Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

NCT06357767 | Recruiting

• 1 other identifier: S06GM146079
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation; Cigarette Smoking

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to week 8

• 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.

  Up to week 8

• 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.

  Up to week 8

Secondary Outcomes (6)

• Biochemical verification of smoking status

  Baseline

• Biochemical verification of smoking status

  End of treatment (approximately 8 weeks following baseline)

• Biochemical verification of smoking status

  3-months post treatment completion

• Quit Attempts

  Baseline

• Quit Attempts

  End of treatment (approximately 8 weeks following baseline)

Other Outcomes (6)

• Alcohol Use Disorders Identification Test (AUDIT)

  Baseline

• Alcohol Use Disorders Identification Test (AUDIT)

  End of treatment (approximately 8 weeks following baseline)

• Alcohol Use Disorders Identification Test (AUDIT)

  3-months post treatment completion

Study Arms (1)

Healing Within

EXPERIMENTAL

A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.

Behavioral: Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence

Interventions

Healing Within: Smoking Cessation Intervention for American Indian Women Experiencing Intimate Partner Violence BEHAVIORAL

A culturally-tailored, trauma-informed group intervention to support smoking cessation by leveraging Lakota values, mindfulness, and a storytelling approach.

Healing Within

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only participants who self-identify as cisgender women will be included.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Indian woman from the Northern Plains
• Live in Rapid City, SD or surrounding area
• Willing to quit smoking during study participation
• years of age or older
• Smoking at least five cigarettes per day
• Experienced physical and/or psychological IPV in the past three months

You may not qualify if:

• 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

Sponsors & Collaborators

• Black Hills Center for American Indian Health: lead
• Yale University: collaborator

Study Sites (1)

Black Hills Center for American Indian Health

Rapid City, South Dakota, 57701, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Cigarette Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Smoking; Smoking; Tobacco Use

Central Study Contacts

Patricia Nez Henderson, MD

CONTACT

(605) 348-6100; pnhenderson@bhcaih.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: April 10, 2024
• Study Start: August 8, 2024
• Primary Completion: July 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

US (1)