About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
American Indian woman from the Northern Plains
Live in Rapid City, SD or surrounding area
Willing to quit smoking during study participation
18 years of age or older
Disqualifiers
Inability to give consent and/or adequately complete questionnaires due to cognitive impairment.
Self-reported pregnancy or intention to become pregnant during the intervention period
Trial design
Single group
Treatments tested in this trial
Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence
BehavioralA culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.
Treatment groups
Trial outcomes
Primary outcomes
Trauma-Informed Practice Scales (TIPS)
Participants perception of cultural responsiveness of the intervention will be assessed using the 8-item Cultural Responsiveness and Inclusivity subscales of the TIPS as an index of intervention acceptability/likability. Items are rated on a 0-3 Likert scale, and mean scores are computed. Scores range from 0-3, with higher scores representing receipt of more trauma-informed, culturally responsive services.
Session Rating Scale (SRS)
Participant ratings of working alliance will be assessed using the SRS as an index of intervention acceptability/likability. The SRS is a 4-item visual analog instrument. Each item is assessed using a 0-10 point scale. A total score is computed by summing each item. Scores will range from 0-60, with an overall score of 36, or 9 on any item, indicating potential concerns in working alliance.
Group Attitude Scale (GAS)
Group cohesion will be assessed using a modified version of the GAS an an index of intervention acceptability/likability. The 20 items are rated on a 1-5 Likert scale. A total score is computed by averaging the items. Scores range from 1-5, with higher scores indicating more group cohesion.
Secondary outcomes
Biochemical verification of smoking status
Expired breath carbon monoxide will be measured using a carbon monoxide breath monitor. Carbon monoxide readings greater than 3ppm are indicative of smoking.
Biochemical verification of smoking status
Expired breath carbon monoxide will be measured using a carbon monoxide breath monitor. Carbon monoxide readings greater than 3ppm are indicative of smoking.
Biochemical verification of smoking status
Expired breath carbon monoxide will be measured using a carbon monoxide breath monitor. Carbon monoxide readings greater than 3ppm are indicative of smoking.
Quit Attempts
Lifetime quit attempts of at least 24 hours will be assessed by self-report.
Other outcomes
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is a 10-item self-report instrument designed to identify individuals for whom the use of alcohol places them at risk for alcohol problems or who are experiencing such problems. The AUDIT items ask about the past year, although a few items have no specific time reference. AUDIT total scores can range from 0 to 40 with higher scores indicating worse outcomes, and scores of 8 or above have been used to identify individuals who may be at risk for or who are experiencing alcohol problems. Considerable empirical evidence supports the instrument's internal consistency.
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is a 10-item self-report instrument designed to identify individuals for whom the use of alcohol places them at risk for alcohol problems or who are experiencing such problems. The AUDIT items ask about the past year, although a few items have no specific time reference. AUDIT total scores can range from 0 to 40 with higher scores indicating worse outcomes, and scores of 8 or above have been used to identify individuals who may be at risk for or who are experiencing alcohol problems. Considerable empirical evidence supports the instrument's internal consistency.
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is a 10-item self-report instrument designed to identify individuals for whom the use of alcohol places them at risk for alcohol problems or who are experiencing such problems. The AUDIT items ask about the past year, although a few items have no specific time reference. AUDIT total scores can range from 0 to 40 with higher scores indicating worse outcomes, and scores of 8 or above have been used to identify individuals who may be at risk for or who are experiencing alcohol problems. Considerable empirical evidence supports the instrument's internal consistency.
NIDA ASSIST
The NIDA ASSIST is a validated screening tool recommended to assess level of risk related to substance use.
Sponsors and contacts
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Black Hills Center for American Indian Health
Lead sponsor
Yale University
Collaborator