Development of a Culturally Grounded, Trauma-Informed Alcohol Intervention With a Reserve-Dwelling First Nation Group

NCT ID: NCT05363878

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2025-09-29

Brief Summary

The objective of this project is to develop and obtain preliminary data on a culturally grounded, trauma-informed alcohol intervention. The specific aims are to (1) use Community-Based Participatory Research methods to deepen partnerships with First Nation through capacity-building and knowledge sharing; (2) collect and apply qualitative data to develop a culturally grounded, trauma-informed alcohol intervention that is focused on historical trauma for use with a First Nation sample; and (3) conduct a pilot RCT study to examine acceptability, sustainability, and initial efficacy data of the intervention compared to waitlist control. This work is important, timely, and innovative. Addressing alcohol use has important implications for the health of Indigenous populations.

Detailed Description

Using a Community-Based Participatory Research (CBPR) approach, the investigators will work with community partners to develop a culturally grounded, trauma-informed alcohol intervention. The investigators will collaborate with community partners to design, implement, and evaluate this intervention program. A strength of this approach is that in using existing structures, settings, and resources, this intervention will be able to be more easily sustained over time. This work will occur in two stages. Stage 1a, will occur in two phases; first, talking circles will be used to develop the intervention/manual. In this stage, the investigators will explore their place in the community, identifying important stakeholders, recognizing strengths and resources at the local level, pinpointing settings in the community where research and intervention can potentially or already is taking place, and developing a strong communication and collaboration plan that involves community members and researchers to allow for an exchange of knowledge that is bi-directional. Talking circles will identify Indigenous knowledge and practices related to historical trauma and alcohol use. Benchmark: The end of this first phase will yield a manual. Results from the talking circle will provide important knowledge on the targets, techniques, and mechanisms of change for the intervention, as well as the structure of the intervention, including number and length of sessions, treatment setting, and format (group or individual). Second, the investigators will conduct an open pilot trail that will provide information on the manual, delivery of the intervention, and acceptability of participants. Community members (n = 5) will be recruited to go through the intervention and provide qualitative feedback after each session that will be used to further refine intervention components. Benchmark: Open pilot participants will help further refine the manual for delivery in the randomized pilot trial. During Stage 1b (pilot randomized trial), the investigators will test the feasibility, acceptability, and potential efficacy of the program in a randomized, 2-group pilot clinical trial. Participants (N=60) will be randomized to either a wait-list-control (WLC) group (n=30) or to the culturally grounded, trauma-informed alcohol intervention (n=30). Alcohol outcomes will be assessed at baseline, completion, and 3 and 6 months post-completion. The investigators will evaluate whether the program shows promise relative to the WLC group in terms of alcohol consumption, historical losses and response, well-being, and community connectedness. Benchmarks: Major intermediate objectives are: 1) adequate recruitment volume, 2) achievement of targeted enrollment goals, and 3) follow-up rates >= 85% in Stage 1b pilot trial. In the unlikely scenario that recruitment lags, the investigators will first increase field efforts at flyering and following up recruitment letters. If recruitment continues to lag, the investigators have existing relationships with other Indigenous communities in the nearby area that share the same cultural heritage and language. If follow-up rates lag, telephone follow-ups will be intensified and follow-up incentives will be increased as allowed by budgetary constraints. The investigators will also consider truncating 6-month follow-ups to include only those items necessary for alcohol use.

Conditions

Alcohol Drinking; Trauma, Psychological; Historical Trauma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Native HEALTH Condition

Participants randomized to the Native HEALTH condition will complete the Native HEALTH intervention. This is a newly developed cultural program designed to reduce harm from alcohol use and improve quality of life among people in Kingsclear First Nation.

Group Type: EXPERIMENTAL

Native HEALTH

Intervention Type: BEHAVIORAL

This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.

Wait-List Control

Participants randomized to the wait-list control group will complete the Native HEALTH intervention after two months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Native HEALTH

This application proposes the development and initial test of a culturally grounded, trauma informed intervention for alcohol use.

Intervention Type: BEHAVIORAL

Other Intervention Names

To be named based on community feedback

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age
• Used alcohol in the past week
• Self-identify as a First Nation member
• Reside within the partner community
• Want to cut down or stop alcohol use

Exclusion Criteria

• Experiencing current psychotic symptoms
• High scores (>10) on the Clinical Institute Withdrawal Assessment for Alcohol, Revised

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nichea S Spillane, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Nicole H Weiss, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rhode Island

Locations

Kingsclear First Nation

Fredericton, New Brunswick, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Nichea S Spillane, Ph.D.

Role: CONTACT

nspillane@uri.edu

4018744252

Nicole H Weiss, Ph.D.

Role: CONTACT

nicole_weiss@uri.edu

4012775492

Facility Contacts

Nichea Spillane, PhD

Role: primary

nspillane@asu.edu

8593219918

Other Identifiers

R34AA028587

Identifier Type: NIH

Identifier Source: secondary_id

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R34AA028587

Identifier Type: NIH

Identifier Source: org_study_id

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