3 cultural model to frame the research question and analysis of stakeholder interviews with 20 AI/AN patients, 12 health care providers, and 9 tribal leaders. Our study found high knowledge levels of the negative health effects of tobacco use; however, most patient participants ascribed negative health effects only to regular, heavy tobacco use and not to light use, which is more common in the population. The majority of patient participants did not endorse use of tobacco cessation treatment despite evidence of efficacy among AI/AN adults. Health promotion messaging to target low-tobacco consuming AI/AN people is needed. Additionally, messaging to promote tobacco cessation treatment using successful AI/AN former tobacco users to improve community perception of tobacco cessation treatment is recommended.