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Behavioral Intervention

Smoking Cessation for American Indian Women

N/A

Recruiting

Research Sponsored by Black Hills Center for American Indian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Indian woman from the Northern Plains

Willing to quit smoking during study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-months post treatment completion

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to develop and test a smoking cessation program specifically designed for American Indian women who have experienced intimate partner violence. The study will involve refining intervention materials, testing the intervention's feasibility and effectiveness,

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention focuses on behavioral support rather than medication, typical medical side effects aren't expected. However, participants may experience stress or emotional discomfort when discussing IPV or while trying to quit smoking.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an American Indian woman from the Northern Plains.

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I am willing to stop smoking for the study.

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I am 18 years old or older.

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I have experienced physical or emotional abuse in the last three months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-months post treatment completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-months post treatment completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post treatment completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Group Attitude Scale (GAS)

Session Rating Scale (SRS)

Trauma-Informed Practice Scales (TIPS)

Secondary study objectives

Biochemical verification of smoking status

Quit Attempts

Other study objectives

Alcohol Use Disorders Identification Test (AUDIT)

NIDA ASSIST

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met